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CTRI Number  CTRI/2021/11/037889 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
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   Different techniques of. thyroidectomy  
Scientific Title of Study   COMPARISON OF OUTCOMES BETWEEN FLAPLESS AND CONVENTIONAL THYROIDECTOMY : A RANDOMISED CONTROLLED STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  chandra bhushan singh 
Designation  Head of department 
Affiliation  Maulana Azad Medical College  
Address  HOd office, deptt of surgery, BL taneja block, maulana azad medical college

Central
DELHI
11002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swapnil Suman 
Designation  Post Graduate  
Affiliation  Maulana Azad Medical College  
Address  BL Taneja Block 2nd floor Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  09654330787  
Fax    
Email  swapnilsuman2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chandra bhushan singh 
Designation  Head of department 
Affiliation  Maulana Azad Medical College  
Address  HOD office, Department of surgery, BL taneja block, maulana azad medical college.

Central
DELHI
110002
India 
Phone  9717212602  
Fax    
Email  drchandrabhushansingh@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medial College ,2, Bahadur Shah Zafar Marg, New Delhi 110002 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  2, BAHADUR SHAH ZAFAR MARG, NEW DELHI 
Type of Sponsor  Research institution 
 
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 
Swapnil suman  Maulana Azad Medical College  2, Bahadur Shah Zafar Marg, New Delhi.
Central
DELHI 		 9654330787

swapnilsuman2@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  Thyroidectomy   Conventional thyroidectomy in control group. Flaps will be raised in this group for removal of thyorid. 
Intervention  Thyroidectomy  Flapless thyroidectomy in test group. Flaps will not be raised for thyroid removal in this group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients of Thyroid enlargement needing hemithyroidectomy or total thyroidectomy.
Age greater than 18 years of age.
 
 
ExclusionCriteria 
Details  History of previous neck surgery.
History of Irradiation to head and neck region in the past.
Requirement of extensive lymph node dissection.
Locally invasive malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of postoperative seroma formation between flapless and conventional thyroidecomy.   1 week 
 
Secondary Outcome  
Outcome  TimePoints 
2.a Intraoperative time
2.b Intraoperative bleeding.
2.c Recurrent Laryngeal nerve injury
2.d Postoperative hypocalcemia
2.e Drain output
 		 Till 1 week after after surgery. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   12/11/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published later.  
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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swapnilsuman2@gmail.com].

  6. For how long will this data be available start date provided 31-08-2021 and end date provided 21-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a comparison between the outomes of techniques between flapless and conventional thyroidectomy with respect to their procedure, intraoperative and post operative outcomes.  
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