Abdominoperineal Resection, Rectal Cancer
Conditions
Keywords
Inferior rectal cancer, Abdominoperineal resection, Miles operation, Supine Miles operation, Prone Miles operation, Total mesorectal excision, Circumferential radial margin
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
Interventions
PROCEDUREAbdominoperineal extra-elevators rectal resection for low lying rectal cancer
Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
Sponsors
Fundacion Para La Investigacion Hospital La Fe
Instituto de Salud Carlos III
Hospital Universitario La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the circumferential resection margin | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological quality of surgical specimen | 15-30 days after | Comparison of the quality of the surgical specimen in terms of integrity of the circumferential resection margin, accidental iatrogenic rupture etc. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oncological outcomes | 5 years | Compare the incidence of local oncological disease, distance metastasis and survival in a 5 year follow up time span. |
| Morbidity of the perineal incision. | 1 day, 60 days ,1 ,2,3,4 and 5 years after surgery | Evaluation the clinical outcome of the perineal wound in terms of infection, dehiscence, perineal hernia etc. |
Countries
Spain
Outcome results
None listed