Concept of Holistic Medicine
Dr. Shriniwas Kashalikar

The concept of holistic medicine emerges as a result of realization of the underlying unity and continuity amongst the apparently different disciplines of medicine. In fact it emerges from the realization of the universal unity and continuity. This is emergence of SATVIKA JNAANA (Geeta 18.20).

It is usual for most of us to get stuck to the differences as they strike our senses; and build our concepts; based on these observations of ours. The knowledge of different disciplines and recognition of their separate existence; as disjointed or disconnected entities; is called RAJASA JNAANA [Geeta 18.21].

Those who either practice mixed or integrated medicine or are not averse to dialogue or advocate it, may fit in this category.

The third variety is ignorance about every other medical discipline and adamant adherence to any given medical discipline alone is state of darkness called TAMASA JNAANA [Geeta 18.22]. Most of the warring factions from different medical disciplines opposing the emergence of holistic medicine can fit in this category.

The word holistic is derived from the Greek word holos which literally means a] Taking in the whole of something b] Whole of organism is a more fruitful field of study than its parts or symptoms.

It can be stated for the sake of simplicity and further clarity that the holistic medicine is
Trans-religious [not religious or not non religious i.e. neither holy nor unholy],
Trans-national [neither national nor non-national/anti-national],
Trans-cultural [neither of a particular culture nor against any particular culture],
Trans-intellectual [neither bound in a particular intellectual framework nor opposed to a particular intellectual framework],
Trans-ideological [neither committed to a particular ideology nor opposed to a particular ideology] and
Trans-scientific [neither unscientific nor locked in rigid criteria of physical sciences]

Study of holistic medicine constitutes efforts to understand, visualize and realize the multi-charactered, multifaceted, multidimensional and multi-layered complex nature of life (in addition to what is learnt in allopathy or what is learnt in any one discipline). The intention of the study is to comprehend the continuity and validity (or otherwise) of the concepts of different disciplines (allopathy, Ayurveda, SAANKHYA philosophy, homeopathy, yoga, Chinese medicine etc.) which emerge and get evolved from different levels of consciousness of differently constituted individuals in different regions with different backgrounds.

The approach of holistic medicine can neither be classified as eclectic, analytical, synthetic or reductionist etc. The holistic approach embodies all these as means to �see� the unity and continuity in different phenomena.

The holistic medicine is therefore not a new system or new discipline of medicine. It is a way to see things as they are rather than how they appear and thereby preserve and promote health and improve effectiveness of healing.

Implications of Holistic Approach
Holistic approach simultaneously makes us aware of possibilities as well as limitations. For example understanding the ayurvedic concepts such as DOSHA, DHATU, MALA, their balance, their imbalance, concept of PRAKRUTI i.e. constitution etc. with holistic approach, add new dimension to the knowledge of the student of physiology as well as to the diagnostic skills of a clinician from the discipline of allopathy.

Understanding of the concepts of panchakarma, naturopathy, yoga etc. with holistic approach makes the treatment also more effective because several different modalities and remedies in the repertoire act at different levels or different points and complementarily.

Besides, holistic understanding of human existence, which is fundamental to the study of holistic medicine gives us insight into the enormous healing powers within the patient and helps us to help him/her to use them beneficially.

This is a great benefit in terms of empowerment of the clinician as well as the patient.

Holistic approach relieves health care providers such as doctors and paramedics and all others; from the unhealthy patronizing and condescending attitude and makes us aware of our limitations, i.e. gives us knowledge of our ignorance! It gives us the courage to see our ignorance and admit it. It imparts intellectual honesty to admit the ignorance hidden under the Greek, Latin, Sanskrit or other esoteric/mystifying terms, characteristic to many branches of science in general and medicine in particular.

(Take for example hysteria. We do not know any physiological mechanisms underlying this condition. But the ignorance is hidden under the term. Another example is that dreams, thoughts , emotions etc. The ignorance about the physical dimensions of dreams, thoughts, emotions etc, even as we can not dispute or disprove their existence; is hidden under several terms)!

Holistic approach reduces hypocrisy and imparts humility.

Some more examples from the disciplines of medicine are as follows. Holistic approach enables us to see the limitations intrinsic to the concept of standardization of weight, height and possible errors in interpretation of biochemical parameters and calculation of regimentalized doses of drugs due to lack of due consideration to variations in the constitutions.

Holistic approach cautions us against indiscriminate use of ayurvedic drugs without due consideration to the variation in the quality, nature, source etc. of the ingredients of the drug as well as the constitution of the patient and the type of climate.

Holistic approach gives us insight into the possible mechanism of the action of homeopathic drugs on the one hand and cautions about the ambiguity in the method of diagnosis arising out of subjective factors related to the doctor as well as the patient, on the other.

Holistic approach reveals to us the possibility of �cosmic homeostasis� on the one hand while simultaneously exposing the possible fallibility intrinsic to bigotry in the practice of gemology, astrology, numerology etc. due to number of different approaches with fundamental differences in the interpretations, without sufficiently convincing reasons.

Beside all above, implication of the holistic approach is readiness to change and accommodate new ideas, i.e. not getting shackled in dogmas of any kind.

