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

History of Changes

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:

MedlinePlus related topics: Gallstones

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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:

Farley DR, Greenlee SM, Larson DR, Harrington JR. Double-blind, prospective, randomized study of warmed, humidified carbon dioxide insufflation vs standard carbon dioxide for patients undergoing laparoscopic cholecystectomy. Arch Surg. 2004 Jul;139(7):739-43; discussion 743-4.

Sammour T, Kahokehr A, Hill AG. Meta-analysis of the effect of warm humidified insufflation on pain after laparoscopy. Br J Surg. 2008 Aug;95(8):950-6. Review.

Yu TC, Hamill JK, Liley A, Hill AG. Warm, Humidified Carbon Dioxide Gas Insufflation for Laparoscopic Appendicectomy in Children: A Double-Blinded Randomized Controlled Trial. Ann Surg. 2012 Jul 20. [Epub ahead of print] PubMed PMID: 22824858.

Nguyen NT, Furdui G, Fleming NW, Lee SJ, Goldman CD, Singh A, Wolfe BM. Effect of heated and humidified carbon dioxide gas on core temperature and postoperative pain: a randomized trial. Surg Endosc. 2002 Jul;16(7):1050-4. Epub 2002 Mar 26.

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 May 23, 2013

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