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CTRI Number  CTRI/2025/08/092214 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparing two ways to remove gall bladder in Keyhole surgery-Through the belly button v/s Upper abdomen.  
Scientific Title of Study   A comparative study of gall bladder extraction techniques in Laparoscopic Cholecystectomy- Umbilical port v/s Epigastric port 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pranay Shukla 
Designation  Junior Resident 
Affiliation  Kasturba hospital, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7355620452  
Fax    
Email  pranay.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Ramesh Udupi 
Designation  Assistant Professor 
Affiliation  Kasturba hospital, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09643488922  
Fax    
Email  vivek.udupi@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Ramesh Udupi 
Designation  Assistant Professor 
Affiliation  Kasturba hospital, Manipal 
Address  Department of General Surgery, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09643488922  
Fax    
Email  vivek.udupi@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka -576104 
 
Primary Sponsor  
Name  Dr Pranay Shukla 
Address  Department of General Surgery, Kasturba Medical College, Manipal, Udupi, Karnataka - 576104 
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 
DrVivek Ramesh Udupi  Kasturba Medical College and Hospital  Department of General Surgery,3rd Floor, New OPD Block, Kasturba Hospital, Manipal, Udupi-576104, Karnataka
Udupi
KARNATAKA 		 9643488922

vivek.udupi@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and Kasturba hospital institutional ethics committee- 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients with symptomatic gall stone disease or previously treated acute cholecystitis planned for interval laparoscopic cholecystectomy. 
 
ExclusionCriteria 
Details  -Age less than 18 yrs.
-Emergency laparoscopic cholecystectomy (Acute cholecystitis, empyema or gangrenous gallbladder.)
-Suspected or confirmed gall bladder carcinoma
-Conversion to open
-Retrieval done without using endo bag
-Other laparoscopic surgeries done along with laparoscopic cholecystectomy
-History of laparoscopic surgeries in the past with umbilical or epigastric ports .
-Laparoscopic cholecystectomy done without using two 10mm ports.
-Diagnosed case of umbilical hernia with primary repair done during laparoscopic cholecystectomy.
-Perioperative TAP block for port site.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare post operative pain at extraction site using VAS score between the two techniques of gallbladdder extraction techniques.  POD 1, 1st follow up and 3months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare outcomes of extraction techniques in laparoscopic cholecystectomy in terms of SSI, postoperative stay, and incidences of port site hernia.  POD 1, 1st follow up and 3 months after surgery. 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The procedure for this study involves enrolling patients scheduled for elective laparoscopic cholecystectomy who meet the inclusion criteria. After obtaining informed preoperative consent, standard laparoscopic cholecystectomy is performed wherein the gallbladder is dissected and placed in an endobag for retrieval. Depending on the surgeon’s preference, the gallbladder is extracted either through the umbilical port or the epigastric port—both of which are standard 10 mm working ports used in the surgery.No randomization is involved, and patients are grouped based on the port used for extraction. Postoperative pain is managed uniformly with intravenous paracetamol 1 gram every 8 hours. Pain scores are assessed using the Visual Analog Scale (VAS) on postoperative day 1, during the first follow-up visit, and again at 3 months via telephone. Additional parameters recorded include the duration of the retrieval process, surgical site infection rates at the extraction port, postoperative hospital stay, and development of port-site hernia at 3 months. Data is collected in a standardized pro forma and subjected to statistical analysis to determine the significance of differences between the two extraction techniques.  
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