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CTRI Number  CTRI/2023/11/059957 [Registered on: 17/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision between early laparoscopic cholecystectomyand delayed laparoscopic cholecystectomy in acute cholecystitis. 
Scientific Title of Study   EARLY VERSUS DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NITU SINGH  
Designation  POST GRADUATE TRAINEE  
Affiliation  SILCHAR MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL

Cachar
ASSAM
788014
India 
Phone  8210596588  
Fax    
Email  nitus0803@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SIDDHARTHA SANKAR BHATTACHARJEE  
Designation  ASSOCIATE PROFESSOR  
Affiliation  SILCHAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL

Cachar
ASSAM
788014
India 
Phone  9435071196  
Fax    
Email  sidharth_dr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  SIDDHARTHA SANKAR BHATTACHARJEE  
Designation  ASSOCIATE PROFESSOR  
Affiliation  SILCHAR MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL

Cachar
ASSAM
788014
India 
Phone  9435071196  
Fax    
Email  sidharth_dr@yahoo.com  
 
Source of Monetary or Material Support  
Silchar Medical College and Hospital,Ghungoor,Masinpur,Silchar,Uttar Krishnapur, Assam ,788014 
 
Primary Sponsor  
Name  NITU SINGH  
Address  SILCHAR MEDICAL COLLEGE AND HOSPITAL,GHUNGOOR, MASINPUR,SILCHAR, UTTAR KRISHNAPUR, ASSAM, 788014 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNITU SINGH  SILCHAR MEDICAL COLLEGE AND HOSPITAL   OFFICE ROOM OF SURGERY DEPARTMENT ,1ST FLOOR, DEPARTMENT OF SURGERY ,SILCHAR MEDICAL COLLEGE AND HOSPITAL
Cachar
ASSAM 
8210596588

nitus0803@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Silchar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis, (2) ICD-10 Condition: K810||Acute cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DELAYED LAPAROSCOPIC CHOLECYSTECTOMY   DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS  
Intervention  EARLY LAPAROSCOPIC CHOLECYSTECTOMY   EARLY LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1)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 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY   3 DAYS  
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Acute cholecystitis is the most common acute disease in hepatobiliary surgery and one of the most common diseases in digestive tract surgery in general (1). With aging, the incidence increases from 4% in the third decade to 27% in the seventh decade of life (2). Biliary calculosis is undoubtedly a disease of modern man. At least 20% of the human population is thought to have cholelithiasis but in the most developed countries of the world this percentage is higher. The fact is that this disease is much more common in areas where the diet is irrational (fat-rich and high- calorie diet).

The incidence of the disease 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 the mechanism and occurrence of biliary calculosis (female, forty, fat and fertile). It should also be known that almost 50% of biliary lithiasis is asymptomatic and is detected accidentally during some clinical trials. Cholecystectomy is method of choice for treatment of gallbladder calculosis. Open cholecystectomy has been the “gold standard” for symptomatic cholelithiasis for a century. However, in the last two decades the introduction of laparoscopic cholecystectomy has revolutionized the treatment of gallbladder calculosis (4).

Laparoscopic cholecystectomy is now considered to be the procedure of choice that achieves a shorter recovery period and reduced treatment costs. In earlier years acute cholecystitis was regarded as a relative contraindication for laparoscopic cholecystectomy because of inflammatory changes that impair tissue quality and make it difficult to accurately visualize anatomical structures.

As technological advances have been accompanied 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 also resolved by laparoscopy.

 
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