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A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease


N/A
16 Years
N/A
Open (Enrolling)
Both
Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative

Thank you

Trial Information

A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease


This study is recruiting patients with distal third rectal pathology, for whom a
conventional sphincter saving procedure is contraindicated, or likely to be technically
impossible.

Recruited patients will initially undergo trial dissection by conventional sphincter
preserving surgical techniques, which if successful will result in patients entering study
arm 1.

However, should this not be possible, a trial anterior perineal dissection will be
attempted, with patients entered into study arm 2 if perineal dissection is adequate to
allow full rectal excision, and preserve sphincter integrity.

If during a trial of anterior perineal dissection it is decided that sphincter preservation
is not safe, or will not allow eradication of rectal disease, conventional proctectomy will
be performed, with patients entering study arm 3.


Inclusion Criteria:



- All patients regardless of sex

- Undergoing surgery (with curative intent) to excise the lower third of the rectum who
may require a permanent stoma

- Deemed suitable by multidisciplinary team.

Exclusion Criteria:

- Patients under the age of 16

- Patients in whom sphincter preservation has already been deemed inappropriate for
medical or surgical reasons (e.g. by an MDT for oncological cure), or in whom surgery
has been deemed generally inappropriate.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Yield (within each arm of study)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Prof Norman S Williams, MS FRCS

Investigator Role:

Study Chair

Investigator Affiliation:

Centre for Academic Surgery, Queen Mary University of London

Authority:

United Kingdom: National Health Service

Study ID:

09/H0704/30

NCT ID:

NCT00534131

Start Date:

April 2004

Completion Date:

March 2012

Related Keywords:

  • Rectal Neoplasms
  • Colitis, Ischemic
  • Colitis, Ulcerative
  • Neoplasms
  • Colitis
  • Colitis, Ulcerative
  • Rectal Neoplasms
  • Ulcer
  • Colitis, Ischemic

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