| CTRI Number |
CTRI/2024/05/066828 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of treatment efficacy for
modern surgery and conservative management in hemorrhoids patients |
|
Scientific Title of Study
|
Evaluation and comparison of the impact of modern surgery and conservative Mangement in hemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Tenpe |
| Designation |
post graduation in clinical Research |
| Affiliation |
Datta Meghe institute of higher education and research Sawangi Meghe Wardha |
| Address |
Dep of shalya-tantra (surgery), Mahtama Gandhi Aryudic Collage Hospital, Sawangi Meghe, Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8177859649 |
| Fax |
|
| Email |
shreyadiya06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devyani Dasar |
| Designation |
Associate Professor dep of Shalya Tantra surgery MGACH RC |
| Affiliation |
Datta Meghe institute of higher education and research Sawangi Meghe Wardha |
| Address |
Dep of shalya-tantra (surgery), Mahtama Gandhi Aryudic Collage Hospital, Sawangi Meghe, Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyani06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Tenpe |
| Designation |
post graduation in clinical Research |
| Affiliation |
Datta Meghe institute of higher education and research Sawangi Meghe Wardha |
| Address |
Dep of clinical research Datta Meghe institute of higher education and research Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8177859649 |
| Fax |
|
| Email |
shreyadiya06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Resaerch |
| Address |
Dept of Clinical research Datta Meghe Institute of Higher Education and Research Sawangi |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| no |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devyani Dasar |
Mahtama gandhi aryudic collage hospital |
Department of Shalya-Tantra (surgery) MGACH and RC
Wardha
MAHARASHTRA |
9503630392
shreyadiya06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are below 45 years
Patients who are willing to do the surgery
Patients who are ready to take the dietry regimen as well as conservative management |
|
| ExclusionCriteria |
| Details |
The age of the patient above 45 years of age
Patients who are not willing to do the surgery
patients who are not willing to follow the dietry regimen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding,Itching and Irritation ,Pain, Discomfort, Swelling and Limphs Soiling |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/06/2024 |
| 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="6"
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
|
This study aimed to evaluate the efficacy of surgical and conservative management approaches for the treatment of hemorrhoids.After giving a proper surgical plan and conservative management for the correct care of the patients for the treatment of hemorrhoids, as well as a dietary plan following the surgical treatments.study population will be gathered from the population fitting in our inclusion and exclusion criteria. Purpose will be to assess blood loss, controlling symptoms and recurrence rates, reducing discomfort during and after surgery, and cutting down on operating times.
|