But possibly the most important implication is development of proper perspective about the health and healing, which would help in development of proper policies of services, education, research, production in the field of mainstream medical care, education, research and coordination of all these with a variety of policies (influencing the health directly and indirectly) in other fields such as education, industry, environment, agriculture etc.

From practical point of view, syllabus of holistic medicine including Namasmaran, prayers, water therapy, proper food (diet), mud packing, massage, yoga, music, colors, aroma and such simple healing methods (so much recommended by Mahatma Gandhi) and so many health promoting research and service activities can be introduced.

It is this holistic approach, which would help the decision-makers; to realize that the national unity and even freedom (which is essential for global unity) would be in jeopardy in absence of such holistic (unifying) steps.

DR. SHRINIWAS KASHALIKAR

Rationale for the Procedure
A number of reports have described the use of DL in ICU patients. The main argument for the use of DL in ICU patients has been for the diagnosis of suspected intra-abdominal pathology in critically ill patients without the need for transport to the operating room with its potential complications. Furthermore, such an approach allows for the uninterrupted treatment of the ICU patient and may minimize the cost of the intervention.
Technique
Many studies have documented the feasibility of the procedure (levels II, III) [1-10]. The most common reason that the procedure fails is the presence of severe adhesions. Although in the initial reports on DL for ICU patients the procedure was performed in the operating room, most recent studies have applied the procedure exclusively at the bedside. Local anesthesia, sedation, and occasionally paralytics have been used for the procedure at the bedside. Many patients who are breathing spontaneously require intubation before the procedure; however, the procedure has also been applied successfully in nonintubated patients. In most instances, a portable laparoscopic cart, which contains a monitor, video camera, light source, and gas supply, is used. A cut-down technique and the Veress needle technique have been used for initial access without reported untoward events. The periumbilical region is the most used site for initial access; however, concerns about intra-abdominal adhesions may dictate the use of another �virgin� site. Pneumoperitoneum has been kept at lower levels (8-12 mm Hg) by many authors due to concerns of hemodynamic compromise in already compromised patients. Nevertheless, level III evidence exists that 15 mm Hg can be used safely without significant hemodynamic or respiratory compromise with the exception of a well tolerated increase in peak inspiratory pressure. No studies have compared different insufflation pressures in ICU patients. Although most studies have used CO2 for insufflation, the use of N2O has also been described. An angled scope is used at the periumbilical trocar site for inspection of the intra-abdominal organs, including the surface of the liver, gallbladder, stomach, intestine, pelvic organs, and visible retroperitoneal surfaces along with examination of free intraperitoneal fluid. Additional (5-mm) trocars are used at the discretion of the surgeon as needed for exposure and for potential therapeutic intervention. The use of laparoscopic ultrasound has not been described in ICU patients. The duration of the procedure is short, ranging between 10 and 70 minutes, with an average duration of about 30 minutes.
Indications
The main indication for DL in the ICU has been unexplained sepsis, systemic inflammatory response syndrome, and multisystem organ failure. In addition, the procedure has been used for abdominal pain or tenderness associated with other signs of sepsis without an obvious indication for laparotomy (i.e., pneumoperitoneum, massive gastrointestinal bleeding, small bowel obstruction), fever and/or leukocytosis in an obtunded or sedated patient not explained by another identifiable problem (such as pneumonia, line sepsis, or urinary sepsis), metabolic acidosis not explained by another process (such as cardiogenic shock), and increased abdominal distention that is not a consequence of bowel obstruction.
Contraindications (Absolute or Relative)
� Patients unable to tolerate pneumoperitoneum or who are so sick that there is no realistic chance of survival even if a �treatable� intra-abdominal process were found
� Patients with an obvious indication for surgical intervention such as a bowel obstruction or perforated viscus
� Patients with an uncorrectable coagulopathy or uncorrectable hypercapnia >50 torr
� Patients with a tense and distended abdomen (i.e., clinically suspected abdominal compartment syndrome)
� Patients with abdominal wall infection (e.g., cellulitis, soft tissue infection, open wounds)
� Patients with extensive previous abdominal surgery with multiple incisional scars or after a laparotomy within the last 30 days
Risks
� Delay in the diagnosis and treatment of patients if the procedure is false negative
� Missed pathology and its associated complications
� Procedure- and anesthesia-related complications
Benefits
� Expeditious diagnosis of suspected intra-abdominal pathology
� Minimization of treatment interruption by not moving the patient outside the ICU
