Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
NCT ID: NCT02163785
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
280 participants
INTERVENTIONAL
2014-06-30
2021-01-31
Brief Summary
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Primary objective:
\- Pathological circumferential resection margin
Secondary objectives:
* 5 year oncological outcomes
* Morbimortality rates
* Surgical specimen quality
* Perineal hernia incidence
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Supine position
Abdominoperineal resection - perineal time- in supine position
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
Prone position
Abdominoperineal resection - perineal time- in prone position
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
Interventions
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Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Locally palliative purpose of the operation
* Age \< 18 years
* Preoperative indication for pelvic exenteration
* Pregnancy
* Lack of patients consent
18 Years
ALL
No
Sponsors
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Fundacion Para La Investigacion Hospital La Fe
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Hospital Universitario La Fe
OTHER
Responsible Party
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Matteo Frasson
MD, PhD
Principal Investigators
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Matteo Frasson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario y Politecnico La Fe
Eduardo Garcia-Granero, MD, PhD, EBSQ-c
Role: STUDY_CHAIR
Hospital Universitario y Politecnico La Fe
Locations
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Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital del SAS
Jerez de la Frontera, Andalusia, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, Spain
Hospital General
Medina del Campo, Castille and León, Spain
Hospital Bellvitge
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Universitario Josep Trueta
Girona, Catalonia, Spain
Hospital Universitario Parc Tauli
Sabadell, Catalonia, Spain
Complexo Hospitalario Universitario
Ourense, Galicia, Spain
Complejo Hospitalario Universitario
Vigo, Galicia, Spain
Complejo Hospitalario
Pamplona, Navarre, Spain
Hospital General Universitario
Elche, Valencia, Spain
Hospital General
Requena, Valencia, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Luis Alcanyis
Xàtiva, Valencia, Spain
Hospital Universitario "Virgen de la Arrixaca"
Murcia, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital Clinico Universitario
Valencia, , Spain
Countries
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References
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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.
Heald 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.
Flor-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.
Frasson 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.
Other Identifiers
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APPRO
Identifier Type: -
Identifier Source: org_study_id
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