NCT00534131: APPEAR

Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Completed NA Last updated 1 March 2023

What this trial tests

NA trial testing Standard abdominal approach for rectal excision in Rectal Neoplasms in 23 participants. Completed in 1 November 2015.

Timeline

1 April 2004

Primary endpoint
1 August 2015

1 November 2015

Quick facts

Lead sponsor	Queen Mary University of London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 April 2004
Primary completion	1 August 2015
Estimated completion	1 November 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Standard abdominal approach for rectal excision
• APPEAR Procedure
• Proctectomy

Conditions studied

• Rectal Neoplasms — all drugs for Rectal Neoplasms →
• Colitis, Ischemic — all drugs for Colitis, Ischemic →
• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

Queen Mary University of London

Who can join

16 and older, any sex, with Rectal Neoplasms or Colitis, Ischemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Anterior Perineal PlanE for Ultra-low Anterior Resection of the Rectum (the APPEAR technique): a prospective clinical trial of a new procedure.
   Williams NS, Murphy J, Knowles CH. · · 2008 · cited 26× · PMID 18438111 · DOI 10.1097/sla.0b013e31816b2ee3