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
DOI	https://doi.org/10.1186/ISRCTN76790866
Protocol serial number	SNUHOBGY001
Sponsor	Seoul National University (South Korea)
Funder	Seoul National University (South Korea) - College of Medicine, Department of Obstetrics and Gynaecology

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

Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul National University
28 Yungun-Dong
Chongno-Gu
Seoul
110-744
Korea, South

Study information

Primary study design	Interventional
Study design	Randomised controlled study
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	60
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/01/2009		Yes	No