Peritoneal Cavity Conditioning During Open Surgery.

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

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.

Study Overview

• Status: Unknown
• Conditions: Thoracotomy; Laparotomy

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Standard open surgery such as hysterectomy, cancer surgery, bowel resections, cardiac surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; open surgery with exposure of the surgical wound to the air.
Full peritoneal conditioning; 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?

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: philippe R Koninckx, MD, UZ Gasthuisberg, KULeuven

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): April 2, 2010
• Last Update Submitted That Met QC Criteria: April 1, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: laparotomy; thoracotomy; humidification; peritoneal conditioning; temperature control
• Other Study ID Numbers: S52233