Pelvic Organ ProlapsePARSECNCT01598467
Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
A study testing Robotic assisted sacrocolpopexy (RASC) in people with Pelvic Organ Prolapse, run by Femke van Zanten at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Robotic assisted sacrocolpopexy (RASC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2011to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
Lorenzo Dutto, MD, 00353(83)3247511, lorenzo.dutto@fastwebnet.it
Barry O'Reilly
About this study
Official title: Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
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.
Read the 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)
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Robotic assisted sacrocolpopexy (RASC)
- Keywords
- pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications, mesh, prolapse repair
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted sacrocolpopexy (RASC)Procedure or surgery
Also called sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy
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
| Study group | Role | What they receive |
|---|---|---|
| Women with pelvic organ prolapse | Other | Women with pelvic organ prolapse (simplified POP-Q > stage 1) Receives: Procedure: Robotic assisted sacrocolpopexy (RASC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year, yearly thereafter (if feasible)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Femke van Zanten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Femke van Zanten, Cork University Hospital
- Investigators
- Barry O'Reilly, Principal investigator, Cork University HospitalSteven E Schraffordt Koops, Study chair, Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The NetherlandsLorenzo Dutto, Study chair, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598467
- Sponsor's protocol ID
- PARSEC-1
- Acronym
- PARSEC
- Status last verified
- Feb 2018
- First submitted
- 8 May 2012
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30924606
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
- ClinicalTrials.gov ID
- NCT01598467
- Acronym / sponsor ID
- PARSEC / PARSEC-1
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Femke van ZantenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pelvic organ prolapse | Other | Procedure: Robotic assisted sacrocolpopexy (RASC)Women with pelvic organ prolapse (simplified POP-Q > stage 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic assisted sacrocolpopexy (RASC)Also: sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexyRobotic 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 | Procedure or surgery | Women with pelvic organ prolapse |
Primary outcome
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Time frame: 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.
7 secondary outcomes
intra- peri- and postoperative complications
Time frame: intraoperative to 6 weeks after surgery
quality of life
Time frame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
postoperative pain
Time frame: on postoperative day 1
intraoperative variables
Time frame: intraoperative
impact of uterus management
Time frame: 6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Time frame: 6 weeks
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Time frame: 1 year, yearly thereafter (if feasible)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 30924606van 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry O'Reilly principal investigator
Cork University Hospital
Steven E Schraffordt Koops study chair
Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands
Lorenzo Dutto study chair
Cork University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted sacrocolpopexy (RASC) in people with Pelvic Organ Prolapse, run by Femke van Zanten at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Dutto, MD (00353-833247511, lorenzo.dutto@fastwebnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.