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Hemorrhoid Treatment with injection of n-butyl-2-cyanoacrylate substance and its results: A Single Center Retrospective Study
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注册号：

Registration number：

 ChiCTR2100046170 

最近更新日期：

Date of Last Refreshed on：

 2021-12-17 01:06:57 

注册时间：

Date of Registration：

 2021-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Hemorrhoid Treatment with injection of n-butyl-2-cyanoacrylate substance and its results: A Single Center Retrospective Study

Public title：

Hemorrhoid Treatment with injection of n-butyl-2-cyanoacrylate substance and its results: A Single Center Retrospective Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Hemorrhoid Treatment with injection of n-butyl-2-cyanoacrylate substance and its results: A Single Center Retrospective Study

Scientific title：

Hemorrhoid Treatment with injection of n-butyl-2-cyanoacrylate substance and its results: A Single Center Retrospective 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：

tülay diken allahverdi 

研究负责人：

tulay diken allahverdi 

Applicant：

tülay diken allahverdi 

Study leader：

tulay diken allahverdi 

申请注册联系人电话：

Applicant telephone：

 +90 50 66319651

研究负责人电话：

Study leader's
telephone：

+90 50 66319651

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：

 drtulaydiken@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 drtulaydiken@hotmail.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：

Ortakap Resul Yld z Caddesi 36100/Kars, Turkey

研究负责人通讯地址：

kafkas univercity medical school

Applicant address：

Ortakap Resul Yld z Caddesi 36100/Kars, Turkey

Study leader's address：

kafkas univercity medical school

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：

土耳其kafkas university general surgery

Applicant's institution：

kafkas university general surgery

研究负责人所在单位：

土耳其kafkas university general surgery

Affiliation of the Leader：

kafkas university general surgery

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：

 80576354-050-99/73

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：

local ethics committee of the faculty of medicine of Kafkas University

Name of the ethic committee：

local ethics committee of the faculty of medicine of Kafkas University

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-04-28 00:00:00

伦理委员会联系人：

local ethics committee of the faculty of medicine of Kafkas University

Contact Name of the ethic committee：

local ethics committee of the faculty of medicine of Kafkas University

伦理委员会联系地址：

?ehitler, Kafkas üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi, Kafkas üniversitesi Kampüsü, 36100 Merkez/Kars

Contact Address of the ethic committee：

?ehitler, Kafkas üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi, Kafkas üniversitesi Kampüsü, 36100 Merkez/Kars

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

Kafkas University

Primary sponsor：

Kafkas University

研究实施负责（组长）单位地址：

Ortakapı Resul Yıldız Caddesi 36100/Kars, Turkey

Primary sponsor's address：

Ortakapı Resul Yıldız Caddesi 36100/Kars, Turkey

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

土耳其

省(直辖市)：

KARS

市(区县)：

MERKEZ

Country：

turkay

Province：

KARS

City：

MERKEZ

单位(医院)：

kafkas university

具体地址：

?ehitler, Kafkas üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi, Kafkas üniversitesi Kampüsü, 36100 Merkez/Kars

Institution
hospital：

kafkas university

Address：

?ehitler, Kafkas üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi, Kafkas üniversitesi Kampüsü, 36100 Merkez/Kars

经费或物资来源：

Kafkas University

Source(s) of funding：

Kafkas University

研究疾病：

hemoroid  

Target disease：

hemoroid

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：

 I期临床试验 

Study phase：

1

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

we believe that n-butyl-2-cyanoacrylate material can be an alternative method to surgical methods that can be applied in hemorrhoids with future studies. We think that this procedure, which can be performed easily and effectively in outpatient clinic conditions, will be an easy method that can be applied to patients who need surgery but are afraid of surgery.  