� Avoid the morbidity of open exploration
� Avoid potential risks associated with transportation to the operating room or radiology for diagnostic tests
� Ability to provide therapeutic intervention
Diagnostic Accuracy of the Procedure
The diagnostic accuracy of the procedure is high, ranging between 90 and 100% in the published series (level II, III) [1-10]. The main limitation of the procedure is for the evaluation of retroperitoneal structures with the few false negative reported findings attributed to retroperitoneal processes like pancreatitis [4,9]. Nevertheless, the procedure appears to have excellent accuracy when evaluating for two of the most prevalent diseases in this population, acalculous cholecystitis and ischemic bowel (level II, III) [4,5,7,10]. The procedure has been reported to prevent unnecessary laparotomies in 36-95% of patients (level III) [1,2,5,6]. Its sensitivity has also been demonstrated in patients with suspected abdominal complications after cardiac surgery [4,9].
Diagnostic laparoscopy has been compared with diagnostic peritoneal lavage and found to have superior diagnostic accuracy in critically ill patients (level II) [5]. It has also been found to be superior to computed tomography (CT) or ultrasound of the abdomen (level III) [3,6,7,10].
Procedure-related Complications and Patient Outcomes
The procedure can be performed safely, is well tolerated in ICU patients (level II) [5], and only a few minor complications have been described (bradycardia and increased peak airway pressure that resolved after release of pneumoperitoneum and perforation of a gangrenous gallbladder during manipulation). Overall morbidity has been reported between 0 and 8%, and no mortality directly associated with the procedure has been described [1-10]. Nevertheless, the ICU patient population has very high mortality rates (33-79%) regardless of the findings of DL.
Cost-effectiveness
While it has been implied that DL in the ICU rather than the operating room can yield substantial cost savings, no direct evidence exists.
Limitations of the Available Literature
A few single-center studies of limited quality, which include small patient cohorts, address the role of DL in the ICU population making generalizations difficult and allowing institutional and personal biases to be introduced into the results. There is also a lack of uniformity and detail in the reported selection criteria and noninvasive imaging prior to the procedure. These limitations of the available literature and the high mortality rates of this patient population make it difficult to draw firm conclusions about the impact of the procedure on patient outcomes and its cost-effectiveness. Furthermore, the impact of the surgeon�s laparoscopic expertise on the diagnostic accuracy of the procedure is unknown.
Recommendations
Diagnostic laparoscopy is technically feasible and can be applied safely in appropriated selected ICU patients (grade B). The procedure should be used in critically ill patients when an intra-abdominal catastrophe is suspected but cannot be ruled out by noninvasive means and would otherwise require an exploratory laparotomy (grade C). It should be given strong consideration in ICU patients with suspected acalculous cholecystitis or ischemic bowel, as its accuracy likely exceeds that of noninvasive studies (grade C). On the other hand, it should be kept in mind that the procedure is unlikely to identify retroperitoneal processes. The decision to undertake DL and at which location (bedside or operating room) should be individualized and should be based on the available resources and laparoscopic expertise of the surgeon.
Bibliography
1. Gagne, D. J., Malay, M. B., Hogle, N. J., and Fowler, D. L. Bedside Diagnostic Minilaparoscopy in the Intensive Care Patient. Surgery 2002;131(5):491-6.
2. Pecoraro, A. P., Cacchione, R. N., Sayad, P., Williams, M. E., and Ferzli, G. S. The Routine Use of Diagnostic Laparoscopy in the Intensive Care Unit. Surgical Endoscopy 2001;15(7):638-41
3. Kelly, J. J., Puyana, J. C., Callery, M. P., Yood, S. M., Sandor, A., and Litwin, D. E. The Feasibility and Accuracy of Diagnostic Laparoscopy in the Septic ICU Patient. Surgical Endoscopy 2000;14(7):617-21.
4. Orlando R, Crowell KL. Laparoscopy in the critically ill. Surg Endosc 1997; 11(11):1072-4.
5. Walsh, R. M., Popovich, M. J., and Hoadley, J. Bedside Diagnostic Laparoscopy and Peritoneal Lavage in the Intensive Care Unit. Surgical Endoscopy 1998;12(12):1405-9.
6. Brandt CP, Priebe PP, Eckhauser ML. Diagnostic laparoscopy in the intensive care patient. Avoiding the nontherapeutic laparotomy. Surg Endosc. 1993 May-Jun;7(3):168-72
7. Brandt CP, Priebe PP, Jacobs DG. Value of laparoscopy in trauma ICU patients with suspected acute acalculous cholecystitis. Surg Endosc. 1994 May;8(5):361-4; discussion 364-5
8. Jaramillo EJ, Trevino JM, Berghoff KR, Franklin ME Jr.
Bedside diagnostic laparoscopy in the intensive care unit: a 13-year experience. JSLS. 2006 Apr-Jun;10(2):155-9.
9. Hackert T, Kienle P, Weitz J, Werner J, Szabo G, Hagl S, B�chler MW, Schmidt J. Accuracy of diagnostic laparoscopy for early diagnosis of abdominal complications after cardiac surgery. Surg Endosc 2003;17(10):1671-4.
10. Almeida J, Sleeman D, Sosa JL, Puente I, McKenney M, Martin L. Acalculous cholecystitis: the use of diagnostic laparoscopy. J Laparoendosc Surg 1995;5(4):227-31.

