An interventional study of Optitherm® device activated and Optitherm® device inactivated in Cholecystolithiasis, sponsored by Kepler University Hospital. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Kepler University Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.
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.
242 studies on the registry are indexed under Cholecystolithiasis; 26 are open to participants now.
This study's enrollment of 148 is above the median of 100 across 163 interventional studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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 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 only activated by the single scrub nurse in those patients randomized to group B.
Also known as: Optitherm® device (Storz, Tuttlingen, Germany)
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)
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)
Time frame: 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)
Time frame: first postoperative day
Core Temperature
Time frame: one day postoperativly
Core Temperature
core temperature during laparoscopic cholecystectomy using a rectal probe
Time frame: during operation
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
| Milestone | Group A: Insufflation With Cold Gas | Group B: Insufflation With Warm Gas |
|---|---|---|
| Started | 67 | 81 |
| Completed | 67 | 81 |
| Not completed | 0 | 0 |
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)
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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)
| units on a scale 0-10 | Group A: Insufflation With Cold Gas | Group B |
|---|---|---|
| Pain (Rated With a Visual Analog Scale for Pain) | 2.22 ± 0.97 | 1.92 ± 0.84 |
core temperature during laparoscopic cholecystectomy using a rectal probe
| degree celsius | Group A: Insufflation With Cold Gas | Group B |
|---|---|---|
| Core Temperature | 36.85 ± 0.46 | 37.07 ± 0.35 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | — | 0/67 (0%) | 0/67 (0%) |
| Group B | — | 0/81 (0%) | 0/81 (0%) |
| Age, Continuous(years) | Group A: Insufflation With Cold Gas | Group B | Total |
|---|---|---|---|
| Mean | 55.87 ± 14.44 | 55.68 ± 16.93 | 55.7 ± 15.14 |
| Sex: Female, Male(Participants) | Group A: Insufflation With Cold Gas | Group B | Total |
|---|---|---|---|
| Female | 46 | 57 | 103 |
| Male | 21 | 24 | 45 |
| Region of Enrollment(participants) | Group A: Insufflation With Cold Gas | Group B | Total |
|---|---|---|---|
| Austria | 67 | 81 | 148 |
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Kepler University Hospital