Trials · 2025
Comparison of standard circular stapler anastomosis with or without circumferential suture enhancement in patients with robot-assisted Ivor-Lewis oesophagectomy due to malignant tumours of the oesophagus and oesophagogastric junction-a multi-centre, randomised, superiority study (STITCHES).
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Hinkelmann Janik, Reitberger Helena, Laverde Bruno Bancke, Weiß Andreas R R, Brunner Maximilian, Grützmann Robert, Weber Georg F, Krautz Christian
Аннотация
BACKGROUND: Morbidity due to anastomotic leakage is a major concern in transthoracic oesophagectomy. The aim of this randomised trial is to evaluate whether a circumferential suture reinforcement of the stapled end-to-side anastomosis in robot-assisted minimally invasive Ivor-Lewis oesophagectomy (RAMIE) leads to a reduced incidence of anastomotic leakages in the postoperative course.
METHODS/DESIGN: This is a multi-centre randomised, double-blind, superiority trial with an adaptive sample size design undergoing RAMIE for malignant tumours. Patients will be randomised 1:1 into two study arms. In study arm A, participants will receive a standard circular-stapled end-to-side oesophagogastric anastomosis, while in study arm B, the anastomosis will have a circumferential suture reinforcement. The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are incision-to-suture time, duration of circumferential suture reinforcement, anastomotic stenosis rate, postoperative morbidity and mortality, and quality of life.
DISCUSSION: This randomised controlled trial will assess the impact of circumferential suture reinforcement of the oesophagogastric anastomosis on short-term outcomes and quality of life of patients undergoing robot-assisted minimally invasive Ivor-Lewis oesophagectomy.
TRIAL REGSITRATION: DRKS00034787. Registered on 7 October 2024.
METHODS/DESIGN: This is a multi-centre randomised, double-blind, superiority trial with an adaptive sample size design undergoing RAMIE for malignant tumours. Patients will be randomised 1:1 into two study arms. In study arm A, participants will receive a standard circular-stapled end-to-side oesophagogastric anastomosis, while in study arm B, the anastomosis will have a circumferential suture reinforcement. The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are incision-to-suture time, duration of circumferential suture reinforcement, anastomotic stenosis rate, postoperative morbidity and mortality, and quality of life.
DISCUSSION: This randomised controlled trial will assess the impact of circumferential suture reinforcement of the oesophagogastric anastomosis on short-term outcomes and quality of life of patients undergoing robot-assisted minimally invasive Ivor-Lewis oesophagectomy.
TRIAL REGSITRATION: DRKS00034787. Registered on 7 October 2024.