Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Summary

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.

Conditions

• Rectal Neoplasms
• Colitis, Ischemic
• Colitis, Ulcerative

Interventions

PROCEDURE

Standard abdominal approach for rectal excision

Standard abdominal approach for rectal excision

PROCEDURE

APPEAR Procedure

Perineal incision to reach the distal rectum

PROCEDURE

Proctectomy

standard rectal excision which does not preserve the anal canal

Sponsors & Collaborators

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Prof Norman S Williams, MS FRCS · Centre for Academic Surgery, Queen Mary University of London

• Charles H Knowles, PhD FRCS · Centre for Academic Surgery, Queen Mary University of London

• Khalid El-Gendy, MBBS MRCS · Centre for Academic Surgery, Queen Mary University of London

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-04-01

Primary Completion

2015-08-01

Completion

2015-11-01

Countries

• United Kingdom

Study Locations