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Holzheimer RG, Mannick JA, editors. Surgical Treatment: Evidence-Based and Problem-Oriented. Munich: Zuckschwerdt; 2001.

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Surgical Treatment: Evidence-Based and Problem-Oriented.

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Cholecystitis and Cholelithiasis

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http://rene-holzheimer.de/ Medical Faculty, Martin Luther University, Halle-Wittenberg, Germany

Pathogenesis and prevalence

In humans, gallstones are composed principally of cholesterol, with pigment stones occuring less commonly. Cholesterol supersaturation, accelerated cholesterol crystal nucleation, and impaired gallbladder motility are believed to support the development of gallstones. Approximately 10–15% of the adult population or more than 20 million people in the United States may have gallstones. There are approximately 1 Million newly diagnosed patients annually, with a higher prevalence in women, in association with multiple pregnancies, obesity, and rapid weight loss, as well in older patients and in certain ethnic groups. In 1991 approximately 600,000 patients underwent cholecystectomy in the United States. (1) Most patients remain asymptomatic; however, consequences of gallstones may be serious, e.g., acute cholecystitis, pancreatitis and rarely gallbladder cancer. Diagnosis and treatment of gallstone-related disease have undergone dramatic changes since the introduction of laparoscopic surgery only a few years ago. Although many trees were sacrificed to provide paper for the numerous publications concerning the management of gallstones, there is little high-level data to prove that the new high-tech therapies are really advantageous.

Indications and contra-indications for laparoscopic cholecystectomy

A NIH consensus conference (1992) agreed that laparoscopic cholecystectomy (LC) is the treatment of choice for most patients with symptomatic gallstone disease (1). For obvious reasons, associated conditions such as generalized peritonitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer are considered contra-indications to LC.

Prior intra-abdominal surgery is not a contra-indication for laparoscopic surgery; there are no more complications and the conversion rate is not necessarily higher (2). With growing experience, and confidence, relative contra-indications to LC, such as acute cholecystitis, morbid obesity, and even early cirrhosis are disappearing.

How did the introduction of LC modify the rate of cholecystectomy? A Swedish study reported that the indication for cholecystectomy did not change with the introduction of LC (3). However other studies suggest that LC - denoting an “easier” cholecystectomy for the patient and his surgeon - more cholecystectomies are being performed. It appears that patients are operated for asymptomatic gallstones or for non-biliary pain, which of course is not ameliorated by a LC. The economic initiatives and consequences of unnecessary LC's are self-explanatory (4).

Laparoscopic cholecystectomy for acute cholecystitis

LC is a feasible and safe procedure even in most cases of acute cholecystitis albeit the conversion rate may be as high as 32%. The risk of bile duct injuries is higher and the operation time longer than in elective LC. Factors associated with the need to convert may be male gender, duration of right upper abdominal pain and severity of inflammatory process (58).

Early LC - within 48 hours of the acute attack - seems to be associated with a “safer” procedure; delayed-interval LC, on the other hand, may result in more technical difficulties and thus with an increased morbidity (9). Therefore, our current approach to acute cholecystitis is to attempt a LC within 24 hours of admission. Patients operated after 72 hours may have a “more difficult operation” resulting in a higher rate of conversion, longer operative time, and prolonged convalescent periods than in patients operated within 72 hours. Elderly patients (>65 years) have an increased risk of conversion, delayed recovery, and prolonged hospital stay (1013).

Minilaparotomy cholecystectomy may be safe as an emergency procedure for acute cholecystitis and compares favorably with the published results of laparoscopic cholecystectomy (14).

Conversion to open treatment

Several studies demonstrated that the risk of conversion depends mainly on the degree of inflammation, pathology of GB disease (e.g., thickness of gallbladder wall), age, male sex, and CBD diameter. Conversion rate in elective laparoscopic cholecystectomy may be 0% to 15%, but in cases of gangrenous cholecystitis or empyema it may be 50% to 83%. Ultrasound may help to predict the risk of conversion. However, the surgeon has to decide intra-operatively whether to convert to open procedure within a short time (1527). It is necessary to stress that the conversion from LC to an open procedure should never be considered as an “adverse outcome” or the surgeon's failure. The opposite is true - an early decision to convert in face of hostile anatomy, or the failure to progress, reflect solid judgement and understanding that patient's safety is more important than the surgeon's ego. Clearly, reporting conversion rates without reporting the severity of gallbladder inflammatory disease means nothing.

Randomized studies comparing open cholecystectomy and laparoscopic cholecystectomy

There is evidence that LC is associated with less impairment of the immune function. TNF-alpha and CRP plasma levels increase less after LC, the increase in oxygen release from macrophages and PMN is more pronounced after OC. Postoperative hypoxemia is reduced after LC when compared to OC (28). Furthermore IL-6 plasma levels, cortisol plasma levels, glucose and catecholamine levels may be less increased after LC procedures. There is an increase in the number of CD3 cells and OKDR cells (29). less NK cell cytotoxicity and higher IL-10 levels after LC (30). Whether these changes lead to an improved clinical outcome in comparison to OC is not known. Only in the study published by Redmond it was reported that the trauma response after open cholecystectomy correlated significantly with higher septic complications (31). However, the data are rather weak because only 42 patients have been investigated. There is evidence that the postoperative pulmonary function is less impaired after LC than after OC (3234). However, it is also reported that peak airway pressure increases after LC and pH and compliance decrease (35). The rate of postoperative complications was not different in both groups. 2 randomized studies reported on less postoperative pain after LC (33, 36). These observed effects might be responsible for a shortened duration of hospitalization and sick leave compared to the open procedure (29, 37). The cost savings per patients were calculated in 1996 to be approximately 309 $ for the society. However, the LC procedure may be more expensive for the hospital. (Table I)

Table I. Randomized studies - Laparoscopic cholecystectomy versus open cholecystectomy.

Table I

Randomized studies - Laparoscopic cholecystectomy versus open cholecystectomy.

In summary, the LC procedure bears several advantages compared to the open procedure. There is a reduced effect on the immune system by the operative trauma, less impairment of the postoperative pulmonary function and a shorter hospital stay followed by a shorter sick leave. There is no evidence that LC leads to longer operation time or more complications in symptomatic gallbladder disease.

Randomized studies comparing mini-cholecystectomy with open cholecystectomy or laparoscopic cholecystectomy

Several studies have compared the effect of mini-laparotomy cholecystectomy (MC) to open cholecystectomy (OC) and/or laparoscopic cholecystectomy (LC) on outcome and other parameters, which may influence the quality of life postoperatively. MC seems to be superior to OC with regard to hospital stay, postoperative analgesic requirements, return to normal activity and patient's satisfaction (14, 38, 39). However, there is some disagreement with regard to postoperative pain and analgesic requirements (40). Laparoscopic cholecystectomy is associated with less impact on the posttraumatic immune response, e.g., CRP, IL-6, T lymphocyte phenotypic surface markers, NK cell subsets, when compared to the immune response launched after MC (4143). The duration of postoperative stay may correlate with the magnitude of the cortisol and CRP response (41). Pulmonary function is less depressed after LC, as are postoperative pain and analgesic requirements in most patients (39, 4447). However, pain may not be more decreased in all patients with laparoscopic surgery (48). Shorter hospital stay and a faster return to normal activity are observed in most patients after laparoscopic cholecystectomy when compared to MC. (Table II)

Table II. Randomized studies - Minicholecystectomy versus laparoscopic cholecystectomy or open cholecystectomy.

Table II

Randomized studies - Minicholecystectomy versus laparoscopic cholecystectomy or open cholecystectomy.

In summary, there is evidence that MC attenuates the operative trauma, which may improve patient's satisfaction and reduce the postoperative stay when compared to open cholecystectomy. The immune response to laparoscopic cholecystectomy is less activated, although the operation time may be longer, when compared to MC. This is followed by a faster recovery of the pulmonary function, less pain, improved quality of life and a shorter hospital stay.