Rationale for the Procedure and/or General Comments
Laparoscopy has been used since 1976 for the evaluation of the non-palpable testis in pediatric patients. The rationale for the procedure has been to decrease the morbidity of open standard surgical exploration for the non-palpable testicle. Furthermore, therapeutic interventions such as orchiopexy and orchiectomy are also feasible using this technique.
Technique
In the operating room under general anesthesia, a second manual palpation is performed to check for testes in the inguinal canal or scrotum. If none is found, the patient is prepped and draped in the usual manner. The primary port is inserted in the periumbilical region. A 5-mm port is placed in the contralateral lower abdominal quadrant for manipulation. A second port can be used for laparoscopic clipping and division of testicular vessels where necessary for the first part of the two-part staged Fowler-Stevens orchiopexy. During this part of the procedure, the testicle is identified and its relation to the spermatic vessels and internal inguinal ring ascertained. A testicle that is normal size for the patient�s age should be salvaged, whereas a testicle that is non-viable should be removed. If no testicle is identified on laparoscopy and blind ending spermatic vessels are seen, the testicle has atrophied and the procedure is terminated. If no testicle is identified, no spermatic vessels are seen, and only the vas deferens is seen going into the inguinal canal, the laparoscopic dissection must continue higher in the retroperitoneum in search of the undescended testicle. The second stage of the procedure is usually performed approximately 6 months later through a high groin incision mobilizing the testicle into the scrotum.
Indications
� Identification of a non-palpable testis on physical exam
Contraindications
� Inability to tolerate the procedure
� Dense abdominal adhesions that may preclude safe access and/or dissection
Risks
� Procedure- and anesthesia-related complications
Benefits
� Decreased morbidity, less pain, and earlier recovery compared with open exploration
Diagnostic Accuracy of the Procedure
Diagnostic laparoscopy identifies the location of a nonpalpable testis with 99-100% accuracy (level III) [1-5]. The procedure reliably demonstrates whether the testicle is present intra-abdominally or whether the vas and the vessels enter the internal inguinal ring. When laparoscopy is applied only for diagnosis, it can still prevent unnecessary abdominal explorations in 13-18% of patients (level III) [1,3]. Inguinal exploration alone may identify up to 34% of testicles and obviate laparoscopy; however, no good predictors exist III) [3]. Laparoscopy by a skilled laparoscopist enables therapeutic intervention (orchidopexy or orchiectomy), minimizes the need for open explorations, and preserves the benefits of the minimally invasive approach. Importantly, physical examination under anesthesia prior to laparoscopy may identify up to 18% of nonpalpable testicles in the groin (level III) [3]. There are little data comparing laparoscopic and open exploration.
Procedure-related Complications and Patient Outcomes
Procedure-related complications have been described to occur in 0-3.2% of patients, the most severe being a bowel injury.
Laparoscopic-assisted orchidopexy has been associated with 0-2.2% testicular atrophy and 97% success rates. This compares favorably with the one-stage Fowler-Stephens orchidopexy (with a 22% atrophy and 74% success rate) and the two-stage Fowler-Stephens orchidopexy (with a 10% atrophy and 88% success rate) (level III) [4,5]. It has been hypothesized that laparoscopic orchidopexy may decrease the rate of testicular atrophy by preserving the vascular supply as it can be performed usually in one stage.
Cost-effectiveness
There are no available data on the cost-effectiveness of the procedure.
Limitations of the Available Literature
The quality of the available literature for laparoscopy in the management of non-palpable testis is limited to level III evidence. No studies compare the open and laparoscopic approach with regard to patient morbidity, and there is inconsistency in the use of preoperative localization studies before laparoscopy. These limitations make strong recommendations difficult.
Recommendations
Patients undergoing DL for nonpalpable testis should have physical examination of the groin under anesthesia before the procedure is started as this approach will identify up to 18% of testicles and obviate the need for the procedure (grade A). Diagnostic laparoscopy should be part of the treatment algorithm of patients with nonpalpable testis as it is likely to improve patient outcomes; however, further higher quality study is needed. (grade C).
Bibliography
1. Lima M, Bertozzi M, Ruggeri G, Domini M, Libri M, Pelusi G, Landuzzi V, Messina P. The nonpalpable testis: an experience of 132 consecutive videolaparoscopic explorations in 6 years. Pediatr Med Chir, 2002 Jan-Feb;24(1):37- 40.
2. Baillie CT, Fearns G, Kitteringham L, Turnock RR. Management of the impalpable testis: the role of laparoscopy. Arch Dis Child, 1998; 79:419-422.
3. Cisek, Lars J, Peters, Craig A.; Atala, Anthony, Bauer, Stuart B, Diamond, David A.; Retik, Alan B. Current findings in diagnostic laparoscopic evaluation of the nonpalpable testis. J Urol. 1998 Sep;160(3 Pt 2):1145-9; discussion 1150.
4. Merguerian PA, Mevorach RA, Shortliffe LD, Cendrn M. Laparoscopy for the evaluation and management of the nonpalpable testicle. Urology. 1998 May;51(5A Suppl):3-6.
5. Baker LA, Docimo SG Surer I, Peters C, Cisek L, Diamond DA, Caldamone A, Koyle M, Strand W, Moore R, Mevorach R, Brady J, Jordan G, Erhard M, Franco I. A multi-institutional analysis of laparoscopic orchidopexy. B J U Int. 2001 apr;87(6):484-9.

