Condition category
Urological and Genital Diseases
Date applied
29/05/2007
Date assigned
25/06/2007
Last edited
20/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jae Weon Kim

ORCID ID

Contact details

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

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 measures

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

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

http://www.snu.ac.kr/

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

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19178748

Publication citations

  1. 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.

Additional files

Editorial Notes