Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy - Full Text View

Sponsor:	Sterling Hospital
Information provided by:	Sterling Hospital
ClinicalTrials.gov Identifier:	NCT00606762

Purpose

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.

Condition	Intervention
Cholelithiasis	Procedure: Laparoscopic cholecystectomy

Study Type:	Interventional
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
Official Title:	A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.

Resource links provided by NLM:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

Further study details as provided by Sterling Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	26
Study Start Date:	October 2006
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Procedure: Laparoscopic cholecystectomy Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606762

Locations

India
Sterling Hospital
Ahmedabad, Gujarat, India, 380052

Sponsors and Collaborators

Sterling Hospital

Investigators

Principal Investigator:

Vismit P Joshipura, MS

Sterling Hospital, Ahmedabad

More Information

No publications provided

Responsible Party:	Dr. Vismit P. Joshipura, Sterling Hospital
ClinicalTrials.gov Identifier:	NCT00606762 History of Changes
Other Study ID Numbers:	1-Joshipura
Study First Received:	January 22, 2008
Last Updated:	February 4, 2008
Health Authority:	India: Institutional Review Board

Keywords provided by Sterling Hospital:

laparoscopic cholecystectomy
low pressure pneumoperitoneum

Additional relevant MeSH terms:

Cholelithiasis
Cholecystolithiasis
Gallstones
Pneumoperitoneum
Biliary Tract Diseases

Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Peritoneal Diseases

ClinicalTrials.gov processed this record on February 12, 2012