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Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
Sterling Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cholelithiasis focused on measuring laparoscopic cholecystectomy, low pressure pneumoperitoneum

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sterling Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

LPLC, HPLC

Arm Description

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

Outcomes

Primary Outcome Measures

Pain

Secondary Outcome Measures

Pulmonary function

Full Information

First Posted
January 22, 2008
Last Updated
February 4, 2008
Sponsor
Sterling Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00606762
Brief Title
Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy
Official Title
A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sterling Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
laparoscopic cholecystectomy, low pressure pneumoperitoneum

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LPLC, HPLC
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure
Primary Outcome Measure Information:
Title
Pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pulmonary function
Time Frame
24 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vismit P Joshipura, MS
Organizational Affiliation
Sterling Hospital, Ahmedabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sterling Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

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