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Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse

Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000651583
Enrollment
8
Registered
2024-05-21
Start date
2023-09-15
Completion date
2028-09-15
Last updated
2024-05-27

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

Conditions

None listed

Brief summary

A study to investigate the differences in subjective, objective and quality of life outcomes between sacral colpopexy with mesh (Type 1 polypropylene) versus alternative graft (autologous fascia lata) at 6, 12, 24 month and 5 years

Interventions

Sacrocolpopexy (laparoscopic or open) - a surgical procedure using a graft material either autologous (harvested fascia lata from that patient's lateral thigh) or synthetic polypropylene mesh (TiLoop Mesh) to attach the vaginal vault to the sacral promontory in order to treat vault prolapse Participating patients are offered sacrocolpopexy for vault prolapse as a treatment option as per the Australian Guideline - if they chose this option they are offered both fascia lata graft or synthetic poly

Sacrocolpopexy (laparoscopic or open) - a surgical procedure using a graft material either autologous (harvested fascia lata from that patient's lateral thigh) or synthetic polypropylene mesh (TiLoop Mesh) to attach the vaginal vault to the sacral promontory in order to treat vault prolapse Participating patients are offered sacrocolpopexy for vault prolapse as a treatment option as per the Australian Guideline - if they chose this option they are offered both fascia lata graft or synthetic polypropylene mesh. This counselling is conducted by Urogynaecology subspecialists. The patient can then select either option, there is no randominisation. Duration of intervention - duration of surgery is between 2-4hours. Duration of expected hospital stay is between 2-4 days. Post operative review in clinic will occur at 6-8 weeks, 6 months, then yearly up to 5 years post surgery, more often if there is clinical need. All cases included will have data collection by an independent research fellow to ensure counselling, consent, surgery and outcomes align with the study protocol.

Sponsors

Gold Coast Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients assessed by subspecialist Urogynaecologist (Certificate of Urogynaecology - RANZCOG) who are candidates for sacrocolpopexy treatment for apical vaginal prolapse - Care at one of the three sites: Varsity Lakes/Robina Hospital, Pindara Private Hospital or Greenslopes Private Hospital - Who have their care between 1st April 2023 – 1st April 2028

Exclusion criteria

Those not appropriate for sacrocolpopexy surgery Those unable to understand the study and/or provide informed consent Those having care at sites not listed for the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026