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Clinical Trials/CTRI/2025/08/092986
CTRI/2025/08/092986
Not yet recruiting
Not Applicable

Comparison of surgical stress response in standard pressure pneumoperitoneum versus isobaric pneumoperitoneum (gasless) in patients undergoing Laparoscopic cholecystectomy: A Randomized Controlled Study.

Maulana Azad medical College1 site in 1 country30 target enrollmentStarted: August 22, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 18-65 years.

Exclusion Criteria

  • Pregnancy and lactation.
  • Known case of Rheumatoid Arthritis, Inflammatory Bowel Disease.
  • BMI above 30 kg/m
  • Empyema Gallbladder.

Outcomes

Primary Outcomes

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.

Time Frame: Preoperative (8 am morning of surgery), immediate postoperative (during skin closure), and postoperative (2 hours and 24 hours after surgery) period.

Secondary Outcomes

  • Comparison of ACTH, Cortisol, IL-6, Neutrophil:Lymphocyte ratio(Early morning of surgery, 2 hours and 24 hours after surgery)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Soukat Ali Khan

Maulana Azad medical College

Study Sites (1)

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