Anal FistulaNCT04377542
RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
A study testing LIFT, Parks and Seton in people with Anal Fistula, run by Mansoura University at 1 site in Egypt.
Trial summary
LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- LIFT, Parks and Seton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Jun 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females
Who cannot join
- Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
- Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
- Patients on long-acting steroids or immunosuppressive drugs.
- Patients with fecal incontinence (FI)
- Patients with previous anorectal operations including surgery for previous anal fistula.
- Patients with ASA score (American society of anesthesiologists) of III and higher
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula
LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.
This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.
- Conditions
- Anal Fistula
- Being tested
- LIFT, Parks, Seton
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFTProcedure or surgery
Ligation of the fistula tract in the intersphincteric plane
ParksProcedure or surgery
Modified Parks fistulotomy with complete internal anal sphincterotomy
SetonProcedure or surgery
Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles
| Study group | Role | What they receive |
|---|---|---|
| LIFT | Active comparator | Ligation of intersphincteric fistula tract Receives: Procedure: LIFT |
| Parks | Active comparator | Modified Parks technique Receives: Procedure: Parks |
| Seton | Active comparator | Two-stage seton placement Receives: Procedure: Seton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of anal fistula
complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377542
- Sponsor's protocol ID
- Mansoura152020
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula
- ClinicalTrials.gov ID
- NCT04377542
- Acronym / sponsor ID
- Mansoura152020
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 May 2020 (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.
LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.
This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIFT | Active comparator | Procedure: LIFTLigation of intersphincteric fistula tract |
| Parks | Active comparator | Procedure: ParksModified Parks technique |
| Seton | Active comparator | Procedure: SetonTwo-stage seton placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females
Key exclusion criteria (6 listed)
- Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
- Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
- Patients on long-acting steroids or immunosuppressive drugs.
- Patients with fecal incontinence (FI)
- Patients with previous anorectal operations including surgery for previous anal fistula.
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 |
|---|---|---|
| LIFTLigation of the fistula tract in the intersphincteric plane | Procedure or surgery | LIFT |
| ParksModified Parks fistulotomy with complete internal anal sphincterotomy | Procedure or surgery | Parks |
| SetonExcision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles | Procedure or surgery | Seton |
Primary outcome
Healing of anal fistula
Time frame: 6 months after surgery
complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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.
Sameh H Emile, M.D. principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFT, Parks and Seton in people with Anal Fistula, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 6 May 2020. 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?
Results are not available in the source record.
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 of anal fistula (time frame: 6 months after surgery). 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 6 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.