Uterine FibroidsNCT00860002
The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
An observational study of Uterine Fibroids, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms directly attributable to these benign tumors represent the most common reason for laparotomy in non-pregnant women in the United… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Uterine Fibroids
- How many people
- 1,200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2014
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 2009 and 2014 booked for treatment who had symptomatic uterine myomas, will be included in the present study. All the treatments for symptomatic uterine myomas, including medical treatment with different kinds of medication, and uterine-sparing surgery including myomectomy, which is performed through traditional exploratory laparotomy (LT), mini-laparotomy (MLT), ultramini-laparotomy (UMLT), laparoscopy (L), the vagina (V) or hysteroscopy (H), and LUVO and combination therapy, and the definite treatment of hysterectomy, through different routes, such as vagina, laparoscopic assistance, and convention exploratory laparotomy. All patients should have uterine fibroids with symptoms, comprising either menstrual problems such as menorrhagia and pain, or compression syndrome, including a bulge-like sensation and frequency. These women will be informed that they can choose to be treated with any one of the above-mentioned procedures, based on their willingness and preference.
Who may be able to join
- symptomatic;
- having a wish to retain their uterus;
- an absence of previous abdominal or pelvic surgery;
- a number of visible uterine masses (myomas) less than or equal to 5 intramural or sub-serous myomas (without peduncle);
- a maximum diameter of no more than 8 cm;
- an absence of prominent or significant pelvic adhesion on clinical evaluation; AND
- at least a 2-year thorough follow-up record available.
Who cannot join
- without pathological diagnosis of myoma if the specimen can be obtained; OR
- any violation the above-mentioned criteria.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Peng-Hui Wang
201, Section 2, Shih-Pai Road, Taipei, Taipei, 112
Wen-Hsun Chang, NB, 886921125253, whchang@vghtpe.gov.tw
Peng-Hui Wang, M.D., Ph.D.
About this study
Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms directly attributable to these benign tumors represent the most common reason for laparotomy in non-pregnant women in the United States (3,4), and also in Taiwan (5). Whereas in decades past, hysterectomy was seen almost as a panacea for uterine leiomyomas, more recently attention has been paid to the development of pharmaceutical agents and less-invasive procedures (6). Frequently, such procedures are designed to retain the uterus (6). Of these, myomectomy may be a choice among the uterine-sparing treatments for symptomatic uterine myoma (7,8).
The surgical mode of access usually employed in myomectomy is traditional exploratory laparotomy or its modification-mini-laparotomy (MLT) (9) or ultra-mini laparotomy (UMLT) (10,11), though recently, laparoscopy (12-14) or a combination of laparoscopy and MLT (9), vaginal surgery (15), and hysteroscopic myomectomy (16-21) have represented valid alternatives. However, myomectomy alone provides varying degrees of symptom control and a high percentage of recurrence, not only for the tumors themselves, but also for the symptoms. For example, one study reported that symptom resolution varied from 84.0% to 100% depending on different items and 21 (19.4%) of 108 patients experienced a recurrence after an average interval of 16 months (range, 1.8-47.4 months) (22). Therefore, an alternative or additional therapy might be required to provide longer durable symptom control and minimize tumor recurrence. One of the strategies is laparoscopic uterine vessel occlusion (LUVO), also known as laparoscopic uterine artery occlusion (LUAO) (23,24).
Read more
The rationale for using LUVO in the management of symptomatic myomas is found in the successful experience with uterine-artery embolization (UAE), which was introduced in 1995 as an alternative technique for treating fibroids (25). Since then it has become increasingly accepted as a minimally invasive, uterine-sparing procedure, and studies have reported the relief of excessive menstrual bleeding or pressure in 80-90% of patients (26-32). LUVO provided similar relief of symptoms (89.4% with symptomatic improvement and 21.2% with complete resolution of symptoms) in 2001 in a 7- to 12-month follow-up of 87 patients after LUVO (33).
Since that time there has been rapid growth in the use of this treatment with various modifications, such as simultaneous accompaniment with myomectomy either through laparoscopy or ML, and there has been considerable research into its outcome (22,34-42). However, in our previous data, we found that a combination of LUVO and myomectomy provided definite effectiveness in symptom control for these women with symptomatic uterine myomas (98.1% to 100% symptom resolution depending on various kinds of items), minimized tumor recurrence, and rendered the vast majority of re-interventions unnecessary (22). Myomectomy can be performed by the laparoscopic approach or by ML when patients are undergoing the LUVO procedure. Before 2002, we often used ML to perform myomectomy (22). However, we have shortened the incision to less than 4 cm, creating ultramini-laparotomy (UMLT) to perform myomectomy (10,11,43).
