Peritoneal Cavity Conditioning During Open Surgery.

Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01098175
• Other study ID #: S52233
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2010
• Last updated: April 1, 2010
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Katholieke Universiteit Leuven
• Contact: Philippe R Koninckx, MD
• Phone: +32 16 344202
• Email: pkoninckx[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparotomy
• Thoracotomy

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No