Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

NCT ID: NCT00606762

Last Updated: 2008-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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LPLC, HPLC

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

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic cholecystectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sterling Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sterling Hospital

Principal Investigators

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Vismit P Joshipura, MS

Role: PRINCIPAL_INVESTIGATOR

Sterling Hospital, Ahmedabad

Locations

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Sterling Hospital

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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1-Joshipura

Identifier Type: -

Identifier Source: org_study_id

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