ChiCTR2400082282 版本V1.0 版本创建时间2024/03/26 10:09:06 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400082282 

最近更新日期：

Date of Last Refreshed on：

 2024-03-26 10:07:42 

注册时间：

Date of Registration：

 2024-03-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

耳内镜下夹层法鼓膜修补手术的应用与示范

Public title：

Application and demonstration of using the sandwich method of repairing the eardrum during endoscopic

注册题目简写：

夹层法鼓膜修补手术的应用与示范

English Acronym：

Application and demonstration of using the sandwich method of repairing the eardrum

研究课题的正式科学名称：

耳内镜下夹层法鼓膜修补手术的应用与示范

Scientific title：

Application and demonstration of using the sandwich method of repairing the eardrum during endoscopic

研究课题代号(代码)：

Study subject ID：

 LC[2024]082

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

唐光俊 

研究负责人：

兰友兴 

Applicant：

Guangjun Tang 

Study leader：

Youxing Lan 

申请注册联系人电话：

Applicant telephone：

 +86 135 9530 2195

研究负责人电话：

Study leader's
telephone：

+86 135 9536 1911

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 tgjdoctor@163.com

研究负责人电子邮件：

Study leader's E-mail：

 lyxassymyy2022@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

贵州省安顺市西秀区黄果树大街140号

研究负责人通讯地址：

贵州省安顺市西秀区黄果树大街140号

Applicant address：

140 Huangguoshu Street, Xixiu District, Anshun City, Guizhou Province

Study leader's address：

140 Huangguoshu Street, Xixiu District, Anshun City, Guizhou Province

申请注册联系人邮政编码：

Applicant postcode：

 561000

研究负责人邮政编码：

Study leader's postcode：

 561000

申请人所在单位：

贵州省安顺市人民医院

Applicant's institution：

People's Hospital of Anshun city Guizhou Province

研究负责人所在单位：

贵州省安顺市人民医院

Affiliation of the Leader：

People's Hospital of Anshun city Guizhou Province

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 〔2023〕安市医伦理专 2 号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

安顺市人民医院医学伦理委员会

Name of the ethic committee：

People's Hospital of Anshun city Guizhou Province of Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-06-26 00:00:00

伦理委员会联系人：

虎飞燕

Contact Name of the ethic committee：

Feiyan Mao

伦理委员会联系地址：

贵州省安顺市西秀区黄果树大街140号

Contact Address of the ethic committee：

140 Huangguoshu Street, Xixiu District, Anshun City, Guizhou Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 183 3401 4787

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 2813852754@qq.com

研究实施负责（组长）单位：

贵州省安顺市人民医院

Primary sponsor：

People's Hospital of Anshun city Guizhou Province

研究实施负责（组长）单位地址：

贵州省安顺市西秀区黄果树大街140号

Primary sponsor's address：

140 Huangguoshu Street, Xixiu District, Anshun City, Guizhou Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州省

市(区县)：

安顺市

Country：

China

Province：

Guizhou Province

City：

Anshun City

单位(医院)：

安顺市人民医院

具体地址：

贵州省安顺市西秀区黄果树大街140号

Institution
hospital：

People's Hospital of Anshun city Guizhou Province

Address：

140 Huangguoshu Street, Xixiu District, Anshun City, Guizhou Province

经费或物资来源：

贵州省科学技术厅

Source(s) of funding：

Guizhou Provincial Department of Science and Technology

研究疾病：

中耳炎  

Target disease：

otitis media

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索耳内镜下夹层法鼓膜修补手术的疗效，为治疗中耳炎鼓膜修补提供理论依据。  

Objectives of Study：

To explore the effect of ear endoscope dissection tympanic membrane repair operation, and provide theoretical basis for the treatment of otitis media tympanic membrane repair.

药物成份或治疗方案详述：

使用德国STORz内镜显像系统和耳内镜(0°和30°，直径为3.0mm和4.0mm)，所有患者的手术均由同一位经验丰富的耳内镜术者完成。手术方法及步骤可保证一致性。术中实施控制性降压将血压维持在100／60mmHg水平。外耳道和耳屏(取植区)注射1％含肾上腺素10滴+0.9%生理盐水10ml局部浸润，减少术中出血。导入耳内镜，剔除穿孔鼓膜边缘约1mm上皮，形成新鲜创面，定位鼓环外侧约5～10mm处做一自6：00～12：00方向的切口。用环切刀精细剥离皮瓣到鼓环层面后仔细辨认鼓环结构，由点及面精细展开鼓膜上皮层使其与纤维层逐渐分离直至完整掀起全部鼓膜上皮层，将皮瓣堆积在外耳道前壁充分暴露完整纤维层鼓环。沿耳屏游离缘内侧约2mm处弧形切开耳屏皮肤，分离皮下组织，根据穿孔大小切取尺寸适宜的耳屏软骨膜，缝合耳屏切口。将裁剪好的耳屏软骨膜置于鼓膜上皮层与纤维层之间并完全覆盖穿孔边缘，复位鼓膜及耳道皮瓣。外耳道适量明胶海绵支撑，耳甲腔碘仿纱条填塞，防止耳屏血肿。 

