Clinical trial NCT01598467: Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Official title: Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
POP
sacrocolpopexy
sacrohysteropexy
promontofixation
colpopexy
robotic surgery
surgical complications
mesh
prolapse repair
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
timeFrame: 6 months
Secondary outcomes:
measure: intra- peri- and postoperative complications
timeFrame: intraoperative to 6 weeks after surgery
measure: quality of life
timeFrame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
measure: postoperative pain
timeFrame: on postoperative day 1
measure: intraoperative variables
timeFrame: intraoperative
measure: impact of uterus management
timeFrame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
measure: anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
timeFrame: 6 weeks
measure: anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
timeFrame: 1 year, yearly thereafter (if feasible)
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
affiliation: Cork University Hospital
name: Barry O'Reilly
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands
name: Steven E Schraffordt Koops
role: STUDY_CHAIR
affiliation: Cork University Hospital
name: Lorenzo Dutto
role: STUDY_CHAIR
References:
citation: van Zanten F, Schraffordt Koops SE, O'Sullivan OE, Lenters E, Broeders I, O'Reilly BA. Robot-assisted surgery for the management of apical prolapse: a bi-centre prospective cohort study. BJOG. 2019 Jul;126(8):1065-1073. doi: 10.1111/1471-0528.15696. Epub 2019 May 2.