UnknownNot Applicable

Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

Belgium, Netherlands1,600 participantsStarted 2021-09-05

Plain-language summary

This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 and above * Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis * Ability to give informed consent Exclusion Criteria: * The need for emergency surgery * Scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure). * The inability to read or understand informed consent material

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of modifiable intraoperative CAL risk factors present during surgery as assessed by the DoubleCheck list

Timeframe: Intraoperative phase

Trial details

NCT IDNCT05250882

SponsorAmsterdam UMC, location VUmc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Anastomotic Leak Small Intestine trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.