International Multicenter Prospective Transtar Registry
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 07/31/2017 |
| İlk Gönderilen: | 05/25/2009 |
| Tahmini Kayıt Gönderildi: | 05/25/2009 |
| İlk Gönderilen: | 05/26/2009 |
| Son Güncelleme Gönderildi: | 08/09/2017 |
| Son Güncelleme Gönderildi: | 08/10/2017 |
| Fiili Çalışma Başlangıç Tarihi: | 01/30/2009 |
| Tahmini Birincil Tamamlanma Tarihi: | 04/29/2012 |
| Tahmini Çalışma Tamamlanma Tarihi: | 04/29/2012 |
Durum veya hastalık
Müdahale / tedavi
Procedure: Chronic constipation - ODS
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Chronic constipation - ODS Adult Patients with ODS | Procedure: Chronic constipation - ODS Transanal Stapling procedure - Stapled Transanal Rectal Resection |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 16 Years İçin 16 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Örnekleme yöntemi | Non-Probability Sample |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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. |
Sonuç
Birincil Sonuç Ölçütleri
1. Change in constipation symptoms measured by KESS score [preoperative, and at 12 months post-op]
İkincil Sonuç Ölçütleri
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]
