Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula
21 de mayo de 2026 actualizado por: Tugberk Tok
Modified LIFT Via a Lateral Approach Versus Standard LIFT for Transsphincteric Anal Fistula: A Prospective Randomized Study
This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach.
Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures.
The main outcome was wound healing time.
Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This was a prospective, single-center, randomized, parallel-group comparative surgical study conducted at the Department of General Surgery, Kayseri City Training and Research Hospital, Türkiye. The study included adult patients aged 18 to 75 years with magnetic resonance imaging-confirmed transsphincteric anal fistula who met the eligibility criteria and provided written informed consent.
Participants were randomly assigned in a 1:1 ratio to undergo either standard ligation of the intersphincteric fistula tract (LIFT) or modified LIFT via a lateral approach. All patients were evaluated by the same surgical team, and postoperative follow-up was performed at weeks 1, 4, 8, and 12.
The study compared early clinical outcomes between the two procedures, including wound healing time, early recurrence or persistence, postoperative pain, and fecal continence. The study was approved by the Kayseri City Hospital Clinical Research Ethics Committee before patient enrollment.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kayseri
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Kayseri, Kayseri, Turquía (Türkiye), 38300
- Kayseri City Training and Research Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 to 75 years
- Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging
- Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage
- Ability and willingness to provide written informed consent
- Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach
Exclusion Criteria:
- Previous definitive surgery for perianal fistula other than abscess drainage
- Perianal Crohn disease
- Horseshoe fistula
- Colorectal cancer
- Malnutrition
- Recurrent anal fistula
- Previous radiotherapy or chemotherapy
- Chronic medication use that could impair wound healing, such as steroids or colchicine
- Refusal or inability to provide written informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Modified LIFT via a Lateral Approach
Participants assigned to this arm underwent modified LIFT via a lateral approach.
The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at this level, and the remaining defect and internal opening were closed while preserving sphincter integrity.
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Modified LIFT via a lateral approach was performed.
The fistula tract was approached from the external opening, dissected and mobilized toward the internal sphincter level, excised at that level, and the remaining defect and internal opening were closed.
|
|
Comparador activo: Standard LIFT
Participants assigned to this arm underwent standard ligation of the intersphincteric fistula tract (LIFT).
The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.
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Standard ligation of the intersphincteric fistula tract was performed.
The intersphincteric plane was approached, and the fistula tract was identified, ligated, and divided according to the standard LIFT technique.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Wound Healing Time
Periodo de tiempo: Up to 12 weeks after surgery
|
Time from surgery to complete clinical epithelialization of the perianal wound without discharge.
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Up to 12 weeks after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Early Recurrence or Persistence of Anal Fistula
Periodo de tiempo: Postoperative weeks 1, 4, 8, and 12
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Presence of persistent or recurrent fistula-related symptoms or clinical findings during postoperative follow-up.
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Postoperative weeks 1, 4, 8, and 12
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Postoperative Pain Assessed Using the Visual Analog Scale
Periodo de tiempo: Postoperative weeks 1, 4, 8, and 12
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Postoperative pain will be assessed using the Visual Analog Scale.
The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Postoperative weeks 1, 4, 8, and 12
|
|
Fecal Continence Assessed Using the Wexner Fecal Incontinence Score
Periodo de tiempo: Postoperative weeks 1, 4, 8, and 12
|
Fecal continence will be assessed using the Wexner Fecal Incontinence Score.
The score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence.
Higher scores indicate worse continence.
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Postoperative weeks 1, 4, 8, and 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tuğberk Tok, MD, Kayseri City Training and Research Hospital
- Director de estudio: Yusuf Sevim, MD, Kayseri City Training and Research Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2024
Finalización primaria (Actual)
1 de mayo de 2024
Finalización del estudio (Actual)
30 de agosto de 2024
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KCTRH-LIFT-944-2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be publicly shared due to ethical, institutional, and privacy restrictions.
De-identified data may be available from the corresponding investigator upon reasonable request, subject to institutional approval.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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