| CTRI Number |
CTRI/2022/03/040913 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
05/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Use of normal saline injection during thyroid surgery to preserve parathyroid
gland function and reduce incidence of postoperative hypoparathyroidism |
|
Scientific Title of Study
|
Use of sub capsular saline injection during thyroid surgery to preserve
parathyroid function. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjith Cheriyan Philip |
| Designation |
Senior PG Registrar in Department of Endocrine Surgery |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room No:1205
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Vellore
TAMIL NADU
632004
India |
| Phone |
9747629806 |
| Fax |
|
| Email |
drranjithcp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Thomas Abraham |
| Designation |
Professor of Department of Endocrine Surgery |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room No :1205
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Vellore
TAMIL NADU
632004
India |
| Phone |
9747629806 |
| Fax |
|
| Email |
abrahamdt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjith Cheriyan Philip |
| Designation |
Senior PG Registrar in Department of Endocrine Surgery |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room.No :1205
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Department of Endocrine Surgery
Christian Medical College,
Vellore – 632004.
Vellore
TAMIL NADU
632004
India |
| Phone |
9747629806 |
| Fax |
|
| Email |
drranjithcp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical college,vellore, India |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjith Cheriyan Philip |
Christian Medical College, Vellore |
Department of Endocrine Surgery,
Room.No :1205
Paul Brand Building
Vellore
TAMIL NADU |
9747629806
drranjithcp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,Christian Medical College,Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E892||Postprocedural hypoparathyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard total thyroidectomy |
Thyroidectomy done as standard operating technique without subcapsular saline injection |
| Intervention |
Subcapsular saline injection during total thyroidectomy |
Thyroid is exposed and the superior pole is mobilised in standard manner. In the
intervention arm, the false capsule is raised and a subcapsular injection of 2 mlof 0.9% normal
saline using a 5-mL syringe and a 26-gauge needle is done in the region of the superior pole.
Capsular dissection is done as per standard protocol. Subcapsular saline injection is done intraoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted for a total thyroidectomy with or without a neck dissection |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing less than total thyroidectomy
2. Previous neck, thyroid and parathyroid surgeries
3. Concurrent parathyroid disease
4. Previous received ablative dose of I-131 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Subcapsular saline injection (SCASI) in reducing the rate of
post-thyroidectomy hypocalcemia and hypoparathyroidism. |
Immediate postop day 1 and 6 months later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
21/03/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thyroidectomy is the most common elective endocrine surgical procedures performed worldwide. Total thyroidectomy is the treatment of choice for both benign and malignant thyroid diseases. The incidence of post-operative hypocalcemia varies from 1.6 – 50% and is caused due to inadvertent removal, mechanical or thermal injury to the parathyroid glands. With improved knowledge of the variations in the position and vascular anatomy of the parathyroid glands, this has resulted in a significant reduction in the incidence of postoperative hypoparathyroidism. However, symptomatic hypocalcemia continues to be one of the leading causes of post thyroidectomy morbidity and can result in psychological and emotional disturbances, prolonged hospital stay and additional financial burden.Various procedures such as preservation of the inferior thyroid vein, parathyroid autotransplantation, and the use of angiography with indocyanine green, carbon nanoparticles, or a gamma probe to identify the parathyroid glands has been tested to reduce the frequency of hypoparathyroidism after total thyroidectomy. However, careful dissection of parathyroid gland by avoiding mechanical and thermal injury remains the mainstay to prevent postoperative hypoparathyroidism. There are only two studies which have demonstrated the efficacy of subcapsular injection of saline during thyroid surgery to reduce post-operative hypoparathyroidism, however with small sample sizes. This aim of our study is to evaluate the efficacy of subcapsular injection of saline (SCASI) during thyroid surgery to reduce post-operative hypoparathyroidism by reducing mechanical and thermal injury during dissection of the parathyroid gland compared with standard thyroidectomy. |