RecruitingNot Applicable

Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line

Austria102 participantsStarted 2024-12-18

Plain-language summary

Each colorectal anastomosis is routinely evaluated intraoperatively by sigmoidoscopy and, in the presence of signs of bleeding, also postoperatively (persistent rectal bleeding within 24 hours after surgery).

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 years * Colorectal surgery with primary colorectal anastomosis using the double-stapling technique, including side-to-end or end-to-end anastomosis * Documented anastomotic orientation (mesenteric vs. antimesenteric) Exclusion Criteria: * TME

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

Intraoperative intraluminal anastomotic bleeding

Timeframe: during surgery until getting the patient is out of the OR

Trial details

NCT IDNCT07506005

SponsorKepler University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-01

Contact for this trial

Sandra Raab, Dr.

+43 (0)5 7680 83 - 2133 sandra.raab@kepleruniklinikum.at

View on ClinicalTrials.gov More Colorectal Cancer 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.