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

NCT ID: NCT01667848

Last Updated: 2023-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Cholecystolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Optitherm® device activated

Intervention Type 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.

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

Group Type EXPERIMENTAL

Optitherm® device inactivated

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Optitherm® device (Storz, Tuttlingen, Germany) Optitherm® device (Storz, Tuttlingen, Germany)

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of cholecystolithiasis

Exclusion Criteria

* Clinical diagnosis of cholecystolithiasis with cholecystitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Klugsberger Bettina

Dr.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Shamiyeh, Univ-Doz Dr

Role: STUDY_CHAIR

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

Locations

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2nd Surgical Department, Academic Teaching Hospital, AKH Linz

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 15249406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18618870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22824858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12165821 (View on PubMed)

Other Identifiers

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LCHE0909

Identifier Type: -

Identifier Source: org_study_id

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