NCT01535833

Brief Summary

The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

4.4 years

First QC Date

February 13, 2012

Last Update Submit

May 10, 2016

Conditions

Pelvic Organ Prolapse

Keywords

robotic sacral colpopexyLearning curvePelvic Organ ProlapseRobotic Surgery

Outcome Measures

Primary Outcomes (1)

  • Learning curve of robotic sacral colpopexy

    To assess learning curve during implementation of a new pelvic floor robotic program which will assess surgical time (total and specific essential portions), simulator training and surgeon, observational surgeon skills by surgeon, assistant and blinded assessor

    24 months

Secondary Outcomes (3)

  • Subjective outcomes for robotic sacral colpopexy

    Two years

  • Adverse events for robotic sacral colpopexy

    Two years

  • Objective outcomes measures associated with robotic sacral colpopexy

    24 months

Study Arms (1)

Robotic sacral colpopexy

OTHER

To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex

Procedure: Device- Robotic sacral colpopexy

Interventions

Device- Robotic sacral colpopexyPROCEDURE

To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse

Also known as: Robotic Laparoscopic Sacral Colpopexy
Robotic sacral colpopexy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • Females only
  • Undergoing robotic assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse
  • Willing to return for follow-up visits
  • Written informed consent obtained from each subject

You may not qualify if:

  • Decline to participate
  • Pregnant or contemplating future pregnancy (within a year)
  • Unable to participate in the informed consent process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Downey

Los Angeles, California, 90242, United States

NOT YET RECRUITING

Kaiser Permanente San Diego

San Diego, California, 92110, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Brown

    Southern California Kaiser permanente

    STUDY DIRECTOR

Central Study Contacts

Shawn A Menefee, MD

CONTACT

6192216398shawn.a.menefee@kp.org

John N Nguyen, MD

CONTACT

5626572642john.n.nguyen@kp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 20, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(2)