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

Primary Purpose

Cholecystolithiasis

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Optitherm® device activated

Optitherm® device inactivated

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

Clinical diagnosis of cholecystolithiasis with cholecystitis

Sites / Locations

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

group B: Insufflation with warm gas

group A: Insufflation with cold gas

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Core Temperature

core temperature during laparoscopic cholecystectomy using a rectal probe

Full Information

NCT ID

NCT01667848

First Posted

July 27, 2012

Last Updated

October 3, 2023

Sponsor

Kepler University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01667848

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kepler University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystolithiasis

Keywords

pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group B: Insufflation with warm gas

Arm Type

Experimental

Arm Description

Arm Title

group A: Insufflation with cold gas

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Optitherm® device activated

Other Intervention Name(s)

Optitherm® device (Storz, Tuttlingen, Germany)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Optitherm® device inactivated

Other Intervention Name(s)

Optitherm® device (Storz, Tuttlingen, Germany)

Intervention Description

The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.

Primary Outcome Measure Information:

Title

Pain (Rated With a Visual Analog Scale for Pain)

Description

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)

Time Frame

operation day

Title

Pain (Rated With a Visual Analog Scale for Pain)

Description

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)

Time Frame

first postoperative day

Secondary Outcome Measure Information:

Title

Core Temperature

Time Frame

one day postoperativly

Title

Core Temperature

Description

core temperature during laparoscopic cholecystectomy using a rectal probe

Time Frame

during operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of cholecystolithiasis Exclusion Criteria: Clinical diagnosis of cholecystolithiasis with cholecystitis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Shamiyeh, Univ-Doz Dr

Organizational Affiliation

Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Official's Role

Study Chair

Facility Information:

Facility Name

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4020

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

15249406

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.

Results Reference

background

PubMed Identifier

18618870

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.

Results Reference

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PubMed Identifier

22824858

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.

Results Reference

background

PubMed Identifier

12165821

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.

Results Reference

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

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