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Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic constipation - ODS | Adult Patients with ODS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapled Transanal Rectal Resection with Contour Transtar | Procedure | Transanal Stapling procedure - Stapled Transanal Rectal Resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in constipation symptoms measured by KESS score | preoperative, and at 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele
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| Name | Affiliation | Role |
|---|---|---|
| Goran Ribaric, MD,PhD | Ethicon Endo-Surgery (Europe) GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andree D'Hoore | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18403378 | Background | Schwandner O, Stuto A, Jayne D, Lenisa L, Pigot F, Tuech JJ, Scherer R, Nugent K, Corbisier F, Basany EE, Hetzer FH. Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers. Surg Innov. 2008 Jun;15(2):105-9. doi: 10.1177/1553350608316684. Epub 2008 Apr 9. | |
| 18654789 |
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via publication
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D020047 | Rectocele |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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| Renzi A, Talento P, Giardiello C, Angelone G, Izzo D, Di Sarno G. Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study. Int J Colorectal Dis. 2008 Oct;23(10):999-1005. doi: 10.1007/s00384-008-0522-0. Epub 2008 Jul 25. |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |