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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: LigaSureTM vessel sealing device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blinded randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Vaginal Hysterectomy, Vaginal Vault Suspension, Prolapse Repair