Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
Recruiting now
Conditions studied: Anastomotic Leak, Colon Cancer, Right Hemicolectomy
In brief
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.
Key facts
- Study ID
- NCT07132970
- Run by
- Aesculap AG
- People needed
- 249
- Starts
- 2026-01-26
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Alb-Fils-Klinikum Göppingen, Dept. General Surgery — Göppingen, Baden-Wurttemberg, Germany (enrolling)
- Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery — Schwäbisch Hall, Baden-Wurttemberg, Germany (enrolling)
- Städtisches Klinikum Lüneburg, Dept. General Surgery — Lüneburg, Lower Saxony, Germany (enrolling)
- AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie — Darmstadt, Germany (enrolling)
Full record on ClinicalTrials.gov
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