Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum (APPEAR)
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|ClinicalTrials.gov Identifier: NCT00534131|
Recruitment Status : Unknown
Verified June 2008 by Queen Mary University of London.
Recruitment status was: Recruiting
First Posted : September 24, 2007
Last Update Posted : July 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms Colitis, Ischemic Colitis, Ulcerative||Procedure: Standard abdominal approach for rectal excision Procedure: APPEAR Procedure Procedure: Proctectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2004|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||March 2012|
Active Comparator: Arm 1
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
Standard abdominal approach for rectal excision
Experimental: Arm 2
Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal
Procedure: APPEAR Procedure
Perineal incision to reach the distal rectum
Other Name: Anterior Perineal PlanE for ultra low rectal excision
Active Comparator: Arm 3
Standard proctectomy to excise the distal third of the rectum and the anal canal
standard rectal excision which does not preserve the anal canal
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534131
|Contact: Khalid El-Gendy, BSc MBBS MRCS||020 7882 email@example.com|
|Contact: Prof Norman S Williams, MS FRCS||020 7882 firstname.lastname@example.org|
|Centre For Academic Surgery, The Royal London Hospital||Recruiting|
|London, England, United Kingdom, E1 1BB|
|Contact: Khalid El-Gendy, MBBS MRCS 020 7882 8751 email@example.com|
|Contact: Prof Norman S Williams, MS FRCS 020 7882 8755 firstname.lastname@example.org|
|Principal Investigator: Khalid El-Gendy, MBBS MRCS|
|Study Chair:||Prof Norman S Williams, MS FRCS||Centre for Academic Surgery, Queen Mary University of London|
|Study Director:||Charles H Knowles, PhD FRCS||Centre for Academic Surgery, Queen Mary University of London|
|Principal Investigator:||Khalid El-Gendy, MBBS MRCS||Centre for Academic Surgery, Queen Mary University of London|