Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

NCT00534131 | Completed DMC

• 1 other identifier: 09/H0704/30
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms; Colitis, Ischemic; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

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

Arm 2

EXPERIMENTAL

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

Procedure: APPEAR Procedure

Arm 3

ACTIVE COMPARATOR

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

Procedure: Proctectomy

Interventions

Standard abdominal approach for rectal excision PROCEDURE

Standard abdominal approach for rectal excision

Arm 1

APPEAR Procedure PROCEDURE

Perineal incision to reach the distal rectum

Also known as: Anterior Perineal PlanE for ultra low rectal excision

Arm 2

Proctectomy PROCEDURE

standard rectal excision which does not preserve the anal canal

Arm 3

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Centre For Academic Surgery, The Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 18438111 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Colitis, Ischemic; Colitis, Ulcerative

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colitis; Gastroenteritis; Colonic Diseases; Vascular Diseases; Cardiovascular Diseases; Inflammatory Bowel Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Prof Norman S Williams, MS FRCS

  Centre for Academic Surgery, Queen Mary University of London

  STUDY CHAIR

• Charles H Knowles, PhD FRCS

  Centre for Academic Surgery, Queen Mary University of London

  STUDY DIRECTOR

• Khalid El-Gendy, MBBS MRCS

  Centre for Academic Surgery, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: April 1, 2004
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 1, 2023

Record last verified: 2008-06

Locations

GB (1)