deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer
Organizational Data
- DRKS-ID:
- DRKS00031827
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-05-15
- Last update in DRKS:
- 2024-01-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
COMPASS
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
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. These results seem to suggest that the BTS approach in patients with left-sided obstructive colon cancer has the potential to significantly reduce perioperative mortality and improve quality of life by reducing perioperative complications and the number of permanent stomas without worsening long-term oncological outcomes. Although these results are promising, the above retrospective studies cannot adequately assess dropout between decompressive stoma creation and resection. A prospective randomised trial is needed to perform an intention-to-treat analysis and confirm these results. This randomised multicentre study compares the postoperative outcomes of patients with left-sided obstructive colon cancer treated with either emergency resection or decompressive stoma as a bridge to elective resection.
Health condition or problem studied
- ICD10:
- C18 - Malignant neoplasm of colon
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Accomplishment of a decompressing stoma followed by a two-stage oncological elective resection after convalescence
- Arm 2:
- Emergency resection of the left-sided obstructive colon tumor
Endpoints
- Primary outcome:
- Perioperative 120-day mortality
- Secondary outcome:
- Patient reported quality of life (EORTC QLQ-C30), Primary anastomosis, 90-day complication rate, Permanent stoma rate after 1 year, comparison of number of resected lymph nodes, comparison of local R0 resection, 3-year overall survival, 3-year cancer-specific survival, 3-year disease-free survival, incisional hernia at 3-years, adjuvant therapy after resection and oncological re-interventions (due to recurrence), quality-adjusted survival (QALY)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätklinikum Carl Gustav Carus an der TU Dresden Dresden
- Medical center Ev. Diakonissenkrankenhaus Leipzig Leipzig
- Medical center Krankenhaus Barmherzige Brüder München München
- University medical center Uniklinik Düsseldorf Düsseldorf
- University medical center Universitätsklinikum Heidelberg Heidelberg
- University medical center Universitätsklinikum Schleswig-Holstein Standort Lübeck Lübeck
- University medical center Universitätsklinikum Schleswig-Holstein Standort Kiel Kiel
- University medical center Universitätsklinikum Würzburg Würzburg
- Medical center St. Elisabeth-Krankenhaus Köln-Hohenlind Köln
- Medical center Rheinlandklinikums Neuss Neuss
- University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
- University medical center Universitätsklinikum Halle-Wittenberg Halle (Saale)
- University medical center Universitätsklinikum des Saarlandes Homburg
- Medical center Klinikum Saarbrücken Saarbrücken
- University medical center Universitätsklinikum Göttingen Göttingen
- University medical center Universitätsklinikum Erlangen Erlangen
- Medical center Krankenhauses Barmherzige Brüder in Regensburg Regensburg
- Medical center Kliniken Köln Köln
- University medical center Helios Universitätsklinikum Wuppertal - Universität Witten/Herdecke Wuppertal
- Medical center Krankenhaus Landshut-Achdorf Landshut
- Medical center Gesundheits- und Pflegezentrum Rüsselsheim gGmbH Rüsselsheim
- University medical center Universitätsklinikum Münster Münster
- Medical center Marienhospital Herne Herne
- Medical center Klinikum Memmingen Memmingen
- Medical center Helios Amper-Klinikums Dachau Dachau
- University medical center Universitätsklinikum Ruppin-Brandenburg Neuruppin
- University medical center Universitätsklinikum Freiburg Freiburg
- Medical center Westpfalz-Klinikum Kaiserslautern Kaiserslautern
- Medical center Helios Klinik München Perlach München
- University medical center LMU Klinikum München
- Medical center Klinikum Chemnitz gGmbH Chemnitz
Recruitment period and number of participants
- Planned study start date:
- 2023-09-01
- Actual study start date:
- 2023-12-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 468
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Colonic obstruction of patients with a left-sided colon or upper rectal tumor (splenic flexure to the intraperitoneal rectum (tumor > 12 cm from the anal verge)) treated with curative intent - the tumor must be highly suspicious for colon cancer in CT or endoscopy - proof of colonic dilatation by computed tomography - the tumor including potential metastases must be deemed curatively resectable - Capacity of the patient to consent
Exclusion Criteria
- Right-sided colon - Extraperitoneal rectal cancer of the lower and middle third (tumor < 12 cm from the anal verge) - life expectancy < 120 days due to advanced tumour disease - locally advanced tumor disease with local infiltration of other structures which excludes a R0 resection or requires a neoadjuvant treatment - patients treated in palliative intent - signs of bowel perforation on CT - patients not eligible for surgery (ASA Score ≥ IV) - lack of compliance - Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
Addresses
Primary Sponsor
- Address:
- Technische Universität Dresden01069 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Christoph KahlertIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +49 6221 56310222
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Christoph KahlertIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +49 6221 56310222
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum HeidelbergProf. Dr. Christoph KahlertIm Neuenheimer Feld 42069120 HeidelbergGermany
- Telephone:
- +49 6221 56310222
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://tu-dresden.de/tu-dresden/organisation/gremien-und-beauftragte/kommissionen/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-06-17
- Ethics committee number:
- BO-EK278062022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-08-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- 01KG2309 - BMBF
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry