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NCT Number: NCT00534131

Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous rectal diseases. However, this has not always been the case and this development has been facilitated by the invention of circular stapling instruments, which allow the bowel to be reconnected to the anal sphincters, where it would almost be impossible to do so manually. Nevertheless, some patients still require a permanent ostomy, as even with stapling devices ultra low joins of the bowel and sphincter muscles cannot always be performed by a conventional surgery. Therefore, a variety of alternative techniques have been proposed to avoid a permanent ostomy, but these have not become widespread due to the technical difficulty in performing them, their failure to completely eradicate rectal disease, and the damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.

The ideal ultra low sphincter preserving operation should remove the rectal disease entirely, allow the small or large bowel to be safely joined to the anal sphincters under direct vision, and retain the sphincter mechanism in its entirety. We propose such a technique that we term the APPEAR procedure, which approaches the lower third of the rectum via an incision between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter integrity, and allows either a stapled or manual join of the bowel to the sphincter mechanism, under direct vision. This trial is being conducted as a pilot study, with the procedure only offered to patients for whom a conventional sphincter saving procedure was technically impossible, or contraindicated.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre For Academic Surgery, The Royal London Hospital

London, England, E1 1BB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard abdominal approach for rectal excision

Procedure

Standard abdominal approach for rectal excision

APPEAR Procedure

Procedure

Perineal incision to reach the distal rectum

Other names: Anterior Perineal PlanE for ultra low rectal excision

Proctectomy

Procedure

standard rectal excision which does not preserve the anal canal

Primary outcomes

  1. Yield (within each arm of study)

    Time frame: 5 years

  2. Functional assessment (faecal continence)

    Time frame: 5 years

  3. Surgical Safety Assessment

    Time frame: 1 year

  4. Oncological safety assessment - where appropriate

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: APPEAR

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2007
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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