Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Nasal morbidity
研究概览
简要总结
This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity.
详细描述
The study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. Each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single blinded study, only the participant is blinded to the group he is going to be in.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with symptomatic pituitary macroadenoma
- •Tumor size ≥ 2 cm
排除标准
- •-Absent sphenoid pneumatization.
- •Temporal or frontal extension.
- •Recurrent pituitary tumor after previous surgery.
- •Previous nasal surgery.
- •Associated nasal disease e.g. rhinosinusitis.
- •Unfit for general anesthesia.
- •Refusal of surgical intervention or signing consent.
研究组 & 干预措施
Double nasoseptal flap
Nasoseptal double flap group:
-On one side full sized nasoseptal flap will be elevated and a smaller sized nasoseptal flap will be elevated on the other side.
干预措施: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique (Procedure)
Rescue nasoseptal flap
Nasoseptal rescue flap group:
- A horizontal incision will be performed in the nasal septum in a posterior to anterior direction starting from the sphenoid ostium to a point opposite anterior end of the middle turbinate ( approximately up to one half of septum).
干预措施: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique (Procedure)
结局指标
主要结局
Nasal morbidity
时间窗: at baseline preoperative and 1 month and 3 months postoperative.
Sinonasal Outcome Test 22 (SNOT-22) arabic translation questionnaire for nasal morbidity SinoNasal Outcome Test - 22 abbreviated (SNOT-22) includes 22 items for assessment by the patient. Each item is graded from 0 to 5. The minimum score is 0. The maximum score is 110. High score means higher nasal morbidity. Low scores mean better nasal morbidity.
次要结局
- Operative data(at time of surgery)