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Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606762
First Posted: February 5, 2008
Last Update Posted: February 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sterling Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.

Further study details as provided by Sterling Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 24 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Vismit P. Joshipura, Sterling Hospital
ClinicalTrials.gov Identifier: NCT00606762     History of Changes
Other Study ID Numbers: 1-Joshipura
First Submitted: January 22, 2008
First Posted: February 5, 2008
Last Update Posted: February 5, 2008
Last Verified: January 2008

Keywords provided by Sterling Hospital:
laparoscopic cholecystectomy
low pressure pneumoperitoneum

Additional relevant MeSH terms:
Pneumoperitoneum
Cholelithiasis
Cholecystolithiasis
Gallstones
Peritoneal Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical