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CTRI Number  CTRI/2022/11/047180 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 07/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of complications of laparoscopic cholecystectomy based on anatomy 
Scientific Title of Study   Complications of laparoscopic cholecystectomy in relation to the normal anatomy and variations in the extrahepatic biliary tree and vascular anatomy: A Cross-sectional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharad Seth 
Designation  Professor and Head 
Affiliation  Rohilkhand medical college and hospital  
Address  Department of General Surgery Room no.-2085 Rohilkhand medical college and hospital,near Suresh Sharma nagar, Bareilly, Uttar Pradesh 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9450364952  
Fax    
Email  sharadseth33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharad Seth 
Designation  Professor and Head 
Affiliation  Rohilkhand medical college and hospital  
Address  Department of General Surgery Room no. -2085 Rohilkhand medical college and hospital,near Suresh Sharma nagar, Bareilly, Uttar Pradesh 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9450364952  
Fax    
Email  sharad_seth2002@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhangi Tiwari 
Designation  Junior Resident 
Affiliation  Rohilkhand medical college and hospital  
Address  Department of General Surgery Rohilkhand medical college and hospital,near Suresh Sharma nagar, Bareilly, Uttar Pradesh 243006
Department of General Surgery Rohilkhand medical college and hospital,near Suresh Sharma nagar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  7898588879  
Fax    
Email  shubhangitiwari509@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College 
 
Primary Sponsor  
Name  Rohilkhand medical college and hospital  
Address  Rohilkhand medical college and hospital, near Suresh Sharma nagar, Bareilly, 243006 
Type of Sponsor  Private medical college 
 
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 
Dr Sharad seth  Rohilkhand medical college and hospital   Department of General Surgery Room no.1063 Rohilkhand medical college and hospital, near Suresh Sharma nagar , Bareilly, up 243006
Bareilly
UTTAR PRADESH 
9450364952

sharadseth33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patients between the ages 18-65 years who will undergo laparoscopic cholecystectomy for symptomatic cholelithiasis 
 
ExclusionCriteria 
Details  Perforated gall bladder
Previous abdominal surgery
Carcinoma of the gall bladder
Choledocholithiasis
American Society of Anaesthesiologists (ASA) grade 3 or 4 patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the complications of laparoscopic cholecystectomy in relation to the normal anatomy and variations in the extrahepatic biliary tree and vascular anatomy  one year 
 
Secondary Outcome  
Outcome  TimePoints 
1)To identify the anomalies of the extra hepatic biliary tree and vascular anatomy during laparoscopic cholecystectomy
2)To document the complications of laparoscopic cholecystectomy in those with normal anatomy and variations in the extrahepatic biliary tree and vascular anatomy with respect to :-
a. Time taken for surgery
b. Early and late complications of surgery

 
One year 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   N/A 
Date of First Enrollment (India)   15/11/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Ding Y.M., Wang B., Wang W.X., Wang P., Yan Y.S. New classification of the anatomic variations of cystic artery during laparoscopic cholecystectomy. World J. Gastroenterol.2007;13(42):5629–34 Hassan AU et al. Int J Res Med Sci. 2013;1(3):183-87 Khayat MF, Al-Amoodi MS, Aldaqal SM, Sibiany A. Abnormal Anatomical Variations of Extra-Hepatic Biliary Tract, and Their Relation to Biliary Tract Injuries and Stones Formation. Gastroenterology Res. 2014;7(1):12-16.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

​Cholecystectomy is one of the most frequent surgical  procedures performed as of today.The first successful open cholecystectomy was done in 1882 by Carl Langenbuch.

Philippe Mouret introduced laparoscopic cholecystectomy in France in 1987 and it quickly revolutionized the treatment of gallstone disease. It superseded open cholecystectomy, and ended attempts for non-invasive management of gallstones such as extracorporeal shock wave or cholangioscopic lithotripsy and medical therapies such as bile salts.

 

 

​Currently laparoscopic cholecystectomy is done for gallstones diseases like symptomatic gallstones, porcelain gallbladder, acute cholecystitis,  choledocholithiasis  and gallstone pancreatitis.It is also done for the other benign diseases of the biliary tree and gallbladder like biliary dyskinesia, acalculous cholecystitis and early stages of carcinoma gallbladder.

 

 

​Laparoscopic cholecystectomy has emerged as a safe and effective treatment for  multiple gallbladder diseases due to its advantages like : early return of bowel function, shorter duration of hospital stay, small incision, cosmetic satisfaction, low post operative pain, cost effectiveness and early return to full activity.

 

 

​Laparoscopic cholecystectomy involves removal of the gall bladder by placement of multiple laparoscopic ports in the abdomen and creation of pneumoperitoneum. The critical view of safety is visualised by clearing the hepatocystic and Calot’striangle.  In the critical view of safety the cystic duct and cystic artery can be seen entering the gallbladder which are then clipped. Once the cystic artery and the cystic duct are clipped the gall bladder is removed of the liver bed and taken out through the laparoscopic port. Thus during laparoscopic cholecystectomy correct identification of the anatomy the gall bladder, hepatoduodenal ligament, Calot’s triangle, hepatocystic triangle, cystic artery and cystic duct is crucial.

However classical description of the anatomy of extra hepatic biliary tree and its arteries is seen only in one out of three people. Variations in the extrahepatic biliary tree and vascular anatomy are the norm rather than an exception.

 

​Following laparoscopic cholecystectomy complications like wound infection, cardiovascular difficulties, retained stones, biliary leak, and conversion to open cholecystectomy are seen.6Variations in the extrahepatic biliary duct’s architecture have been linked to unintentional injury to biliary duct during laparoscopic cholecystectomy.7 Variations in the anatomy of vascular structures supplying the gall bladder and the extra hepatic biliary tree have been associated with increased rates of complications like excessive bleeding and conversion to open cholecystectomy.

 

 

​Despite laparoscopic cholecystectomy being the most commonly performed procedure worldwide, there are amultitude of complications with this procedure including those with variations in the gross and vascular anatomy of the gallbladder and extrahepatic biliary tree. Even though many anatomists and surgeons have documented the anomalies of the vascular and extrahepatic biliary tree, only few research publications have documented the operative and post operative complications for these variations, thus the need for this study.

 
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