Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

Femke van Zanten

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Robotic assisted sacrocolpopexy (RASC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01598467

PARSEC-1

Details and patient eligibility

About

The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Full description

To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Primary outcome: anatomical cure rate (using simplified POP-Q staging system)

Secondary outcomes:

complication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater

Exclusion criteria

• Poor health status with inability to undergo general anaesthesia
• Age < 18 years
• ≥ 3 previous laparotomic surgeries
• Planned pregnancy
• Other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (Lupus, Sjogren Sdr, sclerodermia, etc.), current UTI's, use of steroids, anticoagulants, interstitial cystitis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Women with pelvic organ prolapse

Other group

Description:

Women with pelvic organ prolapse (simplified POP-Q \> stage 1)

Treatment:

Procedure: Robotic assisted sacrocolpopexy (RASC)