Chocolate Cyst of Ovary, Endometriosis of the Cul-de-sac, Fibroid/Myoma (Uterus/Cervix)
Conditions
Keywords
women undergoing laparoscopic surgery
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.
Interventions
PROCEDUREfull conditioning
addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C
PROCEDUREstandard pneumoperitoneum
100% carbon dioxide used for the pneumoperitoenum
Sponsors
University Hospital, Gasthuisberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adhesion formation after laparoscopic surgery | 2 weeks after primary surgery | second look laparoscopy to assess adhesions formed after initial surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | recorded until 3 days after surgery | pain assessed by VAS scores |
| 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) |
Countries
Belgium
Outcome results
None listed