Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications, mesh, prolapse repair
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)
Interventions
PROCEDURERobotic 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
Sponsors
Femke van Zanten
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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 |
| anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) | 6 weeks | 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. |
| 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 |
Countries
Ireland
Contacts
Primary ContactLorenzo Dutto, MD
Outcome results
None listed