Actively Recruiting
A Prospective, Observational Trial Comparing Transvaginal Sacrospinous Hysteropexy and Laparoscopic Uterine Lateral Suspension for Pelvic Organ Prolapse
Led by National Cheng-Kung University Hospital · Updated on 2022-10-21
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pelvic organ prolapse is a condition that can be treated with conservative methods or surgery. This research evaluates two uterus-preserving surgical approaches for treating pelvic organ prolapse: laparoscopic lateral uterine suspension, a modified laparoscopic surgery with expected safety, simplicity, small incisions, and fast recovery; and the conventional transvaginal sacrospinous ligament fixation with native tissue repair. The study aims to compare the long-term therapeutic effectiveness, safety, and adverse events of these two approaches. The study involves two groups: one undergoing laparoscopic uterine lateral suspension, where a mesh is attached to the uterus and abdominal wall fascia through small incisions, possibly combined with anterior and posterior colporrhaphy; and the other undergoing transvaginal sacrospinous fixation, where the uterus is sutured to the right sacrospinous ligament, also possibly combined with colporrhaphy. Both procedures are uterus-preserving surgeries performed under anesthesia. Participants will be followed for up to five years to assess outcomes such as prolapse recurrence, anatomical and functional results, sexual function, and urodynamic measures. Patients will complete questionnaires and undergo evaluations to monitor safety and adverse events over the long term. The total study duration allows for thorough assessment of the efficacy and safety of these surgical treatments for pelvic organ prolapse.
CONDITIONS
Brief Title
Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 21 years old or above
- Diagnosed with uterine prolapse stage 2 or higher (C point distal to -1cm by POP-Q system)
- Willing to undergo uterus-preserving surgery for pelvic organ prolapse
- Suitable for anesthesia after evaluation
- May have had or not had prior conservative treatments for pelvic organ prolapse
- Able and willing to complete questionnaire evaluations
You will not qualify if you...
- Previous hysterectomy or planning hysterectomy during surgery for pelvic organ prolapse
- History of previous surgery for pelvic organ prolapse
- History of adverse events from synthetic mesh
- Chronic or acute pelvic pain
- Prior abdominal or pelvic irradiation
- Unable to undergo surgery due to other health conditions
- Pregnant or planning pregnancy
- Vaginal length less than 5 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo uterus-preserving surgery for pelvic organ prolapse by either laparoscopic uterine lateral suspension or transvaginal sacrospinous fixation. Concomitant anterior and posterior colporrhaphy may be performed. Immediate recovery and care follow the surgery.
1 surgical visit and immediate post-operative visits
Duration - Up to 5 years
Participants are monitored for anatomical, functional, sexual function, and urodynamic outcomes after surgery.
Periodic follow-up visits including assessments up to 6 months and annually up to 5 years
Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
Research Team
Y
Yu Fang Huang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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