Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)

Bordeaux Colorectal Institute

Status: Not yet enrolling

Conditions: Surgery Indication; Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07146334

B.C.I. 2025/01

Details and patient eligibility

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.

Full description

There are a variety of available anastomotic techniques to facilitate restorative surgery following total mesorectal excision (TME) for rectal cancer. However, there is no good quality evidence demonstrating the superiority of any single technique with regards to the potential sequalae of restorative surgery including anastomotic leakage and functional impact. Double-stapled anastomotic technique (DST) for colorectal anastomosis is the most widely used technique worldwide. An alternative to DST is the hand-sewn coloanal anastomotic (CAA) technique, which is traditionally reserved for patients with ultralow rectal tumours requesting restorative surgery or in cases of technical difficulties whereby a low colorectal anastomosis is converted to a coloanal anastomosis. More recently, the Transanal Transection and Single Staple anastomosis (TTSS) technique has been described. The TTSS technique has the potential to mitigate the difficulties encountered with DST and the potential complications and long-term functional sequalae encountered with handsewn anastomosis. Moreover, powered mechanical circumferential staplers represent a significant advancement in colorectal surgery, particularly in performing anastomosis following rectal excision. These devices are designed to provide consistent staple formation and controlled tissue compression, reducing the variability associated with manual stapling.

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques

Description:

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.