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NCT00564083 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial Comparing Acellular Collagen Biomesh (Pelvisoft) to Polypropylene Mesh(Pelvitex) for Sacral Colpopexy
A NA study, sponsored by Atlantic Health System.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT00564083 is a NA study that has completed, run by Atlantic Health System. The registered enrollment target is 120 participants.
The verdict
NCT00564083, a NA study, has completed, sponsored by Atlantic Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) "natural organic mesh" to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy. This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA approved and widely used. The following objectives: anatomic outcomes, graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life, subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy will be evaluated. The study visits are all under standard of care. Study questionnaires are unique to the study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year visits The questionnaires are related to bowel function, bladder function, prolapse and sexual activity. Permission will be requested to contact the patient again 5 years after surgery. Contact in the future will in no way obligate the patient to participate. There may or may not be direct medical benefits to the participant. Decreased risk of erosion may be a possible benefit if placed in the organic "natural" arm of the study. The information learned from this study may benefit other patients in the future
Interventions
- PROCEDURE sacral colpopexy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-12 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00564083
The ClinicalTrials.gov registry entry for NCT00564083 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sacral colpopexy is the first listed.
NCT00564083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00564083 about?
NCT00564083 is a clinical study titled "Randomized Controlled Trial Comparing Acellular Collagen Biomesh (Pelvisoft) to Polypropylene Mesh(Pelvitex) for Sacral Colpopexy". This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) "natural organic mesh" to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy. This surgery involves supp...
What is the current status of trial NCT00564083?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2005-12. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00564083?
The interventions under investigation include: sacral colpopexy (PROCEDURE).
Who is sponsoring clinical trial NCT00564083?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
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