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Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00606762
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : February 5, 2008
Sponsor:
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

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 ]


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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

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

Responsible Party: Dr. Vismit P. Joshipura, Sterling Hospital
ClinicalTrials.gov Identifier: NCT00606762     History of Changes
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:
Pneumoperitoneum
Cholelithiasis
Cholecystolithiasis
Gallstones
Peritoneal Diseases
Digestive System Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical