Standard Treatment Guidelines for Cholecystectomy

These Standard Treatment Guidelines for Cholecystectomy have been created by Dr Arun Prasad and has been issued by the Ministry of Health and Family Welfare. The Group Head Coordinator of Development Team was Dr Ajit Sinha attached to the Department of Surgery at Safdarjung Hospital, New Delhi.

INTRODUCTION:

Cholecystectomy is one of the commonest elective surgical procedure performed in India. Most are performed to address symptoms related to biliary colic from cholelithiasis, to treat complications of gallstones (eg, acute cholecystitis, biliary pancreatitis), or as incidental cholecystectomies performed during other open abdominal procedures. Currently, most cholecystectomies are done using the laparoscopic technique in cities; however, the open technique is required in places where facilities or trained staff are not available.

Ministry of Health and Family Welfare has released standard treatment guidelines on Cholecystectomy. Following are the major recommendations.

DEFINITION:

Cholecystectomy implies the surgical resection the gall bladder.

INDIAN INCIDENCE

In India, the incidence of gall stones is around six percent in the total population. It is 10 per cent in women and three per cent in men. In elderly people it may go up to 20 percent.

INDICATIONS:

Asymptomatic patients

Cholecystectomy is not indicated in most patients with asymptomatic stones because only 2-3% of these patients go on to become symptomatic per year. To properly determine the indications for elective cholecystectomy, the risk of the operation (taking into account the age and comorbid factors of the individual patient) must be weighed against the risk of complications and death without operation.

The widespread use of diagnostic abdominal ultrasonography has led to the increasing detection of clinically unsuspected gallstones. This, in turn, has given rise to a great deal of controversy regarding the optimal management of asymptomatic (silent) gallstones.

Patients who are immunocompromised, are awaiting organ allotransplantation, or have sickle cell disease are at higher risk of developing complications and should be treated irrespective of the presence or absence of symptoms.

Additional reasons to consider prophylactic cholecystectomy include the following:

• Calculi >3 cm in diameter, particularly in individuals in geographical regions with a high prevalence of gallbladder cancer
  
• Chronically obliterated cystic duct
  
• Nonfunctioning gallbladder
  
• Calcified (porcelain) gallbladder
  
• Gallbladder polyp >10 mm or showing rapid increase in size
  
• Gallbladder trauma
  
• Anomalous junction of the pancreatic and biliary ducts
  
• Morbid obesity is associated with a high prevalence of cholecystopathy, and the risk of developing cholelithiasis is increased during rapid weight loss. Routine prophylactic cholecystectomy prior to gastric bypass (RYGB) is controversial, but cholecystectomy should clearly precede or be performed at the time of RYGB in patients with a history of gallbladder pathology 

Symptomatic gallstone disease

Biliary colic with sonographically identifiable stones is the most common indication for elective cholecystectomy.

Acute cholecystitis, when diagnosed within 72 hours from the onset of symptoms, can and usually should be treated by surgery. Once 72 hours pass after the onset of symptoms, inflammatory changes in the surrounding tissues are widely believed to render dissection planes more difficult. Interval cholecystectomy after 4-6 weeks or percutaneous cholecystostomy are other options.

Biliary dyskinesia should be considered in patients who present with biliary colic in the absence of gallstones, and a cholecystokinin–diisopropyl iminodiacetic acid (CCK-DISIDA) scanning should be obtained. The finding of a gallbladder ejection fraction <35% at 20 minutes is considered abnormal and constitutes another indication for cholecystectomy.

Complex gallbladder disease 

Gallstone pancreatitis

Cholecystectomy can be safely performed during the same hospitalization after the clinical signs of mild to moderate biliary pancreatitis have resolved. Patients diagnosed with gallstone pancreatitis should first undergo imaging to rule out the presence of choledocholithiasis.

Cholecystectomy should be delayed in cases of acute moderate to severe biliary pancreatitis (5 Ranson criteria).

