NCT01344486

Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University Hospital, Gasthuisberg · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Endometriosis of the Cul-de-sac
• Chocolate Cyst of Ovary
• Fibroid/Myoma (Uterus/Cervix)

Interventions

Type	Name	Description
PROCEDURE	full conditioning	addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C
PROCEDURE	standard pneumoperitoneum	100% carbon dioxide used for the pneumoperitoenum

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-04-29
• Last updated: 2016-10-25

Locations

1 site across 1 country: Belgium