NCT02667002

Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.

Detailed description

Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Bilateral Abdominal Sacral Hysteropexy	The mesh will be fixed right and left side of sacrum.
PROCEDURE	Conventional abdominal Sacral Hysteropexy	The mesh will be fixed only right side of sacrum
OTHER	Nulliparous women with no uterovaginal prolapsed	This will be control group which consistent patients with no uterovaginal prolapse.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-01-28
• Last updated: 2022-03-28