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

NCT ID: NCT03487328

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-05-01

Brief Summary

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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

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Conditions

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Uterovaginal and Vaginal Vault Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified technique for Sacrospinous-Sacrotuberous Fixation

Modified technique for Sacrospinous-Sacrotuberous Fixation

Group Type ACTIVE_COMPARATOR

Sacrospinous-Sacrotuberous fixation

Intervention Type PROCEDURE

Sacrospinous-Sacrotuberous fixation

Conventional technique for Sacrospinous-Sacrotuberous Fixation

Modified technique for Sacrospinous-Sacrotuberous Fixation

Group Type ACTIVE_COMPARATOR

Sacrospinous-Sacrotuberous fixation

Intervention Type PROCEDURE

Sacrospinous-Sacrotuberous fixation

Interventions

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Sacrospinous-Sacrotuberous fixation

Sacrospinous-Sacrotuberous fixation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1729

Identifier Type: -

Identifier Source: org_study_id

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