Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum (APPEAR)

Queen Mary University of London

Status

Completed

Conditions

Colitis, Ulcerative

Colitis, Ischemic

Rectal Neoplasms

Treatments

Procedure: Proctectomy

Procedure: Standard abdominal approach for rectal excision

Procedure: APPEAR Procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT00534131

09/H0704/30

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 3 patient groups

Arm 1

Active Comparator group

Description:

Patients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate).

Treatment:

Procedure: Standard abdominal approach for rectal excision

Arm 2

Experimental group

Description:

Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal

Treatment:

Procedure: APPEAR Procedure

Arm 3

Active Comparator group

Description:

Standard proctectomy to excise the distal third of the rectum and the anal canal