Clinical trial NCT01645020: Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
Official title: Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Keywords: absorbable mesh
Partially absorbed Mesh
Prolift
Prolift + M
mesh related complications
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2012-07-19
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women been operated at Western Galilee Hospital - Nahariya Israel

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
name: M Neuman, MD
role: PRINCIPAL_INVESTIGATOR
name: Menahem Neuman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.