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

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.