ChiCTR2300073698 版本V1.0 版本创建时间2023/07/19 10:23:04 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：

ChiCTR2300073698 

最近更新日期：

Date of Last Refreshed on：

2023-07-19 10:23:00 

注册时间：

Date of Registration：

2023-07-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Endoscopic Pilonidal Sinus Treatment (EPSiT) For Sacrococcygeal Pilonidal Sinus Disease: A Prospective Long-Term Study

Public title：

Endoscopic Pilonidal Sinus Treatment (EPSiT) For Sacrococcygeal Pilonidal Sinus Disease: A Prospective Long-Term Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Endoscopic Pilonidal Sinus Treatment (EPSiT) For Sacrococcygeal Pilonidal Sinus Disease: A Prospective Long-Term Study

Scientific title：

Endoscopic Pilonidal Sinus Treatment (EPSiT) For Sacrococcygeal Pilonidal Sinus Disease: A Prospective Long-Term Study

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：

Sehrish 

研究负责人：

Mohammad Amir 

Applicant：

Sehrish 

Study leader：

Muhammad Amir 

申请注册联系人电话：

Applicant telephone：

0923444264696

研究负责人电话：

Study leader's telephone：

0923215113460

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：

sehrish64@live.com

研究负责人电子邮件：

Study leader's E-mail：

mamir99@yahoo.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：

sehrish64@live.com

研究负责人通讯地址：

mamir99@yahoo.com

Applicant address：

shifa college of medicine, shifa tameer e millat university islamabad

Study leader's address：

Shifa international hospital; Shifa college of medicine

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：

shifa college of medicine, shifa tameer e millat university islamabad

Applicant's institution：

shifa college of medicine, shifa tameer e millat university islamabad

研究负责人所在单位：

Shifa international hospital; Shifa college of medicine

Affiliation of the Leader：

Shifa international hospital; Shifa college of medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

IRB # 660-108

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：

institutional review board and ethical committee of shifa tameer e millat university and shifa international hospital

Name of the ethic committee：

institutional review board and ethical committee of shifa tameer e millat university and shifa international hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2014-07-01 00:00:00

伦理委员会联系人：

EJAZ A KHAN

Contact Name of the ethic committee：

EJAZ A KHAN

伦理委员会联系地址：

Shifa international hospital, islamabad

Contact Address of the ethic committee：

Shifa international hospital, islamabad

伦理委员会联系人电话：

Contact phone of the ethic committee：

0518463000

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：

Shifa international hospital

Primary sponsor：

Shifa international hospital

研究实施负责（组长）单位地址：

Shifa international hospital

Primary sponsor's address：

Shifa international hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

pakistan

省(直辖市)：

islamabad

市(区县)：

Country：

pakistan

Province：

islamabad

City：

单位(医院)：

Shifa international hospital

具体地址：

Shifa international hospital

Institution
hospital：

Shifa international hospital

Address：

Shifa international hospital

经费或物资来源：

nil

Source(s) of funding：

nil

Target disease：

pilonidal sinus

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The primary outcomes were duration of healing, post-operative morbidities, persistence of discharge and recurrence at 1-7 years (for cases enrolled in 2021 from 2015 respectively). The secondary outcomes were operative time, return to work, cosmetic results and patients satisfaction. Patients were observed for wound healing and discharge on follow up in OPD at 1, 3, 6 and 24 weeks. They were further followed up every year through telephonic survey for persistence or recurrence of symptoms. Patients satisfaction was assessed according to 36- Item Short Form Survey (SF-36) questionnaire filled at admission and then at 6 weeks after the surgery  

Objectives of Study：

The primary outcomes were duration of healing, post-operative morbidities, persistence of discharge and recurrence at 1-7 years (for cases enrolled in 2021 from 2015 respectively). The secondary outcomes were operative time, return to work, cosmetic results and patients satisfaction. Patients were observed for wound healing and discharge on follow up in OPD at 1, 3, 6 and 24 weeks. They were further followed up every year through telephonic survey for persistence or recurrence of symptoms. Patients satisfaction was assessed according to 36- Item Short Form Survey (SF-36) questionnaire filled at admission and then at 6 weeks after the surgery

药物成份或治疗方案详述：

All the patients presenting to the OPD with diagnosis of pilonidal sinus will be offered Endoscopic treatment and will be included in the study after informed consent. The procedure described in 2 phases would be carried out under spinal or general anaesthesia. Patients will be observed at immediate postoperative period and follow up at 1, 3 and 6 weeks, 6 months and 1 year for any persistent symptoms.  

Description for medicine or protocol of treatment in detail：

All the patients presenting to the OPD with diagnosis of pilonidal sinus will be offered Endoscopic treatment and will be included in the study after informed consent. The procedure described in 2 phases would be carried out under spinal or general anaesthesia. Patients will be observed at immediate postoperative period and follow up at 1, 3 and 6 weeks, 6 months and 1 year for any persistent symptoms.  

纳入标准：

All patients presenting to the Outpatients with pilonidal sinus with or without abscess will be included in the study

Inclusion criteria

All patients presenting to the Outpatients with pilonidal sinus with or without abscess will be included in the study

排除标准：

Only failure to give consent will be excluded

Exclusion criteria：

Only failure to give consent will be excluded

研究实施时间：

Study execute time：

从 From 2014-03-01 00:00:00至 To 2023-03-16 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2014-07-01 00:00:00 至 To 2023-03-16 00:00:00  

干预措施：

Interventions：

组别：

Experimental group

样本量：

67

Group：

Experimental group

Sample size：

干预措施：

Endoscopic Pilonidal Sinus Treatment (EPSiT)

干预措施代码：

Intervention：

Endoscopic Pilonidal Sinus Treatment (EPSiT)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 pakistan

省(直辖市)：

 islamabad 

市(区县)：

  

Country：

pakistan 

Province：

islamabad 

City：

 

单位(医院)：

Shifa international hospital 

单位级别：

 

Institution
hospital：

Shifa international hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Wound infection

指标类型：

主要指标

Outcome：

Wound infection

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Visual analogue scale

指标类型：

主要指标

Outcome：

Visual analogue 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：

Recurrence at 6 months to 1 year after surgery

指标类型：

次要指标

Outcome：

Recurrence at 6 months to 1 year after 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：

Time taken to return at work

指标类型：

次要指标

Outcome：

Time taken to return at work

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Patient satisfaction in terms of quality of life, mobility

指标类型：

次要指标

Outcome：

Patient satisfaction in terms of quality of life, mobility

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：

pilonidal sinus

组织：

Sample Name：

pilonidal sinus

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 14 岁 years
最大 Max age 51 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）：

N/A

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

N/A

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：

Blinding：

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

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）：

N/A

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

N/A

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：

N/A

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

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-07-19 10:23:00