Comparing two surgical methods for treating apical prolapse in women
Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial
This study is testing two different surgical methods to see which one works better for women in China with advanced pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 5 sites (Hefei, Anhui and 4 other locations) |
| Trial ID | NCT04213027 on ClinicalTrials.gov |
What this trial studies
This trial investigates the efficacy and safety of two native tissue repair procedures, Sacrospinous Ligament Fixation (SSLF) and Ischial Spinous Fascia Fixation (ISFF), in Chinese women with advanced apical prolapse. Participants will be randomized to receive either SSLF or ISFF using conventional surgical instruments. Baseline data will be collected, and follow-up assessments will occur at multiple intervals post-surgery to evaluate outcomes and any adverse events. The study aims to provide insights into the effectiveness of these surgical approaches for pelvic organ prolapse.
Who should consider this trial
Good fit: Ideal candidates are Chinese women with advanced apical prolapse (POP-Q II-IV) who are eligible for surgical intervention.
Not a fit: Patients with a history of surgical prolapse repair using mesh or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for women suffering from apical prolapse.
How similar studies have performed: Previous studies have shown varying success with similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV) 2. SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously. 3. Women who have been eligible for long-term follow-up. 4. Women who agreed to participate in the study and signed informed consent. Exclusion Criteria: 1. Women who have surgical history for prolapse with mesh. 2. Women who have contraindication for surgical procedure 3. Women who are unable to comply with the study procedures
Where this trial is running
Hefei, Anhui and 4 other locations
- 2nd Affiliated hospital of Anhui Medical college — Hefei, Anhui, China (Recruiting)
- 1st Affiliated hospital of PLA general hospital — Beijing, Beijing, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
- Suzhou City Hospital — Suzhou, Jiangsu, China (Recruiting)
- Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yongxian Lu — 1st Affiliated hospital of PLA general hospital
- Study coordinator: Yuxin Dai, MD
- Email: helen81918@163.com
- Phone: 0086-010-69156204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.