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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Core Temperature | one day postoperativly | |
| Core Temperature | core temperature during laparoscopic cholecystectomy using a rectal probe | during operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Shamiyeh, Univ-Doz Dr | Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Surgical Department, Academic Teaching Hospital, AKH Linz | Linz | Upper Austria | 4020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15249406 | Background | 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. | |
| 18618870 | Background |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Insufflation With Cold Gas | Insufflation with cold gas during laparoskopic cholecystectomy |
| FG001 | Group B: Insufflation With Warm Gas | Insufflation with warm gas during laparoscopic cholecystectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Insufflation With Cold Gas | Insufflation with cold gas during laparoskopic cholecystectomy |
| BG001 | Group B | Insufflation with warm gas during laparoskopic cholecystectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Not Posted | operation day | Participants | |||||||||||
| Secondary | Core Temperature | Not Posted | one day postoperativly | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Insufflation with cold gas during laparoscopic cholecystectomy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bettina Klugsberger | LudwigBoltzmannIOL | +43 732 7806 2133 | Bettina.Klugsberger@akh.linz.at |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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|
| 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. |
|
|
| 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. |
| 22824858 | 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. |
| 12165821 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale 0-10 | first postoperative day |
|
|
|
| Secondary | Core Temperature | core temperature during laparoscopic cholecystectomy using a rectal probe | Posted | Mean | Standard Deviation | degree celsius | during operation |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Group B | Insufflation with warm gas during laparoscopic cholecystectomy | 0 | 81 | 0 | 81 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |