| CTRI Number |
CTRI/2025/09/094931 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| 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
|
Effect of fibrin glue on surgical site discharge in patients undergoing total thyroidectomy. |
|
Scientific Title of Study
|
Comparison of postoperative wound drainage with and without use of fibrin sealant in patients undergoing total thyroidectomy- A Randomized Controlled Study. |
| 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 Ashish Kumar |
| Designation |
Postgraduate resident |
| Affiliation |
Maulana Azad Medical College Dr |
| Address |
Office of Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9354673979 |
| Fax |
|
| Email |
ashishpanghal2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Bhushan Singh |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Maulana Azad Medical College and Associated Hospitals |
| Address |
Office of Head of Department,Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Bhushan Singh |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Maulana Azad Medical College and Associated Hospitals |
| Address |
Office of Head of Department,Department of Surgery, 2nd floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College Campus,2, Bahadur Shah Zafar Marg, Near Delhi Gate, Balmiki Basti,New Delhi, Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Ashish Kumar |
Lok Nayak Hospital |
OT-1, Main OT Block, Department of General surgery, LNJP Colony
New Delhi
DELHI |
9354673979
ashishpanghal2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E05||Thyrotoxicosis [hyperthyroidism], (2) ICD-10 Condition: E06||Thyroiditis, (3) ICD-10 Condition: E07||Other disorders of thyroid, (4) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (5) ICD-10 Condition: D34||Benign neoplasm of thyroid gland, (6) ICD-10 Condition: E079||Disorder of thyroid, unspecified, (7) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fibrin sealant instillation |
After specimen retrieval and achieving hemostasis, 4 ml of fibrin sealant will be put using spray method under both flaps with placement of 10 Fr mini romovac drain before skin closure in total thyroidetomy patients. |
| Comparator Agent |
No fibrin sealant |
After specimen retrieval and achieving hemostasis, flaps will be repositioned and skin closed with placement of 10 Fr Miniromovac drain in total thyroidectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing total thyroidectomy. |
|
| ExclusionCriteria |
| Details |
Revision surgery.
Patients undergoing central and lateral neck dissection.
Pregnancy and lactation.
Coagulation disorders.
History of previous irradiation.
Extrathyroidal extension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative drain output |
At 24 hours post operatively.
Total output till drain removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of drain requirement.
|
POD0 to till drain removal |
| Incidence of hematoma formation. |
42 days post operatively |
| Incidence of surgical site infection. |
42 days post operatively |
| Duration of Hospital Stay. |
POD0 to discharge |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashishpanghal2001@gmail.com].
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is being done to evaluate the role of fibrin sealant in decreasing postoperative complications like seroma and hematoma formation in patients undergoing total thyroidectomy which in turn can lead to decreasing drain requirement and hospital stay aftr thyroid surgery. Multiple earlier studies have shown variable results and the use o fibrin sealant in thyroid surgeries is still under scrutiny. In this study, 4 ml of fibrin sealant will be sprayed in surgical bed and skin closed using standard technique. post operative drain output will be compared in the study and control group and total duration of drain requirement will be assessed. this study can provide a useful role of fibrin sealant in decreasing postoperative morbidity and hospital stay of thyroid patients. |