Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases
Safety and Feasibility of Drainless Thyroid Surgery for Benign Thyroid Diseases Using the Sutureless Technique, Rrandomized Controlled Trial
研究概览
地位
条件
详细说明
Thyroidectomy for benign thyroid diseases is commonly performed with routine placement of surgical drains to prevent postoperative hematoma or seroma. However, drain use may be associated with increased pain, infection risk, prolonged hospital stay, and patient discomfort. Advances in surgical techniques, particularly the use of sutureless energy-based hemostatic devices, have raised the possibility of safely omitting routine drain placement in selected patients.
This prospective randomized controlled trial aims to assess the safety and feasibility of drainless thyroid surgery in patients with benign thyroid diseases. Eligible patients undergoing thyroidectomy are randomly allocated into two groups: a drainless group, in which no postoperative drain is inserted, and a control group, in which a conventional closed suction drain is placed.
All surgeries are performed using a standardized sutureless technique for hemostasis. Patients are followed postoperatively to evaluate surgical and clinical outcomes, including postoperative bleeding or hematoma, seroma formation, wound complications, hypocalcemia, recurrent laryngeal nerve injury, postoperative pain, length of hospital stay, and need for reintervention or readmission.
The results of this study are expected to clarify whether drainless thyroid surgery using a sutureless technique is a safe and feasible alternative to conventional drain placement in benign thyroid surgery and may help optimize postoperative care and patient comfort
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minya、埃及、61111
- Minia University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients (≥18 years)
- Benign thyroid disease confirmed by: clinical assessment, ultrasonography, and fine-needle aspiration cytology (Bethesda II)
- Indicated for elective hemithyroidectomy or total thyroidectomy
- Euthyroid or adequately controlled thyroid function
Exclusion Criteria:
- Thyroid malignancy or indeterminate cytology
- Re-operative thyroid surgery
- Retrosternal goiter
- Coagulation disorders
- Patients on anticoagulation that could not be safely discontinued
- Concomitant neck surgery
- Severe uncontrolled systemic illness (ASA IV or higher)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:thyroidectomy without drain
Participants in this arm undergo sutureless thyroidectomy procedure, but no surgical drain is placed afterward.
The aim is to evaluate whether omitting the drain affects outcomes such as postoperative surgical site complications (like pain, infection, seroma, hematoma) compared with the drained approach.
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Participants undergo sutureless thyroidectomy procedure but no drain is placed postoperatively.
The goal is to assess whether omitting the drain affects postoperative outcomes such as pain, seroma, hematoma, infection, or overall recovery, while maintaining safety.
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有源比较器:thyroidectomy with drain
Participants in this arm undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain at the end of the procedure.
The purpose of using the drain is to evacuate any postoperative fluid such as blood or serous fluid from the surgical site to theoretically reduce complications such as hematoma or seroma accumulation.
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Participants undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain.
The drain is intended to evacuate postoperative fluid (blood or serous fluid) to reduce the risk of complications such as hematoma or seroma formation.
The surgical technique itself follows conventional sutureless thyroidectomy principles.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of postoperative neck hematoma requiring intervention
大体时间:Within 48 hours postoperatively
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Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation
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Within 48 hours postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1. Overall postoperative complication rate
大体时间:Within 30 days postoperatively
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Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury
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Within 30 days postoperatively
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2. Seroma formation
大体时间:Within 14 days postoperatively
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Clinically or ultrasonographically detected fluid collection requiring aspiration
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Within 14 days postoperatively
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3. Postoperative hypocalcemia
大体时间:Within 72 hours postoperatively
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Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation
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Within 72 hours postoperatively
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Recurrent laryngeal nerve injury
大体时间:Within 30 days postoperatively
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Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy
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Within 30 days postoperatively
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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