Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monoplus Suture Material.
- Who it may be relevant to
- Registry conditions: Anastomotic Leak, Colon Cancer, Right Hemicolectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
The study will include patients with right colon cancer, treated with elective colectomy and with local curative intention, in whom primary anastomosis with no protective stoma will be performed. Right colectomy is defined as a resection of terminal 10 cm of ileum, the cecum, the ascending right colon, and right third or half of the transverse colon followed by ileo-colostomy.The anastomosis leakage rate after right-sided hemicolectomy is the most important complication, because it leads to further morbidity of the affected patients. The anastomosis leakage rate ranges between 1-10% depending on the study population (cancer patients vs. non-cancer patients) and the type of anastomosis.
Interventions
- Device Monoplus Suture Material
Ileocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery
Primary outcome measures
- Rate of anastomosis leakage [Time frame: until 30 days postoperatively]
Secondary outcome measures (9)
- Rate of complications [Time frame: discharge, 30 days postoperatively, 1 year postoperatively]
- Mortality rate [Time frame: 30 days postoperatively, 1 year postoperatively]
- Surgical Site infection rate [Time frame: 30 days and 12 months after surgery]
- Length of hospital stay [Time frame: day of discharge after surgery]
- Handling of the used suture material [Time frame: interoperatively]
- Patient satisfaction [Time frame: 30 days postoperavely, 12 months postoperatively]
- Quality of Life, using EQ5D5L [Time frame: preoperatively, 30 day postoperatively and 12 months postoperatively]
- Bowel function assessment [Time frame: Day of discharge after surgery, 30 days postoperatively, 1 year postoperatively]
- Hernia rate [Time frame: 12 months postoperatively]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Alb-Fils-Klinikum Göppingen, Dept. General Surgery — Göppingen
- Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery — Schwäbisch Hall
- Städtisches Klinikum Lüneburg, Dept. General Surgery — Lüneburg
- AGAPLESION ELISABETHENSTIFT, Klinik für Allgemein- und Viszeralchirurgie — Darmstadt
Identifiers
NCT: NCT07132970 · AAG-O-H-25123