Peritoneal Cavity Conditioning During Open Surgery.

Study Overview
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Brief Summary
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Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.

Detailed Description
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Aim of the Trial : RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.

Official Title
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Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit

Conditions
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Laparotomy, Thoracotomy

Participation Criteria
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Eligibility Criteria
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Inclusion criteria : patients will be stratified and randomised according to the type of surgery total laparoscopic hysterectomy, promontofixation cholecystectomy Exclusion criteria : Any pre-existing condition increasing the risk of surgery such as age, pre-existing conditions as clotting disorders, heart or lung impairment etc. Not signed informed consent known allergic reaction to Sprayshield, Intercoat of hyalobarrier gel ® or - any bowel lesion requiring a single or double layer suture. (given that for none of the any anti-adhesion barriers safety has been proven following bowel lesions and suture) Any condition that might interfere with inflammatory parameters or pre-existing such as ,pregnancy, immunodeficiency, chronic inflammatory disease as Crohn's disease, chronic pain conditions as (peripheral neuropathy, pathology of the vertebral column and osteo-articular disease, any condition causing acute pain e.g. trauma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>open surgery with exposure of the surgical wound to the air. | |
| Full peritoneal conditioning<br>Full peritoneum cavity conditioning will be performed as follows. A continuous flow of less than 0.5 l/min of gas will be instilled in the lowest part of the operating wound. As gas premixed bottles with CO2+ 4% of oxygen and 10% of N2O will be used. This gas will be humidified and at 31-32 °C to be achieved by a commercial humidifier (Fisher and Paykel) programmed in order to maintain 100% relative humidity at 31-32°C upon entrance of the peritoneal cavity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint : decreased pain on day 1 and 2 after surgery | Postoperative pain : will be assessed by visual analog scales (cfr Trial by Verguts & Koninckx, addendum I) assessed pain on day 1, 2 and 3 after surgery. Pain medication will be free, but preferentially ibuprofen will be used in order to permit easier comparison of pain killer intake. | 0 to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in CRP and inflammatory parameters on day 1 and 2 or longer | Postoperative inflammatory reaction : daily assessment of inflammatory parameters as CRP, leucocytosis , and temperature for 4 to 7 days are done routinely today. In some subsets of patients other more specific inflammatory parameters as Ca125, IL-6 can be investigated | day 1-4 | 
| lower peritoneal fluid volume on day 2 | Estimation of peritoneal fluid volume by ultrasound on the second day after surgery will be performed in some subsets of patients. We indeed recently validated a non-invasive and reliable assessment of peritoneal fluid volume by ultrasound. (Verguts et all, 2009) We expect that the postoperative peritoneal fluid volume will increase with the degree of peritoneal inflammation. | day 2 after surgery | 
| Shorter time to resumption of transit: time to first flatus and time to first stool | Time to first flatus and time to first stool will be recorded | day1 to 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparotomy, thoracotomy, peritoneal conditioning, humidification, temperature control