Description for medicine or protocol of treatment in detail：

Using the German STORz endoscopic imaging system and otoendoscopy (0° and 30°, diameter 3.0mm and 4.0mm), all patients were operated on by the same experienced otoendoscopist. The surgical method and procedure can ensure consistency. Intraoperative controlled hypotension was performed to maintain blood pressure at 100/60mmHg level. The external ear canal and tragus (implantation area) were injected with 1% 10 drops of epinephrine +0.9% normal saline 10ml for local infiltration to reduce intraoperative bleeding. The ear endoscope was applied to remove the 1mm epithelium at the edge of the perforated tympanic membrane to form a fresh wound. An incision from 6:00 to 12:00 was made about 5-10mm outside the tympanic ring. The structure of the tympanic ring was carefully identified after the skin flap was finely peeled off to the tympanic ring layer with a ring knife. The upper layer of the tympanic membrane was finely expanded from the points and surfaces to gradually separate it from the fiber layer until the entire upper layer of the tympanic membrane was completely lifted, and the flap was accumulated on the front wall of the external auditory canal to fully expose the intact fiber layer of the tympanic ring. The skin of the tragus was incised in an arc about 2mm along the medial free edge of the tragus, the subcutaneous tissue was separated, and the tragus pericperiosteal of appropriate size was cut according to the perforation size, and the tragus incision was sutured. The cut perichondrium of the diaphus was placed between the upper layer of the tympanic membrane and the fibrous layer, and the perforated edge was completely covered, and the flap of the tympanic membrane and ear canal were reset. Appropriate amount of gelatin sponge support in the external ear canal and iodoform gauze filling in the ear conchae cavity can prevent tragus hematoma. 

纳入标准：

1）年龄 18-65周岁，性别不限； 2）慢性中耳炎或外伤导致鼓膜穿孔且 3 个月以上不愈合； 3）鼓膜穿孔位于紧张部，穿孔周围均有残余鼓膜的中央性穿孔； 4）患耳首次手术； 5）电测听结果提示传导性或混合性听力下降； 6）无鼓室炎症或炎症控制可，鼓室内无鳞状上皮侵入； 7）上鼓室、鼓窦和乳突无肉芽、胆脂瘤等异常等； 8）鼓室和乳突气房系统的黏膜炎症处于静息状态； 9）颞骨 CT 提示鼓室内听骨链完整； 10）无全身严重疾病，如心脑血管疾病、肝肾功能不全、造血系统疾病等； 11）能够理解并遵守研究流程，书面签署研究知情同意书表示自愿参加试验的受试者（知情同意书由本人或法定代理人签署）。

Inclusion criteria

1) Age 18-65 years old, gender is not limited; 2) Chronic otitis media or trauma caused by tympanic membrane perforation and more than 3 months do not heal; 3) The perforation of the tympanic membrane is located in the tense part, and there are central perforations of the residual tympanic membrane around the perforation; 4) First operation on the ear; 5) Electrical audiometry results suggest conductive or mixed hearing loss; 6) There is no tympanic inflammation or inflammation control, and no squamous epithelial invasion in the tympanic chamber; 7) The upper tympanum, tympanic sinus and mastoid were free of granulations, cholesteroma and other abnormalities; 8) Mucosal inflammation in tympanic and mastoid air chamber systems was in a resting state; 9) CT of temporal bone indicates that the auditory chain in the tympanic chamber is intact; 10) No serious systemic diseases, such as cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, hematopoietic system diseases; 11) Subjects who are able to understand and abide by the study procedures and voluntarily participate in the study by signing the informed consent form (the informed consent is signed by themselves or their legal representatives).

