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Comparing Postoperative Recovery and Inflammatory markers in Low vs. Standard Pressure Pneumoperitoneum among Laparoscopic Cholecystectomy Patients.

Effect of Low-Pressure Pneumoperitoneum versus Standard Pressure on Post-operative discomfort and changes in various Inflammatory markers in Laparoscopic Cholecystectomy: A Randomized Control Trial. - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071458
Enrollment
100
Registered
2024-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K802- Calculus of gallbladder without cholecystitis Health Condition 3: K802- Calculus of gallbladder without cholecystitis Health Condition 4: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Low Pressure Pneumoperitoneum/ Group A: They will be scheduled to undergo laparoscopic cholecystectomy at a low-pressure Laparoscopic cholecystectomy (LPLC), that is defined as a gas in

Sponsors

AIIMS Gorakhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Any age ranges from 18 to 60 years old. 2. Both sex included with Low Anesthetic Risk Score of 1 or 2 according to the American Society of Anesthesiologists (ASA). 3. Mild to moderate cholecystitis and simple symptomatic gallbladder stone disease, as confirmed by USG.

Exclusion criteria

Exclusion criteria: 1. Gall bladder malignancy. 2. Acute cholecystitis. 3. Choledocholithiasis. 4. H/O ERCP with and without a stent in place. 5. Other causes of shoulder pain such subacromial bursitis, rheumatoid arthritis, tendinitis, and other musculoskeletal conditions; coronary artery diseases; COPD; asthma; history of cancer; jaundice; or any other co-morbidity. 6. Who had previous upper abdomen surgery. 7. BMIs below 18.5 or above 29.9. 8. ASA grades III, IV, or ,V. 9. Cognitive impairment, long-term painkiller use, or a history of alcohol addiction. 10. People who have been found with acute cholecystitis by ultrasonography or who have had it in the past.

Design outcomes

Primary

MeasureTime frame
1. To determine if there is a significant difference in pain levels, as measured by the Visual Analogue Score (VAS), at four pre determined time points: 6hours, 12 hours, 24 hours, and 7 days post-operation among patients undergoing laparoscopic cholecystectomy with low- pressure pneumoperitoneum compared to standard pressure. 2.To evaluate significant changes in inflammatory markers from baseline values in the same patient population.Timepoint: 6hours, 12 hours, 24 hours, and 7 days Post-Laparoscopic Cholecystectomy

Secondary

MeasureTime frame
To assess and compare theneed for additional pain medicationpost-operationbetween the low-pressure and standard-pressure pneumoperitoneum groups. To record and compare the length of time the surgery takes under low-pressure versus standard-pressure pneumoperitoneum. To evaluate and compare the level of difficulty experienced by the surgeon during the procedure in both groups To note and compare the necessity of placing adrain during or after the surgery in both patient groups. To monitor and compare the length ofthe hospital stay post-surgery between thetwo groups.Timepoint: intra op ,6hr,12hr,24hr and 7 days

Countries

India

Contacts

Public ContactSWATI PRASAD

ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR

dr.dharmendrapipal2007@gmail.com7488378703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026