Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study
Launched by REGION VÄSTMANLAND · Nov 21, 2013
Trial Information
Current as of April 26, 2025
Terminated
Keywords
ClinConnect Summary
In patients with rectal cancer, an abdominal operation with anterior resection with total mesorectal excision is the gold standard. Colon is anastomosed to the ano-rectum.The potential risks are bad bowel function with fecal incontinence or a lifethreatening anastomotic dehiscence, especially in patients with severe co-morbidity or reduced general condition.Tumours in the low rectum are usually treated with an abdominoperineal resection where the whole anus is radically excised and a permanent colostomy is created.
For patients with incontinence and/or severe comorbidity, Hartmann´s proced...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Rectal cancer 5cm or more from the anal verge
- • Both procedures should be possible to perform
- • Patients should have co-morbidities and/or have weak anal sphincter where an anterior resection is not suitable
- • Metastases are no contraindication but the procedure should be assessed as locally radical.
- • Patients should be assesed to cope with a major abdominal procedure(ASA I-III)
- Exclusion Criteria:
- • rectal cancer below 5cm from the anal verge where a Hartmann is considered not to be locally radical.
- • patients where an anterior resection is suitable
- • ASA IV or worse
About Region Västmanland
Region Västmanland is a leading healthcare authority in Sweden dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to enhancing health outcomes, the region collaborates with academic institutions, healthcare providers, and industry partners to conduct high-quality research across various therapeutic areas. By prioritizing patient safety and ethical standards, Region Västmanland aims to contribute valuable insights to the medical community and foster the development of new treatments that meet the needs of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Västerås, , Sweden
Patients applied
Trial Officials
Kenneth Smedh, PhD
Principal Investigator
Region Vastmanland
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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