| 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. |
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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 |
|
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Source of Monetary or Material Support
|
| Infrastructure support is provided by All India Institute of Medical Sciences, New Delhi |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Investigator Blinded |
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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 |
|
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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
|
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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.
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