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CTRI Number  CTRI/2024/02/062690 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An interventional study to compare laser hemorrhoidoplasty with open hemorrhoidectomy with respect to quality of life 
Scientific Title of Study   A Randomised controlled trial to compare quality of life by SF36 questionnaire 06 months after the intervention between laser hemorrhoidoplasty versus open hemorrhoidectomy in Grade III and IV haemorrhoids at a tertiary care hospital 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Brig Alok Bhalla 
Designation  Professor and Head of Dept 
Affiliation  armed forces medical college 
Address  department of surgery Armed forces medical college pune-sholapur road Pune

Pune
MAHARASHTRA
411040
India 
Phone  7388741113  
Fax    
Email  dralokbhalla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vitesh Popli 
Designation  Assistant Professor 
Affiliation  armed forces medical college 
Address  department of surgery Armed forces medical college pune-sholapur road Pune

Pune
MAHARASHTRA
411040
India 
Phone  9401171311  
Fax    
Email  vitesh03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vitesh Popli 
Designation  Assistant professor 
Affiliation  armed forces medical college 
Address  department of surgery Armed forces medical college pune-sholapur road Pune


MAHARASHTRA
411040
India 
Phone  9401171311  
Fax    
Email  vitesh03@gmail.com  
 
Source of Monetary or Material Support  
Command hospital (southern command) 
 
Primary Sponsor  
Name  nil 
Address  NA 
Type of Sponsor  Other [Nil] 
 
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 Shreyasi Jha  Armed forces medical college  Department of general surgery armed forces medical college pune-sholapur road pune-411040
Pune
MAHARASHTRA 		 7798148228

shreyasijha18@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laser Hemorrhoidoplasty  Patients who are randomised into this group will undergo laser ablation of the haemorrhoids and SF36 questionnaire will be filled as per protocol to assess quality of life after 06 months 
Intervention  Milligan-Morgan Open Hemorrhoidectomy  Milligan-Morgan Open hemorrhoidectomy is the gold standard procedure for grade III and IV haemorrhoids. Patients who are randomised into this group will undergo excision of the heorrhoids by open method and then SF36 questionnaire will be filled as per protocol to assess post-op quality of life after 06 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  grade III hemorrhoids
grade IV hemorrhoids
Able to give informed consent 
 
ExclusionCriteria 
Details  Younger than 18 years
Patients unable to give informed consent
Spinal anaesthesia contraindicated
Patients with other and-rectal conditions associated - fissure-in-ano, fistula-in-ano
Patients who have undergone interventions for haemorrhoids in the past 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of life by SF36 questionnaire  at 06 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="208"
Sample Size from India="208" 
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 2 
Date of First Enrollment (India)   20/03/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vitesh03@gmail.com].

  6. For how long will this data be available start date provided 23-12-2023 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Hemorrhoidal diseases rank first amongst ano-rectal diseases and have an estimated prevalence of 2.9-27% of which 4% are symptomatic. Multiplicity of treatment modalities has added confusion in decision making regarding treatment method to be chosen. Milligan-Morgan open hemorrhoidectomy remains the gold standard of surgery. However, it is associated with significant complications including pain, bleeding, wound infection which prologn hospital stay and decease subsequent quality of life. This study is to assess the difference in quality of life in open hemorrhoidectomy versus Laser hemorrhoidoplasty using SF36 questionnaire. 
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