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

Cholecystolithiasis Clinical Trial

Official title:

Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667848
• Other study ID #: LCHE0909
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2023
• Source: Kepler University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

• Clinical diagnosis of cholecystolithiasis with cholecystitis

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• Optitherm® device activated
The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.
• Optitherm® device inactivated
The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.

Locations

Country	Name	City	State
Austria	2nd Surgical Department, Academic Teaching Hospital, AKH Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (Rated With a Visual Analog Scale for Pain)	postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.; The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)	operation day
Primary	Pain (Rated With a Visual Analog Scale for Pain)	postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.; The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)	first postoperative day
Secondary	Core Temperature		one day postoperativly
Secondary	Core Temperature	core temperature during laparoscopic cholecystectomy using a rectal probe	during operation