International Multicenter Prospective Transtar Registry
Palabras clave
Abstracto
Descripción
A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.
fechas
| Verificado por última vez: | 07/31/2017 |
| Primero enviado: | 05/25/2009 |
| Inscripción estimada enviada: | 05/25/2009 |
| Publicado por primera vez: | 05/26/2009 |
| Última actualización enviada: | 08/09/2017 |
| Última actualización publicada: | 08/10/2017 |
| Fecha de inicio real del estudio: | 01/30/2009 |
| Fecha estimada de finalización primaria: | 04/29/2012 |
| Fecha estimada de finalización del estudio: | 04/29/2012 |
Condición o enfermedad
Intervención / tratamiento
Procedure: Chronic constipation - ODS
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Chronic constipation - ODS Adult Patients with ODS | Procedure: Chronic constipation - ODS Transanal Stapling procedure - Stapled Transanal Rectal Resection |
Criterio de elegibilidad
| Edades elegibles para estudiar | 16 Years A 16 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score - confirmed internal rectal prolapse or rectocele on dynamic defecography - adequate external sphincter on rectal digital examination. Exclusion Criteria: - Subjects with any other surgical procedure than STARR for ODS - Subjects in whom STARR is not performed with the Contour Transtar stapler - Subjects with a physical or psychological condition which would impair participation in the registry. |
Salir
Medidas de resultado primarias
1. Change in constipation symptoms measured by KESS score [preoperative, and at 12 months post-op]
Medidas de resultado secundarias
1. Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL [preoperative, at 6 weeks and 12 months post-op]
