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Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

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. Identifier: NCT00606762
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : February 5, 2008
Information provided by:
Sterling Hospital

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Laparoscopic cholecystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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.
Study Start Date : October 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00606762

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Sterling Hospital
Ahmedabad, Gujarat, India, 380052
Sponsors and Collaborators
Sterling Hospital
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Principal Investigator: Vismit P Joshipura, MS Sterling Hospital, Ahmedabad
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Responsible Party: Dr. Vismit P. Joshipura, Sterling Hospital Identifier: NCT00606762    
Other Study ID Numbers: 1-Joshipura
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: January 2008
Keywords provided by Sterling Hospital:
laparoscopic cholecystectomy
low pressure pneumoperitoneum
Additional relevant MeSH terms:
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Peritoneal Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical