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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klugsberger Bettina, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier:
NCT01667848
First received: July 27, 2012
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.


Condition Intervention
Cholecystolithiasis
Device: Optitherm® device activated
Device: Optitherm® device inactivated

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ludwig Boltzmann Institute for Operative Laparoscopy:

Primary Outcome Measures:
  • Pain (Rated With a Visual Analog Scale for Pain) [ Time Frame: operation day ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: first postoperative day ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: one day postoperativly ] [ Designated as safety issue: Yes ]
  • Core Temperature [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    core temperature during laparoscopic cholecystectomy using a rectal probe


Enrollment: 148
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis

Exclusion Criteria:

  • Clinical diagnosis of cholecystolithiasis with cholecystitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667848

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

Publications:
Responsible Party: Klugsberger Bettina, Dr.med, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT01667848     History of Changes
Other Study ID Numbers: LCHE0909
Study First Received: July 27, 2012
Results First Received: September 30, 2013
Last Updated: May 4, 2014
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Ludwig Boltzmann Institute for Operative Laparoscopy:
pain

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014