| CTRI Number |
CTRI/2024/06/068335 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessing the benefit of combining endometrial ablation and mirena and endometrial ablation only for heavy menstrual bleeding
|
|
Scientific Title of Study
|
Assessing the efficacy of combining Transcervical resection of the endometrium and Levonorgestrel intrauterine system treatment for abnormal uterine bleeding |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrutika Satish Khapre |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology Ground floor Acharya Vinoba Bhave Rural Hospital Sawangi Meghe Wardha
Sawangi Meghe Wardha Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9075671355 |
| Fax |
|
| Email |
shrutika.khapre.15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neema Acharya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology Ground floor Acharya Vinoba Bhave Rural Hospital Sawangi Meghe Wardha
Sawangi Meghe Wardha Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9326692511 |
| Fax |
|
| Email |
neemasacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neema Acharya |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology Ground floor Acharya Vinoba Bhave Rural Hospital Sawangi Meghe Wardha
Sawangi Meghe Wardha Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9326692511 |
| Fax |
|
| Email |
neemasacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research |
| Address |
Sawangi Meghe Wardha Maharashtra 442004 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Shrutika Khapre |
Acharya Vinoba Bhave Rural Hospital |
Department of Obstetrics and Gynaecology Ground floor Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha Maharashtra 442004
Wardha
MAHARASHTRA |
9075671355
shrutika.khapre.15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, (2) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transcervical Resection Of The Endometrium |
Transcervical Resection Of The Endometrium will be done with a hysteroscopic resectoscope |
| Intervention |
Transcervical Resection Of The Endometrium and Levonorgestrel Intrauterine System |
Transcervical Resection Of The Endometrium will be done with a hysteroscopic resectoscope. Levonorgestrel Intrauterine System will be introduced into the uterine cavity after endometrial resection. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women having the following symptoms were considered for inclusion:
1. Menorrhagia
2. Metrorrhagia
3. Menometrorrhagia
4. Dysmenorrhea defined as cyclic pelvic pain related to menstruation
|
|
| ExclusionCriteria |
| Details |
1. Any evidence of malignancy or hyperplasia
2. Known underlying coagulopathy
3. Postmenopausal Bleeding
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in the menstrual bleeding pattern in patients with abnormal uterine bleeding with dysmenorrhea and without dysmenorrhea
2. Improvement in dysmenorrhea in patients with abnormal uterine bleeding |
The first follow up will be at one month, and the second follow up will be three months after the initial surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abnormal uterine bleeding (AUB) occurs in approximately 10%-35% of women and is commonly associated with restriction of daily activity and a substantial effect on quality of life. Transcervical resection of the endometrium (TCRE) is minimally invasive, as it preserves the uterus, is associated with fewer complications, and is safer compared with hysterectomy. TCRE is widely acknowledged as the first-line surgical treatment of AUB but has a high failure rate. Studies have shown failure rates of between 21% and 36% with Levonorgestrel Intrauterine System (LNG-IUS) as a monotherapy treatment for AUB. Women with AUB may benefit from adding LNG-IUS to TCRE. The aim of this study is to assess the effectiveness of combination treatment with TCRE + LNG-IUS compared with TCRE alone in patients with AUB with/without dysmenorrhea. TCRE will be done with a hysteroscopic resectoscope. The first follow-up time will be one month, and the second follow-up will be three months after their initial surgery. During the follow-up period, patients will be questioned about their menstrual bleeding pattern and dysmenorrhea. Expected outcome - Combined TCRE and LNG-IUS will be superior to either treatment alone. |