NCT03937752

Brief Summary

The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

April 29, 2019

Last Update Submit

February 27, 2024

Conditions

Anal Fistula

Keywords

anal fistulafistula in anoendoanal ultrasound3D ultrasound3D ultrasonographyendoanal ultrasonographydiagnostics

Outcome Measures

Primary Outcomes (3)

  • Fistula position

    Dorsal? Ventral? Lateral - right or left?

    Day 1

  • Fistula level

    Level I-IV (how much of the sphincter is affected?)

    Day 1

  • Fistula length

    Shorter or longer than 3 cm?

    Day 1

Study Arms (1)

Anal fistula

Patients with anal fistulas, no previous fistula procedures. Ultrasound investigation done as a part of surgical treatment, such as loose seton or fistulotomy.

Other: 3D endodanal ultrasound

Interventions

3D endodanal ultrasoundOTHER

Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.

Also known as: 3D endoanal ultrasonography
Anal fistula

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with newly diagnosed anal fistula with no previous anal fistula procedures.

You may qualify if:

  • anal fistula
  • no previous fistula procedures

You may not qualify if:

  • previous fistula procedures
  • ano/rectovaginal fistula
  • inflammatory bowel disease
  • more than one internal openings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pelvic Floor Centre

Malmo, Sweden

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ursula Aho Fält, MD

    Region Skane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 6, 2019

Study Start

April 1, 2018

Primary Completion

March 26, 2020

Study Completion

January 24, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

SE(1)