ChiCTR2600120848 版本V1.1 版本创建时间2026/03/22 23:31:07 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：

 ChiCTR2600120848 

最近更新日期：

Date of Last Refreshed on：

 2026-03-20 14:26:24 

注册时间：

Date of Registration：

 2026-03-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

单孔内窥镜与小切口推刀松解腕横韧带的临床对比研究

Public title：

A comparative clinical study on the release of transverse ligament of the wrist by single-hole endoscope and small incision pusher knife

注册题目简写：

English Acronym：

研究课题的正式科学名称：

单孔内窥镜与小切口推刀松解腕横韧带的临床对比研究

Scientific title：

A comparative clinical study on the release of transverse ligament of the wrist by single-hole endoscope and small incision pusher knife

研究课题代号(代码)：

Study subject ID：

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：

国赵阳 

研究负责人：

王继宏 

Applicant：

Guozhao Yang 

Study leader：

Wang Jihong 

申请注册联系人电话：

Applicant telephone：

 +86 134 0324 7893

研究负责人电话：

Study leader's
telephone：

+86 159 0489 5372

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：

 244192674@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 171263616@qq.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：

内蒙古自治区呼和浩特市赛罕区科尔沁南路59号

研究负责人通讯地址：

内蒙古自治区呼和浩特市赛罕区科尔沁南路59号

Applicant address：

No. 59, Horqin South Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

Study leader's address：

No. 59, Horqin South Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

内蒙古医科大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Inner Mongolia Medical University

研究负责人所在单位：

内蒙古医科大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Inner Mongolia Medical University

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：

 EFY20250090

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：

内蒙古医科大学第二附属医院

Name of the ethic committee：

The Second Affiliated Hospital of Inner Mongolia Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-12 00:00:00

伦理委员会联系人：

冯卫

Contact Name of the ethic committee：

Feng Wei

伦理委员会联系地址：

内蒙古自治区呼和浩特市赛罕区科尔沁南路59号

Contact Address of the ethic committee：

No. 59, Horqin South Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 137 0475 8115

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

内蒙古医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Inner Mongolia Medical University

研究实施负责（组长）单位地址：

内蒙古自治区呼和浩特市赛罕区科尔沁南路59号

Primary sponsor's address：

No. 59, Horqin South Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

内蒙古自治区

市(区县)：

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

单位(医院)：

内蒙古医科大学第二附属医院

具体地址：

内蒙古自治区呼和浩特市赛罕区科尔沁南路59号

Institution
hospital：

The Second Affiliated Hospital of Inner Mongolia Medical University

Address：

No. 59, Horqin South Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

经费或物资来源：

自费

Source(s) of funding：

At your own expense

研究疾病：

腕管综合征  

Target disease：

carpal tunnel syndrome

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：

随机平行对照 

Study design：

Parallel 

研究目的：

即对比单孔内窥镜与改良小切口推刀松解腕横韧带在治疗腕管综合征的临床效果，为临床选择更佳的治疗方案提供依据。  

Objectives of Study：

That is, to compare the clinical effect of single-port endoscopy and modified small incision to release the transverse carpal ligament in the treatment of carpal tunnel syndrome, so as to provide a basis for clinical selection of better treatment options.

药物成份或治疗方案详述：

手术方式：小切口推刀松解腕横韧带术：患者入手术室，常规术前准备，待局麻麻醉成功后，取仰卧位，上腕部止血带。术区常规消毒，铺无菌巾单。手术先取患肢沿手掌 KAPLAN 线与环指桡侧延长线交点位中心纵形切口，长约1.5cm，依次切开皮肤、皮下及筋膜，于掌长肌腱与桡侧屈腕肌肌腱之间部分切开腕横韧带，见腕横韧带肥厚，坚韧，压迫正中神经。用微型腕管推刀置于腕横韧带开口，将腕横韧带完整打开游离正中神经，见有一段正中神经有水肿，将神经鞘膜打开，见外膜增厚，受压神经有膨起，神经束间有粘连，彻底松解束间粘连后，彻底止血，冲洗后，清点纱布器械对数，逐层关口，置引流条后，无菌敷料包扎。手术顺利，术毕在麻醉师监护下安返病房。 单孔内窥镜腕横纹韧带松解术：患者入手术室，常规术前准备。待臂丛麻醉后，取仰卧位，上止血带。术区常规消毒，铺无菌巾单。手术取患肢腕关节掌侧横行切口，长约1.5cm，依次切开皮肤、皮下及筋膜，使用腕管专用开路器开出隧道，将正中神经保护器置入隧道，保护正中神经，上腕关节镜，进入隧道，通过腕关节经观察腕横韧带，见腕横韧带肥厚，坚韧，压迫正中神经。用微型腕管推刀置于腕横韧带开口，将腕横韧带完整打开游离正中神经，见有一段正中神经有水肿，将神经鞘膜打开，见外膜增厚，受压神经有膨起，神经束间有粘连，彻底松解束间粘连后，彻底止血，冲洗后，清点纱布器械对数，逐层关口。手术顺利，术毕在麻醉师监护下安返病房。 

