Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

NCT ID: NCT07132970

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 249 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-26
• Study Completion Date: 2028-03-31

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.

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. Right colectomy is defined as a resection of terminal 10 cm of ileum, the cecum, the ascending right colon, and right third or half of the transverse colon followed by ileo-colostomy.The anastomosis leakage rate after right-sided hemicolectomy is the most important complication, because it leads to further morbidity of the affected patients. The anastomosis leakage rate ranges between 1-10% depending on the study population (cancer patients vs. non-cancer patients) and the type of anastomosis.

Conditions

Anastomotic Leak; Colon Cancer; Right Hemicolectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Monoplus Suture Material

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Golling, Prof. Dr.

Role: STUDY_CHAIR

Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery

Locations

Diakonie-Klinikum Landkreis Schwäbisch Hall

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Petra Baumann, Dr.

Role: CONTACT

studies@aesculap.de

+497461-95 ext. 0

Facility Contacts

Markus Golling, Prof. Dr.

Role: primary

Other Identifiers

AAG-O-H-25123

Identifier Type: -

Identifier Source: org_study_id