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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Queen Mary University of London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00534131
First received: September 21, 2007
Last updated: July 27, 2010
Last verified: June 2008
  Purpose

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 Intervention
Rectal Neoplasms
Colitis, Ischemic
Colitis, Ulcerative
Procedure: Standard abdominal approach for rectal excision
Procedure: APPEAR Procedure
Procedure: Proctectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Yield (within each arm of study) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Functional assessment (faecal continence) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Surgical Safety Assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Oncological safety assessment - where appropriate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2004
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Proctectomy
standard rectal excision which does not preserve the anal canal

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534131

Contacts
Contact: Khalid El-Gendy, BSc MBBS MRCS 020 7882 8751 k.el-gendy@qmul.ac.uk
Contact: Prof Norman S Williams, MS FRCS 020 7882 8755 n.s.williams@qmul.ac.uk

Locations
United Kingdom
Centre For Academic Surgery, The Royal London Hospital Recruiting
London, England, United Kingdom, E1 1BB
Contact: Khalid El-Gendy, MBBS MRCS    020 7882 8751    k.el-gendy@qmul.ac.uk   
Contact: Prof Norman S Williams, MS FRCS    020 7882 8755    n.s.williams@qmul.ac.uk   
Principal Investigator: Khalid El-Gendy, MBBS MRCS         
Sponsors and Collaborators
Queen Mary University of London
Investigators
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
  More Information

No publications provided by Queen Mary University of London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerry Leonard, Queen Mary University of London/Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00534131     History of Changes
Other Study ID Numbers: 09/H0704/30
Study First Received: September 21, 2007
Last Updated: July 27, 2010
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Colitis
Colitis, Ischemic
Colitis, Ulcerative
Rectal Neoplasms
Cardiovascular Diseases
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014