跳至主要内容
临床试验/NCT05363423
NCT05363423Unknown不适用

Lateral Pedicled Nasoseptal Flaps for Endoscopic Draf III Procedure in Patients With Frontal Sinus Inverted Papilloma

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
试验地点
1
主要终点
Whether or not the frontal neo-ostium was restenosed

研究概览

简要总结

This is a retrospective case series study. The Draf III procedure exposes excessive bare bone, resulting in frontal ostium restenosis and surgical failure. For tumors originating from frontal sinus, especially inverted papillomas, abrading of bone around frontal ostium often exacerbate the restenosis. This study aims to retrospectly recruit patients with frontal sinus inverted papillomas who received Draf III procedure in our center during 2015-2021 and investigated the efficacy of a novel pedicled nasoseptal flap for endoscopic frontal sinus procedures. Each subject received a CT and magnetic resonance imaging (MRI) scans before operation. The subjects were followed up postoperative for at least 12 months to check the epithelization status and whether the neo-ostium were patent.

详细描述

The standard Draf III procedure was performed as described by Gross and Wormald using an "outside-in" technique. The cranial portion of the nasal septum was removed, and the frontal process of the maxilla and frontal beak were carefully abraded, resulting in the "frontal T". Distinct to the procedure of Gross and Wormald, the frontal T was then lowered to the first branch of the anterior ethmoidal artery instead of the first olfactory fibre.

Tumors were totally resected under endoscope and lateral pedicled nasoseptal flaps were applied for covering the exposed bone around frontal neo-ostium. The pedicled nasoseptal flaps were applied in the experimental group and no flap was applied in the control group.

The pedicle of the flap was designed to be on the frontal process of the lateral nasal wall. The lateral anterior incision was approximately 1 cm anterior to the maxillary line, with the medial anterior limit in parallel on the septum. The lateral posterior limit was the maxillary line and medial posterior limit parallel to the anterior limit where the first branch of the anterior ethmoidal artery arises on ethmoidal roof. The lower limit of the septal part was at the level of the lower border of the middle turbinate. The flap was carefully elevated from the cartilage and bone, particularly the supra-axillary and olfactory fossa part. The flap was then persevered posteriorly in the nasal floor or maxillary sinus for subsequent use. The contralateral flap was harvested and preserved in a similar manner. Type 1 flaps consisted of mucosa over the lateral nasal wall, and type 2 flaps consisted of the aforementioned mucosa and corresponding septal mucosa.

All patients were followed up for at least 12 months, and the nasal cavity was assessed and cleaned regularly under endoscopy. The neo-ostium section area was compared to that at the end of surgery. Epithelization was identified if the neo-ostium were smooth without edema, discharging or crusting after surgery under endoscope. The time required for epithelialization of each patient was also recorded. Restenosis was defined as >50% reduction in the section area at 12 months postoperatively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with bilateral frontal inverted papilloma who received a endoscopic endonasal Draf III surgery.
  • Ages range from 18-85 years old.
  • Preoperative CT and MRI scanning show favourable frontal sinus pneumatization.
  • Patients who are willing to following up regularly with good compliance.

排除标准

  • Patients who had undergone prior partial septectomy or septal perforation.
  • Patients who can't finish a regular 1-year follow-up.

结局指标

主要结局

Whether or not the frontal neo-ostium was restenosed

时间窗: 12 months postoperatively

Patients were checked under endoscope, and restenosis of neo-ostium was defined as a reduction of more than 50% in the section area compared to that at the end of surgery.

Time needed for epithelization

时间窗: within 12 months postoperatively

Epithelization was defined if the neo-ostium and the fused frontal sinus were smooth without edema, discharging or crusting after surgery under endoscope. Time needed for each subject was recorded.

次要结局

未报告次要终点

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验