UrogynecologyNCT01033786
Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications
An observational study of Urogynecology, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery. 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
- Urogynecology
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2009
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who underwent DaVinci-assisted laparscopic surgery.
Who may be able to join
- The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008.
Who cannot join
- Any women not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery After Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications of Patients Who Did Not Complete Questionnaires
The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.
- Conditions
- Urogynecology
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.
Measured: 09/01/07 - 09/01/08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrogynecologyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunhilde Buchsbaum, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033786
- Sponsor's protocol ID
- 29966
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2009
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications of Patients Who Did Not Complete Questionnaires
- ClinicalTrials.gov ID
- NCT01033786
- Acronym / sponsor ID
- 29966
- Conditions
- Urogynecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Dec 2009 (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 assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent DaVinci-assisted laparscopic surgery.
Key inclusion criteria (1 listed)
- The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008.
Key exclusion criteria (1 listed)
- Any women not meeting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.
Time frame: 09/01/07 - 09/01/08
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 3 Oct 2024.
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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.
Gunhilde Buchsbaum, MD principal investigator
University of Rochester
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 Urogynecology, run by University of Rochester 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 1 inclusion and 1 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 3 Oct 2024. 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?
To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery. (time frame: 09/01/07 - 09/01/08). 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 3 Oct 2024.