Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
Sterling Hospital
ClinicalTrials.gov Identifier:
NCT00606762
First received: January 22, 2008
Last updated: February 4, 2008
Last verified: January 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014