The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT00860002

Collaborator

(none)

1,200

Enrollment

Location

Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Uterine Fibroids

Study Design

Study Type:

Observational

Anticipated 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 :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Surgical technique, patient suffering, and outcomes (symptom control, relapse of symptoms, re-intervention, regularity of menstrual cycles and pregnancy outcome) in both groups. [2-years and 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.