Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Monoplus Suture Material
DeviceIleocolic Anastomosis Construction using Monoplus Suture Material after open or laparoscopic surgery
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
until 30 days postoperativelySecondary outcomes
1
Rate of complications
Stenosis * bleeding * hemmorage * obstruction * intradominal abszess * ileus * peritonitis * sepsis
Time frame
discharge, 30 days postoperatively, 1 year postoperatively2
Mortality rate
Time frame
30 days postoperatively, 1 year postoperatively3
Surgical Site infection rate
Superficial Surgical Site Infection and deep Surgical Site Infection rate according to CDC
Time frame
30 days and 12 months after surgery4
Length of hospital stay
Time frame
day of discharge after surgerySponsors and contacts
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Source ClinicalTrials.gov