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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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
アクティブコンパレータ: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time required to complete bowel program
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Effectiveness of treatment intervention
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Patient satisfaction and anticipated feasibility for home use
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Emily Rosario, PhD、Casa Colina Hospital and Centers for Healthcare

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月4日

一次修了 (推定)

2027年7月4日

研究の完了 (推定)

2027年8月4日

試験登録日

最初に提出

2026年9月1日

QC基準を満たした最初の提出物

2026年9月8日

最初の投稿 (実際)

2026年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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