Predictive factors for anastomotic leakage after colorectal surgery (pREdictVE factors for AL --> REVEAL)

Completed

Conditions: A leak where the intestine was connected back together.
Anastomotic leakage
10017991
10017998

Registration Number: NL-OMON50527

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 574

Inclusion Criteria

-18 years or older
- In need of laparoscopic or open large bowel resection with anastomosis as
standard treatment for colorectal carcinoma or large adenomas (tubular,
tubulovillous, villous and sessile serrated adenomas)

Exclusion Criteria

- patients with colorectal cancer or a premalignant condition not receiving an
anastomosis
- patients who underwent abdominal surgery in the past four weeks
- pregnant patients
- cognitively impaired patients

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter in this study is the occurrence of anastomotic<br /><br>leakage. Anastomotic leakage is defined:<br /><br>1) Leakage of bowel content and/or gas from the surgical connection between the<br /><br>2 bowel ends into the abdomen or pelvis with either spillage and/or fluid<br /><br>collection around the anastomotic site or extravasation through a wound, drain<br /><br>site of anus;<br /><br>2) Clinical manifestion causing fever, abcess, septicaemia, peritonitis and/or<br /><br>organ failure; and<br /><br>3) Confirmation by imaging technique (e.g. radiograph, endoscopy, CT-scan, MRI,<br /><br>sonography) or by digital rectal examination or anoscopy and/or proctoscopy for<br /><br>low rectal anastomoses. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints:<br /><br>• Intestinal microbiome in fecal sample<br /><br>• I-FABP,SM22, Calprotectin, CRP, Citrullin, complement factors in blood<br /><br>• VOCs in exhaled air<br /><br>• COX-2 & MBL polymorphisms in buccal smear<br /><br>• L3-index measurements & evaluation of atherosclerosis on CT-scans<br /><br>• SNAQ & MUST scores</p><br>