Choledocholithiasis

The following treatment options are available for patients found to have choledocholithiasis:

Preoperative ERCP with sphincterotomy

Postoperative ERCP with sphincterotomy

Laparoscopic intraoperative cholangiogram with laparoscopic common bile duct (CBD) exploration

Open CBD exploration and T-tube placement

 Mirizzi syndrome 

Mirizzi described an unusual presentation of gallstones that, when lodged in either the cystic duct or the Hartmann pouch of the gallbladder, externally compressed the common hepatic duct, causing symptoms of obstructive jaundice 

Although an initial trial of dissection may be performed by an experienced laparoscopic biliary surgeon, one must be prepared for conversion and for biliary reconstruction.

Endoscopic stone fragmentation at ERCP, with papillotomy and stenting, is a viable alternative to operative surgery to treat Mirizzi syndrome in the acute setting.[24 ]Subsequent cholecystectomy may be performed.[25 ]

Cholecystoduodenal fistula 

Patients with cholecystoduodenal fistula leading to gallstone ileus should undergo exploratory laparotomy and removal of the stone, followed by exploration of the remainder of the gastrointestinal tract for additional stones. The fistula may be addressed at the time of the initial procedure but is probably better addressed at a second operation (3-4 wk postoperatively) after inflammation has subsided.[25 ]

Cholecystenteric fistula does not represent an absolute contraindication to laparoscopic surgery, although it does require careful visualization of the anatomy and good laparoscopic suturing skills. 

Acalculous cholecystitis 

A greater proportion of patients with acalculous cholecystitis are too ill to undergo surgery. In these situations, percutaneous cholecystostomy guided by CT or ultrasonography is advised. Ninety percent of these patients demonstrate clinical improvement. Once the patient has recovered, the cholecystostomy tube can be removed, usually at 6 weeks, without sequelae. Interval cholecystectomy is not necessary.[27 ]

Incidental gallbladder cancer 

Gallbladder cancer may be an incidental finding at cholecystectomy, with an incidence ranging from 0.3- 5.0%.

Uncertainty of diagnosis, uncertainty of the degree of tumor spread, or postoperative identification of cancer on pathological examination of a routine cholecystectomy specimen should engender early reoperation.

Before reoperation, distant metastases should be excluded by a detailed clinical examination including a per-rectal/per-vaginal examination, examination for supraclavicular lymph nodes, and CT/MRI of the chest and abdomen. 

Special situations

Children

Cholecystectomy is a safe and effective treatment for most children diagnosed with biliary disease (BD).

Cirrhosis  

Cholecystectomy in safe in patients with Child class cirrhosis.

Diabetes mellitus

The presence of diabetes mellitus, in and of itself, does not confer sufficient risk to warrant prophylactic cholecystectomy in asymptomatic individuals.

However, consider that acute cholecystitis in a patient with diabetes is associated with a significantly higher frequency of infectious complications such as sepsis.

Pregnancy

The treatment of biliary colic or uncomplicated cholecystitis in a pregnant patient is conservative management followed by elective cholecystectomy. Using antibiotics, analgesics, and antiemetics help most pregnant women avoid surgical intervention. Surgery is generally indicated for patients with recurrent acute cholecystitis who have failed maximal medical therapy.

Classically, the second trimester is considered the safest time for surgery. This is because of the findings of increased risk for spontaneous abortion and teratogenesis during the first  rimester, and the increased risk for premature labor and difficulties with visualization in the third trimester.

Pregnancy was formerly considered to be an absolute contraindication to the laparoscopic approach because of concern for potential trocar injury to the uterus and the unknown effects of pneumoperitoneum to the fetal circulation. However, this has not been borne out in the literature, and cholecystectomy is now considered safe.

Recommendations for pregnant patients who undergo laparoscopic cholecystectomy include placingthem in the left lateral recumbent position to shift the weight of the gravid uterus off the vena cava and maintenance of insufflation pressures between 10 and 12 mm Hg. In addition, maternal PaCO 2 monitoring must be performed by measuring either arterial blood gases or end-tidal CO 2 , but arterial PaCO 2 may be more accurate.

