| CTRI Number |
CTRI/2025/02/081340 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aims to find the best and safest way associated to inflate the belly with gas before a laparoscopic surgery. The study will compare three ways to insert this needle-
Above the belly button- Supraumbilical and Adjacent the belly button- Palmer and Jain Point for abdominal conditions |
|
Scientific Title of Study
|
Comparing Feasibility And Safety In Creation Of Pneumoperitoneum By Veress Needle Placed At Supraumbilical, Palmers And Jains Point In Laparoscopic Surgeries At A Tertiary Care Centre- A Randomised Control Trial |
| 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 Saubhagya Shikhar |
| Designation |
Junior Resident |
| Affiliation |
KLEs Jawaharlal Nehru Medical College and Dr Prabhakar Kore Hospital and MRC |
| Address |
Department Of General Surgery, Jawaharlal Nehru Medical College and KLEs Dr. Prabhakar Kore Hospital and MRC
Belgaum
KARNATAKA
590010
India |
| Phone |
7709386901 |
| Fax |
|
| Email |
sshikhar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Kenwadekar |
| Designation |
Professor |
| Affiliation |
KLEs Jawaharlal Nehru Medical College and Dr Prabhakar Kore Hospital and MRC |
| Address |
Department Of General Surgery, Jawaharlal Nehru Medical College and KLEs Dr. Prabhakar Kore Hospital and MRC
Belgaum
KARNATAKA
590010
India |
| Phone |
8073753341 |
| Fax |
|
| Email |
dr.rahuldk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saubhagya Shikhar |
| Designation |
Junior Resident |
| Affiliation |
KLEs Jawaharlal Nehru Medical College and Dr Prabhakar Kore Hospital and MRC |
| Address |
Department Of General Surgery, Jawaharlal Nehru Medical College and KLEs Dr. Prabhakar Kore Hospital and MRC
Belgaum
KARNATAKA
590010
India |
| Phone |
7709386901 |
| Fax |
|
| Email |
sshikhar22@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka, 590010 |
|
|
Primary Sponsor
|
| Name |
KLEs Dr Prabhakar Kore Hospital and MRC |
| Address |
KLEs Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka |
| 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 Saubhagya Shikhar |
KLEs Dr Prabhakar Kore Hospital & MRC |
Department Of General Surgery,Jawaharlal Nehru Medical College & KLEs Dr Prabhakar Kore Hospital & MRC, Nehru Nagar
Belgaum
KARNATAKA |
7709386901
sshikhar22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients Opting for Laparoscopic Surgery in any abdominal conditions. |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Surgeries |
To compare feasibility, time taken, re-insertion, conversion to open technique, intra-op and post-op complications while creating pneumoperitoneum via Veress Needle at three points namely Palmers, Jains and Supraumbilical point in all Laparoscopic surgeries. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent for study
Patients age more than 18 years
Patients fit for laparoscopic surgery |
|
| ExclusionCriteria |
| Details |
Patients with previous upper abdominal surgeries
Patients with peritonitis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time taken and need for re-insertion of veress needle for creating pneumoperitoneum in laparoscopic surgeries |
Baseline- intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare intra-op and post-op complications |
1 year |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
07/03/2025 |
| 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="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
|
This study is a RCT study to compare time taken, re-insertion, conversion to open technique, intra-op and post-op complications between three points namely Palmer’s , Jain’s and Supraumbilical to create pneumoperitoneum via Veress needle in all laparoscopic surgeries at a tertiary care center. The study duration is 1 year. |