Rationale for the Procedure
Pancreatic adenocarcinoma is diagnosed in just over 30,000 patients every year in the United States and has a dismal prognosis, with an almost identical yearly death rate. Surgery is the only modality that can lead to cure; however, most patients present with inoperable disease. The overall 5-year survival is <5%. Patients with localized disease have a 15% 5-year survival after curative resection. In a disease with such a poor prognosis even after curative resection, it is not only important to identify patients with resectable disease but also to spare patients with incurable disease the morbidity, inconvenience, and expense of an unnecessary operation. Thus, accurate staging of pancreatic adenocarcinoma is of paramount importance. A high quality CT scan of the pancreas is considered the best initial diagnostic modality for this disease. Nevertheless, even after appropriate preoperative imaging, 11-48% of patients are found to have unresectable disease during laparotomy. For this reason, many authors have introduced SL in the treatment algorithm of pancreatic adenocarcinoma patients in an effort to decrease the number of unnecessary laparotomies.
Technique
The feasibility of SL has been demonstrated in multiple studies with success rates ranging from 94-100% (level II, III). Dense adhesions that impair inspection and examination with the ultrasound probe are the main reason for technical failures. Nevertheless, even patients with adhesions can be examined; however, the extent and yield of the examination may be compromised. Conversions to open surgery are uncommon and have been reported to occur in <2% of patients in a large series (level III) [5].
The procedure is usually performed under general anesthesia, and the majority of reports have used 15 mm Hg insufflation pressures. A thorough evaluation of peritoneal surfaces is performed. The suprahepatic and infrahepatic spaces, the surface of the bowel, the lesser sac, the root of the transverse mesocolon and small bowel, the ligament of Treitz, the paracolic gutters, and pelvis are inspected with frequent bed position changes as necessary. In addition to visual inspection, peritoneal washings can be performed, ascitic fluid, if present, sent for cytology, and biopsy specimens of lesions suspected to be malignant obtained. When no metastatic disease is identified on inspection, a detailed laparoscopic ultrasound examination can be employed during which the deep hepatic parenchyma, the portal vein, mesenteric vessels, celiac trunk, hepatic artery, the entire pancreas, and even pathologic periportal and paraaortic nodes can be evaluated and biopsied. The addition of color flow Doppler can further assist in the assessment of vascular patency.
A controversy exists in the literature about the extent of SL for pancreatic adenocarcinoma patients. Advocates of a short duration procedure that is based only on inspection of abdominal organ surfaces argue that the procedure can be performed quickly (usually within 10�20 min), can be done through one port, does not require significant expertise, minimizes the risk of potential complications by the dissection near vascular structures, and has good diagnostic accuracy (level III) [1,2]. On the other hand, advocates of a more extensive procedure that includes opening the lesser sac and assessment of the vessels argue that the diagnostic accuracy of the procedure can be enhanced by detecting metastatic lesions in the lesser sac, vascular invasion by the tumor, or deep hepatic metastasis, often missed by visual inspection alone, and that it can be performed safely without a significant increase in morbidity and within a reasonable time (level II, III) [3-5].
It is very important, therefore, to consider these differences in the SL technique when evaluating reports of the diagnostic yield of this procedure in patients with pancreatic adenocarcinoma.
Indications
� As a staging procedure for pancreatic adenocarcinoma
� For detection of imaging occult metastatic disease or unsuspected locally advanced disease in patients with resectable disease based on preoperative imaging prior to laparotomy
� For assessment prior to administration of neo-adjuvant chemoradiation
� For selection of palliative treatments in patients with locally advanced disease without evidence of metastatic disease on preoperative imaging
Contraindications (Absolute or Relative)
� Known metastatic disease
� Inability to tolerate pneumoperitoneum or general anesthesia
� Multiple adhesions/prior operations
Risks
� False negative studies that lead to unnecessary exploratory laparotomies and unnecessary cost
� Procedure-related complications
Benefits
� Avoidance of unnecessary exploratory laparotomy with its associated higher morbidity and cost in patients with metastatic disease
� Appropriate selection of patients with true locally advanced disease and exclusion of patients with CT-occult metastatic disease from further unnecessary treatment (chemotherapy or chemoradiation) with its associated morbidity and cost
� Minimizes the delay of primary treatment (chemotherapy or chemoradiation) in the subset of patients whose disease is unresectable by avoiding laparotomy and its associated longer convalescence period
Diagnostic Accuracy of the Procedure
The reported median (range) sensitivity, specificity, and accuracy of SL in detecting imaging-occult, unresectable pancreatic adenocarcinoma in the literature is 94% (range, 93-100%), 88% (range, 80-100%), and 89% (range, 87-98%), respectively (level II, III) [2-23]. However, the procedure misses 6% (range, 5-25) of patients whose disease is identified as unresectable during an ensuing laparotomy (level II-III) [2-23]. Overall, in 4-36% of patients, an unnecessary laparotomy can be avoided (level II-III) [2-23].
