Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SNUHOBGY001
Study information
Scientific title
Acronym
UTAC trial
Study hypothesis
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).
Ethics approval
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).
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Uterine fibroids
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
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.
Overall trial start date
01/05/2007
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Group 1 (LUAC): 30 patients; Group 2 (LAVH): 30 patients
Participant 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 QOL
Recruitment start date
01/05/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul
110-744
Korea, South
Sponsor information
Organisation
Seoul National University (South Korea)
Sponsor details
c/o Kim Jae Weon
Department of Obstetrics and Gynaecology and Cancer Research Institute
28 Yungun-Dong
Chongno-Gu
Seoul
110-744
Korea
South
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Seoul National University (South Korea) - College of Medicine, Department of Obstetrics and Gynaecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19178748
Publication citations
-
Protocol
Kim HS, Kim JW, Kim MK, Chung HH, Lee TS, Jeon YT, Kim YB, Jeon HW, Yun YH, Park NH, Song YS, Kang SB, A randomized prospective trial of the postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids: clinical trial design., Trials, 2009, 10, 8, doi: 10.1186/1745-6215-10-8.