| CTRI Number |
CTRI/2025/02/080085 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [minimally invasive] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare outcomes of 3 percentage polidocanol sclerotherapy versus Modified Barrons rubber band ligation in the management of grade 2 internal hemorrhoidal disease |
|
Scientific Title of Study
|
Comparative analysis between outcomes of 3 percentage polidocanol sclerotherapy versus Modified Barrons rubber band ligation in the management of grade 2 internal hemorrhoidal disease : A non inferiority randomised control 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 Swarnima Shubhadarshini |
| Designation |
junior resident |
| Affiliation |
all india institute of medical sciences patna |
| Address |
department of general surgery all india institute of medical sciences patna aurangabad road phulwari sharif patna bari khagaul bihar
Patna
BIHAR
801507
India |
| Phone |
7488836504 |
| Fax |
|
| Email |
shubhswarnima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swarnima Shubhadarshini |
| Designation |
junior resident |
| Affiliation |
all india institute of medical sciences patna |
| Address |
department of general surgery all india institute of medical sciences patna aurangabad road phulwari sharif patna bari khagaul bihar
BIHAR
801507
India |
| Phone |
7488836504 |
| Fax |
|
| Email |
shubhswarnima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiv Shankar Paswan |
| Designation |
Additional Professor |
| Affiliation |
all india institute of medical sciences patna |
| Address |
department of general surgery opd aiims patna bihar 801507
Patna
BIHAR
801507
India |
| Phone |
6370225503 |
| Fax |
|
| Email |
shiv@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
All India Institute of Medical Sciences Patna Aurangabad road Phulwari Sharif Patna Bari Khagaul Bihar 801507 |
| 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 |
| Dr Swarnima Shubhadarshini |
All India Institute of Medical Sciences Patna |
Department of General Surgery Third floor Aurangabad road Phulwari Sharif Patna Bari Khagaul Bihar
Patna
BIHAR |
7488836504
shubhswarnima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee AIIMS Patna |
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 |
3 percentage polidocanol |
In group A the participants will be treated with 4 ml 3 percentage polidocanol foam via generously lubricated Kelly proctoscope Modified Tessari technique will be used for preparation of polidocanol foam and will be applied immediately to prevent disintegration of microbubbles With patient in Jackknife position foam will be injected using 20 ml disposable syringe with a 20 G spinal needle adapted as a syringe connected to the 20 ml foam syringe Maximum dose per treatment session used is 20 ml: 4 ml sclerosant containing 120 mg polidocanol mixed with 16 ml air More than one haemorrhoidal nodule can be treated in single session |
| Comparator Agent |
Barrons rubber band ligation |
In group B participants will be placed in jackknife position and visualisation will be done by using a generously lubricated Kelly proctoscope Modified Barrons rubber band ligation technique will be used They will be treated with 2 rubber bands placed around redundant rectal mucosa which was grasped proximally using a clamp A reusable metal ligation device connected to suction channel McGown suction was used for this purpose Clamp will thereafter released More than one haemorrhoidal pedicle can be ligated during a single session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years or older with grade 2 hemorrhoidal disease giving consent for participation
Refractory to conservative management given for at least 1 month |
|
| ExclusionCriteria |
| Details |
Grade 1 3 and 4 hemorrhoidal disease
Associated complications like strangulation or thrombosis
Patients with external hemorrhoids
Associated perianal fissure or fistula
Patients who have undergone treatment for hemorrhoidal disease within last 12 months regardless of the type of treatment
Patients with Inflammatory Bowel Disease
Patients with coagulopathies arising from any cause or on anti-coagulation therapy
Immunocompromised individuals
Pregnant females
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the patient related outcomes blood loss pain prolapse itching soiling of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease using Patient Reported Outcome Measures Haemorrhoidal Impact and Satisfaction Score PROM HISS questionnaire |
day 0
1 week
6 weeks
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the complication rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease |
6 weeks
3 months |
| To assess the recurrence rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease where recurrence means subjective return of symptoms as told by patient |
3 months |
|
|
Target Sample Size
|
Total Sample Size="332"
Sample Size from India="332"
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)
|
09/02/2026 |
| 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="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
|
The study will be conducted in the Department of General Surgery AIIMS Patna and will include patients with Grade 2 Internal Hemorrhoidal Disease who have undergone at least one month of conservative management including dietary and lifestyle modifications along with medical management using Micronised Purified Flavonoid Fraction and have not experienced symptom relief Eligible patients will be randomized into two parallel groups Group A receiving 3 percentage Polidocanol Sclerotherapy and Group B undergoing Modified Barrons Rubber Band Ligation with an allocation ratio of 1 to 1 Patients who refuse randomization will be allowed to choose their preferred treatment modality The Sclerotherapy group will receive 4 ml of 3 percentage Polidocanol foam prepared using the Modified Tessari technique and injected via a Kelly proctoscope in the Jackknife position with a maximum dose of 20 ml per session treating multiple nodules if necessary The RBL group will undergo ligation in the Jackknife position using a Kelly proctoscope and a reusable metal ligation device with suction applying two rubber bands per hemorrhoidal pedicle if required Patient related outcomes will be assessed using the Patient Reported Outcome Measure Hemorrhoidal Impact and Satisfaction Score PROM HISS questionnaire which evaluates hemorrhoidal symptoms impact on daily activities and satisfaction with treatment Follow up visits will be conducted at 1 week 6 weeks and 3 months with potential retreatment at 6 weeks if necessary Data will be analyzed on both an intention to treat and per protocol basis with the total study duration expected to be between 1 to 1 year 6 months |