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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00665-34 | Other Identifier | Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps) |
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Unable to find enough patients who accept randomization of surgical procedures.
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The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STARR arm | Experimental | In this group of patients, the STARR transanal stapling system is used to treat the rectocele. |
|
| Elevate arm | Active Comparator | In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STARR rectocele repair | Procedure | The STARR transanal stapling system is used to repair a rectocele. |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence/absence of a 50% drop in the ODS score | presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 6 weeks |
| Frequency of laxative use | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard | 30029 | France | ||
| Hôpital de la Conception |
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| ID | Term |
|---|---|
| D020047 | Rectocele |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Elevate mesh rectocele repair | Procedure | A posterior Elevate mesh is placed transvaginally to repair a rectocele. |
|
| Intervention time (min) | 1 day |
| Questionnaire PFDI 20 | 6 weeks |
| Questionnaire PFIQ 7 | 6 weeks |
| Questionnaire SF 36 | 6 weeks |
| Questionnaire PISQ-12 | 6 weeks |
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 6 months |
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 12 months |
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 36 months |
| Frequency of laxative use | 6 months |
| Frequency of laxative use | 12 months |
| Frequency of laxative use | 36 months |
| Questionnaire PFDI 20 | 6 months |
| Questionnaire PFDI 20 | 12 months |
| Questionnaire PFDI 20 | 36 months |
| Questionnaire PFIQ 7 | 6 months |
| Questionnaire PFIQ 7 | 12 months |
| Questionnaire PFIQ 7 | 36 months |
| Questionnaire SF 36 | 6 months |
| Questionnaire SF 36 | 12 months |
| Questionnaire SF 36 | 36 months |
| Questionnaire PISQ-12 | 6 months |
| Questionnaire PISQ-12 | 12 months |
| Questionnaire PISQ-12 | 36 months |
| Marseille |
| France |
| Clinique Beau Soleil | Montpellier | France |
| Clinique Adassa | Strasbourg | France |
| Hôpital Paule de Viguier, CHU de Toulouse | Toulouse | France |
| Hôpital Purpan, CHU de Toulouse | Toulouse | France |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |