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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667848
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : April 30, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cholecystolithiasis
Interventions Device: Optitherm® device activated
Device: Optitherm® device inactivated
Enrollment 148
Recruitment Details Approval from the local institutional ethics committee was obtained on June 2011. Between July 1st, 2011 and December 28nd, 2013, a total of 148 patients were scheduled for laparoscopic cholecystectomy at the General Hospital in Linz, Austria
Pre-assignment Details Patients converted intraoperative to open cholecystectomy or those undergoing a concomitant procedure were excluded from the study. Irregularities of the study protocol (absence of rectal probe, missing consent form, conversion to open cholecystectomy) entailed in exclusion of the study. Patients with acute cholecystitis were excluded of the study.
Arm/Group Title Group A: Insufflation With Cold Gas Group B: Insufflation With Warm Gas
Hide Arm/Group Description Insufflation with cold gas during laparoskopic cholecystectomy Insufflation with warm gas during laparoscopic cholecystectomy
Period Title: Overall Study
Started 67 81
Completed 67 81
Not Completed 0 0
Arm/Group Title Group A: Insufflation With Cold Gas Group B Total
Hide Arm/Group Description Insufflation with cold gas during laparoskopic cholecystectomy Insufflation with warm gas during laparoskopic cholecystectomy Total of all reporting groups
Overall Number of Baseline Participants 67 81 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 81 participants 148 participants
55.87  (14.44) 55.68  (16.93) 55.7  (15.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 81 participants 148 participants
Female
46
  68.7%
57
  70.4%
103
  69.6%
Male
21
  31.3%
24
  29.6%
45
  30.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 67 participants 81 participants 148 participants
67 81 148
1.Primary Outcome
Title Pain (Rated With a Visual Analog Scale for Pain)
Hide 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
Outcome Measure Data Not Reported
2.Primary Outcome
Title Pain (Rated With a Visual Analog Scale for Pain)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Insufflation With Cold Gas Group B
Hide Arm/Group Description:
Insufflation with cold gas during laparoskopic cholecystectomy
Insufflation with warm gas during laparoskopic cholecystectomy
Overall Number of Participants Analyzed 67 81
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-10
2.22  (0.97) 1.92  (0.84)
3.Secondary Outcome
Title Core Temperature
Hide Description [Not Specified]
Time Frame one day postoperativly
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Core Temperature
Hide Description core temperature during laparoscopic cholecystectomy using a rectal probe
Time Frame during operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A: Insufflation With Cold Gas Group B
Hide Arm/Group Description:
Insufflation with cold gas during laparoskopic cholecystectomy
Insufflation with warm gas during laparoskopic cholecystectomy
Overall Number of Participants Analyzed 67 81
Mean (Standard Deviation)
Unit of Measure: degree celsius
36.85  (0.46) 37.07  (0.35)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description Insufflation with cold gas during laparoscopic cholecystectomy Insufflation with warm gas during laparoscopic cholecystectomy
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/81 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/81 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bettina Klugsberger
Organization: LudwigBoltzmannIOL
Phone: +43 732 7806 2133
EMail: Bettina.Klugsberger@akh.linz.at
Layout table for additonal information
Responsible Party: Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT01667848    
Other Study ID Numbers: LCHE0909
First Submitted: July 27, 2012
First Posted: August 17, 2012
Results First Submitted: September 30, 2013
Results First Posted: April 30, 2014
Last Update Posted: May 15, 2014