Perianal FistulaNCT06616662
Transsphincteric Fistula Management Using LIFT and MAF
An observational study of Perianal Fistula, run by Zagazig University at 1 site in Egypt.
Trial summary
a study that detect the most suitable surgical techniques for treating transsphincteric fistula Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- MAF and LIFT
- Type of treatment
- Surgery or procedure
- How many people
- 257 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Jul 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: two hundred and fifty seven elderly patient with PAF
Who may be able to join
- elderly persons with PAF
Who cannot join
- recurrent fistula
- associated autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Zagazig University
Zagazig, Sharqia Province, 44511
About this study
Official title: Comparative Outcomes of Ligation of the Intersphincteric Fistula Tract and Mucosal Advancement Flap Techniques in Elderly Patients with Transsphincteric Perianal Fistulas: Recurrence, Incontinence and Risk Factors
a study that detect the most suitable surgical techniques for treating transsphincteric fistula
Read the detailed description
we compared between LIFT and MAF in elderly with PAF
- Conditions
- Perianal Fistula
- Being tested
- MAF, LIFT
- Keywords
- perianal fistula,flap,ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAFProcedure or surgery
use mucosal advancement flap to treat PAF
LIFTProcedure or surgery
use LIFT surgery for treating PAF
| Study group | Role | What they receive |
|---|---|---|
| LIFT | Not described Receives: Procedure: LIFT | |
| MAF | Not described Receives: Procedure: MAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate
incidence of healing in both approaches
Measured: three years
Secondary outcomes (1)
incontinence
incidence of incontinence after both approaches
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jul 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
- Investigators
- Tamer. A.A.M. Habeeb, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616662
- Sponsor's protocol ID
- perianal fistula
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habeeb TAAM, Chiaretti M, Kryvoruchko IA, Pesce A, Kechagias A, Elias AA, Adam AAM, Gadallah MA, Ali Ahmed SM, Khyrallh A, Alsayed MH, Tharwat Kamel Awad E, Elshafey MH, Abo Alsaad MI, Ali AK, Elbelkasi H, Abou Zaid MA, Youssef HAA, Al-Zamek MMF, Fiad A, Elshahidy TM, Elballat MR, El Taher AK, Mohamed MMM, AboZeid AK, Mansour MI, Yassin MA, Arafa AS, Lotfy M, Mousa B, Atef B, Naguib SM, Heggy IA, Elnemr M, Zaitoun MA, AbdAllah ES, Moussa MS, Hamed AEM, Elsayed RS. Mucosal advancement flap versus ligation of the inter-sphincteric fistula tract for management of trans-sphincteric perianal fistulas in the elderly: a retrospective study. Int J Colorectal Dis. 2025 Mar 12;40(1):61. doi: 10.1007/s00384-025-04846-5.
PubMed 40072575
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Ligation of the Intersphincteric Fistula Tract and Mucosal Advancement Flap Techniques in Elderly Patients with Transsphincteric Perianal Fistulas: Recurrence, Incontinence and Risk Factors
- ClinicalTrials.gov ID
- NCT06616662
- Acronym / sponsor ID
- perianal fistula
- Conditions
- Perianal Fistula
- Keywords
- perianal fistula,flap,ligation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 27 Sep 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.
a study that detect the most suitable surgical techniques for treating transsphincteric fistula
Detailed description
we compared between LIFT and MAF in elderly with PAF
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFT | – | Procedure: LIFT |
| MAF | – | Procedure: MAF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- two hundred and fifty seven elderly patient with PAF
Key inclusion criteria (1 listed)
- elderly persons with PAF
Key exclusion criteria (2 listed)
- recurrent fistula
- associated autoimmune diseases
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 |
|---|---|---|
| MAFuse mucosal advancement flap to treat PAF | Procedure or surgery | MAF |
| LIFTuse LIFT surgery for treating PAF | Procedure or surgery | LIFT |
Primary outcome
healing rate
Time frame: three years
incidence of healing in both approaches
1 secondary outcome
incontinence
Time frame: three years
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 27 Sep 2024.
- Derived from this study: PubMed 40072575Habeeb TAAM, Chiaretti M, Kryvoruchko IA, Pesce A, Kechagias A, Elias AA, Adam AAM, Gadallah MA, Ali Ahmed SM, Khyrallh A, Alsayed MH, Tharwat Kamel Awad E, Elshafey MH, Abo Alsaad MI, Ali AK, Elbelkasi H, Abou Zaid MA, Youssef HAA, Al-Zamek MMF, Fiad A, Elshahidy TM, Elballat MR, El Taher AK, Mohamed MMM, AboZeid AK, Mansour MI, Yassin MA, Arafa AS, Lotfy M, Mousa B, Atef B, Naguib SM, Heggy IA, Elnemr M, Zaitoun MA, AbdAllah ES, Moussa MS, Hamed AEM, Elsayed RS. Mucosal advancement flap versus ligation of the inter-sphincteric fistula tract for management of trans-sphincteric perianal fistulas in the elderly: a retrospective study. Int J Colorectal Dis. 2025 Mar 12;40(1):61. doi: 10.1007/s00384-025-04846-5.
- Individual participant dataSharing planned: No
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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.
Tamer. A.A.M. Habeeb principal investigator
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 1 inclusion and 2 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 27 Sep 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?
healing rate (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06616662, which also lists 1 linked publication.
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 27 Sep 2024.