Laparoscopic MyomectomyretromyoNCT00672750
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
An observational study of Laparoscopic Myomectomy, run by The Advanced Gynecologic Surgery Institute at 1 site in United States.
Trial summary
This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. Read more about this study
- Who is it for?
- Ages 16 to 70 years, women only
- Conditions the study is for
- Laparoscopic Myomectomy
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to 16 Sep 2016
- 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 16 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999
Who may be able to join
- All patients who are willing to be surveyed
Who cannot join
- Those patients who are not willing to answer the survey will be excluded
- Those patients who are unable to be contacted( ie; moved) will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540
About this study
This will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.
Read the detailed description
Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.
- Conditions
- Laparoscopic Myomectomy
- Keywords
- laparoscopic, myomectomy, menorrhagia, pelvic pain
- Medical subject headings
- Menorrhagia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I | Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present |
What is being measured
The primary outcome is the main question the study is designed to answer.
That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases
Measured: since 1999
Secondary outcomes (1)
That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time
Measured: since 1999
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2008
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
Why it stopped: did not have resources to continue this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic MyomectomyStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Advanced Gynecologic Surgery Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles E Miller MD, The Advanced Gynecologic Surgery Institute
- Investigators
- Charles E Miller, MD, Principal investigator, Advanced gynecologic surgery institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672750
- Sponsor's protocol ID
- 23597
- Acronym
- retromyo
- Status last verified
- Jan 2017
- First submitted
- 1 May 2008
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
- ClinicalTrials.gov ID
- NCT00672750
- Acronym / sponsor ID
- retromyo / 23597
- Conditions
- Laparoscopic Myomectomy
- Keywords
- laparoscopic, myomectomy, menorrhagia, pelvic pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: did not have resources to continue this study
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Advanced Gynecologic Surgery InstituteUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 6 May 2008 (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 will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. All patients who have had laparoscopic myomectomy will be included. Only those not wishing to take part in the survey will be excluded. The data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.
Detailed description
Patients will be called and surveyed using a survey tool. They will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | –Patients of Dr C Miller who have undergone laparoscopic myomectomy from 1999- to present |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Private patients of Dr Charles Miller who have undergone laparoscopic myomectomy since 1999
Key inclusion criteria (1 listed)
- All patients who are willing to be surveyed
Key exclusion criteria (2 listed)
- Those patients who are not willing to answer the survey will be excluded
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
That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases
Time frame: since 1999
1 secondary outcome
That patients who had menorrhagia prior to laparoscopic myomectomy would see a reduction after surgery 75% of the time
Time frame: since 1999
Results and safety
The study was stopped early (reason given: did not have resources to continue this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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 E Miller, MD principal investigator
Advanced gynecologic surgery institute
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 Laparoscopic Myomectomy, run by The Advanced Gynecologic Surgery Institute 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 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: stopped early, as of the sponsor's last update on 26 Jan 2017. 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 was stopped early (reason given: did not have resources to continue this study). Results are not available in the source record.
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?
That patients who had pain prior to laparoscopic myomectomy will have less pain in 75% of the cases (time frame: since 1999). 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 26 Jan 2017.