Rectal CancerAPPRONCT02163785
Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
A study testing Abdominoperineal extra-elevators rectal resection for low lying rectal cancer in people with Rectal Cancer and Abdominoperineal Resection, run by Hospital Universitario La Fe at 19 sites in Spain.
Trial summary
Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Abdominoperineal Resection
- What is being tested?
- Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 19 sitesSpain
- Study dates
- Jun 2014to Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI
Who cannot join
- American Society of Anaesthesiologists classification of Physical Health (ASA) IV patients
- Locally palliative purpose of the operation
- Age < 18 years
- Preoperative indication for pelvic exenteration
- Pregnancy
- Lack of patients consent
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital Bellvitge
Barcelona, Catalonia
Hospital del Mar
Barcelona, Catalonia
Hospital Universitario Reina Sofia
Córdoba, Andalusia
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country
Hospital General Universitario
Elche, Valencia
Hospital Universitario Josep Trueta
Girona, Catalonia
Hospital del SAS
Jerez de la Frontera, Andalusia
Hospital General
Medina del Campo, Castille and León
Hospital Universitario "Virgen de la Arrixaca"
Murcia
Complexo Hospitalario Universitario
Ourense, Galicia
Complejo Hospitalario
Pamplona, Navarre
Hospital General
Requena, Valencia
Hospital Universitario Parc Tauli
Sabadell, Catalonia
Hospital de Sagunto
Sagunto, Valencia
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Hospital Arnau de Vilanova
Valencia
Hospital Clinico Universitario
Valencia
Complejo Hospitalario Universitario
Vigo, Galicia
Hospital Luis Alcanyis
Xàtiva, Valencia
About this study
Official title: Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer.
Primary objective:
- Pathological circumferential resection margin
Secondary objectives:
- 5 year oncological outcomes
- Morbimortality rates
- Surgical specimen quality
- Perineal hernia incidence
- Conditions
- Rectal Cancer, Abdominoperineal Resection
- Being tested
- Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
- Keywords
- Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominoperineal extra-elevators rectal resection for low lying rectal cancerProcedure or surgery
Also called Abdominoperineal resection of the rectum, Abdominoperineal excision of the rectum, Abdominoperineal resection
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Active comparator | Abdominoperineal resection - perineal time- in supine position Receives: Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer |
| Prone position | Experimental | Abdominoperineal resection - perineal time- in prone position Receives: Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the circumferential resection margin
Histopathological report of the circumferential resection margin of the surgical specimen obtained in patients that underwent perineal time of Miles procedure in prone vs supine position.
Measured: 15-30 days after surgery date
Secondary outcomes (1)
Histopathological quality of surgical specimen
Comparison of the quality of the surgical specimen in terms of integrity of the circumferential resection margin, accidental iatrogenic rupture etc.
Measured: 15-30 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: insufficient recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Para La Investigacion Hospital La Fe, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Matteo Frasson, Hospital Universitario La Fe
- Investigators
- Matteo Frasson, MD, PhD, Principal investigator, Hospital Universitario y Politecnico La FeEduardo Garcia-Granero, MD, PhD, EBSQ-c, Study chair, Hospital Universitario y Politecnico La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163785
- Sponsor's protocol ID
- APPRO
- Acronym
- APPRO
- Status last verified
- Sep 2021
- First submitted
- 12 Jun 2014
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Granero E, Faiz O, Munoz E, Flor B, Navarro S, Faus C, Garcia-Botello SA, Lledo S, Cervantes A. Macroscopic assessment of mesorectal excision in rectal cancer: a useful tool for improving quality control in a multidisciplinary team. Cancer. 2009 Aug 1;115(15):3400-11. doi: 10.1002/cncr.24387.
PubMed 19479978Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg. 1998 Aug;133(8):894-9. doi: 10.1001/archsurg.133.8.894.
PubMed 9711965Flor-Lorente B, Frasson M, Montilla E. Extralevator abdominoperineal resection in the prone position. Cir Esp. 2014 Mar;92 Suppl 1:30-9. doi: 10.1016/S0009-739X(14)70006-5. English, Spanish.
PubMed 24842689Frasson M, Garcia-Granero E. Reply to Kelly et al. Colorectal Dis. 2016 Mar;18(3):312-3. doi: 10.1111/codi.13272. No abstract available.
PubMed 26757199
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
- ClinicalTrials.gov ID
- NCT02163785
- Acronym / sponsor ID
- APPRO / APPRO
- Conditions
- Rectal Cancer, Abdominoperineal Resection
- Keywords
- Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment rate
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Collaborators
- Fundacion Para La Investigacion Hospital La Fe, Instituto de Salud Carlos III
- Study start
- Jun 2014
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 16 Jun 2014 (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.
Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer.
Primary objective:
- Pathological circumferential resection margin
Secondary objectives:
- 5 year oncological outcomes
- Morbimortality rates
- Surgical specimen quality
- Perineal hernia incidence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position | Active comparator | Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancerAbdominoperineal resection - perineal time- in supine position |
| Prone position | Experimental | Procedure: Abdominoperineal extra-elevators rectal resection for low lying rectal cancerAbdominoperineal resection - perineal time- in prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI
Key exclusion criteria (6 listed)
- American Society of Anaesthesiologists classification of Physical Health (ASA) IV patients
- Locally palliative purpose of the operation
- Age < 18 years
- Preoperative indication for pelvic exenteration
- Pregnancy
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 |
|---|---|---|
| Abdominoperineal extra-elevators rectal resection for low lying rectal cancerAlso: Abdominoperineal resection of the rectum, Abdominoperineal excision of the rectum, Abdominoperineal resectionAbdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex | Procedure or surgery | Prone position, Supine position |
Primary outcome
Assessment of the circumferential resection margin
Time frame: 15-30 days after surgery date
Histopathological report of the circumferential resection margin of the surgical specimen obtained in patients that underwent perineal time of Miles procedure in prone vs supine position.
1 secondary outcome
Histopathological quality of surgical specimen
Time frame: 15-30 days after
Results and safety
The study was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 19479978Garcia-Granero E, Faiz O, Munoz E, Flor B, Navarro S, Faus C, Garcia-Botello SA, Lledo S, Cervantes A. Macroscopic assessment of mesorectal excision in rectal cancer: a useful tool for improving quality control in a multidisciplinary team. Cancer. 2009 Aug 1;115(15):3400-11. doi: 10.1002/cncr.24387.
- Background: PubMed 9711965Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg. 1998 Aug;133(8):894-9. doi: 10.1001/archsurg.133.8.894.
- Background: PubMed 24842689Flor-Lorente B, Frasson M, Montilla E. Extralevator abdominoperineal resection in the prone position. Cir Esp. 2014 Mar;92 Suppl 1:30-9. doi: 10.1016/S0009-739X(14)70006-5. English, Spanish.
- Derived from this study: PubMed 26757199Frasson M, Garcia-Granero E. Reply to Kelly et al. Colorectal Dis. 2016 Mar;18(3):312-3. doi: 10.1111/codi.13272. No abstract available.
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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.
Matteo Frasson, MD, PhD principal investigator
Hospital Universitario y Politecnico La Fe
Eduardo Garcia-Granero, MD, PhD, EBSQ-c study chair
Hospital Universitario y Politecnico La Fe
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominoperineal extra-elevators rectal resection for low lying rectal cancer in people with Rectal Cancer and Abdominoperineal Resection, run by Hospital Universitario La Fe at 19 sites in Spain.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. 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 was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
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?
Assessment of the circumferential resection margin (time frame: 15-30 days after surgery date). 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 NCT02163785, which also lists 4 linked publications.
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 Oct 2021.