Other recommendations include avoiding rapid changes in intraperitoneal pressures, avoiding rapid changes in patient position, and using open technique for the umbilical port placement. 

Distance from medical centres

In India, another indication can be distance from a treating hospital as long travel that may be needed can lead to complications. 

INVESTIGATIONS

• Haemogram
• Liver Function Tests
• Blood sugar
  
• Serum creatinine
  
• Bleeding time, clotting time and prothrombin time
  
• Xray chest
• ECG
  
• USG abdomen
  
•  In patients with dilated common bile duct or raised liver functions, MRCP or ERCP may be indicated based on availability. Alternatively, an on table cholangiogram or CBD exploration may be done during surgery. Patient can be referred to another centre in case of non-availability of expertise or experience. 

OPERATIVE TECHNIQUES:

Principles of surgery remain the same regardless of whether it is being done by open or laparoscopic technique.

• Safe access to abdomen.
  
• Clear definition of anatomy in the calots triangle showing either the continuity between cystic duct and gall bladder or junction between cytic duct and common bile duct.
• Avoiding diathermy close to common bile duct.
  
• Securing cystic artery safely and close to the gall bladder.
  
• Dissection from liver bed staying close to gall bladder.
  
• Early conversion to open procedure in case of a difficult laparoscopic surgery.
• 
  

REFERRAL CRITERIA: 

• Common bile duct stones if no facilities for management available.
  
• Suspected gall bladder cancer.
  
• Bile duct injury during surgery. Patient should be referred to a tertiary centre as soon as possible.

WHO DOES WHAT?

Doctor:

a) Surgeon: diagnosis & work up

• Pre operative planning
  
• Operative procedure
  
• Post operative follow up

b) Anesthetist: PAC, anesthesia, post op ICU management

NURSE:

• Dressing of the wound
  
• Pre & post operative care

TECHNICIAN

• Pre op equipment and drugs to be checked and kept ready
• Assist anesthetist in the OT
  
• Assist the surgeon, positioning of the patient

RESOURCES REQUIRED FOR ONE PATIENT / PROCEDURE (Patient weight 60 Kgs) 

REFERENCES

1.↵ Sama C, Labate AM, Taroni F, Barbara L. Epidemiology and natural history of gallstone disease. Semin Liver Dis. 1990; 10:149-58.

2.↵ Newman HF, Northup JD. The autopsy incidence of gallstones. Internat Abstr Surg. 1959; 109:1-13.

3.↵ The MICOL Group. Prevalence of gallstone disease in 18 Italian population samples: first results from the MICOL study. In: Capocaccia L, Ricci G, Angelico F, Angelico M, Attili AF, Lalloni F; eds. Recent Advances in the Epidemiology and Prevention of Gallstone Disease. Boston: Kluwer; 1991:37-44.

4.↵ Cucchiaro G, Watters CR, Rossitch JC, Meyers WC. Deaths from gallstones. Incidence and associated clinical factors. Ann Surg. 1989; 209:149-51.

5.↵ Godrey PJ, Bates T, Harrison M, King MB, Padley NR. Gallstones and mortality: a study of all gallstone related deaths in a single health district. Gut. 1984; 25:1029-33.

6.↵ French EB, Robb WA. Biliary and renal colic. Br Med J. 1963; 2: 135-8.

7.↵ Thistle JL, Cleary PA, Lachin JM, Tyor MP, Hersh T. The natural history of cholelithiasis: the National Cooperative Gallstone Study. Ann Intern Med. 1984; 101:171-5.

8.↵ Glambek I, Arnesio B, Soreido O. Correlation between gallstones and abdominal symptoms in a random population. Scand J Gastroenterol. 1989; 24:277-81.

9.↵ Jorgensen T. Abdominal symptoms and gallstone disease: an epidemiological investigation. Hepatology. 1989; 8:856-60.

