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Completed

NCT Number: NCT00606762

Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sterling Hospital

Ahmedabad, Gujarat, 380052, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure

Primary outcomes

  1. Pain

    Time frame: 24 hours

Secondary outcomes

  1. Pulmonary function

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sterling Hospital

Other

Registry information

Official study title

A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 5, 2008
Registry last updated
Feb 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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