Since many conservative therapies might provide less or more therapeutic effects on the symptom control and disease status, the aim of this prospective study tries to evaluate the therapeutic outcomes of these symptomatic uterine myomas after different kinds of therapies in the coming 5 years at Taipei Veterans General Hospital.
- Conditions
- Uterine Fibroids
- Keywords
- myomectomy, uterine artery occlusion, uterine vessel occlusion, fibroids, leiomyomas, Surgical technique, patient suffering and outcomes
- Medical subject headings
- Leiomyoma
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 |
|---|---|---|
| 1 | Ultramini laparotomy (UMLT) myomectomy (UMLT-M) versus laparoscopic myomectomy (LM) | |
| 2 | Laparoscopically aided myomectomy (LAM) versus LM | |
| 3 | LAM versus UMLT-M | |
| 4 | Mini laparotomy myomectomy (ML-M) versus UMLT-M | |
| 5 | Laparoscopic uterine artery occlusion with blockage of anastomosis between the uterine and ovarian vessels (LUVO) versus laparoscopic uterine artery occlusion without blockage of anastomosis between the uterine and ovarian vessels (LUAO) | |
| 6 | LUVO+LAM versus LUAO+LAM | |
| 7 | LUVO+LM versus LUAO+LM | |
| 8 | LUVO+UMLT-M versus LUAO+UMLT-M | |
| 9 | LUVO versus UMLT-UVO | |
| 10 | UMLT-UVO versus UMLT-UAO | |
| 11 | LUAO versus UMLT-UAO | |
| 12 | UMLT-UVO+UMLT-M versus UMLT-UAO+UMLT-M | |
| 13 | LUVO versus LM | |
| 14 | LUVO versus LAM | |
| 15 | LUVO versus LUAO+LM | |
| 16 | LUVO versus LUAO+UMLT-M | |
| 17 | LUVO versus LUAO+LAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical technique, patient suffering, and outcomes (symptom control, relapse of symptoms, re-intervention, regularity of menstrual cycles and pregnancy outcome) in both groups.
Measured: 2-years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860002
- Sponsor's protocol ID
- VGHIRB-98-01-20A
- Status last verified
- Jun 2010
- First submitted
- 10 Mar 2009
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00860002
- Acronym / sponsor ID
- VGHIRB-98-01-20A
- Conditions
- Uterine Fibroids
- Keywords
- myomectomy, uterine artery occlusion, uterine vessel occlusion, fibroids, leiomyomas, Surgical technique, patient suffering and outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Mar 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.
Uterine leiomyomas (i.e., fibroids, myomas) are the most common gynecologic tumors in women of reproductive age (1). Clearly, the majority of such lesions are asymptomatic (2). Symptoms directly attributable to these benign tumors represent the most common reason for laparotomy in non-pregnant women in the United States (3,4), and also in Taiwan (5). Whereas in decades past, hysterectomy was seen almost as a panacea for uterine leiomyomas, more recently attention has been paid to the development of pharmaceutical agents and less-invasive procedures (6). Frequently, such procedures are designed to retain the uterus (6). Of these, myomectomy may be a choice among the uterine-sparing treatments for symptomatic uterine myoma (7,8).
The surgical mode of access usually employed in myomectomy is traditional exploratory laparotomy or its modification-mini-laparotomy (MLT) (9) or ultra-mini laparotomy (UMLT) (10,11), though recently, laparoscopy (12-14) or a combination of laparoscopy and MLT (9), vaginal surgery (15), and hysteroscopic myomectomy (16-21) have represented valid alternatives. However, myomectomy alone provides varying degrees of symptom control and a high percentage of recurrence, not only for the tumors themselves, but also for the symptoms. For example, one study reported that symptom resolution varied from 84.0% to 100% depending on different items and 21 (19.4%) of 108 patients experienced a recurrence after an average interval of 16 months (range, 1.8-47.4 months) (22). Therefore, an alternative or additional therapy might be required to provide longer durable symptom control and minimize tumor recurrence. One of the strategies is laparoscopic uterine vessel occlusion (LUVO), also known as laparoscopic uterine artery occlusion (LUAO) (23,24).
