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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00606762
Other study ID # 1-Joshipura
Secondary ID
Status Completed
Phase N/A
First received January 22, 2008
Last updated February 4, 2008
Start date October 2006
Est. completion date December 2007

Study information

Verified date January 2008
Source Sterling Hospital
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research


Intervention

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

Locations

Country Name City State
India Sterling Hospital Ahmedabad Gujarat

Sponsors (1)

Lead Sponsor Collaborator
Sterling Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 24 hours No
Secondary Pulmonary function 24 hours No
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