Randomized studies comparing different techniques in pneumoperitoneum

Different techniques of pneumoperitoneum have been studied in laparoscopic cholecystectomy. Low-pressure pneumoperitoneum (≤ 10 mmHg) may improve the pulmonary and hemodynamic function in a patient (49, 50). The effect on hepatic function may be less visible (51). Gasless technique, however, is associated with longer operation time and may need further evaluation. There is evidence that this technique may reduce the post-laparoscopic shoulder pain in patients (52). Increased temperature of the insufflated gas may have the opposite effect on shoulder pain together with activation of inflammatory parameters in the abdominal cavity, e.g., IL-6, IL-1-beta, TNF-alpha (53, 54). The insufflation of humidified CO2 gas may have a beneficial effect on pain and lead to a faster return to normal activity (55). (Table III)

Table III. Randomized studies on different techniques in pneumoperitoneum.

Table III

Randomized studies on different techniques in pneumoperitoneum.

In summary, there is evidence that a decreased intra-abdominal pressure during laparoscopic cholecystectomy may improve outcome. Gasless technique or insufflation of warmed gas may not yet be recommended due to lack of firm evidence.

Randomized studies in pain treatment and laparoscopic cholecystectomy

Although there is evidence that laparoscopic cholecystectomy is associated with less pain when compared to MC or OC, incisional pain, pain in the shoulder, postoperative nausea and vomiting (PONV) are observed in many patients after laparoscopic surgery. In several randomized studies the effect of different compounds in different application mode were investigated, e.g., i.m. , i.v., incisional, i.p., and even with the same compound in different concentrations. It is rather obvious that a comparison of the results of these studies is difficult. However, it is yet obvious that in most of the studies the effect of the pain treatment is significantly different only during the first few postoperative hours.

The intraperitoneal or incisional administration of bupivacaine did not result in reduced analgesic requirements, nausea, vomiting, or shoulder pain (5659). Postoperative nausea and vomiting (PONV) was controlled by different compounds (ropivacaine, dexamethasone, ganisetron, droperidol, metoclopramide, ondansetron) to various extents with metoclopramide having the smallest effect (6063). The best effect on postoperative pain treatment may be achieved by a multimodal pain treatment consisting of preoperative i.m. administration of NSAID followed by pre-incisional administration of local anesthesia and routine standard intra-operative anesthesia (64). (Table IV)

Table IV. Randomized studies on pain treatment*.

Table IV

Randomized studies on pain treatment*.

In summary, there is evidence that routine pain treatment in laparoscopic cholecystectomy may be successful only during the first few hours after operation. However, the development of multi-modal pain treatment techniques may help to reduce the analgesic requirements.

Common bile duct exploration and clearance - randomized studies

Bile duct stones and bile duct injuries are main causes for postoperative complications in laparoscopic cholecystectomy. Bile duct injuries are dealt with in another chapter in this book. With regard to common bile duct stones there were several options tested in randomized studies: preoperative and post-operative ERCP, preoperative and intra-operative cholangiography (IOC), laparoscopic intra-operative ultrasound, laparoscopic common bile duct exploration (LCBDE). Operation and clearance of the common bile duct may be either achieved in a single-stage or double-stage procedure. Preoperative visualization and clearance of the common bile duct (ERCP, i.v. cholangiography) may be indicated only in selected patients (6567). Preoperative infusion cholangiography and intra-operative cholangiography were compared in a large study with regard to morbidity, retained stones, and positive predictive value for common bile duct stones. There was no difference between the groups (68). IOC did not improve the outcome in another randomized study (69). Laparoscopic intra-operative ultrasound is feasible and consumes less time than IOC. However, the data supporting the evidence are small (70). Laparoscopic common bile duct exploration has been tested in several prospective studies and has been recommended for routine use in laparoscopic cholecystectomy. However, when compared to selective postoperative ERC in a randomized study there is not enough evidence to support the routine use of this technique (71). The selective use of postoperative ERCP may help to reduce the ERCP use and the hospital stay, to lower the costs of treatment without compromising the safety of the patient or the overall success rate of common bile duct clearance (72). Single stage treatment (LC plus LCBDE) is an attractive alternative, which may decrease the hospital stay of patients. Unfortunately there is a chance of a higher conversion rate when compared to LC plus selective postoperative ERCP (73). (Table V)

Table V. Randomized studies on diagnosis and treatment of common bile duct stones.

Table V

Randomized studies on diagnosis and treatment of common bile duct stones.

In summary, there is no firm evidence to support the routine use of IOC in all laparoscopic cholecystectomies. The decision for single stage treatment or therapeutic splitting may depend on the experience and equipment available to the surgeon. Selective postoperative ERCP may help to reduce the volume of ERCPs and thus decrease the costs of treatment without compromising the success rate of common bile duct clearance.

Antibiotic prophylaxis and laparoscopic cholecystectomy - randomized studies

Before the introduction of laparoscopic surgery there was evidence that antibiotic prophylaxis in open cholecystectomy may help to reduce the overall wound infection rate (74, 75). The introduction of laparoscopic cholecystectomy has decreased the need for antibiotic prophylaxis. Several randomized controlled studies came to the same conclusion that antibiotic prophylaxis has no effect on the development of surgical site infections or other nosocomial infections (7679). (Table VI). In summary, there is no evidence for antibiotic prophylaxis in standard laparoscopic cholecystectomy.

Table VI. Randomized studies on antibiotic prophylaxis.

Table VI

Randomized studies on antibiotic prophylaxis.

Surgical technique and laparoscopic cholecystectomy - randomized studies

Surgical techniques may have an impact on outcome in open or laparoscopic cholecystectomy. The length of incision in open cholecystectomy for treatment of symptomatic gallstones does not influence the outcome (length of hospital stay, pain, pulmonary function)(80). Laser beam, which was used in open surgery, may not be recommended in laparoscopic cholecystectomy. In comparison to electrocautery, laser is associated with increased blood loss (81). The French technique is associated with less impairment of the pulmonary function than the American technique (82). The open introduction of the first trocar can avoid major complications and help to achieve faster the pneumoperitoneum (83). Other techniques, which were investigated, are the intermittent pneumatic sequential compression (ISC) and the micro-laparoscopic cholecystectomy. However, the results of both investigations need further support by randomized studies, as concluded by the authors (84, 85).

With regard to the selection of patients for laparoscopic cholecystectomy, there is evidence for a change in the indication for LC. Acute cholecystitis has been tested in 2 randomized studies. Early LC may not be followed by more complications or a higher conversion rate but reduces the hospital stay of patients (9, 21). Selected patients may be treated in day-care facilities without increased rate of complications or readmissions (86, 87). (Table VII)

Table VII. Randomized studies on different aspects of cholecystitis and cholelithiasis.

Table VII

Randomized studies on different aspects of cholecystitis and cholelithiasis.

In summary, there is evidence for the recommendation of open introduction of the first trocar in LC. The development of the LC technique has contributed to a change in the list of indication for LC: the early laparoscopic treatment of acute cholecystitis may have beneficial effects on the outcome of patients; laparoscopic cholecystectomy is available for day-care treatment in selected patients.

Summary

Despite the obvious advantages of laparoscopic cholecystectomy to open cholecystectomy, serious concerns have been raised regarding the evidence gathered so far in randomized and prospective, non-randomized studies (88, 89). There is an extensive variability in the information presented in publications with regard to the study method (follow up, number of participating surgeons, date of the study, diagnosis, disease severity). Potential differences in patient populations have not been adequately controlled in many series. It is unlikely, given the wide acacceptance of the laparoscopic cholecystectomy, that a large randomized study comparing laparoscopic to open cholecystectomy may ever be performed. However, it is possible to compare treatment modalities, e.g., open versus blind introduction of the trocar, early surgery versus delayed surgery, diagnosis and treatment of common bile duct stones, pain treatment, during the laparoscopic procedure. Furthermore, the vast majority of clinical studies in surgery do not provide sufficient information on economic costs and outcome to enable cost-effectiveness analysis, reflected in “The dawn of a new century” by A Cuschieri (90). The treatment modalities have changed since laparoscopic cholecystectomy became “gold standard” of cholecystolithiasis treatment; the literature documents evidently an appreciation of the remaining difficulties, e.g., one-stage versus two-stage procedures in CBD stone treament.

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