COMPASS: deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer

Trials

Study Protocol

Ulrike Neckmann¹  Sandra Korn¹  Weitz Jürgen²  Distler Marius²  Johannes Fritzmann²  Olga Radulova-Mauersberger²  Pecqueux Mathieu²  Kahlert Christoph²  Anna Klimova³  Christian Praetorius³ 

[1] Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstrasse 74, 01307, Dresden, Germany;Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstrasse 74, 01307, Dresden, Germany;National Center for Tumor Diseases (NCT/UCC), Dresden, Germany;German Cancer Research Center (DKFZ), Heidelberg, Germany;Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany;Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany;National Center for Tumor Diseases (NCT/UCC), Dresden, Germany;German Cancer Research Center (DKFZ), Heidelberg, Germany;Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany;Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany;

关键词: Colon cancer;    Colorectal cancer;    Obstruction;    Emergency;    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07636-y

 received in 2023-07-11, accepted in 2023-09-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundColorectal cancer stands as a prevalent cause of cancer-related mortality, necessitating effective treatment strategies. Acute colonic obstruction occurs in approximately 20% of patients and represents a surgical emergency with substantial morbidity and mortality. The optimal approach for managing left-sided colon cancer with acute colonic obstruction remains debatable, with no consensus on whether emergency resection or bridge-to-surgery, involving initial decompressing stoma and subsequent elective resection after recovery, should be employed. Current studies show a decrease in morbidity and short-term mortality for the bridge-to-surgery approach, yet it remains unclear if the long-term oncological outcome is equivalent to emergency resection.MethodsThis prospective, randomized, multicenter trial aims to investigate the management of obstructive left-sided colon cancer in a comprehensive manner. The study will be conducted across 26 university hospitals and 40 academic hospitals in Germany. A total of 468 patients will be enrolled, providing a cohort of 420 evaluable patients, with an equal distribution of 210 patients in each treatment arm. Patients with left-sided colon cancer, defined as cancer between the left splenic flexure and > 12 cm ab ano and obstruction confirmed by X-ray or CT scan, are eligible. Randomization will be performed in a 1:1 ratio, assigning patients either to the oncological emergency resection group or the bridge-to-surgery group, wherein patients will undergo diverting stoma and subsequent elective oncological resection after recovery. The primary endpoint of this trial will be 120-day mortality, allowing for consideration of the time interval between diverting stoma and resection.DiscussionThe findings derived from this trial possess the potential to reshape the current clinical approach of emergency resection for obstructive left-sided colon cancer by favoring the bridge-to-surgery practice, provided that a reduction in morbidity can be achieved without compromising the oncological long-term outcome.Trial registrationGerman Clinical Trials Register (DRKS) under the identifier DRKS00031827. Registered on May 15, 2023.Protocol: 28.04.2023, protocol version 2.0F.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 1

Fig. 8