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
ISRCTN | ISRCTN76790866 |
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DOI | https://doi.org/10.1186/ISRCTN76790866 |
Secondary identifying numbers | SNUHOBGY001 |
- Submission date
- 29/05/2007
- Registration date
- 25/06/2007
- Last edited
- 20/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jae Weon Kim
Scientific
Scientific
Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul National University
28 Yungun-Dong
Chongno-Gu
Seoul
110-744
Korea, South
Study information
Study design | Randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | |
Study acronym | UTAC trial |
Study objectives | 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(s) | 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). |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/05/2007 |
Completion date | 30/06/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | Group 1 (LUAC): 30 patients; Group 2 (LAVH): 30 patients |
Key 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 |
Key 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 |
Date of first enrolment | 01/05/2007 |
Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul
110-744
Korea, South
110-744
Korea, South
Sponsor information
Seoul National University (South Korea)
University/education
University/education
c/o Kim Jae Weon
Department of Obstetrics and Gynaecology and Cancer Research Institute
28 Yungun-Dong
Chongno-Gu
Seoul
110-744
Korea, South
Website | http://www.snu.ac.kr/ |
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https://ror.org/04h9pn542 |
Funders
Funder type
University/education
Seoul National University (South Korea) - College of Medicine, Department of Obstetrics and Gynaecology
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 29/01/2009 | Yes | No |