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

Not Applicable

Completed

• Conditions: Cholecystolithiasis
• Interventions: Device: Optitherm® device inactivated; Device: Optitherm® device activated

• Registration Number: NCT01667848
• Lead Sponsor: Kepler University Hospital

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Results First Submitted: 2013-09-30
• Results First Submitted QC: 2014-03-30
• Results First Posted: 2014-04-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Clinical diagnosis of cholecystolithiasis

Exclusion Criteria

• Clinical diagnosis of cholecystolithiasis with cholecystitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A: Insufflation with cold gas	Optitherm® device inactivated	group A: Insufflation with cold gas during laparoscopic cholecystectomy, the use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A
group B: Insufflation with warm gas	Optitherm® device activated	Insufflation with warmed, humidified carbon dioxide insufflation during laparoscopic cholecystectomy using the optitherm® device 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.

Primary Outcome Measures

Name	Time	Method
Pain (Rated With a Visual Analog Scale for Pain)	first postoperative day	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)

Secondary Outcome Measures

Name	Time	Method
Core Temperature	during operation	core temperature during laparoscopic cholecystectomy using a rectal probe

Trial Locations

Locations (1)

2nd Surgical Department, Academic Teaching Hospital, AKH Linz; 🇦🇹 Linz, Upper Austria, Austria