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CompletedNCT05192954Updated Nov 22, 2024

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

An interventional study of LigaSureTM vessel sealing device in Pelvic Organ Prolapse, sponsored by Marlana McDowell. Completed at 2 sites in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Marlana McDowell · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pelvic Organ Prolapse

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Keywords

  • Pelvic Organ Prolapse
  • Vaginal Hysterectomy
  • Vaginal Vault Suspension
  • Prolapse Repair
03

In context

Pelvic Organ Prolapse

516 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's enrollment of 95 is above the median of 80 across 334 interventional studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

This is the only study on the registry with Marlana McDowell as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Vessel sealing device

    Vessel sealing device to be utilized for vaginal hysterectomy

    Device: LigaSureTM vessel sealing device

  • No intervention
    Conventional clamping and suturing method

    Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.

Interventions

  • DeviceLigaSureTM vessel sealing device

    Device will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy.

    Also known as: LigaSure, LigaSureTM, Electrosurgical sealing device

06

What researchers measure

Primary outcomes

  1. Postoperative Pain

    Visual Analog Scale, 0-10, with 10 being "most severe pain"

    Time frame: 3-6 hours postoperative

Secondary outcomes

  1. Vaginal Pain

    Visual Analog Scale, 0-10, with 10 being "most severe pain"

    Time frame: 3-6 hours postoperative

  2. Abdominal Pain

    Visual Analog Scale, 0-10, with 10 being "most severe pain"

    Time frame: 3-6 hours postoperative

07

Study locations

2 sites
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
  • Bethesda North Hospital
    Cincinnati, Ohio 45242, United States
08

References and documents

Publications

  • Ray MM, Crisp CC, Pauls RN, Hoehn J, Lewis K, Bonglack M, Yeung J. Use of a Vessel Sealer for Hysterectomy at Time of Prolapse Repair: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):234-242. doi: 10.1097/SPV.0000000000001617. Epub 2024 Dec 9. PubMed 39657205 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05192954
Lead sponsor
Marlana McDowell
Collaborators
TriHealth Hatton Research Institute
Responsible party
Marlana McDowell (Female Pelvic Medicine and Reconstructive Surgery Fellow, TriHealth Inc.) — Sponsor-investigator
First posted
Jan 14, 2022
Start date
Jan 28, 2022
Primary completion
Dec 30, 2023
Completion
Oct 28, 2024
Last update
Nov 22, 2024

Study contacts

Jennifer Yeung, DO
principal investigator · TriHealth Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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