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CTRI Number  CTRI/2026/01/100150 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between rubber band ligation and laser hemorrhoidoplasty in patient presenting with hemorrhoids for resolution of symptoms associated with hemorrhoids (grade II and III) 
Scientific Title of Study   Rubber Band Ligation Versus Laser Haemorrhoidoplasty : A Randomised Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMSA3257/27.02.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nalamwad Durgeshwari Balaji 
Designation  Junior Resident  
Affiliation  AIIMS New Delhi 
Address  Dept. of Surgical Disciplines AIIMS New Delhi Ansari Nagar

South
DELHI
110029
India 
Phone  7020643572  
Fax    
Email  durgeshwari0210@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Uttam Kumar Thakur  
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Dept. of Surgical Disciplines AIIMS New Delhi Ansari Nagar

South
DELHI
110029
India 
Phone  7087009909  
Fax    
Email  ukt005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Uttam Kumar Thakur  
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Dept. of Surgical Disciplines AIIMS New Delhi Ansari Nagar

South
DELHI
110029
India 
Phone  7087009909  
Fax    
Email  ukt005@gmail.com  
 
Source of Monetary or Material Support  
Dept of Surgical Disciplines, AIIMS New Delhi, Ansari Nagar, Delhi. 110029 
 
Primary Sponsor  
Name  Dept of Surgical Disciplines 
Address  AIIMS New Delhi, Ansari Nagar, Delhi. 110029 
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 Nalamwad Durgeshwari  AIIMS New Delhi   Room no 415, fourth floor, Dept. of Surgical Disciplines
South
DELHI 		 7020643572

durgeshwari0210@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitute Ethics Committee, All India Institute of Medical sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K641||Second degree hemorrhoids, (2) ICD-10 Condition: K642||Third degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laser Hemorrhoidoplasty  Laser application to grade II and III haemorrhoids using laser fibre  
Intervention  Rubber band ligation   Rubber band ligation of grade II and III haemorrhoids using rubber band applicator  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria
1. Adult patients aged 18 to 70 years
2. Grade II and III internal haemorrhoids
 
 
ExclusionCriteria 
Details  Exclusion criteria
1. Circumferential haemorrhoids or haemorrhoids in all 3, 7 and 11 o’ clock positions
2. Patients on anticoagulant and antiplatelet agents
3. Patients developing haemorrhoids secondary to portal hypertension
4. Patients who have undergone previous procedure for haemorrhoids
5. Presence of other associated perianal pathology including anal stenosis, anal fissure, fistula or anorectal tumors.
6. Patients on opioids or any substance abuse
7. Immunocompromised patients - Known HIV/ AIDS, patients on immunosuppressive drugs including steroids
8. Previous surgical anastomosis less than 3 cm from dentate line
9. Patients with inflammatory bowel disease
10. Fecal incontinence
11. Obstructed defecation syndrome
12. Irritable bowel syndrome with severe constipation or diarrhoea symptoms
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Resolution of symptoms (rectal bleeding, discomfort, itching, mucous discharge), determined by direct or telephonic interview of patients at three months after RBL or LH
 		 24 hours, 1 week, 2 weeks, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of pain at 24 hours, 1 week, 2 weeks and 3 months, measured by Numerical Pain Rating Scale, on a scale of 0 to 10, where 0 is no pain and 10 is maximum possible pain
2. Procedure time, measured in minutes
3. Incidence of post procedure complications - Oedema, abscess, urinary retention, anal ulcer, acute thrombosis, unplanned hospital visits, hospital admissions at 30 days
4. Incidence of downgrading rates of hemorrhoidal disease by 1 grade or more, determined by direct examination by a trained surgeon during 3-montyh follow up visit.

 		 24 hours, 1 week, 2 weeks, 3 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   07/12/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [durgeshwari0210@gmail.com].

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Internal hemorrhoids are dilated vascular cushions above the dentate line. Internal hemorrhoids can lead to a clinical spectrum of symptoms ranging from bleeding PR, perianal discomfort and itching, constipation, and many more. Currently, a number of treatment modalities exist for the treatment including conservative management, rubber band ligation, open surgeries, etc., with the current gold standard being rubber band ligation for grade 1 to 3 internal hemorrhoids. In this study, we aim to compare the current gold standard with the newer modality that is laser hemorrhoidoplasty for grade 2 and grade 3 hemorrhoids. It uses laser fiber of argon laser fiber of wavelength 1470 nanometer. Preoperatively, the patient is examined to locate the hemorrhoids and intraoperatively laser pulses are given which results in reduced vascular flow and fibrosis in the long term, thus reducing the size of the pile mass and causing symptomatic relief. 
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