Pelvic Organ ProlapseNCT03034499
Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
A study testing Single-port sacrocolpopexy and Multi-port sacrocolpopexy in people with Pelvic Organ Prolapse, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: 1. Via single-port. 2. Via multi-port. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Single-port sacrocolpopexy and Multi-port sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Mar 2017to 1 Apr 2019
- 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.
Who cannot join
- Patients after previous hysterectomy.
- Patients after previous surgical procedures for prolapse repair.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:
- Via single-port.
- Via multi-port.
Read the detailed description
One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:
- Via single-port.
- Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.
Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.
Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Single-port sacrocolpopexy, Multi-port sacrocolpopexy
- 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.
Single-port sacrocolpopexyProcedure or surgery
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Multi-port sacrocolpopexyProcedure or surgery
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Single-port sacrocolpopexy | Active comparator | Patients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy. Receives: Procedure: Single-port sacrocolpopexy |
| Multi-port sacrocolpopexy | Active comparator | Patients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy. Receives: Procedure: Multi-port sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of surgical time
Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.
Measured: Up to four months (2 weeks before surgery until 3 months post-surgery).
Secondary outcomes (2)
Comparison of surgical success
Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.
Measured: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical complications
Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.
Measured: Up to four months (2 weeks before surgery until 3 months post-surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start20 Mar 2017
- Primary completion1 Nov 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034499
- Sponsor's protocol ID
- 0631-16-RMB
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2017
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.
PubMed 31589864
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse
- ClinicalTrials.gov ID
- NCT03034499
- Acronym / sponsor ID
- 0631-16-RMB
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 27 Jan 2017 (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.
A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse:
- Via single-port.
- Via multi-port.
Detailed description
One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy:
- Via single-port.
- Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined.
Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications.
Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port sacrocolpopexy | Active comparator | Procedure: Single-port sacrocolpopexyPatients with vaginal apex prolapse randomized to undergo repair by single-port sacrocolpopexy. |
| Multi-port sacrocolpopexy | Active comparator | Procedure: Multi-port sacrocolpopexyPatients with vaginal apex prolapse randomized to undergo repair by multi- port sacrocolpopexy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with vaginal apex prolapse that are eligible for repair by sacrocolpopexy.
Key exclusion criteria (2 listed)
- Patients after previous hysterectomy.
- Patients after previous surgical procedures for prolapse repair.
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 |
|---|---|---|
| Single-port sacrocolpopexySingle-port sacrocolpopexy surgery for the repair of vaginal apex prolapse. | Procedure or surgery | Single-port sacrocolpopexy |
| Multi-port sacrocolpopexyMulti-port sacrocolpopexy surgery for the repair of vaginal apex prolapse. | Procedure or surgery | Multi-port sacrocolpopexy |
Primary outcome
Comparison of surgical time
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.
2 secondary outcomes
Comparison of surgical success
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical complications
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 31589864Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.
- Individual participant dataSharing planned: No
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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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port sacrocolpopexy and Multi-port sacrocolpopexy in people with Pelvic Organ Prolapse, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of surgical time (time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034499, which also lists 1 linked publication.
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 11 Jun 2019.