10.↵ Price WH. Gallbladder dyspepsia. Br Med J. 1963; 2:138-41.

11.↵ Health and Policy Committee, American College of Physicians. How to study the gallbladder. Ann Intern Med. 1988; 109:752-4.

12.↵ Hutcheon DF, Bayless TM, Gadacz TR. Postcholecystectomy diarrhea. JAMA. 1979; 241:823-4.

13.↵ Ros E, Zambon D. Postcholecystectomy symptoms. A prospective study of gallstone patients before and two years after surgery. Gut. 1987; 28:1500-4.

14.↵ Lasson A. The postcholecystectomy syndrome: diagnostic and therapeutic strategy. Scand J Gastroenterol. 1987; 22:897-902.

15.↵ Bishop YM, Mosteller F. Smoothed Contingency-Table Analysis. In: Bunker JP, Forrest WH Jr, Mosteller F, Vandam LD,; eds. The National Halothane Study. Bethesda, Maryland: National Institute of General Medical Sciences; 1969:238-72.

16.↵ Commission on Professional and Hospital Activities. Hospital Mortality, PAS Hospitals, United

States, 1972-73. Table F. Ann Arbor, Michigan: Commission on Professional and Hospital Activities; 1975.

17.↵ Commission on Professional and Hospital Activities. Hospital Mortality, PAS Hospitals, United

States, 1974-75. Table F. Ann Arbor, Michigan: Commission on Professional and Hospital Activities; 1977.

18.↵ Ransohoff DF, Gracie WA, Wolfenson LB, Neuhauser D. Prophylactic cholecystectomy or expectant

management for persons with silent gallstones. A decision analysis to assess survival. Ann Intern Med.

1983; 99:199-204.

19.↵ Roos LL, Fisher ES, Sharp SM, Newhouse JP, Anderson G, Bubolz TA. Postsurgical mortality in

Manitoba and New England. JAMA. 1990; 263:2453-8.

20.↵ Gilliland TM, Traverso LW. Modern standards for comparison of cholecystectomy with alternative

treatments for symptomatic cholelithiasis with emphasis on long-term relief of symptoms. Surg Gynecol

Obstet.1990; 170:39-44.

21.↵ Morgenstern L, Wong L, Berci G. Twelve hundred open cholecystectomies before the laparoscopic

era. A standard for comparison. Arch Surg. 1992; 127:400-3.

22.↵ Andren-Sandberg A, Alinder G, Bengmark S. Accidental lesions of the common bile duct at

cholecystectomy. Ann Surg. 1985; 201:329-32.

23.↵ Raute M, Schaupp W. Iatrogenic bile duct injuries at cholecystectomy: treatment and results.

Langenbecks Arch Chir. 1988; 373:345-54.

24.↵ Cuschieri A, Dubois F, Mouiel J, Mouret P, Becker H, Buess G, et al. The European experience with

laparoscopic cholecystectomy. Am J Surg. 1991; 161:385-7.

25.↵ Dubois F, Berthelot G, Levard H. Laparoscopic cholecystectomy: historic perspective and personal

experience. Surg Lap Endos. 1991; 1:52-7.

26.↵ Grace PA, Quereshi A, Coleman J, Keans R, McEntee G, Broe P, et al. Reduced postoperative

hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991; 78:160-2.

27.↵ Perissat J, Collet D, Vitale G, Belliard R, Sosso M. Laparoscopic cholecystectomy using

intracorporeal lithotripsy. Am J Surg. 1991; 161:371-6.

28.↵ Peters JH, Gibbons GD, Innes JT, Nichols KE, Front ME, Roby SR, et al. Complications of

laparoscopic cholecystectomy. Surgery. 1991; 110:769-778.

29.↵ Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J

Med. 1991; 324:1073-8.

30.↵ Spaw AT, Reddick J, Olsen DO. Laparoscopic laser cholecystectomy: analysis of 500 procedures.

Surg Lap Endos. 1991; 1:2-7.