Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery

Overview

This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.

Full Title of Study: “Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 1, 2023

Interventions

  • Device: Vessel sealing device
    • Device will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy.

Arms, Groups and Cohorts

  • Experimental: Vessel sealing device
    • Vessel sealing device to be utilized for vaginal hysterectomy
  • No Intervention: Conventional clamping and suturing method
    • Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative Pain
    • Time Frame: 3-6 hours postoperative
    • Visual Analog Scale

Secondary Measures

  • Vaginal Pain
    • Time Frame: 3-6 hours postoperative
    • Visual Analog Scale
  • Abdominal Pain
    • Time Frame: 3-6 hours postoperative
    • Visual Analog Scale

Participating in This Clinical Trial

Inclusion Criteria

  • English speaking, able to understand informed consent – Vaginal hysterectomy with vaginal vault suspension – with or without anterior and posterior repairs – with or without removal of fallopian tubes or ovaries – with or without procedures for stress urinary incontinence Exclusion Criteria:

  • Use of mesh for prolapse repair – Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy – Concomitant procedure done by an additional surgeon – Concomitant anal sphincteroplasty or rectovaginal fistula repair – History of chronic pelvic pain receiving medical care – Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline – Pregnancy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Marlana McDowell
  • Collaborator
    • TriHealth Hatton Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Marlana McDowell, Female Pelvic Medicine and Reconstructive Surgery Fellow – TriHealth Inc.
  • Overall Official(s)
    • Jennifer Yeung, DO, Principal Investigator, TriHealth Inc.
  • Overall Contact(s)
    • Marlana McDowell, MD, 513-463-4300, marlana_mcdowell@trihealth.com

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