A randomised study of the postoperative quality of life: laparoscopic UTerine Artery Clipping versus laparoscopy-assisted vaginal hysterectomy for the management of symptomatic uterine fibroids

Completed

Conditions: terine fibroids
Urological and Genital Diseases
Other noninflammatory disorders of uterus, except cervix

Registration Number: ISRCTN76790866

Lead Sponsor: Seoul National University (South Korea)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1. Aged greater than or equal to 40 years old
2. Patients who do not want conception any more
3. Patients who agree to this study with informed consent
4. More than 2 cm sized uterine fibroids on Ultrasonography (USG)
5. Uterine fibroids with symptoms such as menorrhagia, dysmenorrhoea, lower abdominal discomfort or pain, lower back pain, urologic problems (dysuria, frequency, etc.,)
6. Patients without underlying disease affecting QOL
7. At least six months interval after last medication, if patients have been treated with Gonadotropin-Releasing Hormone (GnRH) agonists

Exclusion Criteria

1. Aged less than 40 years old
2. Patients with subserosal pedunculated fibroid
3. Pregnant women
4. Patients with pelvic inflammatory disease developed within one month
5. Patients with contraindication of surgical treatment
6. Patients with previous history of myomectomy, hysterectomy, myolysis, uterine artery embolisation
7. Less than six months interval after last medication, if patients have been treated with GnRH agonist
8. Patients with underlying disease affecting QO

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative quality of life until one year after surgical treatment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) version 3.0.

Secondary Outcome Measures

Name	Time	Method
1. Volume reduction of uterus, ovary, and fibroids in Group 1: Volume (cm^3) = length (cm) X width (cm) X depth (cm) X 0.5233, measured every three months till one year<br>2. Improvement of subjective symptoms in both groups: 11 point symptom score, ranging from -5 (markedly worse) to +5 (markedly better), checked after one year postoperatively<br>3. Evaluation of postoperative menorrhagia in Group 1: using a simple visual assessment technique, measured monthly using the recording sheet including simple visual assessment technique by herself. After one year postoperatively, we will collect the recording sheets from the patients and analyze the data.