Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery? A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Packing Following Pelvic Reconstructive Surgery
• Intervention / Treatment: Procedure: Vaginal packing; Procedure: No vaginal packing

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States
      • TriHealth Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vaginal packing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and satisfaction	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.	From the first post-operative day up to 6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic fluid collection measurement	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.	In the morning of the first post-operative day.

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 12132-12-089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No