Clinical Trial Information Sheet - COMPASS

Primary Indication

Mortality and Quality of Life Following Emergencies in Obstructive Colorectal Cancer

Study Name (Study Type)

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

Study sponsor

Dresden University of Technology

Registration Number

Investigator Site File DRKS00031827

FOR SKIM READERS:

This study investigates whether, in patients with left-sided colon cancer and obstructive ileus, primary
creation of a decompressive stoma is superior to primary tumor resection in terms of mortality and
stoma-free survival.

DETAILED INFORMATION

The study aims to investigate whether a decompressive stoma, used as a temporary measure until elective surgery, reduces 120-day mortality compared to emergency resection in patients with obstructive left-sided colon cancer. 

Study Title

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

What conditions are being treated in this study?

Colon cancer

Are specific subgroups of patients with one of the listed conditions being treated?

Patients with left-sided colon cancer and obstructive ileus

Study Protocol.

As part of the COMPASS study, there are eight (control arm) or 12 (intervention arm) predefined study visits. Visits 10–12 take place every 12 months for up to 36 months after surgery. 

Inclusion criteria

• Patients with acute, tumor-related left-sided colonic obstruction (from the splenic flexure to the rectum)
• Need for urgent surgical intervention (associated with clinical symptoms of ileus, e.g.
  , abdominal distension, nausea, and/or vomiting)
• Evidence of a dilated colon, with or without small bowel dilation, on CT or
  X-ray imaging
• Age of ≥ 18 years and the presence of informed consent

Exclusion criteria

• Patients with rectal carcinoma (< 16.0 cm from the anal margin on rigid rectoscopy)
• Right-sided colon cancer
• Life expectancy < 90 days due to advanced cancer
• Signs of bowel perforation on CT or X-ray (evidence of free air)
• Locally advanced cancer with local infiltration of
  other structures, precluding R0 resection without neoadjuvant chemotherapy
• Patients who are not candidates for surgery (ASAScore ≥ IV)
• Patients with severe psychiatric or neurological disorders, as well as
  substance abuse

Your Points of Contact: Investigators at the Center and Contact Information

Mr. Nguyen, Trong Anh

Email: Tronganh.Nguyen@~@gp-ruesselsheim.de

Phone: 06142 88-1827

Contact the Clinical Trials Office

Email: Studienambulanz@gp-ruesselsheim.de

Phone: 0162-1392714