Perianal FistulaNCT06314945
Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula
An observational study of Perianal Fistula, run by Zagazig University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: only patients with perianal fistula or abscess in zagazig university hospitals who admitted during the study duration were included in the study
Who may be able to join
- Perianal abscess and\or fistula
- Patients who accidently discovered during transvaginal ultrasound.
- Age group between above 18 years old
Who cannot join
- Informed consent refusal.
- Proved anal malignancy.
- Patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Perianal Fistula
- Keywords
- recto-perineal ultrasound, perianal fistula, trans-sphincteric
What is being measured
The primary outcome is the main question the study is designed to answer.
age
age of patient was recorded in years
Measured: from 2 to 3 days before operation
sex
sex of patients was recorded as male or female
Measured: from 2 to 3 days before surgery
body mass index
patient BMI was recorded by dividing weight in kg by length square in meters
Measured: from 2 to 3 days before surgery
history of abscess drainage
history of perianal abscess was recorded
Measured: from 2 to 3 days before surgery
Internal opening
presence and site of internal opening was assessed by digital rectal examination and utrasound
Measured: 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
Measured: 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
Measured: from 2 to 3 days pre-operative and intraoperatively
abscess cavity
presence or absence of abscess cavity was assessed in ultrasound and intraoperative
Measured: from 2 to 3 days pre-operative and intraoperatively
Secondary outcomes (3)
other anal disease
presence or absence of other anal disease like anal fissure, piles or inflammatory bowel disease from medical records of the patients
Measured: from 2 to 3 days before surgery
external openings
number and site of external openings was assessed by clinical and radiological examination
Measured: 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
Measured: from 2 to 3 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, PhD, Principal investigator, faculty of medicine Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314945
- Sponsor's protocol ID
- #11280-4\12-2023
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Recto-perineal Ultrasound in Perianal Fistula; Pre Versus Intraoperative Findings: a Comparative Cross Section Study
- ClinicalTrials.gov ID
- NCT06314945
- Acronym / sponsor ID
- #11280-4\12-2023
- Conditions
- Perianal Fistula
- Keywords
- recto-perineal ultrasound, perianal fistula, trans-sphincteric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- only patients with perianal fistula or abscess in zagazig university hospitals who admitted during the study duration were included in the study
Key inclusion criteria (3 listed)
- Perianal abscess and\or fistula
- Patients who accidently discovered during transvaginal ultrasound.
- Age group between above 18 years old
Key exclusion criteria (3 listed)
- Informed consent refusal.
- Proved anal malignancy.
- Patients less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
age
Time frame: from 2 to 3 days before operation
age of patient was recorded in years
sex
Time frame: from 2 to 3 days before surgery
sex of patients was recorded as male or female
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
history of abscess drainage
Time frame: from 2 to 3 days before surgery
history of perianal abscess was recorded
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
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
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
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
3 secondary outcomes
other anal disease
Time frame: from 2 to 3 days before surgery
external openings
Time frame: from 2 to 3 days pre-operative and intraoperatively
anal discharge
Time frame: from 2 to 3 days before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Related trials for Perianal Fistula
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn Disease, Perianal Fistula
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
Not yet recruitingPhase 4
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
Perianal Abscess, Anal Fistula
Not yet recruiting
FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
Perianal Fistula
Recruiting
Loose Seton Prior to Surgery for Single-tract Cryptoglandular Fistula vs no Seton
Cryptoglandular Perianal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Zakaria, PhD principal investigator
faculty of medicine Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perianal Fistula, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: from 2 to 3 days before operation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.