排除标准：

(一)相对禁忌证: 1）心肺功能不全； 2）凝血功能障碍者； 3）中耳胆脂瘤、化脓性中耳炎急性期； 4）耳内镜手术操作空间和视野小的患者。 (二)绝对禁忌证: 1）严重心肺疾患，如严重心律亲乱、心肌梗塞急性期、重度心力衰竭、哮喘发作期、呼吸衰竭不能平卧等患者。 2）疑有休克、消化道穿孔等危重患者。 3）严重精神失常不合作的精神病患者。 4）合并慢性化脓性中耳炎颅内外并发症、中耳胆脂瘤、鼓室硬化(Ⅱ、Ⅲ、Ⅳ型)； 5）中耳粘连； 6）合并外中内耳畸形； 7）合并全身系统性疾病无法耐受全麻者； 8）合并精神类疾病。

Exclusion criteria：

(1) Relative contraindications: 1) cardiopulmonary insufficiency; 2) People with coagulation disorders; 3) middle ear cholesteatoma, suppurative otitis media acute stage; 4) Patients with small operating space and visual field in endoscopic surgery. (2) Absolute contraindications: 1) Patients with severe cardiopulmonary diseases, such as severe arrhythmia, acute stage of myocardial infarction, severe heart failure, asthma attack, respiratory failure and so on. 2) Suspected shock, gastrointestinal perforation and other critical patients. 3) Severe mental disorders and uncooperative mental patients. 4) Complicated with intracranial and extracranial complications of chronic suppurative otitis media, cholesteatoma of the middle ear, tympanosclerosis (types Ⅱ, Ⅲ, Ⅳ); 5) middle ear adhesions; 6) Combined with external, middle and inner ear deformity; 7) Patients with systemic diseases who cannot tolerate general anesthesia; 8) Combined with mental illness.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2024-12-01 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 30

Group：

observation group

Sample size：

干预措施：

耳内镜下行夹层法鼓膜修补

干预措施代码：

Intervention：

Using the sandwich method of repairing the eardrum during endoscopic

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州省 

市(区县)：

 安顺市 

Country：

China

Province：

Guizhou Province

City：

Anshun City

单位(医院)：

 贵州省安顺市人民医院 

单位级别：

 三甲 

Institution
hospital：

People's Hospital of Anshun city Guizhou Province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

手术时间

指标类型：

主要指标

Outcome：

time of operation

Type：

Primary indicator

测量时间点：

手术当天

测量方法：

时钟

Measure time point of outcome：

The day of the operation

Measure method：

clock

指标中文名：

鼓膜恢复情况

指标类型：

主要指标

Outcome：

Tympanic membrane recovery

Type：

Primary indicator

测量时间点：

术后 2 周、术后１个月、术后３个月、术后半年

测量方法：

内镜检查

Measure time point of outcome：

2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery

Measure method：

endoscopy

指标中文名：

听力恢复情况

指标类型：

主要指标

Outcome：

Hearing recovery

Type：

Primary indicator

测量时间点：

术后 1 个月、术后 3 个月、术后 6 个月

测量方法：

纯音听阈检查

Measure time point of outcome：

1 month, 3 months and 6 months after surgery

Measure method：

pure tone threshold test

指标中文名：

鼓室曲线恢复情况

指标类型：

主要指标

Outcome：

Tympanic curve recovery

Type：

Primary indicator

测量时间点：

术后 1 个月、术后 3 个月、术后 6 个月

测量方法：

声导抗检查

Measure time point of outcome：

1 month, 3 months and 6 months after surgery

Measure method：

Acoustic immittance check

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

No

Tissue：

No

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

No

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

我们将严格贯彻盲法精神相分离原则，在实验过程中，研究实施者不参与实验数据的统计，对资料统计分析者设盲，而盲底则只有研究设计者知道，并由专人保管；避免向受试者透露分组、治疗等相关信息(涉及患者知情的内容除外）

Blinding：

We will strictly implement the principle of mental phase separation of the blind method. In the process of experiment, the implementer of the research will not participate in the statistics of the experimental data, and the statistical analysis of the data will be blind, and the blind bottom will only be known by the research designer and kept by a special person. Avoid disclosing grouping, treatment and other related information to subjects (except content involving patient knowledge)

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

研究者及时登录ResMan临床试验公共管理平台（www.medresman.org.cn)录入电子数据

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The investigators will log into Clinical Trial Public Management platform (www.medresman.org.cn) in time to input electronic data

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

研究者格局受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表。经过监督员审核、签字后的调查表应及时送交临床研究数据管理员。研究者及时登录ResMan临床试验平台(Web-based Electronic Data Capture, EDC)录入电子数据，同时经临床研究数据管理员核实纸质数据与电子数据是否一致，期间若发现问题及时通知监察员，要求研究者做出回答。他们之间的各种疑问及解答的交换应采用疑问表形式，

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The original observation records of subjects were arranged by researchers, and the data were timely, completely, correctly and clearly recorded in the case report form. The questionnaire reviewed and signed by the supervisor should be sent to the clinical research data manager in time. The researchers timely log in to resman clinical trial platform (www.medresman.org) to input electronic data. Meanwhile, the clinical research data manager verifies whether the paper data is consistent with the electronic data. If any problem is found during the period, the inspector shall be informed in time and the researcher shall be asked to answer. The exchange of questions and answers between them should be in the form of question table, which should be kept for reference.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-26 10:07:42