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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2024-10-28

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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blinded randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Vessel sealing device

Vessel sealing device to be utilized for vaginal hysterectomy

Group Type EXPERIMENTAL

LigaSureTM vessel sealing device

Intervention Type DEVICE

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

Conventional clamping and suturing method

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LigaSureTM vessel sealing device

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

Intervention Type DEVICE

Other Intervention Names

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LigaSure LigaSureTM Electrosurgical sealing device

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes