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

Primary Purpose

Pelvic Organ Prolapse

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LigaSureTM vessel sealing device

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic Organ Prolapse, Vaginal Hysterectomy, Vaginal Vault Suspension, Prolapse Repair

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Good Samaritan HospitalRecruiting
Bethesda North HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vessel sealing device

Conventional clamping and suturing method

Arm Description

Vessel sealing device to be utilized for vaginal hysterectomy

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

Outcomes

Primary Outcome Measures

Postoperative Pain

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

Secondary Outcome Measures

Vaginal Pain

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

Abdominal Pain

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

Full Information

NCT ID

NCT05192954

First Posted

December 29, 2021

Last Updated

May 3, 2022

Sponsor

Marlana McDowell

Collaborators

TriHealth Hatton Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05192954

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 28, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marlana McDowell

Collaborators

TriHealth Hatton Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-blinded randomized controlled trial

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vessel sealing device

Arm Type

Experimental

Arm Description

Vessel sealing device to be utilized for vaginal hysterectomy

Arm Title

Conventional clamping and suturing method

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

LigaSureTM vessel sealing device

Other Intervention Name(s)

LigaSure, LigaSureTM, Electrosurgical sealing device

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative Pain

Description

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

Time Frame

3-6 hours postoperative

Secondary Outcome Measure Information:

Title

Vaginal Pain

Description

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

Time Frame

3-6 hours postoperative

Title

Abdominal Pain

Description

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

Time Frame

3-6 hours postoperative

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marlana McDowell, MD

Phone

513-463-4300

marlana_mcdowell@trihealth.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Hodge, RN

Phone

513-862-2056

jennifer_hodge2@trihealth.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Yeung, DO

Organizational Affiliation

TriHealth Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Good Samaritan Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brandon Ballhaus, BSN RN CNOR

mailto:Brandon_Ballhaus@trihealth.com

Facility Name

Bethesda North Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Young, RN

mailto:Michelle_Young@trihealth.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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