Back to resultsSingle Incision Pelvic Floor Mesh Implants
Primary Purpose
Intra-operative Complications, Post Operative Complications
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Single Incision Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Intra-operative Complications focused on measuring Single Incision, Mesh, Complications
Eligibility Criteria
Inclusion Criteria:
* Patients with Gr 2-3 Pelvic Organ Prolapse
Exclusion Criteria:
*Previous Pelvic irradiation
Sites / Locations
- Assuta MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Incision Mesh
Arm Description
intervention: single incision mesh implantation
Outcomes
Primary Outcome Measures
Operative mesh related complications
Secondary Outcome Measures
Full Information
NCT ID
NCT01909700
First Posted
July 24, 2013
Last Updated
May 4, 2016
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT01909700
Brief Title
Single Incision Pelvic Floor Mesh Implants
Official Title
Single Incision Pelvic Floor Mesh Implants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse.
Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure.
Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.
Detailed Description
Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-operative Complications, Post Operative Complications
Keywords
Single Incision, Mesh, Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Incision Mesh
Arm Type
Experimental
Arm Description
intervention: single incision mesh implantation
Intervention Type
Device
Intervention Name(s)
Single Incision Mesh
Intervention Description
Single Incision Mesh is implanted for pelvic floor reconstruction
Primary Outcome Measure Information:
Title
Operative mesh related complications
Time Frame
12 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
* Patients with Gr 2-3 Pelvic Organ Prolapse
Exclusion Criteria:
*Previous Pelvic irradiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menahem Neuman, Prof.
Organizational Affiliation
Western Galilee MC Nahariya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta MC
City
Tel Aviv
ZIP/Postal Code
45320
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Single Incision Pelvic Floor Mesh Implants
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