Robotic removal of transvaginal mesh for pelvic organ prolapse and stress urinary incontinence

Efficacy of robotic removal of transvaginal mesh for pelvic organ prolapse and stress urinary incontinence

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000570189

Enrollment

Registered

2019-04-11

Start date

2019-04-12

Completion date

2020-10-30

Last updated

2020-08-31

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 is a pilot study for a new application of robotic assisted surgery for removal of urogynaecological mesh from the vagina or pelvis aiming to reduce incision size and therefore surgical harm.This study will examine the use of this approach in improving visualisation and access in order to remove mesh completely via smaller incisions. Our aim is to confirm that this it is techincally possible to completely remove implanted pelvic mesh with a robot-assisted laparoscopic surgical approach.

Interventions

Robotic removal of vaginal mesh a. physical materials used - Da vinci robot will be used to perform robot assisted laparoscopic surgery b. Procedure - transvaginal or transabdominal robotic surgery c . Delivered by urological surgeon (Dr Fong, Dr O'Connell , Dr Zargar) d. Surgical delivery of treamtnet e. Single treatment (1-3 hours) f . In hospital setting, in operating theater g. adherence to intervention: will follow technique developed during cadaveric simulation surgery which was co

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women, 18 and over, with pelvic mesh and symptoms of mesh complications (pain/ dyspareunia/ voiding symptoms/ mesh extrusion)

Exclusion criteria

. Patients who have previously had surgical mesh removal attempted will not be offered participation in this early phase study but may be offered such an approach in subsequent work.

Outcome results