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

NCT05192954 | Completed FDA Device

• 1 other identifier: 21-094
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; Vaginal Hysterectomy; Vaginal Vault Suspension; Prolapse Repair

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

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

  3-6 hours postoperative

Secondary Outcomes (2)

• Vaginal Pain

  3-6 hours postoperative

• Abdominal Pain

  3-6 hours postoperative

Study Arms (2)

Vessel sealing device

EXPERIMENTAL

Vessel sealing device to be utilized for vaginal hysterectomy

Device: LigaSureTM vessel sealing device

Conventional clamping and suturing method

NO INTERVENTION

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

Interventions

LigaSureTM vessel sealing device DEVICE

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

Also known as: LigaSure, LigaSureTM, Electrosurgical sealing device

Vessel sealing device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marlana McDowell: lead
• TriHealth Hatton Research Institute: collaborator

Study Sites (2)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (1)

• 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.

  PMID: 39657205 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Yeung, DO

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be under anesthesia and will not know which surgical method is being utilized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Female Pelvic Medicine and Reconstructive Surgery Fellow

Model Details: Single-blinded randomized controlled trial

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 14, 2022
• Study Start: January 28, 2022
• Primary Completion: December 30, 2023
• Study Completion: October 28, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)