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A clinical study on the efficacy and safety of cutting seton and drainage therapy in the treatment of high perianal abscess

Registration number：

ITMCTR2100005098

Date of Last Refreshed on：

2021-07-25

Date of Registration：

2021-07-25

Registration Status：

Prospective registration

Public title：

A clinical study on the efficacy and safety of cutting seton and drainage therapy in the treatment of high perianal abscess

English Acronym：

Scientific title：

A clinical study on the efficacy and safety of cutting seton and drainage therapy in the treatment of high perianal abscess

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100049198 ; ChiMCTR2100005098

Applicant：

Shi Yuying

Study leader：

Shi Yuying

Applicant telephone：

+86 13581583757

Study leader's telephone：

+86 13581583757

Applicant Fax：

Study leader's fax：

Applicant E-mail：

362948118@qq.com

Study leader's E-mail：

362948118@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

2 Yinghua Street East, Chaoyang District, Beijing, China

Study leader's address：

2 Yinghua Street East, Chaoyang District, Beijing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

China-Japan Friendship Hospital

Approved by ethic committee：

Approved No. of ethic committee：

Approved file of Ethical Committee：

Name of the ethic committee：

Date of approved by ethic committee：

2013/8/26 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

China-Japan Friendship Hospital

Primary sponsor's address：

2 Yinghua Street East, Chaoyang District, Beijing, China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

China-Japan Friendship Hospital

Address：

2 Yinghua Street East, Chaoyang District

Source(s) of funding：

Hospital-level project of China-Japanese Friendship Hospital

Target disease：

High Prianal Abscess

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Phase I clinical trial

Objectives of Study：

Main purpose: 1. To evaluate the efficacy and safety of the combination of virtual and solid with hanging thread in the treatment of high perianal abscess through a clinical randomized controlled study comparing the incision and drainage with radical resection. 2. To establish a new method of combining virtual and solid sutures for the treatment of high perianal abscesses. Compared with radical incision and drainage, evaluate the advantages of the new operation in improving the cure rate, reducing the recurrence rate, and protecting the anus. safety in sphincter function; 3. To provide evidence-based medicine for the new method of treating high perianal abscess, "the combination of virtual and actual".

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Aged 18 to 65 years, male or female; 2. Diagnosed by digital examination and anorectal B-ultrasound, it was confirmed as high perianal abscess; 3. No history of perianal abscess surgery and abnormal anal morphology and function; 4. Patients voluntarily participated in clinical trials, signed informed consent, and were able to cooperate with clinical follow-up.

Exclusion criteria：

1. Patients with severe heart, lung, brain, liver and kidney diseases; 2. Pregnant or planning pregnancy and lactating women; 3. The doctor determines that other medical history has an impact on anal function; 4. Others due to religious ethnicity, diabetes, cancer, intestinal tuberculosis, Crohn's disease, AIDS; 5. Allergic constitution or allergic to the drugs used after surgery.

Study execute time：

From 2022-01-01

To      2023-12-31

Recruiting time：

From 2022-01-01

To      2023-12-31

Interventions：

38

Group：

Experimental group

Sample size：

Intervention：

Cutting Seton and Drainage therapy

Intervention code：

Total sample size ： 38

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

China-Japan Friendship Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Fecal incontinence severity score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

postoperative pain score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cure rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Healing time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Anorectal manometry

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incidence rate of adverse events

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Semi-annual recurrence rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Wall tissue of abscess cavity

Tissue：

perianal tissue

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Patients were numbered according to the time sequence of diagnosis and treatment. The selected cases were divided into groups according to the block table generated by SAS software.

Blinding：

Single blindness (patients are blind and do not know what treatment to receive. Doctors are not blind and schedule operations according to group assignment)

IPD sharing：

Yes

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

http://www.medresman.org

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

Case Record Form, CRF

Data Managemen Committee：

Yes

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

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