A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

Not Applicable

Completed

• Conditions: Uterovaginal and Vaginal Vault Prolapse
• Interventions: Procedure: Sacrospinous-Sacrotuberous fixation

• Registration Number: NCT03487328
• Lead Sponsor: Ain Shams University

Brief Summary

This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-21
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-04
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Age from 40 to 60 years.
2. POP Q stage III & IV
3. Uterovaginal prolapse.
4. Vaginal vault prolapse.
5. BMI >35.

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Exclusion Criteria

1. Age > 40 years or < 60 years.
2. POP Q stage I or II.
3. BMI < 35.
4. Previous repair of uterovaginal or vaginal vault prolapse.
5. Comorbidity with Stress Urinary Incontinence.
6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional technique for Sacrospinous-Sacrotuberous Fixation	Sacrospinous-Sacrotuberous fixation	Modified technique for Sacrospinous-Sacrotuberous Fixation
Modified technique for Sacrospinous-Sacrotuberous Fixation	Sacrospinous-Sacrotuberous fixation	Modified technique for Sacrospinous-Sacrotuberous Fixation

Primary Outcome Measures

Name	Time	Method
Number of participants with recurrence of uterovaginal and vaginal vault prolapse	1 year

Secondary Outcome Measures

Name	Time	Method
blood loss	intraoperative
Injury to surrounding structures	intraoperative	Number of participants that experience injury of important surrounding structure intraoperative
operative time	intraoperative

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt