Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Phase 4

Terminated

• Conditions: Fibroid/Myoma (Uterus/Cervix); Chocolate Cyst of Ovary; Endometriosis of the Cul-de-sac
• Interventions: Procedure: full conditioning; Procedure: standard pneumoperitoneum

• Registration Number: NCT01344486
• Lead Sponsor: University Hospital, Gasthuisberg

Brief 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
• Signed informed consent

Exclusion Criteria

• women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
• Pregnancy
• Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
• a known allergic reaction to Hyalobarrier Gel Endo®
• A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full conditioing	full conditioning	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	standard pneumoperitoneum	induction pneumoperitoneum with carbon dioxide 100%

Primary Outcome Measures

Name	Time	Method
adhesion formation after laparoscopic surgery	2 weeks after primary surgery	second look laparoscopy to assess adhesions formed after initial surgery

Secondary Outcome Measures

Name	Time	Method
inflammation	recorded until 3 days after surgery	bloodsamples to test for C reactive protein and white blood cells
time to first flatus and stool	recorded until 3 days after surgery	patients will be asked when first flatus and first stool appeared. (measured as hours after surgery)
Post-operative pain	recorded until 3 days after surgery	pain assessed by VAS scores

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium