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

February 15, 2018 updated by: Femke van Zanten

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Maternity Hospital
        • Contact:
        • Principal Investigator:
          • Barry O'Reilly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 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)
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
intraoperative to 6 weeks after surgery
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)
6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
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)
on postoperative day 1
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
intraoperative
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 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 (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)
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.
1 year, yearly thereafter (if feasible)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Femke van Zanten

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARSEC-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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