International Multicenter Prospective Transtar Registry
Cuvinte cheie
Abstract
Descriere
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.
Datele
| Ultima verificare: | 07/31/2017 |
| Primul depus: | 05/25/2009 |
| Inscriere estimată trimisă: | 05/25/2009 |
| Prima postare: | 05/26/2009 |
| Ultima actualizare trimisă: | 08/09/2017 |
| Ultima actualizare postată: | 08/10/2017 |
| Data actuală de începere a studiului: | 01/30/2009 |
| Data estimată de finalizare primară: | 04/29/2012 |
| Data estimată de finalizare a studiului: | 04/29/2012 |
Stare sau boală
Intervenție / tratament
Procedure: Chronic constipation - ODS
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Chronic constipation - ODS Adult Patients with ODS | Procedure: Chronic constipation - ODS Transanal Stapling procedure - Stapled Transanal Rectal Resection |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 16 Years La 16 Years |
| Sexe eligibile pentru studiu | All |
| Metoda de eșantionare | Non-Probability Sample |
| Acceptă voluntari sănătoși | da |
| Criterii | 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. |
Rezultat
Măsuri de rezultate primare
1. Change in constipation symptoms measured by KESS score [preoperative, and at 12 months post-op]
Măsuri de rezultate secundare
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]
