Pelvic Organ ProlapseNCT00551993
Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse
A study testing robotic laparoscopic sacrocolpopexy and Laparoscopic Sacral Colpopexy in people with Pelvic Organ Prolapse, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to conduct a trial of robotic assisted versus traditional laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- robotic laparoscopic sacrocolpopexy and Laparoscopic Sacral Colpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2011
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are 21 years of age or greater
- Status post hysterectomy with apical vaginal prolapse POPQ stages II-IV (prolapse from 1cm proximal to the hymen to all points distal) that desire laparoscopic surgical management.
Who cannot join
- Patients that are not candidates for general anesthesia
- Inability to consent
- History of prior sacralcolpopexy
- Suspicious adnexal masses or other factors that may indicate pelvic malignancy
- History of pelvic inflammatory disease
- Morbid obesity (body mass index greater than or equal to 40)
- History of prior or need for concomitant rectopexy with sigmoid resection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
The purpose of this study is to conduct a trial of robotic assisted versus traditional laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.
Read the detailed description
Although laparoscopic sacrocolpopexy (LscASC) has been demonstrated to yield comparable success rates to abdominal sacrocolpopexy (93-99%) for the surgical treatment of pelvic organ prolapse, it has not been widely adopted due to the increased operating time and steep learning curves associated with laparoscopic suturing and knot-tying. For these reasons, robotic systems have been advocated for this technique. The objective of this study is to conduct a prospective single-blinded randomized controlled trial of robotic assisted versus traditional LscASC in the treatment of patients with apical vaginal prolapse stages II-IV (prolapse from 1 cm proximal to the hymen to all points distal).
This is a prospective single-blinded randomized controlled trial. Robotic assisted LscASC will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) in a similar manner as that described above for conventional laparoscopy. Data points recorded during the procedure will include: operating room time of entry and exit, time from incision to closure and time taken for the suturing aspect of the case. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital will be studied as will cost-effectiveness and impact on HRQOL
- Conditions
- Pelvic Organ Prolapse
- Being tested
- robotic laparoscopic sacrocolpopexy, Laparoscopic Sacral Colpopexy
- Keywords
- laparoscopy, robot, vaginal prolapse, sacrocolpopexy, sacral colpopexy
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic laparoscopic sacrocolpopexyProcedure or surgery
Da Vinci Robot
Laparoscopic Sacral ColpopexyProcedure or surgery
Standard laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Robotic Sacral Colpopexy Receives: Procedure: robotic laparoscopic sacrocolpopexy |
| 1 | Active comparator | Laparoscopic Sacral Colpopexy Receives: Procedure: Laparoscopic Sacral Colpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: operative time from incision to closure.
Measured: Primary outcome: will be obtained immediately at the end of each procedure.
Secondary outcomes (1)
Secondary outcomes: perioperative complications, hospital costs and post-operative patient outcomes (anatomic outcomes on physical examination and patient satisfaction using validated condition specific quality of life measures).
Measured: Secondary outcome: will be collected over the course of the first postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2011
- Study completionNov 2011
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.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Fidela M Paraiso, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551993
- Sponsor's protocol ID
- 06-652
- Status last verified
- Feb 2014
- First submitted
- 30 Oct 2007
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
PubMed 21979458
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00551993
- Acronym / sponsor ID
- 06-652
- Conditions
- Pelvic Organ Prolapse
- Keywords
- laparoscopy, robot, vaginal prolapse, sacrocolpopexy, sacral colpopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Nov 2007 (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 purpose of this study is to conduct a trial of robotic assisted versus traditional laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.
Detailed description
Although laparoscopic sacrocolpopexy (LscASC) has been demonstrated to yield comparable success rates to abdominal sacrocolpopexy (93-99%) for the surgical treatment of pelvic organ prolapse, it has not been widely adopted due to the increased operating time and steep learning curves associated with laparoscopic suturing and knot-tying. For these reasons, robotic systems have been advocated for this technique. The objective of this study is to conduct a prospective single-blinded randomized controlled trial of robotic assisted versus traditional LscASC in the treatment of patients with apical vaginal prolapse stages II-IV (prolapse from 1 cm proximal to the hymen to all points distal).
This is a prospective single-blinded randomized controlled trial. Robotic assisted LscASC will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) in a similar manner as that described above for conventional laparoscopy. Data points recorded during the procedure will include: operating room time of entry and exit, time from incision to closure and time taken for the suturing aspect of the case. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital will be studied as will cost-effectiveness and impact on HRQOL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: robotic laparoscopic sacrocolpopexyRobotic Sacral Colpopexy |
| 1 | Active comparator | Procedure: Laparoscopic Sacral ColpopexyLaparoscopic Sacral Colpopexy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who are 21 years of age or greater
- Status post hysterectomy with apical vaginal prolapse POPQ stages II-IV (prolapse from 1cm proximal to the hymen to all points distal) that desire laparoscopic surgical management.
Key exclusion criteria (7 listed)
- Patients that are not candidates for general anesthesia
- Inability to consent
- History of prior sacralcolpopexy
- Suspicious adnexal masses or other factors that may indicate pelvic malignancy
- History of pelvic inflammatory disease
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 |
|---|---|---|
| robotic laparoscopic sacrocolpopexyDa Vinci Robot | Procedure or surgery | 2 |
| Laparoscopic Sacral ColpopexyStandard laparoscopy | Procedure or surgery | 1 |
Primary outcome
Primary outcome: operative time from incision to closure.
Time frame: Primary outcome: will be obtained immediately at the end of each procedure.
1 secondary outcome
Secondary outcomes: perioperative complications, hospital costs and post-operative patient outcomes (anatomic outcomes on physical examination and patient satisfaction using validated condition specific quality of life measures).
Time frame: Secondary outcome: will be collected over the course of the first postoperative year
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 19 Feb 2014.
- Results publication: PubMed 21979458Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
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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.
Marie Fidela M Paraiso, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic laparoscopic sacrocolpopexy and Laparoscopic Sacral Colpopexy in people with Pelvic Organ Prolapse, run by The Cleveland Clinic at 1 site 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 2 inclusion and 7 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 19 Feb 2014. 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 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?
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?
Primary outcome: operative time from incision to closure. (time frame: Primary outcome: will be obtained immediately at the end of each procedure.). 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 NCT00551993, 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 19 Feb 2014.