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

N/ACompletedNCT05192954

Marlana McDowell95 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

LigaSureTM vessel sealing deviceDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Good Samaritan Hospital

Cincinnati, Ohio, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Postoperative Pain

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

Time frame: 3-6 hours postoperative

Secondary Outcomes

Vaginal Pain

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

Time frame: 3-6 hours postoperative

Abdominal Pain

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

Time frame: 3-6 hours postoperative

Data from ClinicalTrials.gov

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