Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)

NCT07146334 | Not Yet Recruiting

• 1 other identifier: B.C.I. 2025/01
• Study Type: observational
• Target: 400
• Locations: 6 countries
• Sites: 15

Brief 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.

Conditions

Rectal Cancer; Surgery Indication

Keywords

rectal cancer; Transanal Transection and Single Staple anastomosis (TTSS); Double-stapled anastomotic (DS); mechanical anastomosis; rectal surgery; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  From the surgery to one month

Secondary Outcomes (11)

• Overall morbidity and mortality rates at 1 month

  At 1 month after the end of the surgery

• The rate of anastomotic leakage at 6 and 12 months after rectal surgery;

  At 12 month after the end of the surgery

• Quality of life with QLQ C30 questionnaire

  At 1, 6 and 12 months after rectal surgery

• Quality of life with QLQ CR29 questionnaire

  At 1,6 and 12 months after rectal surgery

• Qualiy of life with EQ5D-5L

  At 1, 6 and 12 months after rectal surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. This study is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes). 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.

You may qualify 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 qualify 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

Sponsors & Collaborators

• Bordeaux Colorectal Institute: lead

Study Sites (15)

Hôpital Universitaire de Belgique

Leuven, Belgium

Location

Hôpital Universitaire McGill

Montreal, Canada

Location

CHU de Quebec

Québec, Canada

Location

Hôpital Universitaire de Shanghai

Shanghai, China

Location

CHU de Besançon

Besançon, 25030, France

Location

Bordeaux Colorectal Institute

Bordeaux, 33 000, France

Location

Hôpital Bicêtre APHP

Le Kremlin-Bicêtre, 94 270, France

Location

CHU de Lyon

Lyon, 69 495, France

Location

Gp Hospitalier Diaconesses Croix St Simon

Paris, 75 020, France

Location

Hôpital Européen Georges Pompidou APHP

Paris, 75012, France

Location

Hôpital Saint Antoine APHP

Paris, 75012, France

Location

Hôpital Charles Nicolle

Rouen, 76 031, France

Location

Policlinique Universitaire Gemelli

Roma, Italy

Location

Hôpital General universitaire Madrid

Madrid, Spain

Location

Hôpital Universitaire de Vigo

Vigo, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Quentin QD DENOST, Prof

CONTACT

+ 33 (0)5 47 50 15 75; q.denost@bordeaux-colorectal-institute.fr

Hélène HMM MAILLOU-MARTINAUD, CRA

CONTACT

+33 6 68 68 68 05; h.maillou.martinaud@bordeaux-colorectal-institute.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); IT (1); ES (2); BE (1); CA (2); FR (8)