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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02163785
Other study ID # APPRO
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date January 2021

Study information

Verified date September 2021
Source Hospital Universitario La Fe
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Primary objective: - Pathological circumferential resection margin Secondary objectives: - 5 year oncological outcomes - Morbimortality rates - Surgical specimen quality - Perineal hernia incidence


Recruitment information / eligibility

Status Terminated
Enrollment 280
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex

Locations

Country Name City State
Spain Hospital Bellvitge Barcelona Cataluña
Spain Hospital del Mar Barcelona Cataluña
Spain Hospital Universitario Reina Sofia Cordoba Andalucía
Spain Hospital Universitario Donostia Donostia Pais Vasco
Spain Hospital General Universitario Elche Valencia
Spain Hospital Universitario Josep Trueta Girona Cataluña
Spain Hospital del SAS Jerez Andalucia
Spain Hospital General Medina del Campo Castilla Y Leon
Spain Hospital Universitario "Virgen de la Arrixaca" Murcia
Spain Complexo Hospitalario Universitario Orense Galicia
Spain Complejo Hospitalario Pamplona Navarra
Spain Hospital General Requena Valencia
Spain Hospital Universitario Parc Tauli Sabadell Cataluña
Spain Hospital de Sagunto Sagunto Valencia
Spain Hospital Arnau de Vilanova Valencia
Spain Hospital Clinico Universitario Valencia
Spain Hospital Universitario y Politecnico La Fe Valencia
Spain Complejo Hospitalario Universitario Vigo Galicia
Spain Hospital Luis Alcanyis Xativa Valencia

Sponsors (3)

Lead Sponsor Collaborator
Hospital Universitario La Fe Fundacion Para La Investigacion Hospital La Fe, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

García-Granero E, Faiz O, Muñoz E, Flor B, Navarro S, Faus C, García-Botello SA, Lledó 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Oncological outcomes Compare the incidence of local oncological disease, distance metastasis and survival in a 5 year follow up time span. 5 years
Other Morbidity of the perineal incision. Evaluation the clinical outcome of the perineal wound in terms of infection, dehiscence, perineal hernia etc. 1 day, 60 days ,1 ,2,3,4 and 5 years after surgery
Primary 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. 15-30 days after surgery date
Secondary 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. 15-30 days after
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