Coring OutNCT06478615
Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula
A study testing Coring out Fistulectomy with Closure of Internal Sphincter Opening and Lay Open Fistulotomy and Primary Sphincter Repair in people with Coring Out and Fistulectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coring Out, Fistulectomy, Internal Sphincter
- What is being tested?
- Coring out Fistulectomy with Closure of Internal Sphincter Opening and Lay Open Fistulotomy and Primary Sphincter Repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to 1 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I, II.
- Fistula in ano, Trans-sphincteric type
Who cannot join
- Patients with low perianal fistula.
- Recurrent perianal fistula.
- Associated anal conditions such as (piles, anal fissures, and rectal prolapse).
- Patients with inflammatory bowel disease or tuberculosis.
- Patients with acute perianal abscess.
- Patients with major incontinence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula; A Prospective Randomized Comparative Study
This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula
Read the detailed description
Fistula-in-ano is a common medical problem affecting thousands of patients annually. Symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric.
Conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. A transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter.
Coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract
- Conditions
- Coring Out, Fistulectomy, Internal Sphincter, Lay Open Fistulotomy, Sphincter Repair, Transsphincteric Perianal Fistula
- Being tested
- Coring out Fistulectomy with Closure of Internal Sphincter Opening, Lay Open Fistulotomy and Primary Sphincter Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coring out Fistulectomy with Closure of Internal Sphincter OpeningProcedure or surgery
The patient was laid in the lithotomy position. Skin preparation and draping were done. Normal saline irrigation was performed. The anal canal was sufficiently dilated to permit the introduction of a self-retaining retractor. With H2O2 injection into the fistula tract, the internal opening and tract of the fistula will be identified. The incision was made around the external opening, and the tract was all cored out along the tract from the external opening to the internal sphincter. Meticulous hemostasis will be performed, stay suture by PDS 4/0 around fistiolous opening at the internal sphincter, excision of fistulous tract above stay suture, then closure of internal sphincter defect by PDS 3/0. Anal packing with 4 × 4 epinephrine gauze and sterile protective dressing was performed. After the operation, a stool softener and pain controller were prescribed, and patients were discharged.
Lay Open Fistulotomy and Primary Sphincter RepairProcedure or surgery
Patients were put in a lithotomy position and the skin was then draped. After identification of the external fistula orifice probing of the fistula tract with identification of the fistulous tract and internal orifice with H2O2 injection into the fistula tract. The fistula was laid open and fistulectomy was then conducted and dissected with diathermy cautery help. Then Primary repair of the sphincter with PDS 3/0 with proper hemostasis using coagulation diathermy.
| Study group | Role | What they receive |
|---|---|---|
| Coring out Fistulectomy with Closure of Internal Sphincter Opening | Experimental | Patients underwent coring out fistulectomy with closure of internal sphincter opening Receives: Procedure: Coring out Fistulectomy with Closure of Internal Sphincter Opening |
| Lay Open Fistulotomy and Primary Sphincter Repair | Experimental | Patients underwent lay open fistulotomy and primary sphincter repair Receives: Procedure: Lay Open Fistulotomy and Primary Sphincter Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrence of perianal fistula
Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months.
Measured: 3 months postoperatively
Secondary outcomes (4)
Incidence of stool incontinence
Incidence of stool incontinence was recorded for 3 months.
Measured: 3 months postoperatively
Healing time
Healing was defined as cicatrization of all wounds without discharge at 3 months
Measured: 3 months postoperatively
Length of hospital stay
Length of hospital stay was recorded from admission till discharge from hospital.
Measured: 1 week postoperatively
Complications
Complications such as (blood loss, pain, bleeding, discharge, urinary retention, urgency, wound infection) were recorded.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Nov 2022
- 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 Coring OutStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ali Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478615
- Sponsor's protocol ID
- 30/10/2022
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula; A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06478615
- Acronym / sponsor ID
- 30/10/2022
- Conditions
- Coring Out, Fistulectomy, Internal Sphincter, Lay Open Fistulotomy, Sphincter Repair, Transsphincteric Perianal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 27 Jun 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.
This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula
Detailed description
Fistula-in-ano is a common medical problem affecting thousands of patients annually. Symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric.
Conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. A transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter.
Coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coring out Fistulectomy with Closure of Internal Sphincter Opening | Experimental | Procedure: Coring out Fistulectomy with Closure of Internal Sphincter OpeningPatients underwent coring out fistulectomy with closure of internal sphincter opening |
| Lay Open Fistulotomy and Primary Sphincter Repair | Experimental | Procedure: Lay Open Fistulotomy and Primary Sphincter RepairPatients underwent lay open fistulotomy and primary sphincter repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years old.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I, II.
- Fistula in ano, Trans-sphincteric type
Key exclusion criteria (6 listed)
- Patients with low perianal fistula.
- Recurrent perianal fistula.
- Associated anal conditions such as (piles, anal fissures, and rectal prolapse).
- Patients with inflammatory bowel disease or tuberculosis.
- Patients with acute perianal abscess.
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 |
|---|---|---|
| Coring out Fistulectomy with Closure of Internal Sphincter OpeningThe patient was laid in the lithotomy position. Skin preparation and draping were done. Normal saline irrigation was performed. The anal canal was sufficiently dilated to permit the introduction of a self-retaining retractor. With H2O2 injection into the fistula tract, the internal opening and tract of the fistula will be identified. The incision was made around the external opening, and the tract was all cored out along the tract from the external opening to the internal sphincter. Meticulous hemostasis will be performed, stay suture by PDS 4/0 around fistiolous opening at the internal sphincter, excision of fistulous tract above stay suture, then closure of internal sphincter defect by PDS 3/0. Anal packing with 4 × 4 epinephrine gauze and sterile protective dressing was performed. After the operation, a stool softener and pain controller were prescribed, and patients were discharged. | Procedure or surgery | Coring out Fistulectomy with Closure of Internal Sphincter Opening |
| Lay Open Fistulotomy and Primary Sphincter RepairPatients were put in a lithotomy position and the skin was then draped. After identification of the external fistula orifice probing of the fistula tract with identification of the fistulous tract and internal orifice with H2O2 injection into the fistula tract. The fistula was laid open and fistulectomy was then conducted and dissected with diathermy cautery help. Then Primary repair of the sphincter with PDS 3/0 with proper hemostasis using coagulation diathermy. | Procedure or surgery | Lay Open Fistulotomy and Primary Sphincter Repair |
Primary outcome
Incidence of recurrence of perianal fistula
Time frame: 3 months postoperatively
Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months.
4 secondary outcomes
Incidence of stool incontinence
Time frame: 3 months postoperatively
Healing time
Time frame: 3 months postoperatively
Length of hospital stay
Time frame: 1 week postoperatively
Complications
Time frame: 3 months postoperatively
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 28 Jun 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Coring Out
Recruiting
TROPIS Versus Coring Out Fistulectomy in High Anal Fistula
High Anal 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coring out Fistulectomy with Closure of Internal Sphincter Opening and Lay Open Fistulotomy and Primary Sphincter Repair in people with Coring Out and Fistulectomy, run by Ain Shams 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 4 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 28 Jun 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?
Incidence of recurrence of perianal fistula (time frame: 3 months postoperatively). 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 28 Jun 2024.