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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

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date February 22, 2018
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
  • 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)
  • 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)
  • 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)
  • 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 adhesiolisys will also be recorded
  • 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 secundary outcomes
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Official Title  ICMJE Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Organ Prolapse
Intervention  ICMJE 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
Study Arms  ICMJE Women with pelvic organ prolapse
Women with pelvic organ prolapse (simplified POP-Q > stage 1)
Intervention: Procedure: Robotic assisted sacrocolpopexy (RASC)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lorenzo Dutto, MD 00353-833247511 lorenzo.dutto@fastwebnet.it
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598467
Other Study ID Numbers  ICMJE PARSEC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Femke van Zanten, Cork University Hospital
Study Sponsor  ICMJE Femke van Zanten
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Cork University Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP