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CTRI Number  CTRI/2024/02/062432 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 06/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the complications like pain, hernia and operation site infection after surgery between the umbilicus and below the chest bone keyhole in patients undergoing keyhole cholecystectomy 
Scientific Title of Study   A randomized controlled trial of Epigastric vs Umbilical port site gall bladder Retrieval to evaluate postoperative Outcomes in patients undergoing laparoscopic cholecystectomy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramesh Tony 
Designation  PG Registrar 
Affiliation  christian medical college 
Address  Room number 1206 General Surgery unit IV office Paul brand building Christian medical college

Vellore
TAMIL NADU
632004
India 
Phone  9080767672  
Fax    
Email  srameshtony@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suchita Chase 
Designation  Professor 
Affiliation  christian medical college 
Address  Room number 1206 General Surgery unit IV office Paul brand building Christian medical college

Vellore
TAMIL NADU
632004
India 
Phone  8870912727  
Fax    
Email  suchitachase@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramesh Tony 
Designation  PG Registrar 
Affiliation  christian medical college 
Address  Room number 1206 General Surgery unit IV office Paul brand building Christian medical college

Vellore
TAMIL NADU
632004
India 
Phone  9080767672  
Fax    
Email  srameshtony@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Ida scudder road, vellore Tamilnadu 632004 
 
Primary Sponsor  
Name  christian medical college 
Address  IDA Scudder Road, Vellore, Tamil Nadu 632004 
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 Ramesh Tony  Christian medical college Hospital  Room number 1206 General surgery unit IV office Paulbrand building 2nd floor
Vellore
TAMIL NADU 
9080767672

srameshtony@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - Retrieval of gall bladder through umbilical port  In laparoscopic cholecystectomy, the retrieval of gall bladder will be randomized. Here the retrieval through the umbilical port site will be sectioned as Group A and postoperative outcomes like pain, postop op site occurrence measured and total duration of the study 14 months 
Comparator Agent  Group B - Retrieval of gall bladder through epigastric port  In laparoscopic cholecystectomy, the retrieval of gall bladder will be randomized. Here the retrieval through the epigastric port site will be sectioned as Group B and postoperative outcomes like pain, postop op site occurrence measured and total duration of study 14 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  I. Persons of age between 18-75years who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis, gall bladder polyp in surgery unit IV of CMC
II. Persons of age between 18-75years who are undergoing interval Laparoscopic cholecystectomy for acute cholecystitis in surgery unit IV of CMC
 
 
ExclusionCriteria 
Details  I. Acute cholecystitis, empyema GB, mucocele of GB
II. Suspected/proven malignancy of GB
III. Patients undergoing other surgical interventional (eg. Hernia repair) procedures along with laparoscopic cholecystectomy for benign GB disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Assess postoperative pain using Visual Analog scale  Postoperative pain assessment using Visual Analog Scale at 6 12 24 36 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Port site occurrence like seroma, hematoma & infection
Difficulty in GB retrieval by means of time taken for retrieval, GB/Endo bag perforation & multiple stones or single large stone that made retrieval difficult.
Port site hernia
 
For port site occurrence assessment – postoperatively followed up on the day of discharge & 1st follow up visit after discharge
1 month follow up telephonically or OPD visit
6 months follow up for port site hernia through telephonically or OPD visit
 
 
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   N/A 
Date of First Enrollment (India)   19/02/2024 
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  

Since the advent of minimal invasive surgery, laparoscopic cholecystectomy has taken a storm and becomes a preferred procedure for all benign gall bladder condition.  Though it has become the standard procedure, there is still a debate between which port to be used for gall bladder retrieval during four port laparoscopic cholecystectomy. Our study aims to compare the postoperative site pain, surgical site occurrence, difficulty in retrieval of GB and port site hernia after gall bladder (GB) retrieval through the umbilical vs epigastric port site.

This will be a randomized control trial in which total number of patients who are planned for elective cholecystectomy by surgery unit 4 will be chosen and they would be randomized in to two groups: (A) the umbilical port group (GB retrieval through the umbilical port) and (B) the epigastric port group (GB retrieval through the epigastric port).  Both the groups will be prepared similarly in their preoperative period. Laparoscopic cholecystectomy (LC) shall be done by the experienced surgeon. The GB specimen will be removed via umbilical or epigastric port depending upon the allocation of groups using a retrieval bag. Their pain at the respective port site to be assessed by visual analog scale (VAS) at 6, 12, 24 and 36 hours postoperatively as mentioned in the methodology. Wound to be inspected for surgical site occurrence on the day of discharge and 1st follow up visit after discharge. Following that patient shall be followed up telephonically on day 30 to enquire about the status of the surgical site.  Postoperative analgesic of choice will be similar between both the groups mainly bupivacaine locally at the port site following that Injection paracetamol and Tramadol/Diclofenac depending on the renal status of the patient on Day 1 and to be changed to oral tablets on subsequent postoperative days. Then difficulty in retrieval of GB between ports would be assessed by time taken for removal, rupture of the Endo bag, single large stone and presence of multiple stone. Presence of port site hernia at the respective port to be assessed in 6 months, follow up post-surgery. Then all the data will be collected, analyzed to compare the postoperative site pain and surgical site infection after GB retrieval through the umbilical vs epigastric port site in patients undergoing four port elective LC.

 
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