RecruitingNCT07132970

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

Assessment of the Leakage Rate of Ileo-colic Sutured Anastomoses Using a Polydioxanone Based Suture Material After Laparoscopic or Open Right Hemicolectomy to Treat Malignancy


Sponsor

Aesculap AG

Enrollment

249 participants

Start Date

Jan 26, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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)

Interventions

DEVICEMonoplus Suture Material

Ileocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery


Locations(3)

Alb-Fils-Klinikum Göppingen, Dept. General Surgery

Göppingen, Baden-Wurttemberg, Germany

Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery

Schwäbisch Hall, Baden-Wurttemberg, Germany

Städtisches Klinikum Lüneburg, Dept. General Surgery

Lüneburg, Lower Saxony, Germany

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NCT07132970


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