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The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.
According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.
In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal sacral hysteropexy | Other | The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. |
|
| Vaginal sacrospinous hysteropexy | Other | This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion. The outcomes will be obtained as follow; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteropexy | Procedure | Abdominal Sacral cervicopexy: The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. Vaginal Sacrospinous cervicopexy: This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time will be recorded starting from skin incision. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q). | The patients will be followed for recurrence of the symptoms and the degree of descent. | From 6 months to 1 year follow up |
| b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa Ragab Mady | Contact | 0201011431780 | dr.asmaa.r.mady@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Asmaa Ragab Mady | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Recruiting | Cairo | 11511 | Egypt |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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It will be used to assess the safety and tolerability to the procedure. |
| From 6 months to 1 year follow up |