| CTRI Number |
CTRI/2024/06/069030 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two procedures, Total Laparoscopic Hysterectomy and Non-descent Vaginal Hysterectomy in patients with benign uterine pathologies |
|
Scientific Title of Study
|
Effectiveness of Total Laparoscopic Hysterectomy versus Non-descent Vaginal Hysterectomy
in women with benign uterine pathologies: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Sonkusare |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9923352565 |
| Fax |
|
| Email |
abhishek9994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Dixit |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9923009576 |
| Fax |
|
| Email |
drprachidivish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Dixit |
| Designation |
Associate Professor Department of Obstetrics and Gynaecology |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9923009576 |
| Fax |
|
| Email |
drprachidivish@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and
Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India- 440019 |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynaecology |
| Address |
NKP Salve Institute of Medical Sciences and Research Centre and
Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur-440019 |
| 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 Abhishek Sonkusare |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Room No. 3, 3rd Floor,
Department of Obstetrics and Gynaecology
Nagpur
MAHARASHTRA |
9923352565
abhishek9994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-Descent Vaginal Hysterectomy |
The points to be noted intraoperatively will be as follows: 1. Intra-operative blood loss (ml) 2. Operating time (in minutes) 3. Post-operative pain by using Visual Analog Scale 4. Complications will be noted |
| Intervention |
Total Laparoscopic Hysterectomy |
The points to be noted intraoperatively will be as follows:
1. Intra-operative blood loss (ml)
2. Operating time (in minutes)
3. Post-operative pain by using Visual Analog Scale
4. Complications will be noted |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosis of benign uterine pathologies.
2. Uterine size not surpassing 16 weeks of gravid uterus size, with sufficient uterine mobility.
3. Those willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Genital neoplasm, cancer, or malignancy
2. Any adnexal pathology
3. Acute pelvic inflammatory disease
4. Uterine prolapse– stage II and above
5. Those who had any medical issues that could have been made worse by pneumoperitoneum or the Trendelenburg position. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quantitative measure of blood loss intra-operatively
2. Post-operative pain using the Visual Analog Scale |
Immediately post-surgery and on day 2 post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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="2"
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
|
Introduction: The ideal hysterectomy procedure should be minimally invasive, have low morbidity, low health care costs, shorten the length of the hospital stay, and improve patient satisfaction. Therefore, the current study’s objective is to assess and compare the clinical results of two alternative hysterectomy approaches namely Total Laparoscopic Hysterectomy (TLH) and Non-Descent Vaginal Hysterectomy (NDVH). Methodology: A total of 132 women with benign uterine pathologies will be randomized by computer-generated randomization and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (study group) will be the patients undergoing TLH and Group B (control group) will be the patients undergoing NDVH. Result: The blood loss in each group will be calculated using a quantitative method of measuring blood loss intraoperatively. The operation time will be noted and the pain at the suture site will be noted immediately post-surgery and on day 2 of the surgery using the Visual Analog Scale. The statistical analysis will include descriptive and inferential analysis to determine the significant difference. Conclusion: The present study will be comparing and concluding the effectiveness of TLH and NDVH in women with benign uterine pathologies. This will explore the outcome of the surgery in terms of recovery, morbidity, and cost-effectiveness. |