Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: full conditioning
* Procedure: standard pneumoperitoneum


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full conditioing<br>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 | Procedure: full conditioning<br>* addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C<br>|
| Active Comparator: carbon dioxide<br>induction pneumoperitoneum with carbon dioxide 100% | Procedure: standard pneumoperitoneum<br>* 100% carbon dioxide used for the pneumoperitoenum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adhesion formation after laparoscopic surgery | second look laparoscopy to assess adhesions formed after initial surgery | 2 weeks after primary surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | pain assessed by VAS scores | recorded until 3 days after surgery | 
| inflammation | bloodsamples to test for C reactive protein and white blood cells | recorded until 3 days after surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women undergoing laparoscopic surgery