Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

N/ACompletedNCT02000271

TriHealth Inc.77 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vaginal Packing Following Pelvic Reconstructive Surgery

Interventions

Vaginal packingPROCEDURE

No vaginal packingPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: From the first post-operative day up to 6 weeks post-operatively

Secondary Outcomes

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.

Time frame: In the morning of the first post-operative day.

Data from ClinicalTrials.gov

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