Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
Recruiting · NCT07132970 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Monoplus Suture Material
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
4 locations listed.
- AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie - Darmstadt, Germany
- Alb-Fils-Klinikum Göppingen, Dept. General Surgery - Göppingen, Baden-Wurttemberg, Germany
- Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery - Schwäbisch Hall, Baden-Wurttemberg, Germany
- Städtisches Klinikum Lüneburg, Dept. General Surgery - Lüneburg, Lower Saxony, Germany