Clinical trial NCT01667848: Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy
Official title: Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystolithiasis
Keywords: pain
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of 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 criteria: Inclusion Criteria:

* Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

* Clinical diagnosis of cholecystolithiasis with cholecystitis

Primary outcomes:
measure: Pain (Rated With a Visual Analog Scale for Pain)
timeFrame: operation day
measure: Pain (Rated With a Visual Analog Scale for Pain)
timeFrame: first postoperative day
Secondary outcomes:
measure: Core Temperature
timeFrame: one day postoperativly
measure: Core Temperature
timeFrame: during operation
Other outcomes:
Locations:
city: Linz
country: Austria
facility: 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
state: Upper Austria
Study officials:
affiliation: Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
name: Andreas Shamiyeh, Univ-Doz Dr
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1001/archsurg.139.7.739.
citation: 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. doi: 10.1002/bjs.6304.
citation: 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. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.
citation: 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. doi: 10.1007/s00464-001-8237-0. Epub 2002 Mar 26.