The rationale for using LUVO in the management of symptomatic myomas is found in the successful experience with uterine-artery embolization (UAE), which was introduced in 1995 as an alternative technique for treating fibroids (25). Since then it has become increasingly accepted as a minimally invasive, uterine-sparing procedure, and studies have reported the relief of excessive menstrual bleeding or pressure in 80-90% of patients (26-32). LUVO provided similar relief of symptoms (89.4% with symptomatic improvement and 21.2% with complete resolution of symptoms) in 2001 in a 7- to 12-month follow-up of 87 patients after LUVO (33).
Since that time there has been rapid growth in the use of this treatment with various modifications, such as simultaneous accompaniment with myomectomy either through laparoscopy or ML, and there has been considerable research into its outcome (22,34-42). However, in our previous data, we found that a combination of LUVO and myomectomy provided definite effectiveness in symptom control for these women with symptomatic uterine myomas (98.1% to 100% symptom resolution depending on various kinds of items), minimized tumor recurrence, and rendered the vast majority of re-interventions unnecessary (22). Myomectomy can be performed by the laparoscopic approach or by ML when patients are undergoing the LUVO procedure. Before 2002, we often used ML to perform myomectomy (22). However, we have shortened the incision to less than 4 cm, creating ultramini-laparotomy (UMLT) to perform myomectomy (10,11,43).
Since many conservative therapies might provide less or more therapeutic effects on the symptom control and disease status, the aim of this prospective study tries to evaluate the therapeutic outcomes of these symptomatic uterine myomas after different kinds of therapies in the coming 5 years at Taipei Veterans General Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Ultramini laparotomy (UMLT) myomectomy (UMLT-M) versus laparoscopic myomectomy (LM) |
| 2 | – | –Laparoscopically aided myomectomy (LAM) versus LM |
| 3 | – | –LAM versus UMLT-M |
| 4 | – | –Mini laparotomy myomectomy (ML-M) versus UMLT-M |
| 5 | – | –Laparoscopic uterine artery occlusion with blockage of anastomosis between the uterine and ovarian vessels (LUVO) versus laparoscopic uterine artery occlusion without blockage of anastomosis between the uterine and ovarian vessels (LUAO) |
| 6 | – | –LUVO+LAM versus LUAO+LAM |
| 7 | – | –LUVO+LM versus LUAO+LM |
| 8 | – | –LUVO+UMLT-M versus LUAO+UMLT-M |
| 9 | – | –LUVO versus UMLT-UVO |
| 10 | – | –UMLT-UVO versus UMLT-UAO |
| 11 | – | –LUAO versus UMLT-UAO |
| 12 | – | –UMLT-UVO+UMLT-M versus UMLT-UAO+UMLT-M |
| 13 | – | –LUVO versus LM |
| 14 | – | –LUVO versus LAM |
| 15 | – | –LUVO versus LUAO+LM |
| 16 | – | –LUVO versus LUAO+UMLT-M |
| 17 | – | –LUVO versus LUAO+LAM |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 2009 and 2014 booked for treatment who had symptomatic uterine myomas, will be included in the present study. All the treatments for symptomatic uterine myomas, including medical treatment with different kinds of medication, and uterine-sparing surgery including myomectomy, which is performed through traditional exploratory laparotomy (LT), mini-laparotomy (MLT), ultramini-laparotomy (UMLT), laparoscopy (L), the vagina (V) or hysteroscopy (H), and LUVO and combination therapy, and the definite treatment of hysterectomy, through different routes, such as vagina, laparoscopic assistance, and convention exploratory laparotomy. All patients should have uterine fibroids with symptoms, comprising either menstrual problems such as menorrhagia and pain, or compression syndrome, including a bulge-like sensation and frequency. These women will be informed that they can choose to be treated with any one of the above-mentioned procedures, based on their willingness and preference.
Key inclusion criteria (7 listed)
- symptomatic;
- having a wish to retain their uterus;
- an absence of previous abdominal or pelvic surgery;
- a number of visible uterine masses (myomas) less than or equal to 5 intramural or sub-serous myomas (without peduncle);
- a maximum diameter of no more than 8 cm;
Key exclusion criteria (2 listed)
- without pathological diagnosis of myoma if the specimen can be obtained; OR
- any violation the above-mentioned 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
Surgical technique, patient suffering, and outcomes (symptom control, relapse of symptoms, re-intervention, regularity of menstrual cycles and pregnancy outcome) in both groups.
Time frame: 2-years and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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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.
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 Uterine Fibroids, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 8 Jun 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Hsun Chang, NB (886921125253, whchang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical technique, patient suffering, and outcomes (symptom control, relapse of symptoms, re-intervention, regularity of menstrual cycles and pregnancy outcome) in both groups. (time frame: 2-years and 5 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 8 Jun 2010.