Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions
Stopped: Investigator no longer works fulltime at investigational site
Belgium22 participantsStarted 2010-09
Plain-language 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.
Who can participate
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)