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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: LigaSureTM vessel sealing device

• Registration Number: NCT05192954
• Lead Sponsor: Marlana McDowell

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-14
• Study Start: 2022-01-28
• Primary Completion: 2023-12-30
• Study Completion: 2024-10-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vessel sealing device	LigaSureTM vessel sealing device	Vessel sealing device to be utilized for vaginal hysterectomy

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	3-6 hours postoperative	Visual Analog Scale, 0-10, with 10 being "most severe pain"

Secondary Outcome Measures

Name	Time	Method
Vaginal Pain	3-6 hours postoperative	Visual Analog Scale, 0-10, with 10 being "most severe pain"
Abdominal Pain	3-6 hours postoperative	Visual Analog Scale, 0-10, with 10 being "most severe pain"

Trial Locations

Locations (2)

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States