Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Right Hemicolectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monoplus Suture Material | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of anastomosis leakage
- timeFrame
- until 30 days postoperatively
- description
- An anastomosis leak is defined as " leak of luminal contents from a anastomotic site between two hollow viscera" diagnosed (1) radiologically, by a radiographic enema with hydro soluble contrast or by computerized tomography with the presence of intra-abdominal collection adjacent to the anastomosis; (2) clinically with evidence of extravasation of bowel content or gas through a wound or drain; (3) by endoscopy, or (4) intraoperatively. Anastomosis leak will be classified and graded according to Clavien-Dindo. Grade I: Anastomosis leakage requiring no active intervention (e.g. antibiotics) Grade II: Anastomosis leakage requiring active radiological intervention but manageable without surgical intervention. Grade III: Anastomosis leakage requiring surgical re-intervention. Grade IV: Anastomosis leakage leading to life-threatening condition requiring IC /ICU management Grade V: Anastomosis leakage leading to death of the patient
Secondary outcomes (9)
- measure
- Rate of complications
- timeFrame
- discharge, 30 days postoperatively, 1 year postoperatively
- description
- Stenosis * bleeding * hemmorage * obstruction * intradominal abszess * ileus * peritonitis * sepsis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available