Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Incidence of soft palate injury
研究概览
简要总结
This study aims to evaluate whether the use of full-wrap suspension, compared with the traditional double-strap suspension, can effectively reduce the risk of intraoperative and postoperative soft palate injury in transoral/transnasal pharyngeal surgery. Through a prospective, multicenter, randomized controlled design, this study will provide evidence-based support for the clinical promotion and standardized application of full-wrap suspension.
详细描述
This study is a prospective, parallel-group, multicenter clinical study. A total of 138 subjects will be enrolled, including 69 in the control group (using double-strap suspension) and 69 in the experimental group (using full-wrap suspension). By comparing the incidence of soft palate injury, postoperative pain score (VAS), healing time of soft palate injury, incidence of non-soft-palate complications, and System Usability Scale (SUS) score between the two groups, the study aims to investigate whether the use of full-wrap suspension can effectively reduce soft palate injury caused by intraoperative manipulation.
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
- None
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form; for patients aged <18 years, the informed consent form must be signed by their legal guardian.
- •Age between 2 and 70 years (inclusive), male or female.
- •Patients requiring transoral surgery of the nose, pharynx, parapharyngeal space, or skull base, in which intraoperative soft palate suspension is needed.
- •Intact soft palate mucosa with no ulcers, scars, or other lesions before surgery.
排除标准
- •Congenital cleft palate or submucous cleft palate.
- •Patients with limited cervical spine mobility, micrognathia, or other conditions affecting surgical exposure.
- •Pregnant or breastfeeding women.
- •Presence of markedly abnormal laboratory test results, such as significant abnormalities in routine blood tests, blood biochemistry, liver and kidney function, or coagulation function.
- •Patients with active infection or infectious diseases.
- •Severe cardiac insufficiency (NYHA class III-IV).
- •Other conditions deemed unsuitable for surgery after evaluation (e.g., concomitant severe heart, brain, or lung diseases; high anesthetic risk; patients not fit for surgery).
研究组 & 干预措施
Control Group
In the control group, the double-strap suspension method is used intraoperatively. Thin straps are inserted into both nasal cavities, pulled out through the oral cavity, then connected and fixed at both ends to lift the soft palate and ensure adequate exposure of the nasopharynx.
干预措施: Intraoperative soft palate suspension using the double-strap method. (Procedure)
Experimental Group
In the experimental group, the full-wrap suspension method is used. The fixation string attached to one end of the full-wrap protective sleeve is inserted through the nasal cavity, pulled out through the choanae (posterior nares), and then connected to the main body of the sleeve. The main body is then inserted through the oral cavity, moved into position around the soft palate, adjusted and fixed to suspend the soft palate and expose the nasopharynx.
干预措施: Intraoperative soft palate suspension using the full-wrap method. (Procedure)
结局指标
主要结局
Incidence of soft palate injury
时间窗: 24 hours, 1 week, and 1 month postoperatively
Observe the oropharynx (including the condition of the soft palate mucosa) of all patients using an endoscope, and simultaneously take photographs for documentation.
次要结局
- Healing time of soft palate injury(24 hours, 1 week, and 1 month postoperatively)
- Incidence of complications not related to soft palate injury(24 hours, 1 week, and 1 month postoperatively)
- Postoperative VAS pain score(24 hours, 1 week, and 1 month postoperatively)
- System Usability Scale (SUS) score(Within 24 hours postoperatively)
研究者
Ming-Yuan Chen
Professor, Chief physician
Fifth Affiliated Hospital, Sun Yat-Sen University