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.
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Robotic assisted sacrocolpopexy (RASC) will be performed with the Da Vinci Surgical robot (Intuitive Surgical). THe mesh used will be a Type I (Amid classification), polypropylene mesh
Cork University Maternity Hospital
Cork, Ireland
RECRUITINGanatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
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.
Time frame: 6 months
intra- peri- and postoperative complications
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)
Time frame: intraoperative to 6 weeks after surgery
quality of life
impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)
Time frame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
postoperative pain
pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)
Time frame: on postoperative day 1
intraoperative variables
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
Time frame: intraoperative
impact of uterus management
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
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Time frame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
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.
Time frame: 6 weeks
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
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.
Time frame: 1 year, yearly thereafter (if feasible)