Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
NCT ID: NCT07146334
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
400 participants
OBSERVATIONAL
2025-09-30
2029-09-30
Brief Summary
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The choice of technique is left to the discretion of the surgeon based on her/his practices.
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Detailed Description
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AL has a significant impact on clinical, patient-reported, and oncological outcomes. To mitigate the impact of AL a diverting stoma is routinely used to protect the distal anastomosis and facilitate anastomotic healing, with these stomas reversed once the integrity and patency of the distal anastomosis is confirmed. However, there is a significant complication profile associated with the routine use of diverting stomas. Through the incorporation of appropriate pre-operative risk stratification and careful post-operative surveillance a selective stoma strategy is associated with good clinical and functional outcomes.
The use of Double-stapled anastomotic technique (DST) or Transanal Transection Single-Stappled (TTSS) by laparoscopic or robotic approach, using or not a defunctionning stoma could not be separately tested in randomized trial.
In this exploratory, observational, prospective, IDEAL stage 2b International cohort study, we aim to include 400 patients with resection rectal and low powered colorectal anastomosis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques
This is an international cohort (France and other international centers) which consists of including patients undergoing rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques.
Surgeons at each center perform one or both techniques. When both types of stapling are possible, the choice of technique is made by the surgeon during the preoperative consultation, in the best interest of the patients, after a case-by-case assessment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bordeaux Colorectal Institute
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B.C.I. 2025/01
Identifier Type: -
Identifier Source: org_study_id
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