A clinical study was conducted to investigate the potential of diffusion tensor imaging (DTI) in the diagnosis and efficacy evaluation of perianal abscesses with hyperthermic toxicity.

注册号:

Registration number:

ITMCTR2025000068

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

弥散张量成像对热毒炽盛型肛周脓肿疾病诊断及疗效评估的临床研究

Public title:

A clinical study was conducted to investigate the potential of diffusion tensor imaging (DTI) in the diagnosis and efficacy evaluation of perianal abscesses with hyperthermic toxicity.

注册题目简写:

弥散张量成像对肛周脓肿疾病诊断及疗效评估

English Acronym:

Diffusion tensor imaging in the diagnosis of perianal abscess and evaluation of therapeutic effect

研究课题的正式科学名称:

弥散张量成像对热毒炽盛型肛周脓肿疾病诊断及疗效评估的临床研究

Scientific title:

A clinical study was conducted to investigate the potential of diffusion tensor imaging (DTI) in the diagnosis and efficacy evaluation of perianal abscesses with hyperthermic toxicity.

研究课题的正式科学名称简写:

弥散张量成像对肛周脓肿疾病诊断及疗效评估

Scientific title acronym:

Diffusion tensor imaging in the diagnosis of perianal abscess and evaluation of therapeutic effect

研究课题代号(代码):

Study subject ID:

2023SHL-KYYS-104

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:

梅苹苹

研究负责人:

陈龑

Applicant:

Pingping Mei

Study leader:

Yan Chen

申请注册联系人电话:

Applicant telephone:

+86 187 8427 0941

研究负责人电话:

Study leader's telephone:

+86 159 2103 8033

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:

MPP1125069522@163.com

研究负责人电子邮件:

Study leader's E-mail:

498357632@qq.com

申请单位网址(自愿提供):

Study leader's 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:

上海市嘉定区荣联路68号上海市中医医院

研究负责人通讯地址:

上海市嘉定区荣联路68号上海市中医医院

Applicant address:

Shanghai Municipal Hospital of Traditional Chinese Medicin Lane 68 Ronglian Road Jiading Area Shanghai China

Study leader's address:

Shanghai Municipal Hospital of Traditional Chinese Medicine Lane 68 Ronglian Road Jiading Area Shanghai China

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:

上海市中医医院

Applicant's institution:

Shanghai municipal Hospital of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2023SHL-KYYS-104

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海市中医医院伦理委员会

Name of the ethic committee:

Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2023/9/11 0:00:00

伦理委员会联系人:

樊天佑

Contact Name of the ethic committee:

Tianyou Fan

伦理委员会联系地址:

上海市嘉定区荣联路68号上海市中医医院

Contact Address of the ethic committee:

Shanghai Municipal Hospital of Traditional Chinese Medicine Lane 68 Ronglian Road Jiading Area Shanghai China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 56639828

伦理委员会联系人邮箱:

Contact email of the ethic committee:

kycscy@126.com

研究实施负责(组长)单位:

上海市中医医院

Primary sponsor:

Shanghai municipal Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市嘉定区荣联路68号上海市中医医院

Primary sponsor's address:

Shanghai Municipal Hospital of Traditional Chinese Medicine Lane 68 Ronglian Road Jiading Area Shanghai China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

Institution
hospital:

Shanghai municipal Hospital of Traditional Chinese Medicine,

Address:

经费或物资来源:

上海市科学技术委员会

Source(s) of funding:

The Shanghai Municipal Commission of Science and Technology (SMCTS)

研究疾病:

肛周脓肿

研究疾病代码:

Target disease:

perianal abscess

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究的主要⽬标为借助弥散张量成像(DTI)影像序列对热毒炽盛型肛周脓肿患者的内⼝、感染浸润程度、脓肿范围以及侵蚀肛管直肠周围组织肌⾁的关系进⾏清晰显示,寻求⼀种精准诊断该疾病的影像学评估⽅法,探索DTI在诊断肛周脓肿的应⽤价值,提⾼术前评估准确率,减少对肛⻔括约肌的伤害,降低复发率,改善预后和患者⽣活质量

Objectives of Study:

The main objective of this study is to clearly display the relationship between the internal opening degree of infection extent of abscess and erosion of the muscle tissue around the anus and rectum in patients with severe anal abscesses caused by hot toxicity using diffusion tensor imaging (DTI) imaging sequences. The study aims to seek a precise imaging assessment method for diagnosing this disease explore the application value of DTI in diagnosing anal abscesses improve the accuracy of preoperative assessment reduce damage to the anal sphincter lower the recurrence rate improve prognosis and quality of life for patients.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①知情同意并签署知情同意书;②符合⻄医及中医热毒炽盛证型肛周脓肿诊断标准者;③年 龄在18-80岁;④⾃愿接受配合完成要求的⼿术治疗;⑤参加本试验研究期间不接受其他治疗⽅案

