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Clinical study of oral administration of Lianqi Pills to promote postoperative wound repair after TROPIS surgery for intersphincteric anal fistula

注册号：

Registration number：

ITMCTR2025001208

最近更新日期：

Date of Last Refreshed on：

2025-06-18

注册时间：

Date of Registration：

2025-06-18

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

口服连七丸促进括约肌间型肛瘘TROPIS术后创面修复的临床研究

Public title：

Clinical study of oral administration of Lianqi Pills to promote postoperative wound repair after TROPIS surgery for intersphincteric anal fistula

注册题目简写：

English Acronym：

研究课题的正式科学名称：

口服连七丸促进括约肌间型肛瘘TROPIS术后创面修复的临床研究

Scientific title：

Clinical study of oral administration of Lianqi Pills to promote postoperative wound repair after TROPIS surgery for intersphincteric anal fistula

研究课题的正式科学名称简写：

Scientific title acronym：

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：

倪嘉淳

研究负责人：

王振宜

Applicant：

Jiachun Ni

Study leader：

Zhenyi Wang

申请注册联系人电话：

Applicant telephone：

18501659120

研究负责人电话：

Study leader's telephone：

18917073775

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：

15901819387@163.com

研究负责人电子邮件：

Study leader's E-mail：

drxinhuo@163.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：

上海市虹口区甘河路110号1号楼20楼

研究负责人通讯地址：

上海市虹口区甘河路110号1号楼20楼

Applicant address：

20th Floor Building 1 No. 110 Ganhe Road Hongkou District Shanghai

Study leader's address：

20th Floor Building 1 No. 110 Ganhe Road Hongkou District Shanghai

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：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University 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：

2025-148

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：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/5/29 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号8号楼伦理委员会办公室

Contact Address of the ethic committee：

Ethics Committee Office Building 8 No. 110 Ganhe Road Hongkou District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-65161782*8122

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

No. 110 Ganhe Road Hongkou District Shanghai

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(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 110 Ganhe Road Hongkou District Shanghai

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

肛瘘

研究疾病代码：

Target disease：

anal fistula

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

探究口服连七丸是否可缩短括约肌间型肛瘘患者TROPIS术后创面愈合时间、减少创面炎症因子表达、巨噬细胞极化及对创面菌群的影响。

Objectives of Study：

To explore whether oral administration of Lianqi Pills can shorten the wound healing time after TROPIS surgery in patients with intersphincter anal fistula reduce the expression of inflammatory factors in the wound macrophage polarization and its influence on the wound microbiota.

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）符合括约肌间型肛瘘西医诊断标准及肛瘘湿热下注证中医诊断标准者； （2）年龄≥18周岁且≤65周岁，性别不限； （3）拟于我院进行经肛括约肌间切开术，无手术禁忌症； （4）知晓、同意参加本研究，愿意按照要求接受治疗、定期随访且在治疗期间不实用任何可能影响术后创面愈合的药物，并签署知情同意书。

Inclusion criteria

(1) Meet the western medical diagnostic criteria of inter-sphincteric anal fistula and the Chinese medical diagnostic criteria of anal fistula with syndrome of dampness-heat diffusing downward; (2) Age ≥18 years old and ≤65 years old gender is not limited; (3) intend to undergo transanal opening of intersphincteric space in our hospital without contraindications to surgery; (4) Knowing and agreeing to participate in this study willing to receive treatment according to the requirements regular follow-up and not practical any drugs that may affect postoperative wound healing during the treatment period and signing the informed consent form.

排除标准：

（1）合并有造血、凝血机能障碍者； （2）合并有严重心脑血管及肝肾疾病或不受控的代谢疾病者； （3）合并有结核、肿瘤、炎症性肠病或其他可能影响术后创面愈合的疾病者； （4）近期有备孕需求或处于妊娠期或哺乳期者； （5）合并有不受控的精神疾病，治疗期间无法全程配合者； （6）对本研究所用药物过敏者； （7）同时参与其他临床研究者。

Exclusion criteria：

(1) Combined with hematopoietic and coagulation disorders; (2) Those with a combination of serious cardiovascular cerebrovascular and hepatic or renal diseases or uncontrolled metabolic diseases; (3) Those with the combination of tuberculosis tumor inflammatory bowel disease or other diseases that may affect postoperative wound healing; (4) Those who have a recent need to prepare for pregnancy or are in the period of pregnancy or breastfeeding; (5) Those who have uncontrolled mental illnesses and cannot cooperate with the whole process during the treatment; (6) Those who are allergic to the drugs used in this study; (7) Participating in other clinical studies at the same time.

研究实施时间：

Study execute time：

从From 2025-06-25

至To      2026-02-28

征募观察对象时间：

Recruiting time：

从From 2025-06-25

至To      2026-02-28

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

常规换药

干预措施代码：

Intervention：

Routine dressing changes

Intervention code：

组别：

试验组

样本量：

30

Group：

Test group

Sample size：

干预措施：

口服连七丸结合常规换药

干预措施代码：

Intervention：

Take Lianqi Pills orally

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

虹口

Country：

China

Province：

Shanghai

City：

Hongkou

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等医院

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

创面组织中巨噬细胞极化情况

指标类型：

次要指标

Outcome：

Macrophage polarization in wound tissue

Type：

Secondary indicator

测量时间点：

术中、术后一周

测量方法：

与术中、术后一周取患者创面组织行流式细胞分析，筛选出巨噬细胞，探究连七丸对创面组织中巨噬细胞极化的影响。 创面组织采集方式：1）术中：将手术中的切下的瘘管组织置于无菌EP管中低温运送至实验室检测；2）术后一周：用生理盐水棉球擦拭创面，后将擦拭过的棉球置于无菌EP管内，低温运送至实验室检测。

Measure time point of outcome：

Intraoperative and one week postoperative

Measure method：

With intraoperative and one week after the operation, the patient's traumatic tissue was taken for flow cytometric analysis to screen out macrophages and investigate the effect of Lianqi pill on macrophage polarization in traumatic tissue. The traumatic tissue was collected in the following ways: 1) intraoperatively: the fistula tissue excised during surgery was placed in a sterile EP tube and transported to the laboratory at low temperature.

