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临床试验/NCT00798863
NCT00798863已完成不适用

Video Assisted Submandibular Resection, Two Step Technique

University of Alexandria2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
incidence of complications after the operation

研究概览

简要总结

The study addresses a problem that face surgeons who perform key-hole surgery to resect the submandibular salivary gland. The problem is the narrow space available around that gland. This does not allow for a safe operation. The study aims to evaluate a new, two step resection technique, that should overcome this difficulty.

详细描述

The study included twelve adult patients suffering from chronic submandibular sialadenitis and indicated for sialadenectomy. The following exclusion criteria were adopted: Previous history of surgery or irradiation to the neck; History of abscess formation in the region; Patients having large, hard or fixed submandibular gland and where there was suspicion of malignancy. Laboratory work-up and ultrasound of the neck were obtained.All patients had video assisted submandibular sialadenectomy, using a "two step resection" technique as follows:Step 1: A 15 to 20 mm skin incision was performedThe edges of the wound are protected using a rubber cuff. The dissection is done using the harmonic scalpel in one hand and the suction spatula in the other hand. The anterior part of the gland is then dissected off the mylohyoid muscle. The plane of the dissected anterior pole of the gland is used as a guide. This plane is followed all around the gland until the whole superficial part of the gland is dissected free. Step 2: The retractors are adjusted to elevate the roof of the cavity created by removing the superficial part pf the gland. The scope is inserted into the wound to view the deeper part of the operative field. All nearby important structures are now identified and protected. The deep part of the gland is dissected and removed

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patient
  • Has submandibular sialadenitis

排除标准

  • Previous history of surgery or irradiation to the neck
  • History of abscess formation in the region
  • Patients having large, hard or fixed submandibular gland
  • If there was suspicion of malignant submandibular tumour

结局指标

主要结局

incidence of complications after the operation

时间窗: patients are examined for complications the next day of the operation

次要结局

  • operative time(operative time is calculated at the end of the operation)
  • patient satisfaction with the cosmetic result of the operation(12 weeks after the operation)

研究者

申办方类型
Other

研究点 (2)

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