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Investigator no longer works fulltime at investigational site
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Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation.
Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.
Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full conditioing | Experimental | Intervention by alteration of laparoscopic gas with addition of oxygen and nitrous oxide, regulation of humidification and temperature (32°C), injection of 5mg Dexamethasone and application of Hyalobarrier Gel Endo (Nordic Pharma) at the surgical wound |
|
| carbon dioxide | Active Comparator | induction pneumoperitoneum with carbon dioxide 100% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| full conditioning | Procedure | addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C |
|
| Measure | Description | Time Frame |
|---|---|---|
| adhesion formation after laparoscopic surgery | second look laparoscopy to assess adhesions formed after initial surgery | 2 weeks after primary surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | pain assessed by VAS scores | recorded until 3 days after surgery |
| inflammation | bloodsamples to test for C reactive protein and white blood cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Koninckx, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007889 | Leiomyoma |
| D009214 | Myoma |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| standard pneumoperitoneum | Procedure | 100% carbon dioxide used for the pneumoperitoenum |
|
| recorded until 3 days after surgery |
| time to first flatus and stool | patients will be asked when first flatus and first stool appeared. (measured as hours after surgery) | recorded until 3 days after surgery |
| D000091662 | Genital Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |