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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Robotic assisted sacrocolpopexy (RASC)
Sponsored by
Femke van Zanten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications, mesh, prolapse repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cork University Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Women with pelvic organ prolapse

Arm Description

Women with pelvic organ prolapse (simplified POP-Q > stage 1)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
quality of life
impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)
postoperative pain
pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)
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
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
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.
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.

Full Information

First Posted
May 8, 2012
Last Updated
February 15, 2018
Sponsor
Femke van Zanten
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1. Study Identification

Unique Protocol Identification Number
NCT01598467
Brief Title
Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Acronym
PARSEC
Official Title
Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Femke van Zanten

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, POP, sacrocolpopexy, sacrohysteropexy, promontofixation, colpopexy, robotic surgery, surgical complications, mesh, prolapse repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with pelvic organ prolapse
Arm Type
Other
Arm Description
Women with pelvic organ prolapse (simplified POP-Q > stage 1)
Intervention Type
Procedure
Intervention Name(s)
Robotic assisted sacrocolpopexy (RASC)
Other Intervention Name(s)
sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy
Intervention Description
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
Primary Outcome Measure Information:
Title
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
intra- peri- and postoperative complications
Description
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)
Time Frame
intraoperative to 6 weeks after surgery
Title
quality of life
Description
impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)
Time Frame
6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
Title
postoperative pain
Description
pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)
Time Frame
on postoperative day 1
Title
intraoperative variables
Description
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
Time Frame
intraoperative
Title
impact of uterus management
Description
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
Time Frame
6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
Title
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Description
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.
Time Frame
6 weeks
Title
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)
Description
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.
Time Frame
1 year, yearly thereafter (if feasible)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenzo Dutto, MD
Phone
00353-833247511
Email
lorenzo.dutto@fastwebnet.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry O'Reilly
Organizational Affiliation
Cork University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven E Schraffordt Koops
Organizational Affiliation
Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lorenzo Dutto
Organizational Affiliation
Cork University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cork University Maternity Hospital
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Dutto, MD
Phone
00353(83)3247511
Email
lorenzo.dutto@fastwebnet.it
First Name & Middle Initial & Last Name & Degree
Barry O'Reilly

12. IPD Sharing Statement

Citations:
PubMed Identifier
30924606
Citation
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.
Results Reference
derived

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

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