NCT07146334

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Bordeaux Colorectal Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rectal Cancer
• Surgery Indication

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

15 sites across 6 countries: Belgium, Canada, China, France, Italy, Spain