Peritoneal Cavity Conditioning During Open Surgery.

Sponsor

KU Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT01098175

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparotomy Thoracotomy

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Gasthuisberg	Leuven		Belgium	3000

Sponsors and Collaborators

KU Leuven

Investigators

Principal Investigator: philippe R Koninckx, MD, UZ Gasthuisberg, KULeuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01098175

Other Study ID Numbers:

S52233

First Posted:

Apr 2, 2010

Last Update Posted:

Apr 2, 2010

Last Verified:

Mar 1, 2010

Keywords provided by , ,

laparotomy

thoracotomy

peritoneal conditioning

humidification

temperature control

Study Results

No Results Posted as of Apr 2, 2010