Inclusion criteria

The inclusion criteria are as follows: 1. Informed consent and signed informed consent form. 2. Meeting the diagnostic criteria of perianal abscess according to both Western medicine and traditional Chinese medicine syndrome of heat and toxin. 3. Aged 18–80 years. 4. Willing to participate and cooperate in completing the required surgical treatment. 5. Agree to participate in this experimental study without accepting any other treatment options.

排除标准:

①年龄⼩于15岁或超过80岁者;②拒绝本课题治疗⽅案的患者;③合并肝、肾、造⾎系统、内分泌系统、⼼脑⾎管、神经系统等严重原发性疾病、结核、椎体畸形、恶性肿瘤及精神病患者;④怀疑镇静催眠药、阿⽚类镇痛药及酒精滥⽤史者;有⽪肤性疾病及传染性疾病的患者;⑤有⾦属植⼊物不能⾏MRI者;⑥妊娠、准备妊娠或者哺乳期的⼥性;⑦其他原因不宜或不能应⽤本治疗⽅法的患者;⑧有精神障碍、语⾔障碍、运动功能障碍、⼼理疾病的患者。

Exclusion criteria:

1. Patients younger than 15 years old or older than 80 years old. 2. Patients who refuse to participate in the study. 3. Patients with severe primary diseases of the liver kidney hematopoietic system endocrine system cardiovascular and cerebrovascular system nervous system tuberculosis vertebral malformation malignant tumors or mental illness. 4. Patients with a suspected history of abuse of sedative-hypnotics opioid analgesics or alcohol. Patients with skin diseases or infectious diseases. 5. Individuals with metal implants who cannot undergo MRI. 6. Pregnant women women preparing to become pregnant or lactating women. 7. Individuals who are not suitable or unable to use this treatment for other reasons. 8. Individuals with mental disorders language disorders motor dysfunction or psychological diseases.

研究实施时间:

Study execute time:

From 2023-12-01

To      2026-11-30

征募观察对象时间:

Recruiting time:

From 2024-04-01

To      2025-12-31

干预措施:

Interventions:

组别:

MR组

样本量:

45

Group:

MR Group

Sample size:

干预措施:

选用常规MRI图像

干预措施代码:

Intervention:

Use of conventional MRI images

Intervention code:

组别:

DTI组

样本量:

45

Group:

DTI group

Sample size:

干预措施:

选用弥散张量成像(DTI)影像序列

干预措施代码:

Intervention:

Diffusion tensor imaging (DTI) sequences selected

Intervention code:

样本总量 Total sample size : 90

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

单位级别:

三甲

Institution/hospital:

Shanghai municipal Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

术后6月复发率

指标类型:

主要指标

Outcome:

Recurrence rate at 6 months after surgery.

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

与肛门括约肌复合体的关系

指标类型:

次要指标

Outcome:

The relationship between the abscess and the anal sphincter

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者的肛管和直肠各层厚度

指标类型:

次要指标

Outcome:

The differences in the thickness of the various layers of the anal canal

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

提肛肌和内外括约肌厚度

指标类型:

次要指标

Outcome:

rectum and the thickness of the anal sphincter and the internal and external sphincters of the patients.

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肛提肌 有无受累及提肛肌上有无病变

指标类型:

次要指标

Outcome:

Whether the anal sphincter was involved and whether the upper part of the anal sphincter is diseased

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脓腔的位置,深度

指标类型:

次要指标

Outcome:

Location of the perianal abscess and Depth of the abscess in relation to the anal sphincter

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Wexner 肛门失禁评分

指标类型:

次要指标

Outcome:

The Wexner Anal Incontinence Score (Wexner 1990) is a tool used to assess the severity of anal incontinence.

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

累及肛提肌的范围

指标类型:

次要指标

Outcome:

Extent of involvement of the anal sphincter in the infection

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后第3、7天疼痛评分(VAS)

指标类型:

次要指标

Outcome:

The postoperative pain score (VAS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

检测外周血IL-1、IL-6、TNF-α等炎症因子

指标类型:

次要指标

Outcome:

Peripheral blood samples were collected to determine levels of IL-1 IL-6 TNF-α and other inflammatory factors

Type:

Secondary 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:

血液

组织:

Sample Name:

Blood

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

Table of random numbers

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

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

none

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:

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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