Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT01598467
- Lead Sponsor
- Femke van Zanten
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
- Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) 6 months anatomical cure (defined as any simplified POP-Q point \<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.
- Secondary Outcome Measures
Name Time Method intra- peri- and postoperative complications intraoperative to 6 weeks after surgery complications occurring during surgery are defined as "intraoperative complication", within 3 weeks from surgery will be defined as "perioperative complication". Complications occurring after this timeframe will be regarded as "late complications", if related to surgery (e.g. mesh erosion)
quality of life 6 weeks, 6 months, 1 year (yearly thereafter, if feasible) impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)
intraoperative variables intraoperative intraoperative variables are recorded, such as: blood loss, duration of surgery (divided in robotic setup time, console time and surgery completion time). Concomitant procedures, such as adhesiolysis will also be recorded
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) 1 year, yearly thereafter (if feasible) anatomical cure (defined as any simplified POP-Q point \<2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be ≥2, this will be recorded as a recurrent prolapse.
impact of uterus management 6 weeks, 6 months, 1 year (yearly thereafter, if feasible) logistic regression analysis will be performed to evaluate if different surgical approaches in presence, -or absence, of the uterus (e.g. supracervical hysterectomy, uterus sparing surgery), have an effect on primary and secondary outcomes
postoperative pain on postoperative day 1 pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)
Trial Locations
- Locations (1)
Cork University Maternity Hospital
🇮🇪Cork, Ireland
Cork University Maternity Hospital🇮🇪Cork, IrelandLorenzo Dutto, MDContact00353(83)3247511lorenzo.dutto@fastwebnet.itBarry O'ReillyPrincipal Investigator