Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

Not Applicable

Completed

• Conditions: Vaginal Packing Following Pelvic Reconstructive Surgery
• Interventions: Procedure: Vaginal packing; Procedure: No vaginal packing

• Registration Number: NCT02000271
• Lead Sponsor: TriHealth Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal packing	Vaginal packing	Vaginal packing will be placed as is typical following vaginal reconstructive surgery.
No vaginal packing	No vaginal packing	No vaginal packing will be used following vaginal reconstructive surgery.

Primary Outcome Measures

Name	Time	Method
Pain and satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic fluid collection measurement	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.

Trial Locations

Locations (1)

TriHealth Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States