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Clinical Trials/CTRI/2023/11/059957
CTRI/2023/11/059957Not yet recruitingPhase 3

EARLY VERSUS DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS

NITU SINGH1 site in 1 country100 target enrollmentStarted: December 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY

Study Overview

Brief Summary

Acute cholecystitis isthe most common acute disease in hepatobiliary surgery and one of the mostcommon diseases in digestive tract surgery in general (1). With aging, theincidence increases from 4% in the third decade to 27% in the seventh decade oflife (2). Biliary calculosis is undoubtedly a disease of modern man. At least20% of the human population is thought to have cholelithiasis but inthe most developed countries of the world this percentage is higher. The factis that this disease is much more common in areas where the diet is irrational(fat-rich and high- calorie diet).

The incidence of thedisease increases with age.

Women of childbearing age are more likely to suffer than men(1.5-3.0:1). There is a 4F formula that is attractive but does not explain themechanism and occurrence of biliary calculosis (female, forty, fat andfertile). It should also be known that almost 50% of biliary lithiasis isasymptomatic and is detected accidentally during some clinical trials. Cholecystectomy is method of choicefor treatment of gallbladder calculosis.Open cholecystectomy has been the “gold standard†for symptomatic cholelithiasisfor a century. However, in the last two decades the introduction oflaparoscopic cholecystectomy has revolutionized the treatment of gallbladdercalculosis (4).

Laparoscopic cholecystectomy is nowconsidered to be the procedure of choice that achieves a shorter recoveryperiod and reduced treatment costs. In earlier years acute cholecystitis wasregarded as a relative contraindication for laparoscopic cholecystectomybecause of inflammatory changes that impair tissue quality and make it difï¬cultto accurately visualize anatomical structures.

As technological advances have beenaccompanied by improvements in surgical performance laparoscopy has become the“gold standard†in the treatment of chronic cholecystitis with cholelithiasis,and over time the indications widen and acute gallbladder inflammation is alsoresolved by laparoscopy.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Not Applicable

Eligibility Criteria

Ages
16.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients who have been clinically and radiologically diagnosed as acute cholecystitis along with patients who have been previously diagnosed as a case of cholecystitis brought to the hospital with acute attack and planned for laparoscopic cholecystectomy.

Exclusion Criteria

  • •All patients who are medically unfit for laparoscopic cholecystectomy 2)Persisting symptoms or failure of medication 3)Acute Calculus Cholecystitis with CBD stones 4)Perforation/peritonitis 5)Chronic Cholecystitis 6)Common bile duct stones 7)Carcinoma of Gall Bladder 8)Empyema Gall Bladder 9)Emphysematous Cholecystitis.

Outcomes

Primary Outcomes

EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY

Time Frame: 3 DAYS

Secondary Outcomes

  • Early laparoscopic cholecystectomy morbidity & mortality are similar to those of elective delayed cholecystectomy(12 months)
  • EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY(6 WEEKS)

Investigators

Sponsor
NITU SINGH
Sponsor Class
Other [self]

Study Sites (1)

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