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Clinical Trials in Belgium / NCT07146334
Starting soon Observational

Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)

NCT07146334 · tracked via the Priya Life Science Belgium tracker
Sponsor
Bordeaux Colorectal Institute
Phase
Observational
Started
2025-09
Last updated
2025-08-28

Condition(s) studied

Rectal CancerSurgery Indication

Study summary

The objectiive of this prospective, international cohort is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes).

The choice of technique is left to the discretion of the surgeon based on her/his practices.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 * Patients with rectal cancer lower than 12 cm from the anal verge requiring either a stapling anastomosis below 7 cm from the anal verge, * Patients with powered mechanical anastomosis (INTOCARE devices) * Patients with no metastasis * Patients operated on by mini-invasive rectal excision (laparoscopic, robotic or TaTME); * Patients with or without defunctioning ileostomy; * Patients with or without neoadjuvant treatment; * Patient who benefits by medicare system; * Signed and dated informed consent Exclusion Criteria: * Patients with handsewn anastomosis * Patients with perforated rectal cancer or preoperative pelvic sepsis ; * Patients with inflammatory bowel disease; * Patients operated on in emergency ; * Patients with extended-TME or pelvic exenteration; * Pregnancy or breast feeding period * Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study * Persons deprived of liberty or under guardianship

Primary outcome measure(s)

  • To assess and compare the rate of anastomotic leakage at 1 month after rectal excision between double and single-stapling low colorectal anastomosis using advanced powered stapler — From the surgery to one month
    Proportion of anastomotic leakage (clinical and radiological) at 1 month after rectal surgery between double- and single-stapling low colorectal anastomosis using advanced powered stapler.

Trial sites (15)

FacilityCityRegionStatus
Hôpital Universitaire de Belgique Leuven Belgium
Hôpital Universitaire McGill Montreal Canada
CHU de Quebec Québec Canada
Hôpital Universitaire de Shanghai Shanghai China
CHU de Besançon Besançon France
Bordeaux Colorectal Institute Bordeaux France
Hôpital Bicêtre APHP Le Kremlin-Bicêtre France
CHU de Lyon Lyon France
Gp Hospitalier Diaconesses Croix St Simon Paris France
Hôpital Européen Georges Pompidou APHP Paris France
Hôpital Saint Antoine APHP Paris France
Hôpital Charles Nicolle Rouen France
Policlinique Universitaire Gemelli Roma Italy
Hôpital General universitaire Madrid Madrid Spain
Hôpital Universitaire de Vigo Vigo Spain

Other trials for the same condition

Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary Recruiting
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable) Recruiting
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors Active, not recruiting
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07146334 on ClinicalTrials.gov ↗ ← All trials in Belgium