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Completed

NCT Number: NCT06314945

Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula

Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings.

study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings.

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Key information

Conditions

Perianal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University Hospitals

Zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Perianal abscess and\\or fistula
  • Patients who accidently discovered during transvaginal ultrasound.
  • Age group between above 18 years old

Exclusion criteria

  • Informed consent refusal.
  • Proved anal malignancy.
  • Patients less than 18 years old

Treatment and study plan

Primary outcomes

  1. age

    Time frame: from 2 to 3 days before operation

    age of patient was recorded in years

  2. sex

    Time frame: from 2 to 3 days before surgery

    sex of patients was recorded as male or female

  3. body mass index

    Time frame: from 2 to 3 days before surgery

    patient BMI was recorded by dividing weight in kg by length square in meters

  4. history of abscess drainage

    Time frame: from 2 to 3 days before surgery

    history of perianal abscess was recorded

  5. Internal opening

    Time frame: from 2 to 3 days pre-operative and intraoperatively

    presence and site of internal opening was assessed by digital rectal examination and utrasound

  6. fistula branches

    Time frame: from 2 to 3 days pre-operative and intraoperatively

    presence of fistula branches and their number were assessed by ultrasound and during surgery

  7. type fistulous tract

    Time frame: from 2 to 3 days pre-operative and intraoperatively

    type of fistula was detected in relation to anal sphincters by ultrasound and intraoperative

  8. abscess cavity

    Time frame: from 2 to 3 days pre-operative and intraoperatively

    presence or absence of abscess cavity was assessed in ultrasound and intraoperative

Secondary outcomes

  1. other anal disease

    Time frame: from 2 to 3 days before surgery

    presence or absence of other anal disease like anal fissure, piles or inflammatory bowel disease from medical records of the patients

  2. external openings

    Time frame: from 2 to 3 days pre-operative and intraoperatively

    number and site of external openings was assessed by clinical and radiological examination

  3. anal discharge

    Time frame: from 2 to 3 days before surgery

    presence or absence of anal discharge, its color, odor and viscosity were assessed by history of soiling underwear and clinical examination by soiling of gloves or direct vision of discharge during digital rectal examination

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula; Pre Versus Intraoperative Findings: a Comparative Cross Section Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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