Perianal FistulaNCT06527833
Procedure-Specific Approach To Minimize Fistulaization of The Perianal Abscess Cavity After Surgical Drainage
A study testing Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage in people with Perianal Fistula, run by Suez Canal University at 1 site in Egypt.
Trial summary
Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- above 18 years old with
- perianal abscesses for the first time.
Who cannot join
- sepsis,
- Previous pelvic radiation
- Pregnancy or lactation
- Immunosuppressive state
- Malignancy
- Refusal to participate will be excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Symptoms include perianal pain, back pain, fever, and more. The main treatment is incision and drainage, but packing during drainage can reduce fistula incidence, though it is associated with pain and cost. Research comparing outcomes with and without packing is limited.
Read the detailed description
Perianal abscess is a common anorectal condition. Most perianal abscesses are due to infection of the glandular crypts of the rectum and anus caused by non-specific obstruction. A small percentage of cases, around 10%, can be attributed to alternative causes such as Crohn's disease, trauma, human immunodeficiency virus, sexually transmitted diseases, radiation therapy, or foreign bodies.
Perianal abscesses are considered one of the most common colorectal pathologies with an estimated annual incidence of around 20,000 people in Egypt. Perianal abscesses are more common in males as compared to females and more in younger males than older. Also, there is an increased risk of anorectal abscess in conditions such as diabetes, and obesity.
Perianal pain is the most common presentation of perianal abscesses, which may increase with defecation, movement, sitting or coughing. Supra-levator abscesses may present with lower back pain or a dull ache in the pelvic region. Patients may also report fever, malaise, rectal drainage, erythema of surrounding skin and possibly urinary retention. The severity of pain can sometimes prevent the clinician from performing a digital rectal examination or anoscopic examination, therefore if the diagnosis is in doubt, an examination under general anaesthesia should be performed.
Anorectal abscesses can spread into the ischiorectal fossa. They can lead to a horse-shoe-shaped collection or track up towards and through the levator musculature, making management more challenging. Perianal fistulae are a common complication of peri-anal abscesses. Fistulae can be classified according to their tract location in relation to the internal and external sphincters as transphincteric fistula, high intersphincteric fistula, suprasphincteric fistula or extra sphincteric fistula.
In the presence of a perianal fistula, imaging modalities such as CT scans help diagnose intraabdominal pathology such as Crohn's disease and detecting air within the fistulous tract and the abscess cavity. However, MRI is the investigation of choice in evaluating secondary extensions from the fistulous tract and differentiating it from nearby pelvic soft tissue structures.
The management of perianal abscesses is incision and drainage. Without adequately eliminating the source of infection, antibiotics will be ineffective. Minimizing the patient's pain, protecting anal sphincter function and reducing the recurrence of anal fistulae is as important as curing the abscess. Packing at the time of abscess drainage, which requires multiple dressing changes per week for several weeks, can be helpful in providing hemostasis of the inflamed, hypervascular abscess cavity.
However, about 40% of patients with perianal abscess subsequently develop fistula after management. Packing is frequently accompanied by postoperative pain and discomfort, slow wound healing, and increased financial burden yet lower rate of incidence of fistula as demonstrated in Pearce study. Also, there is lack of information comparing postoperative outcomes in managing the perianal abscess cavity with packing and with no packing.
- Conditions
- Perianal Fistula
- Being tested
- Non Packing of perianal abscess cavity after drainage, Packing of perianal abscess cavity after drainage
- Keywords
- perianal abcess, perianal fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Packing of perianal abscess cavity after drainageProcedure or surgery
- All patients will undergo incision and drainage under general anaesthesia.
- In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intention. The patient was advised to have a sitz bath and apply a dressing over the cavity.
Packing of perianal abscess cavity after drainageProcedure or surgery
an elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed.
| Study group | Role | What they receive |
|---|---|---|
| Non Packing group | Experimental | • In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intension. The patient was advised to have a sitz bath and apply dressing over the cavity. Receives: Procedure: Non Packing of perianal abscess cavity after drainage |
| Packing group | Other | In group (B [Packing group]), an elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed. Receives: Procedure: Packing of perianal abscess cavity after drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianal fistula formation
To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach.
