NCT07132970 Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
| NCT ID | NCT07132970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Anastomotic Leak |
| Study Type | OBSERVATIONAL |
| Enrollment | 249 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 249 participants in total. It began in 2026-01-26 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Markus Golling, Prof. Dr.
STUDY CHAIR
Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery
Frequently Asked Questions
Who can join the NCT07132970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anastomotic Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07132970 currently recruiting?
Yes, NCT07132970 is actively recruiting participants. Contact the research team at studies@aesculap.de for enrollment information.
Where is the NCT07132970 trial being conducted?
This trial is being conducted at Göppingen, Germany, Schwäbisch Hall, Germany, Lüneburg, Germany, Darmstadt, Germany.
Who is sponsoring the NCT07132970 clinical trial?
NCT07132970 is sponsored by Aesculap AG. The principal investigator is Markus Golling, Prof. Dr. at Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery. The trial plans to enroll 249 participants.