Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

NCT02000271 | Completed

• 1 other identifier: 12132-12-089
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Packing Following Pelvic Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pelvic fluid collection measurement

  In the morning of the first post-operative day.

Study Arms (2)

Vaginal packing

OTHER

Vaginal packing will be placed as is typical following vaginal reconstructive surgery.

Procedure: Vaginal packing

No vaginal packing

EXPERIMENTAL

No vaginal packing will be used following vaginal reconstructive surgery.

Procedure: No vaginal packing

Interventions

Vaginal packing PROCEDURE

Vaginal packing

No vaginal packing PROCEDURE

No vaginal packing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

US (1)