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

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ClinicalTrials.gov Identifier: NCT01598467
Recruitment Status : Recruiting
First Posted : May 15, 2012
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Femke van Zanten, Cork University Hospital

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Robotic assisted sacrocolpopexy (RASC) Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Study Start Date : August 2011
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Women with pelvic organ prolapse
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
Other Name: sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. intra- peri- and postoperative complications [ Time Frame: 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)

  2. quality of life [ Time Frame: 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)

  3. postoperative pain [ Time Frame: on postoperative day 1 ]
    pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)

  4. intraoperative variables [ Time Frame: 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

  5. impact of uterus management [ Time Frame: 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

  6. anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) [ Time Frame: 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.

  7. anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse) [ Time Frame: 1 year, yearly thereafter (if feasible) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598467


Contacts
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Contact: Lorenzo Dutto, MD 00353-833247511 lorenzo.dutto@fastwebnet.it

Locations
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Ireland
Cork University Maternity Hospital Recruiting
Cork, Ireland
Contact: Lorenzo Dutto, MD    00353(83)3247511    lorenzo.dutto@fastwebnet.it   
Principal Investigator: Barry O'Reilly         
Sponsors and Collaborators
Femke van Zanten
Investigators
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Principal Investigator: Barry O'Reilly Cork University Hospital
Study Chair: Steven E Schraffordt Koops Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands
Study Chair: Lorenzo Dutto Cork University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Femke van Zanten, Study Coordinator, urologist, urogynaecology fellow, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01598467    
Other Study ID Numbers: PARSEC-1
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Keywords provided by Femke van Zanten, Cork University Hospital:
pelvic organ prolapse
POP
sacrocolpopexy
sacrohysteropexy
promontofixation
colpopexy
robotic surgery
surgical complications
mesh
prolapse repair
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical