Status:
COMPLETED
Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery
Lead Sponsor:
Marlana McDowell
Collaborating Sponsors:
TriHealth Hatton Research Institute
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 clampin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05192954
Start Date
January 28 2022
End Date
October 28 2024
Last Update
November 22 2024
Active Locations (2)
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1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
2
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242