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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

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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