Clinical Trial: Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official 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
Brief 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.
Detailed Summary:
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.
Sponsor: Queen Mary University of London
Current Primary Outcome:
- Yield (within each arm of study) [ Time Frame: 5 years ]
- Functional assessment (faecal continence) [ Time Frame: 5 years ]
- Surgical Safety Assessment [ Time Frame: 1 year ]
- Oncological safety assessment - where appropriate [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Queen Mary University of London
Dates:
Date Received: September 21, 2007
Date Started: April 2004
Date Completion: March 2012
Last Updated: July 27, 2010
Last Verified: June 2008
