Pelvic Organ ProlapseNCT00581334
Robotic-assisted Laparoscopic Sacrocolpopexy
An observational study of Pelvic Organ Prolapse, run by University of California, Irvine at 1 site in United States.
Trial summary
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Robotic-assisted laparoscopic sacrocolpopexy and Open sacrocolpopexy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2012
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female urogynecology patient with symptomatic apical prolapse
Who may be able to join
- Non-pregnant women
- Age >18 years
- Eligible for sacrocolpopexy
- Prior hysterectomy
- Stage II or greater post hysterectomy vault prolapse
- Satisfied parity
- Patients electing for an abdominal repair to posthysterectomy vault prolapse
Who cannot join
- Prisoners
- Cognitively impaired adults
- Not medically stable to undergo laparoscopic or abdominal surgery
- Previous pelvic/vaginal radiation
- Participants electing to proceed with a vaginal repair of vaginal vault prolapse
- Participants electing to proceed with the traditional abdominal sacrocolpopexy
- History of recurrent vaginal infections
- Known urologic and/or gynecologic cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
Read the detailed description
Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Robotic-assisted laparoscopic sacrocolpopexy, Open sacrocolpopexy
- Keywords
- Pelvic organ prolapse, Robotic-assisted laparoscopic sacrocolpopexy, Post hysterectomy prolapse, Symptomatic apical prolapse of stage II or >
- 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.
Robotic-assisted laparoscopic sacrocolpopexyProcedure or surgery
Also called DaVinci Robotic System
4 abdominal incisions will be made: 1 infraumbilical port and 3 lateral ports. The peritoneum overlaying the sacrum is entered and the anterior longitudinal ligament is exposed. 3 permanent sutures are placed through the ligament at the S2-S3. Then a vaginal obturator is placed transvaginally and the apex of vagina is elevated into the operative field. The peritoneum overlying the anterior and posterior vaginal epithelium is reflected and the bladder is dissected off the underlying vagina to expose 4cm of apical vagina. 2 segments of polypropylene mesh are prepared and one segment is anchored along the anterior vagina with a series of interrupted permanent suture and the second segment is anchored along the posterior vagina. These 2 segments are brought together to the previously placed sutures within the anterior longitudinal ligament of the sacrum. The peritoneum is then closed over the graft complex and the pelvis irrigated. The 4 robotic ports are removed and the abdomen closed.
Open sacrocolpopexyProcedure or surgery
mesh augmented repair for post-hysterectomy prolapse performed via open laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic Sacrocolpopexy Group | laparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot Receives: Procedure: Robotic-assisted laparoscopic sacrocolpopexy | |
| Open Sacrocolpopexy Group | matched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy Receives: Procedure: Open sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
time, estimated blood loss, UTI, duration-of stay
Measured: 2 years
Secondary outcomes (1)
Secondary outcomes will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire.
validated questionnaires
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2012
- Study completionJun 2012
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicia Lane, University of California, Irvine
- Investigators
- Felicia Lane, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581334
- Sponsor's protocol ID
- 20054606
- Status last verified
- Aug 2023
- First submitted
- 21 Dec 2007
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00581334
- Acronym / sponsor ID
- 20054606
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Robotic-assisted laparoscopic sacrocolpopexy, Post hysterectomy prolapse, Symptomatic apical prolapse of stage II or >
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Dec 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.
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
Detailed description
Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Sacrocolpopexy Group | – | Procedure: Robotic-assisted laparoscopic sacrocolpopexylaparoscopic mesh augmented prolapse repair for post-hysterectomy prolapse repair using the Da Vinci robot |
| Open Sacrocolpopexy Group | – | Procedure: Open sacrocolpopexymatched cohort that underwent mesh augmented prolapse repair for post-hysterectomy prolapse performed via open laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female urogynecology patient with symptomatic apical prolapse
Key inclusion criteria (7 listed)
- Non-pregnant women
- Age >18 years
- Eligible for sacrocolpopexy
- Prior hysterectomy
- Stage II or greater post hysterectomy vault prolapse
Key exclusion criteria (8 listed)
- Prisoners
- Cognitively impaired adults
- Not medically stable to undergo laparoscopic or abdominal surgery
- Previous pelvic/vaginal radiation
- Participants electing to proceed with a vaginal repair of vaginal vault prolapse
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-assisted laparoscopic sacrocolpopexyAlso: DaVinci Robotic System4 abdominal incisions will be made: 1 infraumbilical port and 3 lateral ports. The peritoneum overlaying the sacrum is entered and the anterior longitudinal ligament is exposed. 3 permanent sutures are placed through the ligament at the S2-S3. Then a vaginal obturator is placed transvaginally and the apex of vagina is elevated into the operative field. The peritoneum overlying the anterior and posterior vaginal epithelium is reflected and the bladder is dissected off the underlying vagina to expose 4cm of apical vagina. 2 segments of polypropylene mesh are prepared and one segment is anchored along the anterior vagina with a series of interrupted permanent suture and the second segment is anchored along the posterior vagina. These 2 segments are brought together to the previously placed sutures within the anterior longitudinal ligament of the sacrum. The peritoneum is then closed over the graft complex and the pelvis irrigated. The 4 robotic ports are removed and the abdomen closed. | Procedure or surgery | Robotic Sacrocolpopexy Group |
| Open sacrocolpopexymesh augmented repair for post-hysterectomy prolapse performed via open laparotomy | Procedure or surgery | Open Sacrocolpopexy Group |
Primary outcome
The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
Time frame: 2 years
time, estimated blood loss, UTI, duration-of stay
1 secondary outcome
Secondary outcomes will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire.
Time frame: 2 Years
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 23 Aug 2023.
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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.
Felicia Lane, M.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by University of California, Irvine 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 7 inclusion and 8 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 23 Aug 2023. 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?
The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q). (time frame: 2 years). 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 23 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.