Un programa de manejo intestinal (enema rectal retrógrado) para el tratamiento del síndrome de resección anterior baja en pacientes con cáncer de recto
Síndrome de resección anterior baja: programa de enema retrógrado versus tratamiento médico
This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.
Descripción general del estudio
Estado
Descripción detallada
PRIMARY OBJECTIVE:
I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.
SECONDARY OBJECTIVE:
I. The determination of feasibility to complete this treatment pathway.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.
GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.
Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: The Ohio State Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- Ohio State University Comprehensive Cancer Center
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Contacto:
- Alessandra C. Gasior, DO
- Número de teléfono: 614-722-3879
- Correo electrónico: Alessandra.gasior@osumc.edu
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Investigador principal:
- Alessandra C. Gasior, DO
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years old
- Moderate to Severe LARS diagnosis
- Patients with history of rectal cancer that was treated with proctectomy
- Has undergone standard medical management without improvement of symptoms for 3-6 months
Exclusion Criteria:
- Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
- Patients with any chemo or radiation therapy in the last 6 months
- Patients who currently have colorectal cancer
- Patients with recurrent colorectal cancer
- Patients who have undergone a colorectal surgical procedure within the last three months
- Patients with progressive neurological disease
- Patients with active or recurrent sacral infection
- Patients < 18 years old
- Active sacral nerve simulator
- Pregnant or planning to become pregnant during the treatment portion of the study
- Altered mental status or mental disability that would alter ability to self-administer enema
- Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group I (RRE, medical management)
Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial. |
Ancillary studies Receive dietary fiber
Otros nombres:
Undergo RRE
Otros nombres:
Receive loperamide hydrochloride
Otros nombres:
Undergo pelvic floor physical therapy
Otros nombres:
Undergo abdominal film x-ray
Otros nombres:
|
|
Comparador activo: Group II (medical management)
Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement. |
Ancillary studies Receive dietary fiber
Otros nombres:
Receive loperamide hydrochloride
Otros nombres:
Undergo pelvic floor physical therapy
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fecal incontinence
Periodo de tiempo: Up to 1 year from start of treatment
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Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire [MSKCC BFI]). Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Up to 1 year from start of treatment
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Effectiveness assessed using LARS validated scoring tool
Periodo de tiempo: Up to 1 year from start of treatment
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Will be assessed using LARS validated scoring tool. Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Up to 1 year from start of treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility measured by Patient Satisfaction Survey
Periodo de tiempo: At 1 year from start of treatment
|
Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d > 0.80) will be computed to ensure the effect of findings. P < 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
At 1 year from start of treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alessandra C Gasior, DO, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades del Colon
- Condiciones Patológicas, Signos y Síntomas
- Síndrome de resección anterior baja
- Neoplasias Rectales
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Terapéutica
- Terapia con drogas
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Carbohidratos dietéticos
- Carbohidratos
- Fenómeno físico
- Equipos y suministros
- Piperidinas
- Rehabilitación
- Fenómenos electromagnéticos
- Fenómeno magnético
- Radiación electromagnética
- Radiación
- Radiación, ionizante
- Loperamida
- Fibra dietética
- Rayos X
- Fantasmas, imágenes
- Modalidades de fisioterapia
- Enema
Otros números de identificación del estudio
- OSU-22312
- NCI-2024-03173 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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