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

November 20, 2024 updated by: Marlana McDowell

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vessel sealing device
Vessel sealing device to be utilized for vaginal hysterectomy
Device: LigaSureTM vessel sealing device
Device will be used to clamp, cauterize, seal, and transect tissue during vaginal hysterectomy.
Other Names:
  • LigaSure
  • LigaSureTM
  • Electrosurgical sealing device
No Intervention: Conventional clamping and suturing method
Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
3-6 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Pain
Time Frame: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
3-6 hours postoperative
Abdominal Pain
Time Frame: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
3-6 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marlana McDowell

Collaborators

TriHealth Hatton Research Institute

Investigators

  • Principal Investigator: Jennifer Yeung, DO, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

October 28, 2024

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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