A number of studies have also evaluated the added benefit of laparoscopic ultrasound at the time of laparoscopic staging indicating that the diagnostic accuracy of the procedure can be improved by 12-14% (level II-III) [3-8,19-22]. In addition, peritoneal washings have been reported to augment the yield of the procedure. Reports on the sensitivity of peritoneal washings have ranged widely (25-100%) [2,17,24-26]. The highest sensitivity for peritoneal cytology has been reported in patients with a disrupted ventral pancreatic margin (when peripancreatic fatty tissue cannot be differentiated from the tumor by helical CT scan) (level III) [26]. In addition, locally advanced pancreatic cancers have a higher incidence of positive cytology (level III) [12,17,27]. Importantly, studies have reported a 7-14% incidence of positive peritoneal washings in the absence of other findings of metastatic disease during preoperative imaging and SL (level III) [2,17]. This incidence seems to be lower in studies that include a variety of periampullary tumors (level II) [14].
The diagnostic yield of the procedure also depends on the histology, stage of disease, tumor size, and location. There is convincing evidence that the yield of SL is significantly higher in patients with pancreatic cancer compared with other types of periampullary tumors (level III) [11,12,16,23]. Furthermore, SL appears to have a higher yield in patients with locally advanced cancer compared with patients with localized disease. Identification of metastatic disease by SL in patients with locally advanced disease by high quality imaging studies has been reported in 34-37% of cases, which compares favorably with the identification rates of metastatic disease in patients with localized disease (level III) [1,27,28].
Tumors of the pancreas body and tail are associated with a higher chance for unsuspected metastasis found at laparoscopy (level III) [2,17]. Larger tumors appear to be associated with a higher incidence of imaging occult metastatic disease (level III) [12,23,29,30]. Although the tumor size at which the risk of occult M1 disease justifies the added time and cost of laparoscopy is currently unknown, some studies have suggested that tumors > 3 cm are more likely to be associated with metastatic disease at exploration (level III) [29,30]. Moreover, a Ca 19-9 level <150 has been associated with a lower chance for metastatic disease and consequently a lower yield for SL (level III) [31].
Procedure-related Complications and Patient Outcomes
Procedure-related morbidity has been reported to range 0 and 4% (level II, III) [1-30]. Most complications are minor and consist of wound infections, bleeding at port sites, or skin emphysema. Nevertheless, complications such as myocardial infarction, pulmonary embolism, and intestinal or vascular injury during the procedure have been described. The majority of the literature reports mortality rates of 0% (level II, III) [1-30]; however, at least one death has been reported due to a missed colonic injury during the procedure. Although studies comparing open and laparoscopic staging are scarce, the morbidity and mortality rates reported in the literature compare favorably to reports of negative exploratory laparotomies. No studies compare a short-duration inspection-only SL with a more extended procedure.
With regard to oncologic safety, initial concerns for more port-site recurrences after laparoscopic procedures in cancer patients have not been substantiated. Multiple studies report a 0-2% incidence of port-site recurrences after SL, which is similar to the incidence after open explorations of cancer patients (level III) [8,23,32]. In one comparative study of 235 patients who had undergone exploratory laparotomy or SL, laparoscopy was not associated with increased port-site recurrences or peritoneal disease progression (level III) [32]. Furthermore, there is evidence from the Surveillance Epidemiology and End Results (SEER) database suggesting no survival differences between pancreatic cancer patients who underwent a laparoscopic procedure compared with an open surgery (level II) [33].
Hospital length of stay after SL has been reported to range from 1 to 4 days [23]. Level III evidence suggests that the hospital stay is shorter after laparoscopic staging compared with open staging in pancreatic cancer patients [10].
In patients with locally advanced disease, SL has been reported to be superior to exploratory laparotomy, as it decreases length of hospital stay, increases the number of patients who receive chemotherapy, and shortens the time to initiation of such treatment (level III) [18,32].
Cost-effectiveness
Although high quality evidence on the cost effectiveness of SL is lacking, the literature suggests that SL is more cost-effective than open exploration when it is the only procedure required (i.e., in patients with unsuspected metastatic disease identified during SL) (level II) [34]. This is a consequence of decreased patient length of stays. On the other hand, the cost-effectiveness of SL when applied in the diagnostic algorithm of all pancreatic cancer patients appears to be linked directly to the yield of the procedure in identifying patients with imaging occult disease. In a cost utility analysis of the most effective management strategy for pancreatic cancer patients, at least a 30% yield was needed for SL to be more cost-effective than open exploration (level III) [35].
Literature Controversies
The main controversy regarding SL is whether it should be used routinely or selectively in patients with pancreatic adenocarcinoma deemed resectable on preoperative imaging. Proponents for the routine use of SL cite the high incidence of imaging occult metastatic disease found during laparoscopic examination of the abdominal cavity that leads to avoidance of unnecessary operations and thus benefits patients [3,20,27]. Proponents for the selective use of SL argue that when high quality imaging is used, only a small percentage of patients benefit from SL, and under these circumstances the procedure is not cost-effective [12,14]. As discussed in the technique section, there is also a controversy about whether to perform a limited or extended procedure.
Limitations of the Available Literature
The quality of the available studies on SL for patients with pancreas cancer is limited; no level I evidence exists. Furthermore, population-based data are very limited, as the majority of studies are single institution reports from highly specialized centers, making generalizations difficult and allowing institutional and personal biases to be introduced into the results.
