Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

NCT07132970 | Recruiting

• 1 other identifier: AAG-O-H-25123
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Anastomotic Leak; Colon Cancer; Right Hemicolectomy

Outcome Measures

Primary Outcomes (1)

• Rate of anastomosis leakage

  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

  until 30 days postoperatively

Secondary Outcomes (9)

• Rate of complications

  discharge, 30 days postoperatively, 1 year postoperatively

• Mortality rate

  30 days postoperatively, 1 year postoperatively

• Surgical Site infection rate

  30 days and 12 months after surgery

• Length of hospital stay

  day of discharge after surgery

• Handling of the used suture material

  interoperatively

Interventions

Monoplus Suture Material DEVICE

Ileocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective, primary open or laparoscopic right hemicolectomy or right extended hemicolectomy for malignancy with the creation of an intracorporeal or extracorporeal ileo-colic anastomosis.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (3)

Alb-Fils-Klinikum Göppingen, Dept. General Surgery

Göppingen, Baden-Wurttemberg, 73035, Germany

RECRUITING

Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

RECRUITING

Städtisches Klinikum Lüneburg, Dept. General Surgery

Lüneburg, Lower Saxony, 21339, Germany

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Markus Golling, Prof. Dr.

  Diak Klinikum Landkreis Schwäbisch Hall, Dept. of General Surgery

  STUDY CHAIR

Central Study Contacts

Petra Baumann, Dr.

CONTACT

+497461-95; studies@aesculap.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 20, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)