NCT07132970

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 249 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not 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.

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

Interventions

Type	Name	Description
DEVICE	Monoplus Suture Material	Ileocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery

Timeline

• Start date: 2026-01-26
• Primary completion: 2027-07-01
• Completion: 2028-03-01
• First posted: 2025-08-20
• Last updated: 2026-03-27

Locations

3 sites across 1 country: Germany