Post Operative Complications Clinical Trial
Official title:
Single Incision Pelvic Floor Mesh Implants
Verified date | July 2013 |
Source | Western Galilee Hospital-Nahariya |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 157 |
Est. completion date | February 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 90 Years |
Eligibility |
Inclusion Criteria: * Patients with Gr 2-3 Pelvic Organ Prolapse Exclusion Criteria: *Previous Pelvic irradiation |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Assuta MC | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Western Galilee Hospital-Nahariya |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative mesh related complications | 12 Months | Yes |
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