NCT07146334Not yet recruiting
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
Low Powered Colorectal Anastomosis After Rectal Excision : An Exploratory, Observational, Prospective, IDEAL Stage 2b International Cohort Study (OASIS)
Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2029
- Lead sponsor
- Bordeaux Colorectal Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT07146334
What you commit to
- Study type: Observational
- Planned participants: 400
- From Sept 2025 to the primary completion date, Sept 2029
- 15 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with perforated rectal cancer or preoperative pelvic sepsis ;
- Patients with inflammatory bowel disease;
Other
- Patients with handsewn anastomosis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Universitaire de Belgique Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Hôpital Universitaire McGill Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHU de Quebec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Hôpital Universitaire de Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Hôpital General universitaire Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hôpital Universitaire de Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Bordeaux Colorectal Institute Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Bicêtre APHP Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CHU de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Européen Georges Pompidou APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Saint Antoine APHP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Gp Hospitalier Diaconesses Croix St Simon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Policlinique Universitaire Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.