Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

NCT ID: NCT05044182

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anal Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decompression and drainage seton

Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter.

Group Type EXPERIMENTAL

Decompression and drainage seton

Intervention Type PROCEDURE

Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.

Cutting seton

Intervention Type PROCEDURE

Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.

Cutting seton

Cutting seton will be put around the internal and external anal sphincter.

Group Type EXPERIMENTAL

Decompression and drainage seton

Intervention Type PROCEDURE

Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.

Cutting seton

Intervention Type PROCEDURE

Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decompression and drainage seton

Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.

Intervention Type PROCEDURE

Cutting seton

Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients suffering from high horseshoe anal fistula

Exclusion Criteria

* Specific cause of fistula e.g. Crohn's disease.
* Previous anorectal surgery.
* Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
* Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hui Li

Associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China-Japan friendship

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hui Li, bachelor

Role: CONTACT

0861084206250

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hui Li, bachelor

Role: primary

+861084206250

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-1-QN-10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.