指标中文名：

复发情况

指标类型：

次要指标

Outcome：

Recurrence rate

Type：

Secondary indicator

测量时间点：

术后3月、6月与1年

测量方法：

于术后3月、6月与1年随访患者，判断患者术后是否复发，复发率=（复发人数/总人数）×100%

Measure time point of outcome：

Three months, six months and one year after the operation

Measure method：

The patients were followed up at 3 months, 6 months and 1 year after the operation to determine whether there was recurrence after the operation. Relapse rate = (number of relapses/total number of patient) x 100%

指标中文名：

创面愈合时间

指标类型：

次要指标

Outcome：

Wound healing time

Type：

Secondary indicator

测量时间点：

从术后直至创面愈合

测量方法：

创面愈合时间即为创面完全上皮化所需要的时间，上皮化依靠肉眼观察。

Measure time point of outcome：

From the operation until the wound heals

Measure method：

The wound healing time is the time required for complete epithelialization of the wound, and epithelialization is observed with the naked eye.

指标中文名：

术后创面炎症因子

指标类型：

次要指标

Outcome：

Postoperative wound inflammatory factors

Type：

Secondary indicator

测量时间点：

术后3天、1周、2周、4周

测量方法：

于术后3天、1周、2周、4周时取患者创面分泌物，检测其中炎症因子的表达水平

Measure time point of outcome：

Three days, one week, two weeks and four weeks after the operation

Measure method：

The secretions of the patients' wounds were collected at 3 days, 1 week, 2 weeks and 4 weeks after the operation to detect the expression levels of inflammatory factors

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse event

Type：

Adverse events

测量时间点：

术后至创面愈合

测量方法：

严格观察受试者不良事件发生情况

Measure time point of outcome：

From the operation to the wound healing

Measure method：

Strictly observe the occurrence of adverse events in the subjects

指标中文名：

术后一月创面显愈率

指标类型：

主要指标

Outcome：

The postoperative wound healing rate in the first month

Type：

Primary indicator

测量时间点：

术后一月

测量方法：

于术后一月内各组患者统计创面显愈率，创面显愈率=（痊愈人数+显效人数）/总人数×100%

Measure time point of outcome：

One month after the operation

Measure method：

The wound healing rate of patients in each group was statistically analyzed within one month after the operation. The wound healing rate = (number of cured people + number of people with significant improvement)/total number of people ×100%.

指标中文名：

肝肾功

指标类型：

副作用指标

Outcome：

Liver and kidney function tests

Type：

Adverse events

测量时间点：

术后一月

测量方法：

抽取受试者静脉血

Measure time point of outcome：

one month post-operative

Measure method：

Drawing of venous blood from the subject

指标中文名：

血常规

指标类型：

副作用指标

Outcome：

Blood routine examination

Type：

Adverse events

测量时间点：

术后一月

测量方法：

抽取受试者静脉血

Measure time point of outcome：

one month post-operative

Measure method：

Drawing of venous blood from the subject

指标中文名：

创面菌群16sr RNA检测

指标类型：

次要指标

Outcome：

Detection of 16sr RNA of wound microbiota

Type：

Secondary indicator

测量时间点：

术前、术后一周

测量方法：

与术前、术后一周取创面渗出物行16sr RNA检测，有对比治疗前后的菌群组成、丰度变化

Measure time point of outcome：

Pre-operative and one week post-operative

Measure method：

With preoperative and one-week postoperative wound exudates were taken for 16sr RNA testing, there were comparisons of changes in flora composition and abundance before and after treatment

指标中文名：

创面改良图像伤口评价工具评分

指标类型：

次要指标

Outcome：

Wound evaluation tool score for improved wound images

Type：

Secondary indicator

测量时间点：

术后第3天、第1周、第2周、第4周

测量方法：

于术后第3天、第1周、第2周、第4周对创面进行拍照并用创面改良图像伤口评价工具进行评分，分数越低则创面愈合情况越好

Measure time point of outcome：

On the 3rd day, the 1st week, the 2nd week and the 4th week after the operation

Measure method：

The wound were photographed on the 3rd day, 1st week, 2nd week and 4th week after the operation and scored using the modified image wound evaluation tool. The lower the score, the better the wound healing condition

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

渗出物

组织：

Sample Name：

Exudation

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
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）：

研究者采用SAS软件将001-060号受试者随机分为试验组与对照组，各患者按时间顺序入组

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

The researchers randomly divided subjects 001-060 into the experimental group and the control group using SAS software and each patient was enrolled in chronological order

盲法：

Blinding：

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）：

如需原始数据可联系项目负责人

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

Datasets are available on request: The raw data supporting the conclusions of this article will be made available by the researchers

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：

数据记录于病例记录表中

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

The data are recorded in the case record form

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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