Objectives of Study：

we believe that n-butyl-2-cyanoacrylate material can be an alternative method to surgical methods that can be applied in hemorrhoids with future studies

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

No

Exclusion criteria：

No

研究实施时间：

Study execute time：

从 From 2021-05-07 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-05-07 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

grade 3 hemoroids

样本量：

 14

Group：

grade 3 hemoroids

Sample size：

干预措施：

hemoroidectomy

干预措施代码：

Intervention：

hemoroidectomy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 KARS 

市(区县)：

 MERKEZ 

Country：

turkey

Province：

KARS

City：

MERKEZ

单位(医院)：

 kafkas university medicine school 

单位级别：

  

Institution
hospital：

kafkas university medicine school

Level of the institution：

测量指标：

Outcomes：

指标中文名：

grade 3 hemoroid

指标类型：

主要指标

Outcome：

grade 3 hemoroid

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：

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 70 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients out of 127 patients who underwent hemorrhoidectomy. 4 of our patients were women and 10 were men. The average age of women was 49.25 and the average age of men was 43.7.

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

Between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients out of 127 patients who underwent hemorrhoidectomy. 4 of our patients were women and 10 were men. The average age of women was 49.25 and the average age of men was 43.7.

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：

N/A

Blinding：

N/A

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

否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）：

Among 127 patients who underwent hemorrhoidectomy between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients. 4 of our patients were women and 10 were men.

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

Among 127 patients who underwent hemorrhoidectomy between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients. 4 of our patients were women and 10 were men.

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：

Among 127 patients who underwent hemorrhoidectomy between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients. 4 of our patients were women and 10 were men. The mean age of women was 49.25, mean age of men was 43.7. In general, grade 3 hemorrhoids were found in 12 patients, 3 hemorrhoid pouches in 12 patients, n-butyl-2-cyanoacrylate substance was applied to 4 hemorrhoid pouches in 2 patients. All patients had anal fissure in addition to hemorrhoid pouches. Therefore, all patients underwent lateral internal sphincterotomy. The mean operative time was 35 minutes. The application time of n-butyl-2-cyanoacrylate was 8 minutes for each hemorrhoid pack on average. Our injection dose of n-butyl-2-cyanoacrylate was 1 ml for each hemorrhoid pouch. Postoperative findings were present in all patients on postoperative day 1 with mild analgesic relief. There was no pain on the postoperative 2nd day. There were social reasons such as the distance between the hospital and the place where the patient was sitting, and the unsuitability of road conditions due to winter conditions in patients who underwent surgery in winter. No findings compatible with bleeding or pain were found in our patients after surgery and during their follow-up. This was the case for 2 of our patients. These patients were given antispasmodic drugs for 2 months postoperatively. As a result of the colonoscopy performed on our patients in the 6th month, we found that the prolapse detected before the operation completely disappeared. No recurrence or complication developed in the 1-year follow-up of our patients.

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

Among 127 patients who underwent hemorrhoidectomy between January 2012 and December 2020, n-butyl-2-cyanoacrylate was administered to 14 patients. 4 of our patients were women and 10 were men. The mean age of women was 49.25, mean age of men was 43.7. In general, grade 3 hemorrhoids were found in 12 patients, 3 hemorrhoid pouches in 12 patients, n-butyl-2-cyanoacrylate substance was applied to 4 hemorrhoid pouches in 2 patients. All patients had anal fissure in addition to hemorrhoid pouches. Therefore, all patients underwent lateral internal sphincterotomy. The mean operative time was 35 minutes. The application time of n-butyl-2-cyanoacrylate was 8 minutes for each hemorrhoid pack on average. Our injection dose of n-butyl-2-cyanoacrylate was 1 ml for each hemorrhoid pouch. Postoperative findings were present in all patients on postoperative day 1 with mild analgesic relief. There was no pain on the postoperative 2nd day. There were social reasons such as the distance between the hospital and the place where the patient was sitting, and the unsuitability of road conditions due to winter conditions in patients who underwent surgery in winter. No findings compatible with bleeding or pain were found in our patients after surgery and during their follow-up. This was the case for 2 of our patients. These patients were given antispasmodic drugs for 2 months postoperatively. As a result of the colonoscopy performed on our patients in the 6th month, we found that the prolapse detected before the operation completely disappeared. No recurrence or complication developed in the 1-year follow-up of our patients.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-05-08 00:06:31
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