A Randomised Study comparing post-hystectomy vaginal vault prolapse repair with either suspension to uterosacral ligament (vaginal approach) or sacrocolpopexy (open or keyhole approach)

Randomised Controlled Trial of Post-hysterectomy Vaginal Vault Prolapse Treatment with either Extraperitoneal Uterosacral Ligament Suspension or Sacrocolpopexy (Abdominal and Laparoscopic)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000102370

Enrollment

126

Registered

2008-02-22

Start date

2007-12-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To find out the efficacy of vaginal vault prolapse repair with uterosacral ligament suspension via vaginal approach to those of the current gold standard surgery of sacrocolpopexy

Interventions

Extraperitoneal Uterosacral Ligament Suspension versus Sacrocolpopexy techniques. In the former technique, an incision is made inside to vagina to gain access to the remnant ligaments that normally anchor the cervix to the pelvis (uterosacral ligament). The top end of the vagina (vaginal vault) is then attached to these ligaments to stop them from prolapsing downwards. This often take about 30 to 90 minutes to perform.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Post-hysterectomy vaginal vault prolapse at least Pelvic Organ Prolapse Quantification stage 2 (meaning the leading edge of the vaginal prolapse drops to at least 1cm from the hymen)

Exclusion criteria

unfit for surgery, history of genital tract malignancy or fistula, previous major mesh complication

Outcome results