| CTRI Number |
CTRI/2025/08/092986 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of surgical stress response in standard pressure pneumoperitoneum versus isobaric pneumoperitoneum (gasless) in patients undergoing Laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of surgical stress response in standard pressure pneumoperitoneum versus isobaric pneumoperitoneum (gasless) in patients undergoing Laparoscopic cholecystectomy: A Randomized Controlled Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soukat Ali Khan |
| Designation |
Post graduate resident, Department of General Surgery |
| Affiliation |
Maulana Azad medical College |
| Address |
Balmiki basti
Dr B C Roy hostel, Balmiki basti, New Delhi, 110002
New Delhi
DELHI
110002
India |
| Phone |
09564236711 |
| Fax |
|
| Email |
soukatkhan5822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soukat Ali Khan |
| Designation |
Post graduate resident, Department of General Surgery |
| Affiliation |
Maulana Azad medical College |
| Address |
Narayanpur
Narayanpur, Amiya narayanpur, west Bengal 741165
Nadia
WEST BENGAL
741165
India |
| Phone |
09564236711 |
| Fax |
|
| Email |
soukatkhan5822@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soukat Ali Khan |
| Designation |
Post graduate resident, Department of General Surgery |
| Affiliation |
Maulana Azad medical College |
| Address |
Narayanpur
Narayanpur, Amiya narayanpur, west Bengal 741165
Nadia
WEST BENGAL
741165
India |
| Phone |
09564236711 |
| Fax |
|
| Email |
soukatkhan5822@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
New Delhi, india, 110002 |
| 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 |
| Soukat Ali Khan |
Maulana Azad medical College |
New Delhi, india, 110002
Central
DELHI |
09564236711
soukatkhan5822@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Cholecystectomy |
Laparoscopic cholecystectomy and Comparison of hs-CRP, ACTH, Cortisol, IL-6, Neutrophil:Lymphocyte ratio |
| Comparator Agent |
Laparoscopic cholecystectomy (Gasless) |
Laparoscopic cholecystectomy and Comparison of hs-CRP, ACTH, Cortisol, IL-6, Neutrophil:Lymphocyte ratio |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18-65 years |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation.
Known case of Rheumatoid Arthritis, Inflammatory Bowel Disease.
BMI above 30 kg/m2.
Empyema Gallbladder.
|
|
|
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 |
| Percentage change in hs-CRP in Laparoscopic Cholecystectomy with standard pressure pneumoperitoneum and isobaric pneumoperitoneum(gasless) at preoperative (8 am morning of surgery), immediate postoperative (during skin closure), and postoperative (2 hours and 24 hours after surgery) period. |
Preoperative (8 am morning of surgery), immediate postoperative (during skin closure), and postoperative (2 hours and 24 hours after surgery) period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of ACTH, Cortisol, IL-6, Neutrophil:Lymphocyte ratio |
Early morning of surgery, 2 hours and 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2025 |
| 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 Yet Recruiting |
| 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
|
To compare surgical stress response in standard pressure pneumoperitoneum versus isobaric pneumoperitoneum (gasless) in patients undergoing laparoscopic cholecystectomy in terms of hs-CRP.
PRIMARY OBJECTIVES: To compare surgical stress response in terms of hs-CRP in both groups.
SECONDARY OBJECTIVES: To compare ACTH, Cortisol, IL-6, Neutrophil:Lymphocyte ratio in both groups. To compare postoperative pain and duration of hospital stay in both groups.
|