Puborectalis Sling RCT - a study on reducing pelvic organ prolapse recurrences following prolapse surgery.

Reducing the levator hiatus with a puborectalis sling - a multi centre randomised controlled trial for patients undergoing pelvic organ prolapse surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000236897

Acronym

N/A

Enrollment

200

Registered

2012-02-24

Start date

2012-03-01

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

This study aims to determine if a new technique in treating prolapse will give a better long term result than the current standard treatment. The new technique aims to reduce the size of the opening in the pelvic floor and is done at the same time as the standard prolapse repair surgery.

Interventions

Randomised Controlled trial - 2 arms. One arm - patients undergoing standard pelvic organ prolapse repair surgery which may include a combination of vaginal hysterectomy, anterior +/- posterior vaginal wall repair, sacrospinous fixation +/- anti-incontinence procedures. In total, the procedure may vary from 60 minutes to 120 minutes. Intervention arm - patients undergoing standard pelvic organ prolapse repair ( as per above) will receive in addition, a puborectalis sling insertion, which is an additional 3x15cm strip of polypropylene mesh inserted via the obturator foramen, traversing the ischio-rectal fossa and post-anally from one side to the other. This additional mesh insertion may require an additional 15 - 30 minutes of surgical operating time.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing conventional/standard pelvic organ prolapse surgery with an enlarged levator hiatus (>30cm2) and have completed family

Exclusion criteria

Overt neuromuscular abnormality, Levator hiatus of <30cm2, Inability to attend follow-up or comply with study protocol or inability to give informed consent and patients who are still intending on future pregnancies

Outcome results