Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• 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

+ 3 more sites.

Who to contact

Quentin QD DENOST, Prof · + 33 (0)5 47 50 15 75 · q.denost@bordeaux-colorectal-institute.fr

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07146334.