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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01344486
Study type Interventional
Source University Hospital, Gasthuisberg
Contact
Status Terminated
Phase Phase 4
Start date September 2010
Completion date December 2013