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Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?

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TriHealth

Status

Completed

Conditions

Vaginal Packing Following Pelvic Reconstructive Surgery

Treatments

Procedure: No vaginal packing
Procedure: Vaginal packing

Study type

Interventional

Funder types

Other

Identifiers

NCT02000271
12132-12-089

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

Female

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

77 participants in 2 patient groups

Vaginal packing
Other group
Description:
Vaginal packing will be placed as is typical following vaginal reconstructive surgery.
Treatment:
Procedure: Vaginal packing
No vaginal packing
Experimental group
Description:
No vaginal packing will be used following vaginal reconstructive surgery.
Treatment:
Procedure: No vaginal packing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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