pelvic organ prolapse
Conditions
Interventions
A modified PTFE mesh was used, in which the edges of the body portion were folded approximately 5 mm and double-layered by suturing with PTFE thread, for use in standard laparoscopic sacrocolpopexy.
Sponsors
Japanese Red Cross Gifu Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with pelvic organ prolapse who wish to undergo surgical treatment using mesh. 2. Patients who have received a full explanation of the study and provided written informed consent. 3. Patients with an ECOG Performance Status of 0. 4. Patients who are eligible for general anesthesia and laparoscopic surgery.
Exclusion criteria
Exclusion criteria: 1. Patients aged under 50 or over 80 at the time of consent. 2. Patients with suspected malignancy based on preoperative evaluation. 3. Patients judged to have impaired decision-making capacity. 4. Patients in whom mesh fixation is considered difficult based on pelvic examination or imaging findings. 5. Patients with a history of severe intra-abdominal adhesions or other conditions making laparoscopic surgery difficult. 6. Patients with severe glaucoma. 7. Patients with poorly controlled diabetes mellitus. 8. Any other patients deemed unsuitable for participation in this study or for undergoing the surgical procedure, as judged by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT scores for mesh visualization at 3 days and 6 weeks after laparoscopic sacrocolpopexy | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety, including the presence of mesh-related complications, up to 3 years after laparoscopic sacrocolpopexy | — |
Countries
Japan
Contacts
Public ContactAkane Yamaguchi
University of Tsukuba hospital Urology
Outcome results
None listed