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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
Intervention / Comparator Agent
|
|
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. |