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ISRCTN
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ISRCTN76790866
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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UTAC trial
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Serial number at source
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SNUHOBGY001
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Study hypothesis
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Laparoscopic Uterine Artery Clipping (LUAC) may be an alternative treatment for the improvement of postoperative Quality Of Life (QOL) in patients with symptomatic uterine fibroids, compared with Laparoscopy-Assisted Vaginal Hysterectomy (LAVH).
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Ethics approval
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The ethical committee of Seoul National University College of Medicine and Seoul National University Hospital approved the protocol for this study on the 9th May 2007 (IRB no.: H-0704-032-205).
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Study design
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Randomised controlled study
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Countries of recruitment
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South Korea
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Disease/condition/study domain
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Uterine fibroids
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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 QOL
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Anticipated start date
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01/05/2007
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Anticipated end date
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30/06/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Group 1 (LUAC): 30 patients; Group 2 (LAVH): 30 patients
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Interventions
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Group 1: treated with Laparoscopic Uterine Artery Clipping (LUAC)
Group 2: treated with Laparoscopy-Assisted Vaginal Hysterectomy (LAVH)
After both treatments, we will follow up the enrolled patients in this trial during one year. We will compare preoperative and postoperative (after one year) QOLs between two groups.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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
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.
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Sources of funding
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Seoul National University (South Korea) - College of Medicine, Department of Obstetrics and Gynaecology
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Trial website
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19178748
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Contact name
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Prof
Jae Weon
Kim
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Address
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Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul National University
28 Yungun-Dong
Chongno-Gu
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City/town
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Seoul
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Zip/Postcode
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110-744
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Country
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Korea, South
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Sponsor
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Seoul National University (South Korea)
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Address
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c/o Kim Jae Weon
Department of Obstetrics and Gynaecology and Cancer Research Institute
28 Yungun-Dong
Chongno-Gu
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City/town
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Seoul
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Zip/Postcode
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110-744
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Country
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Korea, South
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Sponsor website:
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http://www.snu.ac.kr/
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Date applied
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29/05/2007
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Last edited
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20/07/2009
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Date ISRCTN assigned
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25/06/2007
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