Chocolate Cyst of Ovary Clinical Trial
Official title:
Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions
| Verified date | October 2016 |
| Source | University Hospital, Gasthuisberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Gasthuisberg |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | adhesion formation after laparoscopic surgery | second look laparoscopy to assess adhesions formed after initial surgery | 2 weeks after primary surgery | No |
| Secondary | Post-operative pain | pain assessed by VAS scores | recorded until 3 days after surgery | No |
| Secondary | inflammation | bloodsamples to test for C reactive protein and white blood cells | recorded until 3 days after surgery | No |
| Secondary | 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 | No |