Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

Study Overview
=================
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)

Official Title
-----------------
Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Robotic assisted sacrocolpopexy (RASC)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Women with pelvic organ prolapse<br>Women with pelvic organ prolapse (simplified POP-Q > stage 1) | Procedure: Robotic assisted sacrocolpopexy (RASC)<br>* 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<br>* Other names: sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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 | 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 | 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. | 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. | 1 year, yearly thereafter (if feasible) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications, mesh, prolapse repair