Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified April 2013 by Ludwig Boltzmann Institute for Operative Laparoscopy
Sponsor:
Information provided by (Responsible Party):
Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier:
NCT01667848
First received: July 27, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.


Condition
Cholecystolithiasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ludwig Boltzmann Institute for Operative Laparoscopy:

Primary Outcome Measures:
  • pain (rated with a visual analog scales) [ Time Frame: first day after operation ] [ Designated as safety issue: Yes ]
    postoperative pain (rated with a visual analog scales) and analgesic requirements at the first postoperative day


Secondary Outcome Measures:
  • core temperature [ Time Frame: one day postoperativly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 146
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
warmed, humidified carbon dioxide
warmed, humidified carbon dioxide insufflation vs standard carbon dioxide in laparoscopic cholecystectomy

Detailed Description:

Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic cholecystectomy will have less postoperative pain than patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation. The study design is a double-blind, prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included postoperative pain (rated with a visual analog scales) and analgesic requirements.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Clinical diagnosis of cholecystolithiasis

Criteria

Inclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis with cholecystitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667848

Contacts
Contact: Bettina Klugsberger, Dr 0732/7806-2133 Bettina.Klugsberger@akh.linz.at

Locations
Austria
2nd Surgical Department, Academic Teaching Hospital, AKH Linz Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Andreas Shamiyeh, Univ.-Doz.Dr         
Principal Investigator: Klugsberger Bettina, Dr.         
Sponsors and Collaborators
Ludwig Boltzmann Institute for Operative Laparoscopy
Investigators
Study Chair: Andreas Shamiyeh, Univ-Doz Dr Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
  More Information

Publications:
Responsible Party: Klugsberger Bettina, Dr.med, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT01667848     History of Changes
Other Study ID Numbers: LCHE0909
Study First Received: July 27, 2012
Last Updated: April 29, 2013
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Ludwig Boltzmann Institute for Operative Laparoscopy:
pain

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014