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OpenTrials
Completed

NCT Number: NCT02911584

Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion criteria

  • Age > 70 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy
  • Previous surgical procedure for POP correction

Treatment and study plan

Laparoscopic procedure

Procedure

Primary outcomes

  1. Number of patients with anatomical correction of the prolapse

    Time frame: up to 6 months

    Anatomical correction of the prolapse evaluated by gynecological visit

Secondary outcomes

  1. Rate of recurrence

    Time frame: up to 6 months

  2. Post operative quality of life

    Time frame: up to 6 months

    Subjective satisfaction of the patient evaluated by a quality of life questionnaire.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Miulli General Hospital

Registry information

Official study title

Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Dec 6, 2017

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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