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

NCT01667848 | Completed Results

• 1 other identifier: LCHE0909
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystolithiasis

Keywords

pain

Outcome Measures

Primary Outcomes (2)

• 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)

  operation day

• 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)

  first postoperative day

Secondary Outcomes (2)

• Core Temperature

  one day postoperativly

• Core Temperature

  during operation

Study Arms (2)

group B: Insufflation with warm gas

EXPERIMENTAL

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

group A: Insufflation with cold gas

EXPERIMENTAL

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

Interventions

Optitherm® device activated DEVICE

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.

Also known as: Optitherm® device (Storz, Tuttlingen, Germany)

group B: Insufflation with warm gas

Optitherm® device inactivated DEVICE

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

Also known as: Optitherm® device (Storz, Tuttlingen, Germany)

group A: Insufflation with cold gas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of cholecystolithiasis

You may not qualify if:

• Clinical diagnosis of cholecystolithiasis with cholecystitis

Sponsors & Collaborators

• Kepler University Hospital: lead

Study Sites (1)

2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Linz, Upper Austria, 4020, Austria

Location

Related Publications (4)

• 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.

  PMID: 15249406 BACKGROUND

• 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.

  PMID: 18618870 BACKGROUND

• 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.

  PMID: 22824858 BACKGROUND

• 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.

  PMID: 12165821 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis; Pain

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Bettina Klugsberger
• Organization: LudwigBoltzmannIOL

Bettina.Klugsberger@akh.linz.at

+43 732 7806 2133

Study Officials

• Andreas Shamiyeh, Univ-Doz Dr

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 17, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 5, 2023
• Results First Posted: April 30, 2014

Record last verified: 2023-10

Locations

AU (1)