Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

January 22, 2008

Last Updated Date

February 4, 2008

Start Date ^ICMJE

October 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00606762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pulmonary function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Health Services Research, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cholelithiasis

Intervention ^ICMJE

Procedure: Laparoscopic cholecystectomy

Study Arms / Comparison Groups

Active Comparator: 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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00606762

Responsible Party

Dr. Vismit P. Joshipura, Sterling Hospital

Study ID Numbers ^ICMJE

1-Joshipura

Study Sponsor ^ICMJE

Sterling Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vismit P Joshipura, MS

Sterling Hospital, Ahmedabad

Information Provided By

Sterling Hospital

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP