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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50527

Enrollment

588

Registered

2015-06-10

Start date

2015-09-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A leak where the intestine was connected back together. Anastomotic leakage

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results