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Search / Trial NCT01995396

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

Rectal Cancer, Fecal Incontinence, Severe Co Morbidity, Hartmann´S Procedure, Abdominoperineal Excision With Intersphincteric Dissection, Postoperative Complications, Pelvic Abscess, Perineal Infections

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.

Locations

Västerås, , Sweden

Patients applied

0 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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