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Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

NCT01995396 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2021-12-16

No results posted yet for this study

Summary

In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable.

In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

Conditions

  • Rectal Cancer
  • Sphincter Ani Incontinence
  • Other Diagnoses, Comorbidities, and Complications

Interventions

PROCEDURE

APE with intersphincteric dissection

Abdominal operation where the rectum is resected down to the levator and then the anus is resected by an intersphincteric dissection and order to leave the outer sfincter and levator in place to avoid a large wound and a high rate of infectious complications.

PROCEDURE

Hartmann´s procedure

Abdominal operation where the rectum is resected and stapled off distally and a stoma is created

Sponsors & Collaborators

  • Region Västmanland

    lead OTHER

Principal Investigators

  • Kenneth Smedh, PhD · Region Vastmanland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995396 on ClinicalTrials.gov