NCT01598467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

10 years

First QC Date

May 8, 2012

Last Update Submit

February 15, 2018

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapsePOPsacrocolpopexysacrohysteropexypromontofixationcolpopexyrobotic surgerysurgical complicationsmeshprolapse repair

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (7)

  • intra- peri- and postoperative complications

    intraoperative to 6 weeks after surgery

  • quality of life

    6 weeks, 6 months, 1 year (yearly thereafter, if feasible)

  • postoperative pain

    on postoperative day 1

  • intraoperative variables

    intraoperative

  • impact of uterus management

    6 weeks, 6 months, 1 year (yearly thereafter, if feasible)

  • +2 more secondary outcomes

Study Arms (1)

Women with pelvic organ prolapse

OTHER

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

Procedure: Robotic assisted sacrocolpopexy (RASC)

Interventions

Robotic assisted sacrocolpopexy (RASC)PROCEDURE

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

Also known as: sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy
Women with pelvic organ prolapse

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Maternity Hospital

Cork, Ireland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30924606DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Barry O'Reilly

    Cork University Hospital

    PRINCIPAL INVESTIGATOR

  • Steven E Schraffordt Koops

    Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands

    STUDY CHAIR

  • Lorenzo Dutto

    Cork University Hospital

    STUDY CHAIR

Central Study Contacts

Lorenzo Dutto, MD

CONTACT

00353-833247511lorenzo.dutto@fastwebnet.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator, urologist, urogynaecology fellow

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

IE(1)