Peritoneal Cavity Conditioning During Open Surgery.

• Conditions: Laparotomy; Thoracotomy

• Registration Number: NCT01098175
• Lead Sponsor: KU Leuven

Brief Summary

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

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 Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Last Update Submitted: 2010-04-01
• Study First Posted: 2010-04-02
• Last Update Posted: 2010-04-02
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint : decreased pain on day 1 and 2 after surgery	0 to 7 days	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.

Secondary Outcome Measures

Name	Time	Method
decrease in CRP and inflammatory parameters on day 1 and 2 or longer	day 1-4	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
lower peritoneal fluid volume on day 2	day 2 after surgery	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.
Shorter time to resumption of transit: time to first flatus and time to first stool	day1 to 5	Time to first flatus and time to first stool will be recorded

Trial Locations

Locations (1)

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium