NCT00606762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
Last Updated

February 5, 2008

Status Verified

January 1, 2008

Enrollment Period

1.1 years

First QC Date

January 22, 2008

Last Update Submit

February 4, 2008

Conditions

Cholelithiasis

Keywords

laparoscopic cholecystectomylow pressure pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

  • Pain

    24 hours

Secondary Outcomes (1)

  • Pulmonary function

    24 hours

Study Arms (1)

LPLC, HPLC

ACTIVE COMPARATOR

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

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure

LPLC, HPLC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic gall stone disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sterling Hospital

Ahmedabad, Gujarat, 380052, India

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Vismit P Joshipura, MS

    Sterling Hospital, Ahmedabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

February 5, 2008

Record last verified: 2008-01

Locations

IN(1)