| CTRI Number |
CTRI/2025/07/091873 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING EFFICACY OF POLIDOCANOL FOAM SCLEROTHERAPY AND RUBBER BAND LIGATION FOR THE TREATMENT OF GRADE 1 GRADE 2 AND EARLY GRADE 3 INTERNAL HEMORRHOIDS |
|
Scientific Title of Study
|
RANDOMISED CONTROL TRAIL COMPARING EFFICACY OF POLIDOCANOL FOAM SCLEROTHERAPY AND RUBBER BAND LIGATION FOR THE TREATMENT OF GRADE 1 GRADE 2 AND EARLY GRADE 3 INTERNAL 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 |
Dr Jitendra Kumar |
| Designation |
Specialist grade 1 and H.O.D. Department of surgery |
| Affiliation |
Dr Babasaheb Ambedkar medical college and hospital |
| Address |
Unit 1 SOPD Room no. 1131 and ward 52 Department of Surgery
Dr Babasaheb ambedkar medical college and hospital, North west Delhi
North West
DELHI
110085
India |
| Phone |
9968242627 |
| Fax |
|
| Email |
jkumar33@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Kumar |
| Designation |
Specialist grade 1 and H.O.D. Department of surgery |
| Affiliation |
Dr Babasaheb Ambedkar medical college and hospital |
| Address |
Unit 1 SOPD Room no. 1131 and ward 52 Department of Surgery
Dr Babasaheb ambedkar medical college and hospital, North west Delhi
North West
DELHI
110085
India |
| Phone |
9968242627 |
| Fax |
|
| Email |
jkumar33@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham mishra |
| Designation |
DNB PG ,Surgery, Department of surgery |
| Affiliation |
Dr Babasaheb Ambedkar medical college and hospital |
| Address |
Unit 1 SOPD room no. 1131 and ward 52 Department of surgery. Dr Babasaheb Ambedkar medical college and hospital
North West
DELHI
110085
India |
| Phone |
9721664351 |
| Fax |
|
| Email |
Dr.shubhamdmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Baba Saheb Ambedkar Medical College & Hospital. Govt. of NCT DELHI,Rohini sec 6,Delhi ,110085, India |
|
|
Primary Sponsor
|
| Name |
Department of general surgery Room no Dr B S A Medical College Hospital Govt of NCT DELHI |
| Address |
Sector - 6 Rohini DELHI 110085, India |
| Type of Sponsor |
Government 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 Shubham Mishra |
Dr B S A Medical College & Hospital. Govt. of NCT DELHI |
Department of general surgery, Room no 1128
North West
DELHI |
9721664351
dr.shubhamdmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polidocanol foam sclerotherapy in grade 1, grade 2 and early grade 3 internal haemorrhoids . Total duration of intervention including follow up period will be 6 months after approval from institutional ethical committee and ctri registration |
In this arm patients will be treated with polidocanol foam sclerotherapy in grade 1,grade 2 and early grade 3 internal hemorroid. Total duration of follow up will be 6 month |
| Comparator Agent |
Rubber band ligation in grade 1 ,grade 2 and early grade 3 internal haemorrhoids . Total duration of intervention including follow up period will be 6 month after approval from institutional ethical committee and ctri registration |
In this arm patients will be treated with rubber band ligation for the treatment of grade 1, grade 2 and early grade 3 internal haemorrhoids. Total duration will be 6 months after the approval from the institutional ethical committee and ctri registration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years to 70 years
All patients having grade1 & Grade2 and early grade 3 haemorrhoid |
|
| ExclusionCriteria |
| Details |
1.Recurrent hemorrhoids earlier treated with rubber band ligation or Sclerotherapy
2.Any inflammatory or infective pathology around anus and anal area
3.Patient allergic to polidocanol
4.Known case of inflammatory bowel disease, Rectal ulcer and colonic polyposis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare
1.Per rectal bleeding
2.post operstive pain
3.Decrese in grading of hemorrhoids |
To compare
1.Per rectal bleeding with dichotomous scale on 48 hrs,2weeks ans 4weeks
2.post operstive pain assessed with visual analogue score on 48 hrs,2weeks and 4weeks
3.Decrese in grading of hemorrhoids on prctoscopy at 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1.Patient satisfaction
2.Recurrence rate |
To compare
1.Patient satisfaction with patient satisfaction score on 6 months
2.Recurrence rate on proctoscopy examination at 6 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="0"
Months="6"
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
|
Treatment approches for hemorrhoidal disease vary and it depends on disease"s nature and severity,patient preferances and treating doctors expertise.the most common in office procedures are rubber band ligation and foam sclerotherapy.Most of the the stuides avilable in the current literature compare conventional sclerotherapy with rubber band ligation .Our study aims to compare rubber band ligation and foam sclerotherapy in grade 1 ,grade 2 and early grade 3 internal hemorrpides . |