NCT05044182

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

September 5, 2021

Last Update Submit

February 15, 2023

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    recurrence was defined as the clinical reappearance of the fistula after complete healing.

    12 months after the procedure

Study Arms (2)

Decompression and drainage seton

EXPERIMENTAL

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

Procedure: Decompression and drainage setonProcedure: Cutting seton

Cutting seton

EXPERIMENTAL

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

Procedure: Decompression and drainage setonProcedure: Cutting seton

Interventions

Decompression and drainage setonPROCEDURE

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

Cutting setonDecompression and drainage seton
Cutting setonPROCEDURE

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

Cutting setonDecompression and drainage seton

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from high horseshoe anal fistula

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan friendship

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Decompression

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Central Study Contacts

Hui Li, bachelor

CONTACT

0861084206250358219241@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

September 5, 2021

First Posted

September 14, 2021

Study Start

October 8, 2021

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)