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

Kepler University Hospital

Status: Completed

Conditions: Cholecystolithiasis

Treatments: Device: Optitherm® device activated; Device: Optitherm® device inactivated

Study type: Interventional

Funder types: Other

Identifiers

NCT01667848

LCHE0909

Details and patient eligibility

About

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

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of cholecystolithiasis

Exclusion criteria

• Clinical diagnosis of cholecystolithiasis with cholecystitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

group B: Insufflation with warm gas

Experimental group

Description:

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.

Treatment:

Device: Optitherm® device activated

group A: Insufflation with cold gas

Experimental group

Description:

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

Treatment:

Device: Optitherm® device inactivated