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CTRI Number  CTRI/2024/11/076979 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Endoscopic]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the efficacy of two different types of treatments using endoscopy in patients with bleeding internal hemorrhoids. 
Scientific Title of Study   Endoscopic band ligation versus injection sclerotherapy in patients with bleeding internal hemorrhoids: a prospective randomised study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeraj Singla 
Designation  Consultant,  
Affiliation  First floor, Department of Gastroenterology, Fortis Hospital Ludhiana  
Address  Fortis hospital, Chandigarh road, Ludhiana
First Floor, Main Building, Fortis hospital, Chandigarh road, Ludhiana
Ludhiana
PUNJAB
141015
India 
Phone  7888619216  
Fax    
Email  Dr.neerajsingla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Singla 
Designation  Consultant,  
Affiliation  Department of Gastroenterology  
Address  Fortis hospital, Chandigarh road, Ludhiana
First Floor, Main Building, Fortis hospital, Chandigarh road, Ludhiana
Ludhiana
PUNJAB
141015
India 
Phone  7888619216  
Fax    
Email  Dr.neerajsingla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeraj Singla 
Designation  Consultant,  
Affiliation  Department of Gastroenterology  
Address  Fortis hospital, Chandigarh road, Ludhiana
First Floor, Main Building, Fortis hospital, Chandigarh road, Ludhiana
Ludhiana
PUNJAB
141015
India 
Phone  7888619216  
Fax    
Email  Dr.neerajsingla@gmail.com  
 
Source of Monetary or Material Support  
Fortis Hospital Ludhiana, Punjab, India, Pin 141001 
 
Primary Sponsor  
Name  Neeraj Singla 
Address  Fortis Hospital, Chandigarh Road, Ludhiana 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeraj Singla  Fortis hospital   First Floor, Department of gastroenterology, Main Building,
Ludhiana
PUNJAB 		 7888619216

Dr.neerajsingla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Fortis hospital, Ludhiana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K640||First degree hemorrhoids, (2) ICD-10 Condition: K641||Second degree hemorrhoids, (3) ICD-10 Condition: K642||Third degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic Band Ligation  It is a technique where rubber bands are deployed over the hemorrhoids using an endoscope band ligator to obliterate them. 
Comparator Agent  Endoscopic Sclerotherapy  It is a technique where a medicine is injected into the base of hemorrhoids using an sclerotherapy needle through the endoscope to obliterate them. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Symptomatic patients presenting with lower gastrointestinal bleed.
No age limit. 
 
ExclusionCriteria 
Details  Patients a known case or have previous history of chronic liver disease, liver cirrhosis, perianal or rectal surgery, anal fistula, perianal abscess, internal hemorrhoids infected or containing thrombi or inflammation, ulceration or gangrene, rectal or perianal malignancy, bleeding disorders, patients on antiplatelet or anticoagulant medications, pregnancy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the improvement in symptoms like bleeding, pain, prolapse.  three months 
 
Secondary Outcome  
Outcome  TimePoints 
To study any adverse events with any of the procedure  three months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/12/2024 
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="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  

Title

Endoscopic Band ligation versus injection sclerotherapy in patients with bleeding internal hemorrhoids: a prospective randomised study.

Objective

Primary objective- To compare the efficacy of Endoscopic band ligation and endoscopic Injection sclerotherapy procedures in patients with bleeding internal hemorrhoids.

Secondary objective- To test safety in terms of complications as a result of these procedures.

Rationale

The rationale of this study is to compare the efficacy of two commonly used procedures for internal hemorrhoids. The results of this study will help clinicians in deciding which modality to use in patients presenting with bleeding internal hemorrhoids.

Population

This prospective randomized controlled study will be done on patients presenting with rectal bleeding to the OPD/ IPD/ Emergency satisfying inclusion and exclusion criteria will be included.

Design

This prospective randomized controlled study will be conducted at Fortis Hospital, Ludhiana from 1st July 2024 to 31st Dec, 2024. A total of 50 patients will be enrolled with 25 patients in each arm.

Methodology

Patients presenting with symptoms will be screened for eligilibilty and informed written consent will be taken. Pre-procedural assessment with complete blood count, liver function tests, INR, TSH, HbA1c, and colonoscopy/sigmoidoscopy will be done on all the patients. Eligible patients as per inclusion criteria will be included in the trial and will be randomly allotted to one of the groups of RBL and IS procedure. Two arms: one with endoscopic band ligation, other with sclerotherapy using a sclerosant (polidochonol).

Statistics

Data will be expressed as median and percentile values (5th, 25th, 75th and 95th      percentiles). The upper limit of normal will be defined as the 95th percentile of expected values. P≤0.05 will be considered statistically significant.
 
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