Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy (LICOSARH)

Aesculap

Status: Enrolling

Conditions: Colon Cancer; Right Hemicolectomy; Anastomotic Leak

Treatments: Device: Monoplus Suture Material

Study type: Observational

Funder types: Industry

Identifiers

NCT07132970

AAG-O-H-25123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)