NCT04796376

Brief Summary

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

Study Start

First participant enrolled

October 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 12, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 19, 2021

Last Update Submit

March 11, 2021

Conditions

High Anal Fistula

Keywords

Cutting setonFistulectomy

Outcome Measures

Primary Outcomes (1)

  • - Cure of high perianal fistulas -Reduce incontinence rate

    Cure from the main problem of the patient and prevent its recurrence

    1 year

Study Arms (1)

Cutting seton

OTHER

A piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal.

Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure

Interventions

combined partial fistulectomy or fistulotomy and cutting seton procedurePROCEDURE

Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract

Cutting seton

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with age of or above 18 years.
  • Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
  • Patients sable to comply to with the study protocol.

You may not qualify if:

  • Patients with low perianal fistula
  • Patients with preoperative incontinence.
  • Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
  • Patients diagnosed with acute anal sepsis
  • Recurrent cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Study Officials

  • Mina Nb Zaher, Resident doc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at General surgery department, faculty of medicine, Assiut University, Egypt

Study Record Dates

First Submitted

February 19, 2021

First Posted

March 12, 2021

Study Start

October 10, 2020

Primary Completion

October 1, 2021

Study Completion

March 1, 2023

Last Updated

March 12, 2021

Record last verified: 2021-02

Locations

EG(1)