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Transvaginal single-port laparoscopy pelvic reconstruction with Titanium coated mesh versus transvaginal single-port laparoscopy sacro-uerospianl ligament suspension in pelvic organ prolapse: a prospective randomized controlled trail

Transvaginal single-port laparoscopy pelvic reconstruction with Titanium coated mesh versus transvaginal single-port laparoscopy sacro-uerospianl ligament suspension in pelvic organ prolapse: a prospective randomized controlled trail

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062402
Enrollment
Unknown
Registered
2022-08-04
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Pelvic organ prolapse

Interventions

A:Transvaginal single-port laparoscopy pelvic reconstruction with Titanium coated mesh
B:Transvaginal single-port laparoscopy sacro-uerospianl ligament suspension

Sponsors

Affiliated Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with pelvic organ prolapse diagnosed and treated in the affiliated obstetrics and Gynecology Hospital of Fudan University from July 2021 to November 2022; 2. Patients who have informed consent and signed the informed consent form; 3. Adult women aged 50-80; (1) Patients with grade III or above in at least one part and grade II or above in other parts; (2) Patients who refused conservative treatment and failed conservative treatment; 93) Patients with sexual needs; 4. Patients who were followed up for 2-3 years after the operation.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pelvic radiotherapy; 2. Patients with a history of prolapse treated with transvaginal mesh; 3. Women with reproductive requirements; Pregnant or lactating patients; 4. Patients with immune diseases and long-term use of steroids; 5. Patients currently smoking; 6. Patients with pelvic pain syndrome (such as fibromyalgia, bladder pain syndrome) that may lead to increased sensitivity to pelvic pain; 7. Patients suspected of pelvic malignancy; 8. Patients with pain caused by lumbar and sacral organic diseases (such as lumbar disc herniation and mandatory spondylitis); 9. Patients who are too old to tolerate surgery or whose surgical benefits are significantly less than surgical trauma.

Design outcomes

Primary

MeasureTime frame
Failure rate;Vaginal length;Vaginal width;Urinary incontinence;Urinary retention;Improvement of quality of life;Socio-economic evaluation;

Secondary

MeasureTime frame
Operation time;Amount of bleeding;Length of hospital stay;Hospitalization expenses;Pain score;Whether there are intraoperative complications and their specific conditions;

Countries

China

Contacts

Public ContactChen Yisong

Affiliated Obstetrics and Gynecology Hospital of Fudan University

cys373900207@aliyun.com+86 13601913713

Outcome results

None listed

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