Leakage risk after ileo-colic sutures using MonoPlus® following 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
This will try MonoPlus® suture material for ileo-colic anastomosis in adults having elective right hemicolectomy for colon cancer to see if the 30-day leakage rate is not higher than published rates.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 249 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 3 sites (Göppingen, Baden-Wurttemberg and 2 other locations) |
| Trial ID | NCT07132970 on ClinicalTrials.gov |
What this trial studies
This observational multicenter project enrolls adults undergoing elective right hemicolectomy with primary ileo-colic anastomosis constructed using MonoPlus® suture material. Patients may have open or laparoscopic procedures and either fully hand-sewn or partially sutured anastomoses, while emergency cases, those needing a stoma, and patients with peritoneal carcinomatosis are excluded. The primary outcome is anastomotic leakage within 30 days after surgery, compared against leakage rates reported in the literature to test non-inferiority. Perioperative details, surgical technique, and 30-day clinical follow-up are collected at participating German hospitals.
Who should consider this trial
Good fit: Adults (≥18) with right-sided colon cancer scheduled for elective right hemicolectomy who will receive a primary ileo-colic anastomosis without a protective stoma are eligible.
Not a fit: Patients undergoing emergency surgery, those requiring a stoma, with inflammatory bowel disease, prior bowel resections, re-operation on an anastomosis, or peritoneal carcinomatosis are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If results show non-inferiority, this could support MonoPlus® as a safe suture option for ileo-colic anastomoses and reduce uncertainty about short-term leak risk after right hemicolectomy.
How similar studies have performed: Prior observational and comparative studies report ileo-colic leak rates around 1–10% and various suturing techniques have produced broadly comparable outcomes, so applying a specific MonoPlus® material is a focused but not wholly novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Göppingen, Baden-Wurttemberg and 2 other locations
- Alb-Fils-Klinikum Göppingen, Dept. General Surgery — Göppingen, Baden-Wurttemberg, Germany (Recruiting)
- Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery — Schwäbisch Hall, Baden-Wurttemberg, Germany (Recruiting)
- Städtisches Klinikum Lüneburg, Dept. General Surgery — Lüneburg, Lower Saxony, Germany (Recruiting)
Study contacts
- Study coordinator: Petra Baumann, Dr.
- Email: studies@aesculap.de
- Phone: +497461-95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.