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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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Germany
Alb-Fils-Klinikum Göppingen, Dept. General Surgery
RECRUITING
Göppingen
Städtisches Klinikum Lüneburg, Dept. General Surgery
RECRUITING
Lüneburg
Diakonie-Klinikum Landkreis Schwäbisch Hall, Dept. General Surgery
RECRUITING
Schwäbisch Hall
Contact Information
Primary
Petra Baumann, Dr.
studies@aesculap.de
+497461-95
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2028-03
Participants
Target number of participants: 249
Related Therapeutic Areas
Sponsors
Leads: Aesculap AG

This content was sourced from clinicaltrials.gov

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