Rectal NeoplasmsAPPEARNCT00534131
Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum
A study testing Standard abdominal approach for rectal excision, APPEAR Procedure and Proctectomy in people with Rectal Neoplasms and Colitis, Ischemic, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative
- What is being tested?
- Standard abdominal approach for rectal excision, APPEAR Procedure and Proctectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2004to 1 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre For Academic Surgery, The Royal London Hospital
London, England, E1 1BB
About this study
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
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.
Read the 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
- Being tested
- Standard abdominal approach for rectal excision, APPEAR Procedure, Proctectomy
- Medical subject headings
- Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard abdominal approach for rectal excisionProcedure or surgery
Standard abdominal approach for rectal excision
APPEAR ProcedureProcedure or surgery
Also called Anterior Perineal PlanE for ultra low rectal excision
Perineal incision to reach the distal rectum
ProctectomyProcedure or surgery
standard rectal excision which does not preserve the anal canal
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Procedure: APPEAR Procedure |
| Arm 3 | Active comparator | Standard proctectomy to excise the distal third of the rectum and the anal canal Receives: Procedure: Proctectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield (within each arm of study)
Measured: 5 years
Functional assessment (faecal continence)
Measured: 5 years
Surgical Safety Assessment
Measured: 1 year
Oncological safety assessment - where appropriate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study start1 Apr 2004
- Primary completion1 Aug 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Norman S Williams, MS FRCS, Study chair, Centre for Academic Surgery, Queen Mary University of LondonCharles H Knowles, PhD FRCS, Study director, Centre for Academic Surgery, Queen Mary University of LondonKhalid El-Gendy, MBBS MRCS, Principal investigator, Centre for Academic Surgery, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534131
- Sponsor's protocol ID
- 09/H0704/30
- Acronym
- APPEAR
- Status last verified
- Jun 2008
- First submitted
- 21 Sep 2007
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18438111
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00534131
- Acronym / sponsor ID
- APPEAR / 09/H0704/30
- Conditions
- Rectal Neoplasms, Colitis, Ischemic, Colitis, Ulcerative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: Standard abdominal approach for rectal excisionPatients for whom a standard abdominal approach is adequate to excise the distal third of the rectum (without jeopardising oncological clearance if appropriate). |
| Arm 2 | Experimental | Procedure: APPEAR ProcedureCombined abdominal and trans-perineal approach to excise the distal third of the rectum, while preserving the anal canal |
| Arm 3 | Active comparator | Procedure: ProctectomyStandard proctectomy to excise the distal third of the rectum and the anal canal |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard abdominal approach for rectal excisionStandard abdominal approach for rectal excision | Procedure or surgery | Arm 1 |
| APPEAR ProcedureAlso: Anterior Perineal PlanE for ultra low rectal excisionPerineal incision to reach the distal rectum | Procedure or surgery | Arm 2 |
| Proctectomystandard rectal excision which does not preserve the anal canal | Procedure or surgery | Arm 3 |
Primary outcome
Yield (within each arm of study)
Time frame: 5 years
Functional assessment (faecal continence)
Time frame: 5 years
Surgical Safety Assessment
Time frame: 1 year
Oncological safety assessment - where appropriate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 18438111Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Norman S Williams, MS FRCS study chair
Centre for Academic Surgery, Queen Mary University of London
Charles H Knowles, PhD FRCS study director
Centre for Academic Surgery, Queen Mary University of London
Khalid El-Gendy, MBBS MRCS principal investigator
Centre for Academic Surgery, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard abdominal approach for rectal excision, APPEAR Procedure and Proctectomy in people with Rectal Neoplasms and Colitis, Ischemic, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield (within each arm of study) (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00534131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.