None listed
Conditions
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 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
Study design
Eligibility
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