Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?
Completed · Not applicable
Conditions studied: Vaginal Packing Following Pelvic Reconstructive Surgery
In brief
Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little data to support the practice, purported benefits include reduced pelvic fluid accumulation or blood loss. Patients often complain of discomfort associated with the packing or its removal. This randomized controlled trial seeks to document differences in subjective impressions of pain in women undergoing vaginal repairs treated with and without packing. The investigators also aim to assess differences in postoperative fluid collection in those with and without packing.
Key facts
- Study ID
- NCT02000271
- Run by
- TriHealth Inc.
- People needed
- 77
- Starts
- 2013-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2014-10-17
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Any female aged 18-85 planning to undergo a vaginal hysterectomy with vaginal reconstructive surgery for pelvic organ prolapse, with or without a suburethral sling. Must be able to speak and read English and be able to understand the informed consent.
You may not qualify if…
- Undergoing abdominal prolapse repair or repairs not involving hysterectomy, use of mesh, obliterative procedures, concurrent removal of mesh kit, performance of vaginal relaxing incisions, presence of vaginal, uterine, cervical or ovarian malignancy, having a clotting disorder, taking anticoagulation, needing heparin prior to surgery, having intraoperative blood loss greater than 500 cc, or use of regional anesthesia for surgery.
Where it is running
- TriHealth Good Samaritan Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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