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
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

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 designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study acronymUTAC trial
Study objectivesLaparoscopic 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) studiedUterine fibroids
InterventionGroup 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 typeOther
Primary outcome measurePostoperative 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 measures1. 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 date01/05/2007
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsGroup 1 (LUAC): 30 patients; Group 2 (LAVH): 30 patients
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2007
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Obstetrics and Gynecology and Cancer Research Institute
Seoul
110-744
Korea, South

Sponsor information

Seoul National University (South Korea)
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/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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