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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with pelvic organ prolapse | Other | Women with pelvic organ prolapse (simplified POP-Q > stage 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted sacrocolpopexy (RASC) | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Dutto, MD | Contact | 00353-833247511 | lorenzo.dutto@fastwebnet.it |
| Name | Affiliation | Role |
|---|---|---|
| Barry O'Reilly | Cork University Hospital | Principal Investigator |
| Steven E Schraffordt Koops | Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Maternity Hospital | Recruiting | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30924606 | Derived | van Zanten F, Schraffordt Koops SE, O'Sullivan OE, Lenters E, Broeders I, O'Reilly BA. Robot-assisted surgery for the management of apical prolapse: a bi-centre prospective cohort study. BJOG. 2019 Jul;126(8):1065-1073. doi: 10.1111/1471-0528.15696. Epub 2019 May 2. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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) |
| Lorenzo Dutto | Cork University Hospital | Study Chair |