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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Wen-Hsun Chang, NB contact

886921125253

whchang@vghtpe.gov.tw

Ling-Wei Yang, MS contact

886928994443

sammy680106@hotmail.com

Taiwan1 site, 1 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.

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT00860002
Study groupRoleWhat they receive
1Ultramini laparotomy (UMLT) myomectomy (UMLT-M) versus laparoscopic myomectomy (LM)
2Laparoscopically aided myomectomy (LAM) versus LM
3LAM versus UMLT-M
4Mini laparotomy myomectomy (ML-M) versus UMLT-M
5Laparoscopic 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)
6LUVO+LAM versus LUAO+LAM
7LUVO+LM versus LUAO+LM
8LUVO+UMLT-M versus LUAO+UMLT-M
9LUVO versus UMLT-UVO
10UMLT-UVO versus UMLT-UAO
11LUAO versus UMLT-UAO
12UMLT-UVO+UMLT-M versus UMLT-UAO+UMLT-M
13LUVO versus LM
14LUVO versus LAM
15LUVO versus LUAO+LM
16LUVO versus LUAO+UMLT-M
17LUVO versus LUAO+LAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted11 Mar 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

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)
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

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.

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