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Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02000271
First received: April 30, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention
Vaginal Packing Following Pelvic Reconstructive Surgery
Procedure: Vaginal packing
Procedure: No vaginal packing

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 77
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000271

Locations
United States, Ohio
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
Sponsors and Collaborators
TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02000271     History of Changes
Other Study ID Numbers: 12132-12-089
Study First Received: April 30, 2013
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014