Abdominoperineal Extra-Elevators Rectal Resection for NCT02163785

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

Related Conditions & MeSH terms

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
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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Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position

Clinical Trial Details — Status: Terminated

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (3)

Country where clinical trial is conducted

References & Publications (3)

Outcome