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Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

NCT ID: NCT01645020

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-06-30

Brief Summary

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Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.

Detailed Description

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Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.

During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.

A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.

The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.

Conditions

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Postoperative Complications

Keywords

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absorbable mesh Partially absorbed Mesh Prolift Prolift + M mesh related complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.

Exclusion Criteria

* Women with significant pre-operative pain
* Women with collagen diseases
* Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M Neuman, MD

Role: PRINCIPAL_INVESTIGATOR

Menahem Neuman

Role: PRINCIPAL_INVESTIGATOR

Locations

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Western Galilee Hospital

Nahariya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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M Neuman, MD

Role: CONTACT

Phone: 972 3 956 3105

Email: [email protected]

R sawaid, MD

Role: CONTACT

Phone: 972 4 956 3035

Email: [email protected]

References

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Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011 Nov;22(11):1405-11. doi: 10.1007/s00192-011-1482-4. Epub 2011 Jul 1.

Reference Type BACKGROUND
PMID: 21720912 (View on PubMed)

Related Links

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http://www.ethicon.com/our-story/press-room/prolift_POP_launch

GYNECARE PROLIFT+M™ was developed by Ethicon Women's Health \& Urologyoffers. this company offers treatment solutions for a range of female pelvic health disorders.

Other Identifiers

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20

Identifier Type: -

Identifier Source: org_study_id