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NCT05192954 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05192954
Other study ID # 21-094
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 28, 2022
Est. completion date April 1, 2024

Study information
Verified date January 2024
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date April 1, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Marlana McDowell TriHealth Hatton Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Pain Visual Analog Scale, 0-10, with 10 being "most severe pain" 3-6 hours postoperative
Secondary Vaginal Pain Visual Analog Scale, 0-10, with 10 being "most severe pain" 3-6 hours postoperative
Secondary Abdominal Pain Visual Analog Scale, 0-10, with 10 being "most severe pain" 3-6 hours postoperative
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