Pelvic Organ ProlapseNCT01535833
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
A study testing Device- Robotic sacral colpopexy in people with Pelvic Organ Prolapse, run by Kaiser Permanente at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Device- Robotic sacral colpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- Decline to participate
- Pregnant or contemplating future pregnancy (within a year)
- Unable to participate in the informed consent process
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Kaiser Permanente Downey
Los Angeles, California, 90242
John N Nguyen, MD, 562-657-2642
John N Nguyen, MD
- Recruiting
Kaiser Permanente San Diego
San Diego, California, 92110
Gisselle Zazueta, 619-221-6274
Linda MacKinnon, 6192216418
About this study
Official title: Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Subjective and Objective Outcomes With Learning Curves in the Development of a New Pelvic Floor Robotics Program
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.
Read the detailed description
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.
The investigators primary outcomes will be:
- Surgical time: Key portion of procedure will be assessed along with total time for completion
- Learning curve: Will be assessed using surgical times, VAS of camera skills, surgical skills involving tissue handling and movements and overall performance by surgeon, assistant and blind reviewer
- Length of hospitalization: measured by days in hopsital
The investigators secondary outcomes will be:
- Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months.
- Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20)
- Mesh erosion,
- Estimated blood loss,
- Complications (bowel or bladder injury) and,
- Wound infection,
- Patient Global Impressions of Improvement
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Device- Robotic sacral colpopexy
- Keywords
- robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device- Robotic sacral colpopexyProcedure or surgery
Also called Robotic Laparoscopic Sacral Colpopexy
To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| Robotic sacral colpopexy | Other | To assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex Receives: Procedure: Device- Robotic sacral colpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (3)
Subjective outcomes for robotic sacral colpopexy
Subjective outcomes for robotic sacral colpopexy for prolapse and incontinence symptoms and sexual function using validated measures (PFDI-20), (PISQ-12)
Measured: Two years
Adverse events for robotic sacral colpopexy
Adverse events for robotic sacral colpopexy including estimated blood loss, GU and GI injury, wound infection and mesh erosion
Measured: Two years
Objective outcomes measures associated with robotic sacral colpopexy
To assess prolapse outcomes using POP-Q assessment of postoperative support at 12 and 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn A Menefee, MD, Kaiser Permanente
- Investigators
- Cynthia Brown, Study director, Southern California Kaiser permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535833
- Sponsor's protocol ID
- KP IRB 20111224
- Status last verified
- May 2016
- First submitted
- 13 Feb 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Subjective and Objective Outcomes With Learning Curves in the Development of a New Pelvic Floor Robotics Program
- ClinicalTrials.gov ID
- NCT01535833
- Acronym / sponsor ID
- KP IRB 20111224
- Conditions
- Pelvic Organ Prolapse
- Keywords
- robotic sacral colpopexy, Learning curve, Pelvic Organ Prolapse, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators primary outcomes will be:
- Surgical time: Key portion of procedure will be assessed along with total time for completion
- Learning curve: Will be assessed using surgical times, VAS of camera skills, surgical skills involving tissue handling and movements and overall performance by surgeon, assistant and blind reviewer
- Length of hospitalization: measured by days in hopsital
The investigators secondary outcomes will be:
- Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months.
- Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20)
- Mesh erosion,
- Estimated blood loss,
- Complications (bowel or bladder injury) and,
- Wound infection,
- Patient Global Impressions of Improvement
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic sacral colpopexy | Other | Procedure: Device- Robotic sacral colpopexyTo assess subjects with stage 2 pelvic organ prolapse undergoing robotic sacral colpopex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (3 listed)
- Decline to participate
- Pregnant or contemplating future pregnancy (within a year)
- Unable to participate in the informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device- Robotic sacral colpopexyAlso: Robotic Laparoscopic Sacral ColpopexyTo assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse | Procedure or surgery | Robotic sacral colpopexy |
Primary outcome
Learning curve of robotic sacral colpopexy
Time frame: 24 months
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
3 secondary outcomes
Subjective outcomes for robotic sacral colpopexy
Time frame: Two years
Adverse events for robotic sacral colpopexy
Time frame: Two years
Objective outcomes measures associated with robotic sacral colpopexy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
Related trials for Pelvic Organ Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Brown study director
Southern California Kaiser permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device- Robotic sacral colpopexy in people with Pelvic Organ Prolapse, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn A Menefee, MD (6192216398, shawn.a.menefee@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curve of robotic sacral colpopexy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.