Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative

Intervention / Treatment
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* Procedure: Standard abdominal approach for rectal excision
* Procedure: APPEAR Procedure
* Procedure: Proctectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Patients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate). | Procedure: Standard abdominal approach for rectal excision<br>* Standard abdominal approach for rectal excision<br>|
| Experimental: Arm 2<br>Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal | Procedure: APPEAR Procedure<br>* Perineal incision to reach the distal rectum<br>* Other names: Anterior Perineal PlanE for ultra low rectal excision;|
| Active Comparator: Arm 3<br>Standard proctectomy to excise the distal third of the rectum and the anal canal | Procedure: Proctectomy<br>* standard rectal excision which does not preserve the anal canal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yield (within each arm of study) |  | 5 years | 
| Functional assessment (faecal continence) |  | 5 years | 
| Surgical Safety Assessment |  | 1 year | 
| Oncological safety assessment - where appropriate |  | 5 years |