Clinical trial · Interventional
Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ischemic | — | UNRESOLVED | — |
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APPEAR Procedure | Procedure | — | UNRESOLVED |
| Proctectomy | Procedure | — | UNRESOLVED |
| Standard abdominal approach for rectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Patients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate).
- interventionNames
- Procedure: Standard abdominal approach for rectal excision
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Combined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal
- interventionNames
- Procedure: APPEAR Procedure
- type
- ACTIVE_COMPARATOR
- label
- Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWilliams 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