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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Hospices Civils de Lyon.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT00859417

First received: March 10, 2009

Last updated: July 14, 2009

Last verified: July 2009

History of Changes

Purpose

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.

Condition	Intervention
Anterior Prolapse	Procedure: Traditional surgery Device: Perigee® prosthesis

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Correction of prolapse, which is defined by a stage < II on the classification POP-Q, one year after surgery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Correction of prolapse 2 years after surgery [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Pain after surgery [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Duration of intervention [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	190
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Traditional surgical method without prosthesis	Procedure: Traditional surgery Traditional surgical method without prosthesis (correction of the anterior prolapse through vaginal tract with the use of autologous tissue).
Experimental: 2 Surgical method with Perigee prosthesis	Device: Perigee® prosthesis Surgical method with Perigee® prosthesis

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859417

Contacts

Contact: Georges MELLIER, MD	+33472355886	georges.mellier@chu-lyon.fr
Contact: Stépahnie MORET	+33472355878	stephanie.moret@chu-lyon.fr

Locations

France
Hôpital femme Mère Enfant	Recruiting
Bron, France, 69677
Contact: MELLIER Georges, MD +33472355886 georges.mellier@chu-lyon.fr
Principal Investigator: MELLIER Georges, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

MELLIER Georges, MD

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Pr Georges MELLIER, Hopsices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00859417 History of Changes
Other Study ID Numbers:	2007.485/28
Study First Received:	March 10, 2009
Last Updated:	July 14, 2009
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:

correction of anterior prolapse
prosthetic trans-obturator way kit
randomized study

Additional relevant MeSH terms:

Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013

To Top