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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Western Galilee Hospital-Nahariya.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01645020
First received: July 17, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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


Condition
Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Estimated Enrollment: 240
Study Start Date: August 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women been operated at Western Galilee Hospital - Nahariya Israel

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645020

Contacts
Contact: M Neuman, MD 972 3 956 3105 mneuman@netvision.net.il
Contact: R sawaid, MD 972 4 956 3035 raneen.sawaid@gmail.com

Locations
Israel
Western Galilee Hospital Recruiting
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: M Neuman, MD
Principal Investigator: Menahem Neuman
  More Information

Additional Information:
Publications:
Responsible Party: Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01645020     History of Changes
Other Study ID Numbers: 20
Study First Received: July 17, 2012
Last Updated: July 18, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:
absorbable mesh
Partially absorbed Mesh
Prolift
Prolift + M
mesh related complications

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Postoperative Complications
Prolapse
Pathological Conditions, Anatomical
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014