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Completed

NCT Number: NCT03487328

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

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.

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Key information

Conditions

Uterovaginal and Vaginal Vault Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 40 to 60 years.
  • POP Q stage III & IV
  • Uterovaginal prolapse.
  • Vaginal vault prolapse.
  • BMI >35.

Exclusion criteria

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

Treatment and study plan

Sacrospinous-Sacrotuberous fixation

Procedure

Sacrospinous-Sacrotuberous fixation

Primary outcomes

  1. Number of participants with recurrence of uterovaginal and vaginal vault prolapse

    Time frame: 1 year

Secondary outcomes

  1. blood loss

    Time frame: intraoperative

  2. Injury to surrounding structures

    Time frame: intraoperative

    Number of participants that experience injury of important surrounding structure intraoperative

  3. operative time

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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