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

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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 Description
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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.

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Device: Optitherm® device activated Device: Optitherm® device inactivated Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial
Study Start Date : July 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: group B: Insufflation with warm gas
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.
 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.
Other Name: Optitherm® device (Storz, Tuttlingen, Germany)
Experimental: group A: Insufflation with cold gas
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
 Device: 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.
Other Name: Optitherm® device (Storz, Tuttlingen, Germany)


Outcome Measures
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Primary Outcome Measures :
  1. Pain (Rated With a Visual Analog Scale for Pain) [ Time Frame: operation 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)


  2. Pain (Rated With a Visual Analog Scale for Pain) [ Time Frame: 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 :
  1. Core Temperature [ Time Frame: one day postoperativly ]
  2. Core Temperature [ Time Frame: during operation ]
    core temperature during laparoscopic cholecystectomy using a rectal probe


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis with cholecystitis
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667848


Locations
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Austria
2nd Surgical Department, Academic Teaching Hospital, AKH Linz
Linz, Upper Austria, Austria, 4020
Sponsors and Collaborators
Ludwig Boltzmann Institute for Operative Laparoscopy
Investigators
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Study Chair: Andreas Shamiyeh, Univ-Doz Dr Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
More Information
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Publications:

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Responsible Party: Klugsberger Bettina, Dr.med, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT01667848    
Other Study ID Numbers: LCHE0909
First Posted: August 17, 2012    Key Record Dates
Results First Posted: April 30, 2014
Last Update Posted: May 15, 2014
Last Verified: May 2014
Keywords provided by Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy:
pain
Additional relevant MeSH terms:
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Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
 Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical