Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?
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.
Vaginal Packing Following Pelvic Reconstructive Surgery
Procedure: Vaginal packing
Procedure: No vaginal packing
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery? A Randomized Controlled Trial|
- Pain and satisfaction [ Time Frame: From the first post-operative day up to 6 weeks post-operatively ] [ Designated as safety issue: No ]Composite of pain and satisfaction as determined by a visual analog scale (validated measure) rating pain as well as a visual analog scale rating satisfaction with either having or not having the vaginal packing placed.
- Pelvic fluid collection measurement [ Time Frame: In the morning of the first post-operative day. ] [ Designated as safety issue: Yes ]
Dimensions of pelvic fluid will be measured via transvaginal ultrasound. Length, height, and width will be measured in centimeters
*This portion of the study has been discontinued due to concerns of patient discomfort during ultrasound.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Vaginal packing will be placed as is typical following vaginal reconstructive surgery.
|Procedure: Vaginal packing|
Experimental: No vaginal packing
No vaginal packing will be used following vaginal reconstructive surgery.
|Procedure: No vaginal packing|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000271
|Contact: Lauren B. Westermann, DO||513-862-7265|
|Contact: Vivian Ghodsi, RNfirstname.lastname@example.org|
|United States, Ohio|
|TriHealth Good Samaritan Hospital||Recruiting|
|Cincinnati, Ohio, United States|
|Contact: Lauren Westermann 513-862-7265|