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Completed

NCT Number: NCT05192954

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bethesda North Hospital, Cincinnati, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LigaSureTM vessel sealing device

Device

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

Other names: LigaSure, LigaSureTM, Electrosurgical sealing device

Primary outcomes

  1. Postoperative Pain

    Time frame: 3-6 hours postoperative

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

Secondary outcomes

  1. Vaginal Pain

    Time frame: 3-6 hours postoperative

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

  2. Abdominal Pain

    Time frame: 3-6 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Marlana McDowell

Other

Collaborators

  • TriHealth Hatton Research Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 14, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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