Clinical trial NCT00534131: Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum
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
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Colitis, Ischemic
Colitis, Ulcerative
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yield (within each arm of study)
timeFrame: 5 years
measure: Functional assessment (faecal continence)
timeFrame: 5 years
measure: Surgical Safety Assessment
timeFrame: 1 year
measure: Oncological safety assessment - where appropriate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre For Academic Surgery, The Royal London Hospital
state: England
Study officials:
affiliation: Centre for Academic Surgery, Queen Mary University of London
name: Prof Norman S Williams, MS FRCS
role: STUDY_CHAIR
affiliation: Centre for Academic Surgery, Queen Mary University of London
name: Charles H Knowles, PhD FRCS
role: STUDY_DIRECTOR
affiliation: Centre for Academic Surgery, Queen Mary University of London
name: Khalid El-Gendy, MBBS MRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.