Measured: 6 months
Recurrence of perianal abscess
To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start10 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
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 Suez Canal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Ghareeb, Suez Canal University
- Investigators
- Waleed Mostafa Ghareeb, MD, PhD, Principal investigator, Suez canal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527833
- Sponsor's protocol ID
- 5697#
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be available and can be provided by the study investigators on reasonable request according to the regulations of our institute.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedure-Specific Approach To Minimize Fistulaization of The Perianal Abscess Cavity After Surgical Drainage
- ClinicalTrials.gov ID
- NCT06527833
- Acronym / sponsor ID
- 5697#
- Conditions
- Perianal Fistula
- Keywords
- perianal abcess, perianal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 30 Jul 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 abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Symptoms include perianal pain, back pain, fever, and more. The main treatment is incision and drainage, but packing during drainage can reduce fistula incidence, though it is associated with pain and cost. Research comparing outcomes with and without packing is limited.
Detailed description
Perianal abscess is a common anorectal condition. Most perianal abscesses are due to infection of the glandular crypts of the rectum and anus caused by non-specific obstruction. A small percentage of cases, around 10%, can be attributed to alternative causes such as Crohn's disease, trauma, human immunodeficiency virus, sexually transmitted diseases, radiation therapy, or foreign bodies.
Perianal abscesses are considered one of the most common colorectal pathologies with an estimated annual incidence of around 20,000 people in Egypt. Perianal abscesses are more common in males as compared to females and more in younger males than older. Also, there is an increased risk of anorectal abscess in conditions such as diabetes, and obesity.
Perianal pain is the most common presentation of perianal abscesses, which may increase with defecation, movement, sitting or coughing. Supra-levator abscesses may present with lower back pain or a dull ache in the pelvic region. Patients may also report fever, malaise, rectal drainage, erythema of surrounding skin and possibly urinary retention. The severity of pain can sometimes prevent the clinician from performing a digital rectal examination or anoscopic examination, therefore if the diagnosis is in doubt, an examination under general anaesthesia should be performed.
Anorectal abscesses can spread into the ischiorectal fossa. They can lead to a horse-shoe-shaped collection or track up towards and through the levator musculature, making management more challenging. Perianal fistulae are a common complication of peri-anal abscesses. Fistulae can be classified according to their tract location in relation to the internal and external sphincters as transphincteric fistula, high intersphincteric fistula, suprasphincteric fistula or extra sphincteric fistula.
In the presence of a perianal fistula, imaging modalities such as CT scans help diagnose intraabdominal pathology such as Crohn's disease and detecting air within the fistulous tract and the abscess cavity. However, MRI is the investigation of choice in evaluating secondary extensions from the fistulous tract and differentiating it from nearby pelvic soft tissue structures.
The management of perianal abscesses is incision and drainage. Without adequately eliminating the source of infection, antibiotics will be ineffective. Minimizing the patient's pain, protecting anal sphincter function and reducing the recurrence of anal fistulae is as important as curing the abscess. Packing at the time of abscess drainage, which requires multiple dressing changes per week for several weeks, can be helpful in providing hemostasis of the inflamed, hypervascular abscess cavity.
However, about 40% of patients with perianal abscess subsequently develop fistula after management. Packing is frequently accompanied by postoperative pain and discomfort, slow wound healing, and increased financial burden yet lower rate of incidence of fistula as demonstrated in Pearce study. Also, there is lack of information comparing postoperative outcomes in managing the perianal abscess cavity with packing and with no packing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Packing group | Experimental | Procedure: Non Packing of perianal abscess cavity after drainage• In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intension. The patient was advised to have a sitz bath and apply dressing over the cavity. |
| Packing group | Other | Procedure: Packing of perianal abscess cavity after drainageIn group (B [Packing group]), an elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- above 18 years old with
- perianal abscesses for the first time.
Key exclusion criteria (6 listed)
- sepsis,
- Previous pelvic radiation
- Pregnancy or lactation
- Immunosuppressive state
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Packing of perianal abscess cavity after drainage* All patients will undergo incision and drainage under general anaesthesia. * In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intention. The patient was advised to have a sitz bath and apply a dressing over the cavity. | Procedure or surgery | Non Packing group |
| Packing of perianal abscess cavity after drainagean elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed. | Procedure or surgery | Packing group |
Primary outcome
Perianal fistula formation
Time frame: 6 months
To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach.
Recurrence of perianal abscess
Time frame: 6 months
To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups .
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 17 Apr 2025.
- Individual participant dataSharing planned: No. The IPD will be available and can be provided by the study investigators on reasonable request according to the regulations of our institute.
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.
Waleed Mostafa Ghareeb, MD, PhD principal investigator
Suez canal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage in people with Perianal Fistula, run by Suez Canal 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 2 inclusion and 6 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 17 Apr 2025. 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?
Perianal fistula formation (time frame: 6 months). The study lists 2 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 17 Apr 2025.