The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860002
Recruitment Status : Unknown
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : March 11, 2009
Last Update Posted : June 8, 2010
Information provided by:
Taipei Veterans General Hospital, Taiwan

Brief 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.

Condition or disease
Uterine Fibroids

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
Study Start Date : January 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2014

Ultramini laparotomy (UMLT) myomectomy (UMLT-M) versus laparoscopic myomectomy (LM)
Laparoscopically aided myomectomy (LAM) versus LM
LAM versus UMLT-M
Mini laparotomy myomectomy (ML-M) versus UMLT-M
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)
LUVO versus LM
LUVO versus LAM

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00860002

Contact: Wen-Hsun Chang, NB 886921125253
Contact: Ling-Wei Yang, MS 886928994443

Peng-Hui Wang Recruiting
201, Section 2, Shih-Pai Road, Taipei, Taipei, Taiwan, 112
Contact: Wen-Hsun Chang, NB    886921125253   
Principal Investigator: Peng-Hui Wang, M.D., Ph.D.         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

Responsible Party: Peng-Hui Wang, M.D., Ph.D., Associate Professor, Department of Obstetrics and Gynecology, Taipei Veterans General Hospital Identifier: NCT00860002     History of Changes
Other Study ID Numbers: VGHIRB-98-01-20A
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2010

Keywords provided by Taipei Veterans General Hospital, Taiwan:
uterine artery occlusion
uterine vessel occlusion
Surgical technique, patient suffering and outcomes

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases