Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula

NCT06314945 | Completed

• 1 other identifier: #11280-4\12-2023
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perianal Fistula

Keywords

recto-perineal ultrasound; perianal fistula; trans-sphincteric

Outcome Measures

Primary Outcomes (8)

• age

  age of patient was recorded in years

  from 2 to 3 days before operation

• sex

  sex of patients was recorded as male or female

  from 2 to 3 days before surgery

• body mass index

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

  from 2 to 3 days before surgery

• history of abscess drainage

  history of perianal abscess was recorded

  from 2 to 3 days before surgery

• Internal opening

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

  from 2 to 3 days pre-operative and intraoperatively

• fistula branches

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

  from 2 to 3 days pre-operative and intraoperatively

• type fistulous tract

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

  from 2 to 3 days pre-operative and intraoperatively

• abscess cavity

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

  from 2 to 3 days pre-operative and intraoperatively

Secondary Outcomes (3)

• other anal disease

  from 2 to 3 days before surgery

• external openings

  from 2 to 3 days pre-operative and intraoperatively

• anal discharge

  from 2 to 3 days before surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

only patients with perianal fistula or abscess in zagazig university hospitals who admitted during the study duration were included in the study

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, 44519, Egypt

Location

Study Officials

• Reham Zakaria, PhD

  faculty of medicine Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

EG (1)