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)

Hinkelmann J, Reitberger H, Bancke Laverde B, Weiß A, Brunner M, Grützmann R, Weber G, Krautz C (2025)

Publication Language: English

Publication Type: Journal article

Publication year: 2025

Journal

Trials BioMed Central

Book Volume: 26

Article Number: 341

Journal Issue: 1

DOI: 10.1186/s13063-025-08995-4

Abstract

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.

Authors with CRIS profile

Janik Hinkelmann Lehrstuhl für Allgemein- und Viszeralchirurgie Helena Reitberger Department of Surgery Bruno Bancke Laverde Department of Surgery Andreas Weiß Department of Surgery Maximilian Brunner Department of Surgery Robert Grützmann Lehrstuhl für Allgemein- und Viszeralchirurgie Georg Weber Department of Surgery Christian Krautz Department of Surgery

How to cite

APA:

Hinkelmann, J., Reitberger, H., Bancke Laverde, B., Weiß, A., Brunner, M., Grützmann, R.,... Krautz, C. (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). Trials, 26(1). https://doi.org/10.1186/s13063-025-08995-4

MLA:

Hinkelmann, Janik, et al. "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)." Trials 26.1 (2025).

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