Status:

RECRUITING

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

Lead Sponsor:

Aesculap AG

Conditions:

Anastomotic Leak

Colon Cancer

Eligibility:

All Genders

18+ years

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 hemi...

Detailed Description

The study will include patients with right colon cancer, treated with elective colectomy and with local curative intention, in whom primary anastomosis with no protective stoma will be performed. Righ...

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)

Key Trial Info

Start Date :

January 26 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2028

Estimated Enrollment :

249 Patients enrolled

Trial Details

Trial ID

NCT07132970

Start Date

January 26 2026

End Date

March 1 2028

Last Update

March 27 2026

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Alb-Fils-Klinikum Göppingen, Dept. General Surgery

Göppingen, Baden-Wurttemberg, Germany, 73035

2

Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery

Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523

3

Städtisches Klinikum Lüneburg, Dept. General Surgery

Lüneburg, Lower Saxony, Germany, 21339