- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Megan Narintarangkool
- Numéro de téléphone: 5233 (909)596-7733
- E-mail: mnarintarangkool@casacolina.org
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time required to complete bowel program
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effectiveness of treatment intervention
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient satisfaction and anticipated feasibility for home use
Délai: 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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux central
- Maladies du système nerveux
- Blessures et Blessures
- Maladies intestinales
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies du côlon, fonctionnelles
- Traumatisme, système nerveux
- Maladies de la moelle épinière
- Blessures à la moelle épinière
- Intestin neurogène
- Équipement chirurgical
- Équipement et fournitures
- Pessaires
Autres numéros d'identification d'étude
- BowelManagement
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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