In addition, reported data are not uniform across studies, making their analysis difficult. A number of studies assess the role of laparoscopy indirectly without having ever performed a single laparoscopic staging procedure (referred to as �phantom� studies by some authors) and assume that only visible metastatic disease would have been detected at the time of laparoscopy, ignoring the value of laparoscopic ultrasound and cytology. Other studies do not clearly report the quality of preoperative imaging, the criteria used to define resectability, and the number of R0 resections. Importantly, studies often evaluate inhomogeneous patient samples, including patients with localized and locally advanced pancreatic cancers, with periampullary and other non-pancreatic cancers or even with benign disease and do not report results separately. Moreover, the information on the cost-effectiveness of the procedure is limited, and there are no studies that assess the quality of life of patients undergoing SL compared with patients undergoing open exploration.
Recommendations
Staging laparoscopy can be performed safely in patients with pancreatic adenocarcinoma (grade B). The procedure should be considered after high quality imaging studies have excluded metastatic disease in appropriately selected patients with either localized or locally advanced pancreatic adenocarcinoma (grade C). The use of laparoscopic ultrasound and peritoneal washings is encouraged, since they may improve the diagnostic accuracy of the procedure (grade C). Based on the available evidence, selective rather than routine use of the procedure may be better justified and more cost-effective (grade C). Patient selection may be based on the available evidence that suggests that the diagnostic accuracy of SL may be higher in patients with larger tumors, tumors of the neck, body, and tail or with clinical, laboratory (such as higher levels of Ca 19-9), or imaging findings suggestive of more advanced disease (grade C). Nevertheless, the effectiveness of such selection criteria needs to be verified by additional prospective studies.
Bibliography
1. Luque-de Leon, E., Tsiotos, G. G., Balsiger, B., Barnwell, J., Burgart, L. J., and Sarr, M. G. Staging Laparoscopy for Pancreatic Cancer Should Be Used to Select the Best Means of Palliation and Not Only to Maximize the Resectability Rate. Journal of Gastrointestinal Surgery 1999;3(2):111-7.
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Rationale for the Procedure
Exploratory laparotomies in trauma patients with suspected intra-abdominal injuries are associated with a high negative laparotomy rate and significant procedure-related morbidity. Diagnostic laparoscopy has been proposed for trauma patients to prevent unnecessary exploratory laparotomies with their associated higher morbidity and cost.
Technique
Many studies have documented the feasibility and safety of the procedure in trauma patients (level I-III) [1-25]. The procedure is usually performed under general anesthesia; however, local anesthesia with IV sedation has also been used successfully. The latter, in conjunction with a dedicated mobile cart, facilitates the procedure in the emergency department. A recent study demonstrated the safety and advantages of awake laparoscopy under local anesthesia in the emergency department over standard DL in the operating room (level III) [21]. Many authors have used low insufflation pressures (8-12 mm Hg); however, pressures up to 15 mm Hg have been described without untoward events. Special attention should be given to the possibility of a tension pneumothorax caused by the pneumoperitoneum due to an unsuspected diaphragmatic rupture. The pneumoperitoneum is created usually through a periumbilical incision using a Veress needle or open technique after insertion of a nasogastric tube and a Foley catheter.
In the case of penetrating wounds, air leaks can be controlled with sutures. A 30-degree laparoscope is advantageous, and additional trocars are used for organ manipulations. The peritoneal cavity can be examined systematically taking advantage of patient positioning manipulations. The colon can be mobilized and the lesser sac inspected. Suction/irrigation may be needed for optimal visualization, and methylene blue can be administered IV or via a nasogastric tube to help identify urologic or stomach injuries, respectively. In penetrating injuries, peritoneal violation can be determined.
Indications
� Suspected but unproven intra-abdominal injury after blunt or penetrating trauma
� More specific indications include:
� Suspected intra-abdominal injury despite negative initial workup after blunt trauma
� Abdominal stab wounds with proven or equivocal penetration of fascia
� Abdominal gunshot wounds with doubtful intraperitoneal trajectory
� Diagnosis of diaphragmatic injury from penetrating trauma to the thoracoabdominal area
� Creation of a transdiaphragmatic pericardial window to rule out cardiac injury
Contraindications (Absolute or Relative)
� Hemodynamic instability (defined by most studies as systolic pressure < 90 mm Hg)
� A clear indication for immediate celiotomy such as frank peritonitis, hemorrhagic shock, or evisceration
� Known or obvious intra-abdominal injury
� Posterior penetrating trauma with high likelihood of bowel injury
� Limited laparoscopic expertise
Risks
� Delay to definitive treatment
� Missed injuries with their associated morbidity
� Procedure- and anesthesia-related complications
Benefits
� Reduction in the rate of negative and nontherapeutic laparotomies (with a subsequent decrease in hospitalization, morbidity, and cost after negative laparoscopy)
� Accurate identification of diaphragmatic injury
� Ability to provide therapeutic intervention
Diagnostic Accuracy of the Procedure
