Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

NCT ID: NCT00534131

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-01
• Study Completion Date: 2015-11-01

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.

Conditions

Rectal Neoplasms; Colitis, Ischemic; Colitis, Ulcerative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard abdominal approach for rectal excision

Intervention Type: PROCEDURE

Standard abdominal approach for rectal excision

Arm 2

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

Group Type: EXPERIMENTAL

APPEAR Procedure

Intervention Type: PROCEDURE

Perineal incision to reach the distal rectum

Arm 3

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

Group Type: ACTIVE_COMPARATOR

Proctectomy

Intervention Type: PROCEDURE

standard rectal excision which does not preserve the anal canal

Interventions

Standard abdominal approach for rectal excision

Standard abdominal approach for rectal excision

Intervention Type: PROCEDURE

APPEAR Procedure

Perineal incision to reach the distal rectum

Intervention Type: PROCEDURE

Proctectomy

standard rectal excision which does not preserve the anal canal

Intervention Type: PROCEDURE

Other Intervention Names

Anterior Perineal PlanE for ultra low rectal excision

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Norman S Williams, MS FRCS

Role: STUDY_CHAIR

Centre for Academic Surgery, Queen Mary University of London

Charles H Knowles, PhD FRCS

Role: STUDY_DIRECTOR

Centre for Academic Surgery, Queen Mary University of London

Khalid El-Gendy, MBBS MRCS

Role: PRINCIPAL_INVESTIGATOR

Centre for Academic Surgery, Queen Mary University of London

Locations

Centre For Academic Surgery, The Royal London Hospital

London, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 18438111 (View on PubMed)

Other Identifiers

09/H0704/30

Identifier Type: -

Identifier Source: org_study_id