Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?
|ClinicalTrials.gov Identifier: NCT02000271|
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : October 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Packing Following Pelvic Reconstructive Surgery||Procedure: Vaginal packing Procedure: No vaginal packing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery? A Randomized Controlled Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- Pain and satisfaction [ Time Frame: From the first post-operative day up to 6 weeks post-operatively ]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. ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000271
|United States, Ohio|
|TriHealth Good Samaritan Hospital|
|Cincinnati, Ohio, United States|