| CTRI Number |
CTRI/2024/10/075633 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2026 |
| 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 Outcomes Between The Conventional And Modified Epigastric Port Insertion Techniques In Laparoscopic Cholecystectomy
|
|
Scientific Title of Study
|
A Randomized Controlled Trial To Compare The Outcomes Between The Conventional And Modified Epigastric Port Insertion Techniques In 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 |
Arunkumar V |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute
of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8884842973 |
| Fax |
|
| Email |
velarun95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute
of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9891981331 |
| Fax |
|
| Email |
dramit2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arunkumar V |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of General Surgery, Level 6, Medical college building, All India Institute
of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249203
India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8884842973 |
| Fax |
|
| Email |
velarun95@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh,Uttrakhand,India,249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Rishikesh, Uttrakhand, India,249203 |
| Type of Sponsor |
Government 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 Arunkumar V |
All India Institute of Medical Sciences, Rishikesh |
C block,Level 5,division 531,
IPD,Department of General
Surgery, All India Institute of
Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL |
8884842973
velarun95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical sciences,Rishikesh, Instituitional Ethics committee |
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 |
| Comparator Agent |
Conventional epigastric port insertion |
In conventional group, after making skin incision 2 cm below the below the xiphoid, abdomen will be entered on right side of falciform ligament. |
| Intervention |
Modified Epigastric port insertion |
Epigastric port in this group, will be inserted under direct vision through the linea alba after making skin incision 2 finger breadth below the xiphoid. After entering the abdomen falciform ligament is pierced from left to right and port will be positioned towards gallbladder |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective laparoscopic cholecystectomy in the age group of 18 years and above.
|
|
| ExclusionCriteria |
| Details |
1)Suspected malignancy
2)Pregnant patient
3)Frozen calots with or without surrounding dense adhesions
4)Patients who require CBD exploration
5)Cases that get converted to open
6)Patients with portal hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative epigastric port site pain using VAS score between the conventional and modified epigastric port insertion techniques in laparoscopic cholecystectomy
|
6 hours, 12 hours and 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken for extraction of gall bladder between the
modified epigastric port insertion group and conventional epigastric port
group in laparoscopic cholecystectomy. |
Intraoperative
|
To compare the total duration of surgery between the modified epigastric
port insertion group and the conventional epigastric port group in
laparoscopic cholecystectomy |
Intraoperative |
To compare the 30 day epigastric wound complication rate using
Southampton scale between both the groups. |
Postoperative day 30 |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Laparoscopic cholecystectomy (LC) is one of the most frequently done abdominal surgeries and is the standard of care for symptomatic cholelithiasis. LC is associated with good surgical results, insignificant blood loss, reduced severity of postoperative pain, and early discharge. Port site pain depends on the type and the method of trocar insertion as well as the nociceptive impulse can be from both the skin incision and the muscle damage and intramuscular hematoma that can occur during the port insertion. One of the important aspects of laparoscopic cholecystectomy is the proper port position in relation to the target organ of dissection. Although there is no controversy about the position of umbilical, right subcostal (midclavicular) and right anterior axillary ports in laparoscopic cholecystectomy, but there is no uniform consensus about the position of epigastric port. Conventionally epigastric port is inserted to the right of falciform ligament. In literature, position to the left of ligament is also mentioned. As in the modified technique of epigastric port insertion the port is inserted directly under vision through the linea alba instead of the muscle fibres there is less expected chances of muscle injury and intramuscular bleed. Lack of literature comparing both the above-mentioned techniques of epigastric port insertion especially with respect to the epigastric port site pain.The purpose of this study is to define the optimal epigastric port position for laparoscopic cholecystectomy by comparing the outcomes between conventional and modified epigastric port insertion techniques in laparoscopic cholecystectomy with respect to parameters like postoperative pain, total requirement of postoperative analgesia, gallbladder retrieval time, total duration of surgery and port site infection (SSI). |