Fibroid UterusNCT00910468
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
An observational study of Fibroid Uterus, run by Ascher-Walsh, Charles, M.D. at 1 site in United States.
Trial summary
This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroid Uterus
- What is being tested?
- Robot-assisted Laparoscopic myomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2008
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with fibroid uterus desiring surgical management
Who may be able to join
- uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.
Who cannot join
- significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount SInai School of Medicine
New York, New York, 10029
About this study
This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables
- Conditions
- Fibroid Uterus
- Being tested
- Robot-assisted Laparoscopic myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted Laparoscopic myomectomyProcedure or surgery
Robot-assisted Laparoscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Laparoscopic Myomectomy | Not described Receives: Procedure: Robot-assisted Laparoscopic myomectomy | |
| Myomectomy via Laparotomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJul 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascher-Walsh, Charles, M.D.
- Investigators
- Charles Ascher-Walsh, MD, MPH, Principal investigator, Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910468
- Sponsor's protocol ID
- HSD08-00631
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
- ClinicalTrials.gov ID
- NCT00910468
- Acronym / sponsor ID
- HSD08-00631
- Conditions
- Fibroid Uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ascher-Walsh, Charles, M.D.
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 May 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.
This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Laparoscopic Myomectomy | – | Procedure: Robot-assisted Laparoscopic myomectomy |
| Myomectomy via Laparotomy | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with fibroid uterus desiring surgical management
Key inclusion criteria (1 listed)
- uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.
Key exclusion criteria (1 listed)
- significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.
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 |
|---|---|---|
| Robot-assisted Laparoscopic myomectomyRobot-assisted Laparoscopic myomectomy | Procedure or surgery | Robot Assisted Laparoscopic Myomectomy |
Primary outcome
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
Time frame: 1 day
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 29 May 2009.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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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.
Charles Ascher-Walsh, MD, MPH principal investigator
Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
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 Fibroid Uterus, run by Ascher-Walsh, Charles, M.D. 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 29 May 2009. 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?
Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity (time frame: 1 day). 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 29 May 2009.