Trial Outcomes & Findings for Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy (NCT NCT01667848)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

148 participants

Primary outcome timeframe

operation day

Results posted on

2023-10-05

Participant Flow

Approval from the local institutional ethics committee was obtained on June 2011. Between July 1st, 2011 and December 28nd, 2013, a total of 148 patients were scheduled for laparoscopic cholecystectomy at the General Hospital in Linz, Austria

Patients converted intraoperative to open cholecystectomy or those undergoing a concomitant procedure were excluded from the study. Irregularities of the study protocol (absence of rectal probe, missing consent form, conversion to open cholecystectomy) entailed in exclusion of the study. Patients with acute cholecystitis were excluded of the study.

Participant milestones

Participant milestones
Measure	Group A: Insufflation With Cold Gas Insufflation with cold gas during laparoskopic cholecystectomy	Group B: Insufflation With Warm Gas Insufflation with warm gas during laparoscopic cholecystectomy
Overall Study STARTED	67	81
Overall Study COMPLETED	67	81
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: Insufflation With Cold Gas n=67 Participants Insufflation with cold gas during laparoskopic cholecystectomy	Group B n=81 Participants Insufflation with warm gas during laparoskopic cholecystectomy	Total n=148 Participants Total of all reporting groups
Age, Continuous	55.87 years STANDARD_DEVIATION 14.44 • n=93 Participants	55.68 years STANDARD_DEVIATION 16.93 • n=4 Participants	55.7 years STANDARD_DEVIATION 15.14 • n=27 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	57 Participants n=4 Participants	103 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	24 Participants n=4 Participants	45 Participants n=27 Participants
Region of Enrollment Austria	67 participants n=93 Participants	81 participants n=4 Participants	148 participants n=27 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Group A: Insufflation With Cold Gas n=67 Participants Insufflation with cold gas during laparoskopic cholecystectomy	Group B n=81 Participants Insufflation with warm gas during laparoskopic cholecystectomy
Pain (Rated With a Visual Analog Scale for Pain)	2.22 units on a scale 0-10 Standard Deviation 0.97	1.92 units on a scale 0-10 Standard Deviation 0.84

SECONDARY outcome

Timeframe: one day postoperativly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during operation

core temperature during laparoscopic cholecystectomy using a rectal probe

Outcome measures

Outcome measures
Measure	Group A: Insufflation With Cold Gas n=67 Participants Insufflation with cold gas during laparoskopic cholecystectomy	Group B n=81 Participants Insufflation with warm gas during laparoskopic cholecystectomy
Core Temperature	36.85 degree celsius Standard Deviation 0.46	37.07 degree celsius Standard Deviation 0.35

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bettina Klugsberger

LudwigBoltzmannIOL

Phone: +43 732 7806 2133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place