- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07817199
Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury
Time Comparison of Bisacodyl Suppository, Enemeez and Peristeen on Bowel Programs in Patients With Diagnosis of Spinal Cord Injury and Neurogenic Bowel
The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are:
- Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs?
- Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation?
- Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided.
Participants in this study will:
- Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital
- Will receive the same tool for their bowel program for the majority or entirety of their stay
- Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed
- Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the study is to guide clinical practice with the goal of reducing burden of care and improving patient experience with bowel program. The study specifically aims to determine the difference in time spent on bowel programs with either Suppository, Enemeez or Peristeen. This study aims to advance the process of bowel programs, which currently is a large time cost for our staff. By making bowel programs more efficient, we will allow our nursing staff to devote more time to other aspects of care while improving both patient and staff satisfaction. Ultimately, determining the most efficient bowel management for patients with diagnosis of spinal cord injury and neurogenic bowel will improve the continuum of care.
All patients admitted to inpatient rehab unit will be reviewed for diagnosis of spinal cord injury with reflexic neurogenic bowel. From this population we will exclude according to our exclusion criteria. Participants will then be recruited from these patients.
The primary goal of this study is to determine which intervention produces the most time effective bowel program: suppository, Enemeez or Peristeen. The study will consist of 3 cohorts of participants. Participants will be placed in a cohort based on the date of bowel program initiation. Each month will be assigned a different intervention type, and all participants with bowel program initiated during that month will be using the assigned intervention. During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours. If a participant is on a program at the time of cohort transition, that participant will remain on their established program.
Our secondary outcome is effectiveness of treatment which will be assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
The tertiary outcome of the study is to assess patient satisfaction and anticipated feasibility for home use. This will be assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. Questionnaires will be distributed upon enrollment and after the intervention period, which may differ to discharge or several days prior to discharge depending on the bowel program chosen.
Following participation in treatment, patients will be transitioned to a bowel program that is accessible at home as prescribed by their physician.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Megan Narintarangkool
- Número de teléfono: 5233 (909)596-7733
- Correo electrónico: mnarintarangkool@casacolina.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- admission to acute rehab inpatient unit
- diagnosis of spinal cord injury
- reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation
Exclusion Criteria:
- anal or rectal stenosis
- active inflammatory bowel disease
- acute diverticulitis
- colorectal cancer
- ischemic colitis
- rectal surgery within the last 3 months
- endoscopic polypectomy within the last 4 weeks
- areflexic bowel
- severe autonomic dysreflexia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Suppository
Bowel Program managed via Suppository (current standard of care at Casa Colina Hospital)
|
The patient will receive a suppository 15-20 minutes prior to being transferred to toilet.
Then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
|
|
Comparador activo: Enemeez
Bowel Program via use of the Enemeez mini enema device
|
The patient will receive the 5mL enema then be transferred onto the toilet.
If no evacuation occurs within 15 minutes, then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
|
|
Comparador activo: Peristeen
Bowel Program via the Peristeen Transanal Irrigation tool
|
The Peristeen device will be prepared prior to sitting the participant on the toilet.
The lubricated rectal catheter will be inserted, and the retention balloon will be gently inflated to ensure a rectal seal.
The irrigation pump will then pump water into the rectum.
The balloon will be deflated and the catheter removed to allow for emptying of the water and stool.
The catheter will be discarded.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time required to complete bowel program
Periodo de tiempo: Every morning for approximately two hours, from enrollment and lasting 21 days
|
During the bowel program nursing staff will document time suppository or Enemeez is given.
In the case of Pertisteen, the nurse will document the time out of bed instead.
This will be done manually via a paper chart that is placed in the patient's room.
The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours.
|
Every morning for approximately two hours, from enrollment and lasting 21 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effectiveness of treatment intervention
Periodo de tiempo: Assessed every morning via chart review from enrollment and lasting 21 days
|
Assessed by episodes of bowel incontinence and constipation.
This will be evaluated by a chart review.
We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g.
abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
|
Assessed every morning via chart review from enrollment and lasting 21 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient satisfaction and anticipated feasibility for home use
Periodo de tiempo: Upon enrollment and again at 3 weeks
|
Assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research.
The questionnaire will assess domains of patient satisfaction and feasibility for home use utilizing a 5-point Likert Scale from "Strongly Disagree" to "Strongly Agree."
Higher scores will indicate higher satisfaction and feasibility.
|
Upon enrollment and again at 3 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
Publicaciones y enlaces útiles
Publicaciones Generales
- Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006 Sep;131(3):738-47. doi: 10.1053/j.gastro.2006.06.004.
- Johns J, Krogh K, Rodriguez GM, Eng J, Haller E, Heinen M, Laredo R, Longo W, Montero-Colon W, Wilson C, Korsten M. Management of Neurogenic Bowel Dysfunction in Adults after Spinal Cord Injury: Clinical Practice Guideline for Health Care Providers. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):75-151. doi: 10.46292/sci2702-75. Epub 2021 May 24. No abstract available.
- Wincentak J, Xu Y, Rudden L, Kassam-Lallani D, Mullin A, Truong C, Krog K, Kingsnorth S. Current State of Knowledge on Digital Rectal Stimulation in Individuals With Traumatic and Nontraumatic Spinal Cord Injury: A Scoping Review. Arch Phys Med Rehabil. 2021 Sep;102(9):1816-1825. doi: 10.1016/j.apmr.2020.12.023. Epub 2021 Jan 30.
- House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil. 1997 Oct;78(10):1062-5. doi: 10.1016/s0003-9993(97)90128-3.
- Dunn KL, Galka ML. A comparison of the effectiveness of Therevac SB and bisacodyl suppositories in SCI patients' bowel programs. Rehabil Nurs. 1994 Nov-Dec;19(6):334-8. doi: 10.1002/j.2048-7940.1994.tb01336.x.
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
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades intestinales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades del Colon Funcionales
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Lesiones de la médula espinal
- Intestino neurogénico
- Equipo quirúrgico
- Equipos y suministros
- Pesarios
Otros números de identificación del estudio
- BowelManagement
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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