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Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
RECRUITINGSponsored by Aesculap AG
Actively Recruiting
SponsorAesculap AG
Started2026-01-26
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07132970
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
Age: 18 Years+Healthy volunteers accepted
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)
Conditions4
Anastomotic LeakCancerColon CancerRight Hemicolectomy
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Actively Recruiting
SponsorAesculap AG
Started2026-01-26
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07132970