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

Primary Purpose

Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard abdominal approach for rectal excision
APPEAR Procedure
Proctectomy
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre For Academic Surgery, The Royal London Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Yield (within each arm of study)
Functional assessment (faecal continence)
Surgical Safety Assessment
Oncological safety assessment - where appropriate

Secondary Outcome Measures

Full Information

First Posted
September 21, 2007
Last Updated
February 27, 2023
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00534131
Brief Title
Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum
Acronym
APPEAR
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 1, 2004 (Actual)
Primary Completion Date
August 1, 2015 (Actual)
Study Completion Date
November 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Patients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate).
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Standard proctectomy to excise the distal third of the rectum and the anal canal
Intervention Type
Procedure
Intervention Name(s)
Standard abdominal approach for rectal excision
Intervention Description
Standard abdominal approach for rectal excision
Intervention Type
Procedure
Intervention Name(s)
APPEAR Procedure
Other Intervention Name(s)
Anterior Perineal PlanE for ultra low rectal excision
Intervention Description
Perineal incision to reach the distal rectum
Intervention Type
Procedure
Intervention Name(s)
Proctectomy
Intervention Description
standard rectal excision which does not preserve the anal canal
Primary Outcome Measure Information:
Title
Yield (within each arm of study)
Time Frame
5 years
Title
Functional assessment (faecal continence)
Time Frame
5 years
Title
Surgical Safety Assessment
Time Frame
1 year
Title
Oncological safety assessment - where appropriate
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Norman S Williams, MS FRCS
Organizational Affiliation
Centre for Academic Surgery, Queen Mary University of London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles H Knowles, PhD FRCS
Organizational Affiliation
Centre for Academic Surgery, Queen Mary University of London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khalid El-Gendy, MBBS MRCS
Organizational Affiliation
Centre for Academic Surgery, Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre For Academic Surgery, The Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18438111
Citation
Williams NS, Murphy J, Knowles CH. Anterior Perineal PlanE for Ultra-low Anterior Resection of the Rectum (the APPEAR technique): a prospective clinical trial of a new procedure. Ann Surg. 2008 May;247(5):750-8. doi: 10.1097/SLA.0b013e31816b2ee3.
Results Reference
derived

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Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

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