COMPASS - Studie

Colorectal cancer is the third leading cause of cancer death in both men and women in the United States and the second leading cause of cancer death in men and the third leading cause of cancer death in women in Europe. Worldwide, colorectal cancer is responsible for 19.0 million (18.5-19.5) disability-adjusted life years (DALYs). The risk of developing colorectal cancer increases into old age. More than half of patients develop the disease after the age of 70, and only about 10% of cancers occur before the age of 55. About 20 % of patients initially present with acute colonic obstruction, which is one of the most common causes of surgical emergencies. International guidelines do not agree on the optimal treatment for left-sided obstructing colon cancer. In general, two therapeutic approaches are common: Emergency single-stage resection of the obstructing tumour, with or without creation of a stoma, or two-stage resection with a decompressive stoma creation in the first stage and elective oncological resection after convalescence in the second stage, usually after about 20-30 days. Both procedures have advantages and disadvantages. Data from recent retrospective studies suggest that the two-stage bridge-to-surgery (BTS) approach may reduce 90-day mortality and long-term survival in patients with left-sided obstructive colon cancer. In addition to reducing mortality, BTS may also reduce the number of patients requiring a permanent stoma and facilitate the performance of minimally invasive colon resection, leading to a higher quality of life.

{ "short_title": "COMPASS - Studie", "data_mode": "900", "data_mode_number": "000002292", "official_title": "Decompressing stoma and two-stage elective resection vs. emergency resection in patients with left-sided obstructive colon cancer", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Dr. med. Mathieu Pecqueux", "description_laie_de": "Die COMPASS Studie untersucht zwei chirurgische Verfahren bei Patienten mit einem akuten oder drohenden Darmverschluss durch ein Darmgeschwulst am linksseitigen Dickdarm. Eine Operation ist in jedem Fall notwendig, da durch den Darmverschluss eine akute Notfallsituation eingetreten ist oder eintreten kann. Ohne Operation kann es zu schwerwiegenden Komplikationen kommen.\r\nF\u00fcr die Entfernung des Darmgeschwulstes bei akutem oder drohendem Darmverschluss gibt es zwei chirurgische Verfahren: \r\nVerfahren 1: Beim einzeitigen Verfahren wird das Darmgeschwulst mit dem betroffenen Darmabschnitt im Rahmen einer Operation entfernt.\r\nVerfahren 2: Bei dem zweizeitigen Verfahren wird dem Patienten zun\u00e4chst ein k\u00fcnstlicher Darmausgang (Stoma) angelegt. Dadurch wird der gestaute Darm (verursacht durch das Darmgeschwulst mit akutem oder drohendem Darmverschluss) zun\u00e4chst entlastet. Sobald sich die Patient:innen von den Folgen des akuten Darmverschlusses erholt haben, erfolgt eine zweite Operation. Diese Operation findet in etwa 30 Tage nach der ersten Operation statt. Im Rahmen der zweiten Operation wird das darmverschlie\u00dfende Geschwulst entfernt. Au\u00dferdem wird \u2013 wenn m\u00f6glich - der k\u00fcnstliche Darmausgang zur\u00fcckverlegt.\r\nDer Vorteil des einzeitigen Vorgehens besteht darin, dass die Dickdarmgeschwulstes bereits bei der ersten Operation entfernt werden kann. Andererseits k\u00f6nnen gr\u00f6\u00dfere Operationen w\u00e4hrend eines akuten Darmverschlusses zu Problemen f\u00fchren. Aktuelle Daten aus verschiedenen Studien geben Hinweise darauf, dass bei Patienten mit akutem oder drohendem Darmverschluss durch ein Dickdarmgeschwulst das zweizeitige Vorgehen die Sterblichkeit in den ersten 120 Tagen senken kann. Dar\u00fcber hinaus gibt es Hinweise darauf, dass bei einem zweizeitigen Vorgehen h\u00e4ufiger ein minimalinvasiver Zugang (\u201eSchl\u00fcssellochchirurgie\u201c) m\u00f6glich ist und Komplikationen/Langzeitfolgen wie ein dauerhafter k\u00fcnstlicher Darmausgang gesenkt werden k\u00f6nnen.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "Colorectal cancer is the third leading cause of cancer death in both men and women in the United States and the second leading cause of cancer death in men and the third leading cause of cancer death in women in Europe. Worldwide, colorectal cancer is responsible for 19.0 million (18.5-19.5) disability-adjusted life years (DALYs). The risk of developing colorectal cancer increases into old age. More than half of patients develop the disease after the age of 70, and only about 10% of cancers occur before the age of 55. About 20 % of patients initially present with acute colonic obstruction, which is one of the most common causes of surgical emergencies. International guidelines do not agree on the optimal treatment for left-sided obstructing colon cancer. In general, two therapeutic approaches are common: Emergency single-stage resection of the obstructing tumour, with or without creation of a stoma, or two-stage resection with a decompressive stoma creation in the first stage and elective oncological resection after convalescence in the second stage, usually after about 20-30 days. Both procedures have advantages and disadvantages. \r\n\r\nData from recent retrospective studies suggest that the two-stage bridge-to-surgery (BTS) approach may reduce 90-day mortality and long-term survival in patients with left-sided obstructive colon cancer. In addition to reducing mortality, BTS may also reduce the number of patients requiring a permanent stoma and facilitate the performance of minimally invasive colon resection, leading to a higher quality of life.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 2, "sub_cat_id": 6 }

Settings