Description for medicine or protocol of treatment in detail：

Surgical Procedure: Small Incision Push Knife Release of the Transverse Carpal Ligament: The patient was admitted to the operating room and underwent routine preoperative preparation. After successful local anesthesia, the patient was placed in a supine position with a tourniquet applied to the upper wrist. The surgical site was routinely disinfected and covered with sterile drapes. The procedure began with an incision approximately 1.5 cm long, made along the center of the intersection between the KAPLAN line of the palm and the radial extension of the ring finger. The skin, subcutaneous tissue, and fascia were sequentially incised. The transverse carpal ligament was partially incised between the palmaris longus tendon and the radial flexor carpi radialis tendon. The ligament was found to be thickened and tough, compressing the median nerve. A microcarpal tunnel push knife was placed at the opening of the transverse carpal ligament to completely release the ligament and expose the median nerve. Edema was observed in a segment of the median nerve. The nerve sheath was opened, revealing thickened outer membranes and compressed nerves with bulging. Adhesions between nerve bundles were thoroughly released. After complete hemostasis and irrigation, the number of gauze and instruments was counted. The incision was closed layer by layer, and a drainage strip was placed before sterile dressing. The procedure was successful, and the patient was transferred to the ward under the supervision of the anesthesiologist. Single-port endoscopic transverse carpal ligament release: The patient was admitted to the operating room and underwent routine preoperative preparation. After brachial plexus anesthesia, the patient was placed in a supine position with an upper tourniquet applied. The surgical site was routinely disinfected and covered with sterile gauze. A transverse incision approximately 1.5 cm long was made on the palmar side of the wrist joint of the affected limb. The skin, subcutaneous tissue, and fascia were sequentially incised. A dedicated carpal tunnel opener was used to create a tunnel, and a median nerve protector was placed into the tunnel to protect the median nerve. The anteroposterior wrist arthroscope was inserted into the tunnel, and the transverse carpal ligament was observed through the wrist joint. The ligament was found to be thickened and tough, compressing the median nerve. A microcarpal tunnel retractor was placed at the opening of the transverse carpal ligament to completely dissect and free the median nerve. Edema was observed in a segment of the median nerve. The nerve sheath was opened, revealing thickened outer membranes, protruding compressed nerves, and adhesions between nerve bundles. After thorough release of the interbundular adhesions, complete hemostasis was achieved. The site was irrigated, and the number of gauze and instruments was counted. The incision was closed layer by layer. The procedure was successful, and the patient was transferred to the ward under the supervision of the anesthesiologist. 

纳入标准：

1.结合病史、体征及神经电生理检查确诊为腕管综合征 2.“顾玉东腕管综合征分级标准”符合中度和重度的患者 3.保守治疗症状不缓解或持续加重 4.已获知情同意的患者；

Inclusion criteria

1. Patients diagnosed with carpal tunnel syndrome based on medical history, signs and neuroelectrophysiological examinations, 2. Patients with moderate and severe "Gu Yudong carpal tunnel syndrome grading criteria" 3. Patients whose symptoms are not alleviated or continue to worsen with conservative treatment, 4. Patients who have obtained informed consent;

排除标准：

1.既往已接受其它手术治疗； 2.手腕部外伤史以及腕管内有占位性病变等疾病的患者排除在外； 3.除了压迫以外引起神经功能障碍的任何原因，如糖尿病、肝肾功能不全、颈椎病等； 4.伴有严重自身免疫病，精神疾病的患者； 5.患有严重的基础病，或心脑肾等重要器官疾病，或心血管、凝血系统疾病,具有出血倾向等的患者； 6.未完成随访。

Exclusion criteria：

1. Patients who have undergone other surgical treatments in the past; 2. Patients with a history of wrist trauma and space-occupying lesions in the carpal tunnel are excluded; 3. Any cause of neurological dysfunction other than compression, such as diabetes, liver and kidney insufficiency, cervical spondylosis, etc.; 4. Patients with severe autoimmune diseases and psychiatric diseases; 5. Patients with serious underlying diseases, or diseases of important organs such as heart, brain and kidney, or cardiovascular and coagulation system diseases, and patients with bleeding tendency, etc. 6. did not complete follow-up.

研究实施时间：

Study execute time：

从 From 2024-06-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-06-01 00:00:00 至 To 2025-06-11 00:00:00

干预措施：

Interventions：

组别：

单孔内窥镜手术组

样本量：

 41

Group：

Single-port endoscopic surgery group

Sample size：

干预措施：

使用内窥镜进行手术

干预措施代码：

Intervention：

Surgery is performed using an endoscope

Intervention code：

组别：

小切口推刀手术组

样本量：

 39

Group：

Small incision pusher surgery group

Sample size：

干预措施：

使用小推刀进行手术

干预措施代码：

Intervention：

The operation was performed using a small pusher knife

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 内蒙古自治区 

市(区县)：

  

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

单位(医院)：

 内蒙古医科大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Inner Mongolia Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

波士顿评分量表

指标类型：

主要指标

Outcome：

Boston Rating Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

捏力

指标类型：

主要指标

Outcome：

Pinching force

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

握力

指标类型：

主要指标

Outcome：

grip strength

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Duration of surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院时间

指标类型：

次要指标

Outcome：

Length of hospital stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者满意度

指标类型：

次要指标

Outcome：

Patient satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

并发症情况

指标类型：

主要指标

Outcome：

Complications

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

温哥华瘢痕评估量表

指标类型：

主要指标

Outcome：

Vancouver Scar Assessment Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Posas评分

指标类型：

主要指标

Outcome：

Posas score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

not

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

采用区组随机法,由本项目的统计人员通过SAS软件生成随机分配表。

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

Using the block randomization method, the statistical personnel of this project generated a random allocation table through SAS software.

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：

患者和术者双盲

Blinding：

Patient and surgeon are double-blind

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）：

2026年6月 Vivli（https://vivli.org/）

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

June 2026 Vivli (https://vivli.org/)

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-03-20 14:26:04