Clinical trial NCT02163785: Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position
Official title: Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
Collaborators: name: Fundacion Para La Investigacion Hospital La Fe
name: Instituto de Salud Carlos III
First posted: 2014-06-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary objective:

- Pathological circumferential resection margin

Secondary objectives:

* 5 year oncological outcomes
* Morbimortality rates
* Surgical specimen quality
* Perineal hernia incidence


Eligibility criteria: Inclusion Criteria:

* Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of the circumferential resection margin
timeFrame: 15-30 days after surgery date
Secondary outcomes:
measure: Histopathological quality of surgical specimen
timeFrame: 15-30 days after
Other outcomes:
measure: Oncological outcomes
timeFrame: 5 years
measure: Morbidity of the perineal incision.
timeFrame: 1 day, 60 days ,1 ,2,3,4 and 5 years after surgery
Locations:
city: Jerez
country: Spain
facility: Hospital del SAS
state: Andalucia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Medina del Campo
country: Spain
facility: Hospital General
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Hospital Bellvitge
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Girona
country: Spain
facility: Hospital Universitario Josep Trueta
state: Cataluña
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli
state: Cataluña
city: Orense
country: Spain
facility: Complexo Hospitalario Universitario
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario
state: Galicia
city: Pamplona
country: Spain
facility: Complejo Hospitalario
state: Navarra
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Pais Vasco
city: Elche
country: Spain
facility: Hospital General Universitario
state: Valencia
city: Requena
country: Spain
facility: Hospital General
state: Valencia
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Xativa
country: Spain
facility: Hospital Luis Alcanyis
state: Valencia
city: Murcia
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: Hospital Universitario y Politecnico La Fe
name: Matteo Frasson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario y Politecnico La Fe
name: Eduardo Garcia-Granero, MD, PhD, EBSQ-c
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.