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
|
|
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
|
|
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. |