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临床试验/NCT01075269
NCT01075269Unknown不适用

Does Robotic Assistance Significantly Reduce Postoperative Distress and Patient Complaints About Cosmetic Outcomes After Thyroid Surgery? A Preliminary Report.

Korean Association of Endocrine Surgeons1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
84
试验地点
1
主要终点
Surgical outcomes, postoperative pain and cosmetic outcomes

研究概览

简要总结

Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.

Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.

详细描述

Patient assessment A prospective study addressing perioperative outcomes and postoperative patient discomfort after thyroidectomy was commenced in April 2009 and is currently continuing. All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. The study protocol was approved by our Institutional Review Board.

Patients were included if they had (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter. Exclusion criteria included (a) previous neck operations; (b) age <21 or >65 years; (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN). The extent of thyroid resection was determined for each patient using American Thyroid Association guidelines. All patients underwent prophylactic ipsilateral central compartment node dissection (CCND; pretracheal, prelaryngeal, and paraesophageal).

Surgical outcomes Surgical outcomes included operating time, intraoperative blood loss, number of retrieved central lymph nodes, length of hospital stay, and postoperative complications. We also assessed the incidence of postoperative seromas and hematomas for at least 3 weeks postoperatively. Operating time was defined as the interval from skin incision to closure. The drainage extent was measured over 24 h, and a drain was removed if drainage was <30 mL in this interval. Study patients were discharged the day after drain removal.

Mobility of the vocal cords was assessed by videostrobolaryngoscopic examination, performed both preoperatively and 1 week and 3 months postoperatively. Vocal cord palsy was defined as permanent when there was no evidence of recovery within 6 months.

Postoperative pain and cosmetic outcomes To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or
  • (b) a papillary thyroid carcinoma ≤2 cm in diameter.

排除标准

  • (a) previous neck operations;
  • (b) age <21 or >65 years;
  • (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy;
  • (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or
  • (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)

结局指标

主要结局

Surgical outcomes, postoperative pain and cosmetic outcomes

时间窗: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery

Surgical outcomes included operating time, intraoperative blood loss, length of hospital stay, and postoperative complications. To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery. Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses.

次要结局

  • Subjective voice and swallowing evaluation(before surgery and at 1 week and 3 months after surgery.)

研究者

发起方
Korean Association of Endocrine Surgeons
申办方类型
Network

研究点 (1)

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