NCT05192954CompletedNot Applicable
Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Marlana McDowell2 sites in 1 country95 target enrollmentStarted: January 28, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 95
- Locations
- 2
- Primary Endpoint
- Postoperative Pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participant will be under anesthesia and will not know which surgical method is being utilized.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Vessel sealing device
Experimental
Vessel sealing device to be utilized for vaginal hysterectomy
Intervention: LigaSureTM vessel sealing device (Device)
Conventional clamping and suturing method
No Intervention
Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 3-6 hours postoperative
Visual Analog Scale, 0-10, with 10 being "most severe pain"
Secondary Outcomes
- Abdominal Pain(3-6 hours postoperative)
- Vaginal Pain(3-6 hours postoperative)
Investigators
Marlana McDowell
Female Pelvic Medicine and Reconstructive Surgery Fellow
TriHealth Inc.
Study Sites (2)
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