A pilot study assessing the efficacy of the Capio device for sacrospinous ligament fixation.

A pilot study assessing the objective and subjective outcomes of the Capio device compared to published data on outcomes of the same surgery using the Miya Hook in women undergoing sacrospinous ligament fixation.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001273875

Enrollment

Registered

2012-12-10

Start date

2013-01-01

Completion date

2014-12-31

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 analyse the outcomes of surgery to correct apical vaginal prolapse using the Capio Suturing Device.

Interventions

The Capio suturing device will be used to place the sacrospinous suture in the operation. The Capio suturing device is a single use instrument used to placed the sacrospinous suture. (The Miya Hook is a reusable instrument) Two sutures will be placed through the sacrospinous ligament and the apex of the vagina during each operation. The operation usually takes between 30 and 40minutes. There is some suggestion in the literature that the Capio device requires less tissue dissection than the

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women consented to undergo a sacrospinous ligament fixation

Exclusion criteria

Unfit for surgery Unable to fill in online questionnaires Women preferring or electing to undergo abdominal or uterosacral vault suspension Women undergoing mesh surgery Women undergoing uterine preservation surgery

Outcome results