Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Hysteropexy


Participation Criteria
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Eligibility Criteria
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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: Symptomatic apical descent stage II or more. Eligible for both surgical procedures No uterine or cervical pathology. Able to consent to participate in the trial. Exclusion Criteria: Women with contraindication to any surgical procedures. Women with previous apical prolapse surgery. One of the two surgical approaches is not feasible. Women with concomitant surgical procedures apart from correction of the prolapse. Women who prefer to have hysterectomy.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Abdominal sacral hysteropexy<br>The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh. | Procedure: Hysteropexy<br>* 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.<br>|
| Other: Vaginal sacrospinous hysteropexy<br>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; | Procedure: Hysteropexy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time will be recorded starting from skin incision. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | It will be used to assess the safety and tolerability to the procedure. | From 6 months to 1 year follow up |