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
- 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
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
- 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)
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital🇺🇸Cincinnati, Ohio, United States