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Transvaginal single port laparoscopic pelvic reconstruction with Y-shaped mesh V.S. sacrospinous ligament fixation combined with anterior / posterior colporrhaphy for advanced multi-compartment prolapse: a prospective randomized controlled study

Transvaginal single port laparoscopic pelvic reconstruction with Y-shaped mesh V.S. sacrospinous ligament fixation combined with anterior / posterior colporrhaphy for advanced multi-compartment prolapse: a prospective randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052977
Enrollment
Unknown
Registered
2021-11-07
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

Group A:Transvaginal single-port laparoscopic Y-net pelvic floor reconstruction
Group B:sacrospinous ligament fixation combined with anterior / posterior colporrhaphy

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pelvic organ prolapse who came to Fudan University Affiliated Obstetrics and Gynecology Hospital from November 2021 to June 2023; 2. Patients who gave informed consent and signed the informed consent; 3. Adult women aged 50-80; 4. Using the POP-Q score method, patients with at least one pelvic II prolapse of grade III and above; 5. Patients with postoperative follow-up for 2 years.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pelvic radiotherapy; 2. Patients with prolapse treated by transvaginal mesh; 3. Women with fertility requirements; pregnant or lactating patients; 4. The patients with pelvic pain caused by pelvic floor muscle spasm were found under basic condition; 5. Patients with long-term use of steroid hormone in immune diseases; 6. Current smokers; 7. Patients with pain syndrome, which may lead to increased sensitivity to pelvic pain (such as fibromyalgia, bladder pain syndrome); 8. Patients who may have malignant tumors; 9. Patients who are too old to tolerate surgery or whose surgical benefits are significantly smaller than surgical trauma.

Design outcomes

Primary

MeasureTime frame
Uterine Prolapse POP-Q Score;the quality of life questionnare;complications;recurrence;

Countries

China

Contacts

Public ContactChen Yisong

Obstetrics and Gynecology Hospital of Fudan University

cys373900207@qq.com+86 13601913713

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026