FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075600 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of patient satisfaction, cosmesis and quality of life in two approaches of parathyroidectomy to identify a best approach. 
Scientific Title of Study   A randomized controlled trial to compare patient satisfaction, cosmesis, quality of life, safety and feasibility of Endoscopic Parathyroidectomy by Ipsilateral Axillo-Breast approach versus open focussed Parathyroidectomy in patients with primary hyperparathyroidism due to a single gland disease 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hitesh Goel 
Designation  Junior Resident, Department of Surgical Disciplines 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 421, Surgery Office, 4th floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
Room 310, 3rd Floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
New Delhi
DELHI
110029
India 
Phone  8527132887  
Fax    
Email  hiteshgoel7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yashwant Rathore 
Designation  Additional Professor, Department of Surgical Disciplines  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 429, 4th floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
Room 421, Surgery Office, 4th floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
New Delhi
DELHI
110029
India 
Phone  9911337726  
Fax    
Email  dryashvant.r@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kamal Kataria 
Designation  Additional Professor, Department of Surgical Disciplines  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 417, 4th floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
Room 421, Surgery Office, 4th floor, Surgery Block(Department of Surgical Disciplines), AIIMS, New Delhi -110029
New Delhi
DELHI
110029
India 
Phone  9212678920  
Fax    
Email  drkamalkataria@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure support is provided by All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar, New Delhi, India - 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  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 Hitesh Goel  All India Institute of Medical Sciences  Room 421, Surgery Office, Department of Surgical Disciplines, Surgery Block, AIIMS, NEW DELHI -110029
New Delhi
DELHI 
8527132887

hiteshgoel7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences  Approved 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E210||Primary hyperparathyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic parathyroidectomy via ipsilateral axillo breast approach (IABA)  Endoscopic parathyroidectomy via ipsilateral axillo-breast approach (IABA) is a minimally invasive surgical procedure aimed at removing parathyroid adenomas while minimizing scarring and reducing recovery time. The procedure begins with the patient in a supine position, with the arm on the side of the affected parathyroid gland raised to provide access to the axilla and breast region. Several small incisions, typically less than 1.5 cm in size, are made in these areas. An endoscope with a camera is inserted through one incision to visualize the surgical field, while specialized instruments are inserted through the other incisions for dissection and manipulation. The surgeon carefully dissects around the parathyroid gland to identify the adenoma, taking care to preserve surrounding structures such as the recurrent laryngeal nerve and thyroid gland. Once located, the adenoma is dissected and removed. Hemostasis is achieved, and the incisions are closed with sutures or surgical adhesive. Duration of the procedure - 2 hours 
Comparator Agent  Open focused parathyroidectomy  Open-focused parathyroidectomy is a surgical procedure intended to remove a single parathyroid adenoma while safeguarding nearby healthy tissue. Unlike the minimally invasive approach of endoscopic parathyroidectomy, open-focused parathyroidectomy involves making a single, slightly larger incision in the neck. Through this incision, the surgeon meticulously dissects to locate and excise the adenoma, ensuring the preservation of surrounding parathyroid tissue. This technique allows for direct visualization of the surgical field, aiding in precise adenoma removal and minimizing the risk of damage to nearby structures. The procedure typically entails careful dissection, identification, and removal of the adenoma, followed by closure of the incision. Duration - 1 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Biochemically proven cases of Sporadic primary hyperparathyroidism in which
only a single parathyroid gland responsible for hyperparathyroidism would be included.
 
 
ExclusionCriteria 
Details  1. Age below 18 years
2. Refusal to give consent
3. Patients not fit for general anaesthesia/ neck extension required for surgical
positioning
4. History of head and neck surgery and previous irradiation
5. Multiglandular disease
6. Parathyroid adenoma of size greater than 3 cm.
7. Pregnancy and Lactation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain and discomfort of the patient will be assessed on a 5-point Likert scale using related questions.
2. Cosmetic assessment will be done by the patient using a 4-point Likert scale.
3. Cosmetic assessment will be done by a surgeon and a nurse using a 5-point Likert scale, who are not a part of the operating and care team. 
1. On POD 1 and POD3
2. 4 weeks after surgery
3. 4 weeks after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. The ease of doing the procedure will be assessed on a Likert scale of 1 to 5.
2. Post-operative complication - RLN injury via Laryngoscopy
3. Post-operative complication - RLN injury via Voice analysis
4. Post-operative complication - formation of seroma
5. Post-operative complication - subcutaneous ecchymosis
6. Post-operative complication - Respiratory distress
7. Post-operative complication - Paraesthesia 
1. Immediately after the surgery
2. Before surgery and Immediately after surgery
3. On POD10, at 3 months and at 6 months after surgery
4. On POD1, POD2 and after 1 week
5. On POD1 and POD10
6. On POD1 and POD2
7. On POD1 and POD2 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 3 
Date of First Enrollment (India)   01/11/2024 
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="2"
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 - NO
Brief Summary  

The study aims to compare endoscopic parathyroid surgery with conventional open parathyroid surgery in terms of complications and cosmesis. The primary objective is to assess patient satisfaction and cosmesis, while secondary objectives include comparing safety, feasibility, and quality of life between the two approaches. In terms of safety parameters, recurrent laryngeal nerve (RLN) injury, subcutaneous ecchymosis, and seroma formation are assessed. RLN injury is evaluated intraoperatively, at extubation, and through voice analysis post-surgery. Subcutaneous ecchymosis severity is graded, and seroma is detected clinically and confirmed by ultrasound. The inclusion criteria encompass patients above 18 years with biochemically proven sporadic primary hyperparathyroidism involving a single parathyroid adenoma. Exclusion criteria include patients unfit for general anesthesia, with a history of head and neck surgery, multiglandular disease, large adenomas (>3 cm), pregnancy, or lactation. The study design is a single-centered, parallel, open-label randomized controlled trial with superiority hypothesis. Patients are randomized into two arms: Arm A undergoes endoscopic parathyroidectomy via the ipsilateral axillo breast approach, and Arm B undergoes open focused parathyroidectomy. The study is conducted at AIIMS, New Delhi. Preoperative evaluations include detailed history, physical examination, voice assessment, lab investigations, and imaging. Invasive interventions are performed after obtaining informed consent. Primary outcome measures include pain and discomfort assessed on a Likert scale and cosmetic assessment by patients and independent assessors. Secondary outcomes include the ease of procedure, postoperative complications, and quality of life assessed using the SF-36 questionnaire. Sample size calculation is based on overall satisfaction parameters from a similar study, with 28 patients allocated to each arm. Statistical analysis will be performed using SPSS software, with continuous variables expressed as mean ± SD and statistical significance defined by a p-value less than 0.05. In summary, the study aims to provide valuable insights into the comparative effectiveness and safety of endoscopic versus conventional open parathyroid surgery, focusing on patient satisfaction, cosmesis, and quality of life. By employing rigorous methodology and statistical analysis, the findings are expected to contribute to informed decision-making in clinical practice regarding the choice of surgical approach for primary hyperparathyroidism.

 

 
Close