Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula

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

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.

Study Overview

• Status: Completed
• Conditions: Perianal Fistula

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Zagazig university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
other anal disease	presence or absence of other anal disease like anal fissure, piles or inflammatory bowel disease from medical records of the patients	from 2 to 3 days before surgery
external openings	number and site of external openings was assessed by clinical and radiological examination	from 2 to 3 days pre-operative and intraoperatively
anal discharge	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	from 2 to 3 days before surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Reham Zakaria, PhD, Faculty of Medicine Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: perianal fistula; recto-perineal ultrasound; trans-sphincteric
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: #11280-4\12-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No