NCT01645020

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

4.4 years

First QC Date

July 17, 2012

Last Update Submit

July 18, 2012

Conditions

Postoperative Complications

Keywords

absorbable meshPartially absorbed MeshProliftProlift + Mmesh related complications

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women been operated at Western Galilee Hospital - Nahariya Israel

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21720912BACKGROUND

Related Links

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • M Neuman, MD

    PRINCIPAL INVESTIGATOR

  • Menahem Neuman

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M Neuman, MD

CONTACT

972 3 956 3105mneuman@netvision.net.il

R sawaid, MD

CONTACT

972 4 956 3035raneen.sawaid@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

August 1, 2008

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

IL(1)