Peritoneal Cavity Conditioning During Open Surgery.

KU Leuven40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Laparotomy Thoracotomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

UZ Gasthuisberg

Leuven, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 0 to 7 days

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: day1 to 5

Central Contacts

Philippe R Koninckx, MD

CONTACT

+32 16 344202 pkoninckx@gmail.com

Marleen Craessaerts, RN

CONTACT

+32 16 343606 mcraessaerts@gmail.com

Data from ClinicalTrials.gov

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