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

Marlana McDowell

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: LigaSureTM vessel sealing device

Study type: Interventional

Funder types: Other

Identifiers

NCT05192954

21-094

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

Vessel sealing device

Experimental group

Description:

Vessel sealing device to be utilized for vaginal hysterectomy

Treatment:

Device: LigaSureTM vessel sealing device

Conventional clamping and suturing method

No Intervention group

Description:

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