CClinicalTrials.gg
Status unknownNCT00860002Updated Jun 8, 2010

The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids

An observational study in Uterine Fibroids, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,200
Ages
20 Years to 60 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Uterine Fibroids

Keywords

  • myomectomy
  • uterine artery occlusion
  • uterine vessel occlusion
  • fibroids
  • leiomyomas
  • Surgical technique, patient suffering and outcomes
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 150 across 119 observational studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • without pathological diagnosis of myoma if the specimen can be obtained; OR
  • any violation the above-mentioned criteria.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,200 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Peng-Hui Wang
    201, Section 2, Shih-Pai Road, Taipei, Taipei 112, Taiwan
    • Wen-Hsun Chang, NB · Contact · whchang@vghtpe.gov.tw · 886921125253
    • Peng-Hui Wang, M.D., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00860002
Lead sponsor
Taipei Veterans General Hospital, Taiwan
First posted
Mar 11, 2009
Start date
Jan 2009
Primary completion
Dec 2010 (estimated)
Completion
Dec 2014 (estimated)
Last update
Jun 8, 2010

Study contacts

Wen-Hsun Chang, NB
Contact
whchang@vghtpe.gov.tw
886921125253
Ling-Wei Yang, MS
Contact
sammy680106@hotmail.com
886928994443

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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