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insufficient recruitment rate
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| Name | Class |
|---|---|
| Fundacion Para La Investigacion Hospital La Fe | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine position | Active Comparator | Abdominoperineal resection - perineal time- in supine position |
|
| Prone position | Experimental | Abdominoperineal resection - perineal time- in prone position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominoperineal extra-elevators rectal resection for low lying rectal cancer | Procedure | Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oncological outcomes | Compare the incidence of local oncological disease, distance metastasis and survival in a 5 year follow up time span. | 5 years |
| Morbidity of the perineal incision. | Evaluation the clinical outcome of the perineal wound in terms of infection, dehiscence, perineal hernia etc. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matteo Frasson, MD, PhD | Hospital Universitario y Politecnico La Fe | Principal Investigator |
| Eduardo Garcia-Granero, MD, PhD, EBSQ-c | Hospital Universitario y Politecnico La Fe | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofia | Córdoba | Andalusia | Spain | |||
| Hospital del SAS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19479978 | Background | 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. | |
| 9711965 | Background |
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|
| 1 day, 60 days ,1 ,2,3,4 and 5 years after surgery |
| 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 | 46026 | Spain |
| Hospital Arnau de Vilanova | Valencia | Spain |
| Hospital Clinico Universitario | Valencia | Spain |
| 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. |
| 24842689 | Background | 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. |
| 26757199 | Derived | 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. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000078542 | Proctectomy |
| ID | Term |
|---|---|
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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