RecruitingACTRN12608000102370

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)


Sponsor

Dr Yik Lim

Enrollment

126 participants

Start Date

Dec 1, 2007

Study Type

Interventional

Conditions

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


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques for fixing vaginal vault prolapse — a condition where the top of the vagina (vault) drops down after a hysterectomy, sometimes causing discomfort or a bulge. One approach involves stitching the vault to a ligament inside the body through the vagina. The other is a more complex procedure called sacrocolpopexy, which can be done either as open surgery or through keyhole surgery. The study aims to find out if the simpler vaginal approach works as well as the current gold standard. You may be eligible if: - You are a woman who has previously had a hysterectomy - You have been diagnosed with vaginal vault prolapse at Stage 2 or higher (meaning the prolapse drops to within 1 cm of the vaginal opening) You may NOT be eligible if: - You are not fit for surgery - You have a history of cancer of the genital tract - You have had a vaginal fistula (abnormal connection between organs) - You have had a major complication from surgical mesh in the past Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12608000102370