| CTRI Number |
CTRI/2017/11/010501 [Registered on: 15/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing catheter mediated uterine vessel occlusion with uterine removal by surgery for treatment of uterine fibroids |
|
Scientific Title of Study
|
A Pilot study comparing efficacy of Uterine artery embolisation vs hysterectomy in patients with symptomatic uterine fibroids. |
| Trial Acronym |
UAE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Shivanand R Gamanagatti |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.81-B, Department of Radiodiagnosis, near RAK OPD
All India Institute of medical sciences,
Ansari Nagar, New Delhi-29 Room no.52, department of radiology, JPN Apex trauma centre, New Delhi South DELHI 110029 India |
| Phone |
01126594567 |
| Fax |
|
| Email |
Shiv223@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Shivanand R Gamanagatti |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.81-B, Department of Radiodiagnosis, near RAK OPD
All India Institute of medical sciences,
Ansari Nagar, New Delhi-29 Room no.52, department of radiology, JPN Apex trauma centre, New Delhi South DELHI 110029 India |
| Phone |
01126594567 |
| Fax |
|
| Email |
Shiv223@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Shivanand R Gamanagatti |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.81-B, Department of Radiodiagnosis, near RAK OPD
All India Institute of medical sciences,
Ansari Nagar, New Delhi-29 Room no.52, department of radiology, JPN Apex trauma centre, New Delhi South DELHI 110029 India |
| Phone |
01126594567 |
| Fax |
|
| Email |
Shiv223@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Scences
Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Radiodiagnosis |
| Address |
Department of Radiodiagnosis, Near RAK OPD, All India Institute of Medical Sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Shivanand R Gamanagatti |
All India Institute of Medical Sciences |
Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi. South DELHI |
01126594567
shiv223@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients presenting with menorrhagia(PBAC score 100) and pelvic pain, pressure symptoms attributable to uterine fibroids., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hysterectomy |
Patients who have completed their family and have severe symptoms attributable to uterine fibroids not controlled on medical management will undergo hysterectomy if they dont want to preserve their uterus. |
| Intervention |
Uterine artery embolisation |
Endovascular catheter uterine artery embolisation will be done using particulate material like poly vinyl alcohol(PVA) to reduce the vascular supply and cause infarction of uterine fibroids to control symptoms. It will be done in patients who have completed their family and want to preserve their uterus. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Menstruating women with symptomatic uterine fibroids who have completed their family
Uterus size≤ 24 weeks on bimanual examination. Ultrasonography suggestive ofat least one uterine myoma of ≥ 3 cm diameter in size
|
|
| ExclusionCriteria |
| Details |
1.Uterine size > 24 weeks on clinical examination.
2. Any single myoma size > 12 cm on ultrasonography. Patients can also be taken up for UAE post trial of GnRH agonists if the fibroid 3. size at presentation is more than 12 cm at initial presentation
4.Active pelvic infection or pregnancy
5.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia.
6. Known case of uncontrolled coagulation disorder, renal insufficiency, severe contrast allergy
7. Large uterine polyp (>2 cm), Submucosal fibroid (class 0 & 1 under myoma sub-classification system)
8. Large subserosal fibroids with narrow stalk
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fibroid size as assessed by USG or MRI
Uterine fibroid Quality of life assessment score
|
6 months after treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief of symptoms like pain, pressure symptoms and menorrhagia
Percentage necrosis of myoma on post embolization MRI |
Relief of symptoms in 6 months
Percentage necrosis on post embolisation MRI in 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Project will be started in next 15 days. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Uterine myomas are benign uterine neoplasms that arise from the smooth muscle of uterus. They constitute the most common benign gynecological tumors affecting 20-50% of women of reproductive age group, thirty percent of these presenting with menstrual abnormality and menorrhagia being most common (1). Other presenting symptoms include pelvic pain (34%), infertility (27%) and pelvic mass (9%) (1). Occasionally they are associated with bladder and bowel pressure symptoms. Uterine fibroids may occur singly but most often are multiple and vary in size from an unnoticeable few millimetres to over 20 cm in diameter, significantly enlarging the abdominal cavity. They are named according to their location. Intramural fibroids lie wholly within the uterine walls, submucosal fibroids project into the uterine cavity and subserosal fibroids project from the outer surface of the uterus. They may also be pedunculated, where they are attached to the uterine wall by a stalk-like structure. Most of the myomas are asymptomatic and does not require treatment until symptomatic or causing infertility. The management of symptomatic fibroids has traditionally been surgical; however, alternative pharmacological treatments have been proposed to control symptoms. The choice of appropriate therapeutic approach depends on several factors including: age, parity, childbearing aspirations, extent and severity of symptoms, size, number, location of myomas, proximity to menopause. Ravina et al (2) first reported transcatheter embolization of the uterine arteries for treatment of uterine leiomyomata in 1995. The safety and efficacy of the procedure have been extensively studied, and UFE is now accepted as a treatment option for fibroids by the American Congress of Obstetricians and Gynecologists (3). UFE has been shown to reduce pain, bulk symptoms (pressure and abdominal wall distortion), and menorrhagia in most cases (4). Although hysterectomy has long been considered the definitive treatment for symptomatic fibroids and remains the most common intervention for fibroids, there is growing interest in less invasive therapies and treatments that avoid removal of the uterus, including medical management, abdominal or laparoscopic myomectomy, endometrial ablation, focused US, and UFE (5). Uterine embolization has emerged as one of the most important of these uterine-sparing options. Uterine artery embolization (UAE) involves complete occlusion of either one or both uterine arteries with particulate emboli to cause ischaemic necrosis of the uterine fibroids. The closure of the arteries is considered permanent, thereby blocking blood supply to the fibroid but without any permanent adverse effect on the otherwise normal uterus. Since there are studies that Uterine artery embolization may cause a reduction in the reproductive potential of women as compared to a laparoscopic myomectomy and also it might predispose nulliparous women to placental abnormalities, we plan to use it only for women who have completed their family and seek treatment for bleeding, pain and pressure symptoms. Given its minimally invasive nature, established favorable cost profile, and associated rapid recovery and return to work, UAE should be considered a front-line therapy for leiomyomata and should therefore be presented to all patients as an option for symptomatic leiomyomas. With this background, we plan to study the therapeutic effect of uterine artery embolization for treating symptomatic fibroids. |