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Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases

2026年5月29日 更新者:Hosam M. Hamza、Minia University

Safety and Feasibility of Drainless Thyroid Surgery for Benign Thyroid Diseases Using the Sutureless Technique, Rrandomized Controlled Trial

This randomized controlled trial evaluates the safety and feasibility of drainless thyroid surgery for benign thyroid diseases using a sutureless hemostatic technique. Patients undergoing thyroidectomy are randomized to either drainless surgery or surgery with drain placement. The study compares postoperative outcomes, including complications, pain, hospital stay, and need for reintervention.

研究概览

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

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Minya、埃及、61111
        • Minia University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Adult patients (≥18 years)
  2. Benign thyroid disease confirmed by: clinical assessment, ultrasonography, and fine-needle aspiration cytology (Bethesda II)
  3. Indicated for elective hemithyroidectomy or total thyroidectomy
  4. 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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
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.
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.
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.

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
Incidence of postoperative neck hematoma requiring intervention
大体时间:Within 48 hours postoperatively
Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation
Within 48 hours postoperatively

次要结果测量

结果测量
措施说明
大体时间
1. Overall postoperative complication rate
大体时间:Within 30 days postoperatively
Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury
Within 30 days postoperatively
2. Seroma formation
大体时间:Within 14 days postoperatively
Clinically or ultrasonographically detected fluid collection requiring aspiration
Within 14 days postoperatively
3. Postoperative hypocalcemia
大体时间:Within 72 hours postoperatively
Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation
Within 72 hours postoperatively
Recurrent laryngeal nerve injury
大体时间:Within 30 days postoperatively
Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy
Within 30 days postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年10月20日

初级完成 (实际的)

2025年12月20日

研究完成 (实际的)

2026年1月3日

研究注册日期

首次提交

2026年5月29日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MUFMIRB9251023

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data will not be shared because the study contains sensitive clinical and surgical information. Sharing individual-level data may compromise participant confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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