Leakage risk after ileo-colic sutures using MonoPlus® following right hemicolectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie
  Darmstadt, Germany Recruiting

Study contacts

• Study coordinator: Petra Baumann, Dr.
• Email: studies@aesculap.de
• Phone: +497461-95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.