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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01667848
Other study ID # LCHE0909
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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