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OpenTrials
Completed

NCT Number: NCT01842464

Sacro-Spinous Ligaments Anterior Apical Anchoring

Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

35 year–95 year

Sex eligibility

Female

Study type

Observational

About this study

Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pelvic Floor Prolapse > Gr 2,
  • Anterior > Posterior defect,
  • Apical Supportive Defect

Exclusion criteria

  • Active Pelvic Inflammation,
  • Patient Refusal

Treatment and study plan

Anterior Sacro-Spinous

Procedure

Anterior Sacro-Spinous

Primary outcomes

  1. The Change With Distance Between the Vaginal Apex and the Introitus

    Time frame: One year

    The change with distance measured by centimeters, between the vaginal apex and the introitus

  2. Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring

    Time frame: one year

    Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.

  3. Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure

    Time frame: one year

    Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 29, 2013
Registry last updated
Jun 19, 2015

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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