RecruitingNot Applicable

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

Germany249 participantsStarted 2026-01-26

Plain-language summary

The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.

Who can participate

Age range

18 Years

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: * Patients undergoing a primary, elective either open or laparoscopic right hemicolectomy or right extended hemicolectomy due to malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis. * Either complete hand-sewn anastomosis or partial sutured anastomosis (e.g. combination of stapling and suturing) * Open or laparoscopic as well as conversion from open to laparoscopic surgery * Absence of peritoneal carcinomatosis * Absence of vascular, nervous or bone infiltration * Age ≥ 18 years * Written data protection declaration (Written Informed consent) Exclusion Criteria: * Left hemicolectomy or left extended hemicolectomy or sigma resection * Inflammatory bowel disease (e.g. Crohn´s disease) * Emergency surgery * Previous abdominal surgery with bowel resection * Re-operation of an anastomosis (anastomosis revision surgery) * Need for stoma creation * Non-compliant patients * Participation in an interventional randomized controlled study (RCT)

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

Rate of anastomosis leakage

Timeframe: until 30 days postoperatively

Trial details

NCT IDNCT07132970

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-07

Contact for this trial

Petra Baumann, Dr.

+497461-95 studies@aesculap.de

View on ClinicalTrials.gov More Anastomotic Leak trials