Clinical Trials Logo
  1. Home
  2. Cholelithiasis
  3. NCT00606762
  4. Details
NCT00606762 Clinical Trial

Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:
A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00606762
Other study ID # 1-Joshipura
Secondary ID
Status Completed
Phase N/A
First received January 22, 2008
Last updated February 4, 2008
Start date October 2006
Est. completion date December 2007

Study information
Verified date January 2008
Source Sterling Hospital
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
India Sterling Hospital Ahmedabad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Sterling Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain 24 hours No
Secondary Pulmonary function 24 hours No
See also
  Status Clinical Trial Phase
Completed NCT00530998 - Minimally Invasive Surgery: Using Natural Orfices
Completed NCT00616616 - Single Incision Laparoscopy N/A
Recruiting NCT00416234 - Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis N/A
Recruiting NCT05975385 - Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy N/A
Recruiting NCT06038201 - Cholecystectomy vs EUS-guided GBD With Stone Removal N/A
Not yet recruiting NCT03981315 - Bile Composition in Healthy and Gallstones Patients
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Completed NCT00971750 - Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients N/A
Active, not recruiting NCT04279223 - Does Using a 5 mm Telescope in Laparoscopic Cholecystectomy Reduce the Incidence of Trocar Site Hernia? N/A
Terminated NCT01708109 - Optimal Handling of Common Bile Duct Calculus, a Prospective Study N/A
Completed NCT01881399 - Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy N/A
Withdrawn NCT01146184 - Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) N/A
Terminated NCT00910325 - Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy Phase 1/Phase 2
Completed NCT04672902 - Treatment of Mirizzi Syndrome
Completed NCT03180229 - Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy Phase 4
Completed NCT02375529 - A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy N/A
Not yet recruiting NCT01339325 - Laparo-endoscopic Single Site (LESS) Cholecystectomy Versus Standard LAP-CHOLE Phase 4
Terminated NCT00486655 - NOTES-Assisted Laparoscopic Cholecystectomy Surgery N/A
Completed NCT00131131 - Epidemiology of Gallbladder Sludge and Stones in Pregnancy N/A
Terminated NCT00042549 - Lithotripsy for the Treatment of Gallstones Phase 4