The sensitivity, specificity, and diagnostic accuracy of the procedure when used to predict the need for laparotomy are high (75-100%) (level I-III) [1-25]; however, they depend on several factors (see Limitations of the Available Literature). When DL has been used as a screening tool (i.e., early conversion to open exploration with the first encounter of a positive finding like the identification of peritoneal penetration in penetrating trauma or active bleeding/peritoneal fluid in blunt trauma patients), the number of missed injuries is <1% (level II, III) [2-8]. Although early studies cautioned about the low sensitivity and high missed injury rates of the procedure when used to identify specific injuries (level II, III) [9-12], studies published recently consistently report a 0% missed injury rate even when DL is used for reasons other than screening (level I-III) [1-7,14,16-25]. This rate holds true for studies that have used laparoscopy to treat the majority of identified injuries (level II, III) [22,24,25].
Studies of DL for trauma report negative procedures in a median 57% (range, 17-89) of patients, sparing them an unnecessary exploratory laparotomy (level I-III) [1-7, 13-25]. On the other hand, the median percentage of negative exploratory laparotomies after a positive DL (false positive rate) is reported to be around 6% (range, 0-44) (level I-III) [1-7,14,16-25]. While most authors have converted to open exploration after a positive DL, some authors have successfully treated the majority of patients (up to 83%) laparoscopically (level II, III) [22,24,25]. The safety and accuracy of the procedure has also been demonstrated in pediatric trauma patients (level III) [22].
Procedure-related Complications and Patient Outcomes
Procedure-related complications occur in up to 11% of patients and are usually minor (level I-III) [1-25]. A 1999 review of 37 studies, which included more than 1,900 patients demonstrated a procedure-related complication rate of 1% [9]. Recent studies report a median of 0 (range, 0-10%) morbidity and 0% mortality (level I-III) [1-7,14,16-25]. Intraoperative complications can occur during creation of the pneumoperitoneum, trocar insertion, or during the diagnostic examination. These complications include tension pneumothorax caused by unrecognized injuries to the diaphragm, perforation of a hollow viscus, laceration of a solid organ, vascular injury (usually trocar injury of an epigastric artery or lacerated omental vessels), and subcutaneous or extraperitoneal dissection by the insufflation gas. Port site infections may occur during the postoperative course.
Negative DL is associated with shorter postoperative hospital stays compared with negative exploratory laparotomy (2-3 days vs. 4-5 days, respectively) (level II, III) [2,4-9,14,16-20,22-25]. Although a few studies have even demonstrated shorter stays after therapeutic laparoscopy compared with open (level III) [22,24,25], the only level I study available demonstrated a statistically significant shorter hospital stay after DL (5.1 vs. 5.7 days) [1]. In a very recent study, awake laparoscopy in the emergency department under local anesthesia resulted in discharge of patients from the hospital faster compared with DL in the operating room (7 vs. 18 hours, respectively; p<0.001) (level III) [21].
Comparative studies also suggest lower morbidity rates after negative DL compared with negative exploratory laparotomy (level II, III) [5,19,21], whereas other studies have shown similar outcomes (level I-III) [1,7].
Cost-effectiveness
A number of reports have demonstrated higher costs (up to two times higher) after negative exploratory laparotomy compared with negative DL (levels II, III) [6,14,17] as a direct consequence of shorter hospital stays. Nevertheless, a level I study did not demonstrate cost differences when an intention-to-treat analysis was used to compare a DL-treated group with that of an exploratory laparotomy-treated group [1]. Recently a level III study reported cost savings of $2,000 per patient when awake laparoscopy under local anesthesia was used in the emergency department compared with DL in the operating room [21].
Limitations of the Available Literature
The available literature has limited quality (only one small, level I study exists) and is very inhomogeneous, making generalizations and conclusions difficult. Study populations have been variable (blunt, penetrating, or mixed), and some studies have focused only on patients with suspected diaphragmatic injuries or blunt bowel injuries. Moreover, the indication for conversion to exploratory laparotomy has also been inconsistent. Most studies use peritoneal penetration or bleeding and free peritoneal fluid as an immediate reason for conversion, whereas others have converted only after specific injuries have been identified, and others have converted only when laparoscopic repair was impossible. The impact of laparoscopic expertise on the diagnostic accuracy of the procedure has not been assessed. Since the sensitivity, specificity, accuracy, and number of missed injuries can be substantially influenced by most of these factors, it is difficult to provide firm recommendations on the role of DL in trauma patients.
Recommendations
Diagnostic laparoscopy is technically feasible and can be applied safely in appropriately selected trauma patients (grade B). The procedure has been shown to effectively decrease the rate of negative laparotomies and minimize patient morbidity. It should be considered in hemodynamically stable blunt trauma patients with suspected intra-abdominal injury and equivocal findings on imaging studies or even in patients with negative studies but a high clinical likelihood for intra-abdominal injury (grade C). It may be particularly useful and should be considered in patients with penetrating trauma of the abdomen with documented or equivocal penetration of the anterior fascia (grade C). It should be used in patients with suspected diaphragmatic injury, as imaging occult injury rates are significant, and DL offers the best diagnostic accuracy (grade C). Patients should be followed cautiously postoperatively for the early identification of missed injuries. Therapeutic intervention can be provided safely when laparoscopic expertise is available (grade C). To optimize results, the procedure should be incorporated in institutional diagnostic and treatment algorithms for trauma patients.
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