Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Ain Shams University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Operative time
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Mohamed Hassan Mohamed Mostafa
Doctor
Ain Shams University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Operative time
Time Frame: intraoperative
Operative time will be recorded starting from skin incision.
Secondary Outcomes
- a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).(From 6 months to 1 year follow up)
- b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0(From 6 months to 1 year follow up)