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Completed

NCT Number: NCT00859417

Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.

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Key information

Conditions

Anterior Prolapse

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital femme Mère Enfant

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women over 18 years old
  • Genital anterior prolapse requiring surgical correction and with stage III or IV in the classification of Pelvic Organ Prolapse - Quantification or POP-Q
  • Ability to understand the information and to sign a consent form
  • Patients wishing an intervention because of the inconvenience caused by the prolapse.

Exclusion criteria

  • Prolapse stage <III in the classification POP-Q, and prolapse without functional inconvenience
  • Progressive or latent infection, or signs of tissue necrosis in the clinical examination
  • Troubles resulting in an unacceptable risk of post-surgery complications investigated at the interview with the patient (disorders of blood clotting, immune system disorders, progressive diseases….)
  • Mobility of the lower limbs reduced (not permitting the positioning for the surgery)
  • Pregnancy or any desire of pregnancy during the study, within two years
  • Pelvic surgery in the last 6 months
  • Patients who have had radiotherapy of the pelvic area in an irrespective time
  • A history of pelvic cancer
  • Known hypersensitivity to any component of the prosthesis (polypropylene)
  • Uncontrolled diabetes (HbA1c> 8%)
  • Treatment modifying the immune response (immuno-modulators), current or stopped for less than one month
  • Inability to understand the information and to sign a consent
  • A person not subject to social security, deprived of freedom, or under legal guardian

Treatment and study plan

Traditional Surgery

Procedure

Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).

Perigee® prosthesis

Device

Surgical method with Perigee® prosthesis

Primary outcomes

  1. Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery

    Time frame: 12 months

Secondary outcomes

  1. Correction of prolapse 2 years after surgery

    Time frame: 24 months

  2. Changes in quality of life, occurrence of complications during surgery, evolution of sexuality, onset or worsening of urinary incontinence

    Time frame: at 3,12, 24 months

  3. Pain after surgery

    Time frame: 24 months

  4. Duration of intervention

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2009
Registry last updated
May 28, 2019

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.