Postoperative and long-term outcomes of Transanal Transection and Single-stapled anastomosis (TTSS) in rectal cancer patients A multicentric international IDEAL Stage 2b prospective parallel cohort study

Trial Overview

Acronym	TTSS-REC
Number	098-2024
Protocol Link	https://clinicaltrials.gov/study/NCT06314646?titles=ttss-rec&rank=1
Public Trial Registry Link	https://clinicaltrials.gov/study/NCT06314646?titles=ttss-rec&rank=1
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

In rectal cancer surgery, Transanal Transection and Single Stapled anastomosis (TTSS) has become a valid alternative to standard double-stapled technique. The objective of the study is to prospectively and internationally validate previous retrospective single-center results, comparing postoperative, functional, and oncological outcomes of TTSS versus double-stapled technique. This is a multicentric, observational, two-parallel cohort study. The primary endpoint will be the rate of 90-day anast

Chief Investigator

Antonino Spinelli
Professor

Profile Link

Lead Centre

IRCCS Humanitas Research Hospital
via Manzoni 56
Rozzano
20089
Italy

Website

Additional Information

Full Research Summary

Objective:	The objective of the study is to evaluate the postoperative and long-term outcomes of the TTSS technique. The hypothesis of the study is that the TTSS approach may provide better postoperative outcomes compared with the double-stapled approach, reducing the risk of anastomotic leak. This hypothesis relies on the recent findings by our group, comparing TTSS with double-stapled and TaTME interventions. This study will prospectively and externally validate the initial findings by our group, also exploring patient-important outcomes, such as postoperative recovery and functional outcomes.
Aim:	The aim of the study is to compare the postoperative and long-term outcomes of TTSS and double-stapled TME techiques in patients with rectal cancer.
Methods:	This is an international, multicentric, observational ambidirectional (retrospective and prospective), two-parallel cohort study. The study is categorized as a stage 2b according to the IDEAL framework. Sites and surgeons may include patients in both the cohorts unless they have performed at least ten procedures. The study cohorts will include patients undergoing double-stapled and TTSS rectal resection. Both the techniques may be performed using an open, laparoscopic, or robotic approach. Once the number of required subjects is achieved in one of the study cohorts, the enrolment for the cohort will be closed. Patients included in the study will perform a screening visit to collect the baseline data and the preoperative functional status. Ninety days after surgery, patients will undergo a clinical assessment to collect any postoperative complications. Six, 12, and 24 months after surgery (or stoma closure) patients will be contacted to collect oncological and functional outcomes.
Reason for International Trial:	The multicentric and international design will allow a pragmatic approach, providing real-word data collection.