Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula

Perianal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06314945
• Other study ID #: #11280-4\12-2023
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Perianal Fistula
• Rectal Fistula

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	age	age of patient was recorded in years	from 2 to 3 days before operation
Primary	sex	sex of patients was recorded as male or female	from 2 to 3 days before surgery
Primary	body mass index	patient BMI was recorded by dividing weight in kg by length square in meters	from 2 to 3 days before surgery
Primary	history of abscess drainage	history of perianal abscess was recorded	from 2 to 3 days before surgery
Primary	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
Primary	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
Primary	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
Primary	abscess cavity	presence or absence of abscess cavity was assessed in ultrasound and intraoperative	from 2 to 3 days pre-operative and intraoperatively
Secondary	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
Secondary	external openings	number and site of external openings was assessed by clinical and radiological examination	from 2 to 3 days pre-operative and intraoperatively
Secondary	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