An interventional study of Robotic assisted sacrocolpopexy (RASC) in Pelvic Organ Prolapse, sponsored by Femke van Zanten. Status unknown at 1 site in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Femke van Zanten · Not applicable, Interventional, and Treatment
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)
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's planned enrollment of 300 is above the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →This is the only study on the registry with Femke van Zanten as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women with pelvic organ prolapse (simplified POP-Q \> stage 1)
Procedure: Robotic assisted sacrocolpopexy (RASC)
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
Also known as: sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy
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 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
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)
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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