Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT00606762
• Lead Sponsor: Sterling Hospital

Brief Summary

The physiological changes and postoperative pain are directly related with the degree of intra-abdominal pressure kept during the laparoscopy. The present study aims to examine difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function, arterial blood gas changes etc.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2008-01
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-04
• Last Update Submitted: 2008-02-04
• Study First Posted: 2008-02-05
• Last Update Posted: 2008-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• symptomatic gall stone disease

Exclusion Criteria

• pyocele
• gangrene of gall bladder
• history of cholangitis
• simultaneous CBD stones
• gall stone pancreatitis
• who does not give consent if they will be randomized to LPLC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPLC, HPLC	Laparoscopic cholecystectomy	LPLC: Low pressure pneumoperitoneum is defined as intraabdominal pressure kept at8 mm Hg after initial trocar insertion at 12 mm Hg HPLC: High pressure pneumoperitoneum is defined as intra abdominal pressure kept at 12 mm Hg throughout the procedure

Primary Outcome Measures

Name	Time	Method
Pain	24 hours

Secondary Outcome Measures

Name	Time	Method
Pulmonary function	24 hours

Trial Locations

Locations (1)

Sterling Hospital; 🇮🇳 Ahmedabad, Gujarat, India