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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05192954

Enrollment

Registered

2022-01-14

Start date

2022-01-28

Completion date

2024-10-28

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse, Vaginal Hysterectomy, Vaginal Vault Suspension, Prolapse Repair

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.

Interventions

DEVICELigaSureTM vessel sealing device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participant will be under anesthesia and will not know which surgical method is being utilized.

Intervention model description

Single-blinded randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026