At-Home Bowel Stimulation

Официальное название

At-Home Bowel Stimulation: A Prospective Cohort Study

Обзор

Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. One proposed contributor to POI is prolonged inactivity of the bowel segment distal to the ileostomy prior to restoration of intestinal continuity. Previous studies, including a multicenter randomized controlled trial, have shown that preoperative bowel stimulation of the defunctionalized intestine can reduce rates of POI and shorten length of hospital stay. However, these interventions were performed in outpatient or hospital settings and required specialized nursing support. This single-center, prospective interventional study aims to evaluate the feasibility and clinical impact of a patient-performed, at-home bowel stimulation program prior to ileostomy closure. Participants will perform daily bowel stimulation sessions at home for 3 weeks before surgery, following an initial supervised session. The primary objective is to assess feasibility, defined as successful completion of at least 6 of 9 at-home stimulation sessions by more than 75% of participants. Secondary outcomes include return to normal bowel function and length of hospital stay. Exploratory outcomes include postoperative bowel function, quality of life, and patient satisfaction. Study outcomes will be compared with a retrospective cohort of patients who previously underwent ileostomy closure without at-home bowel stimulation. The long-term goal of this research is to support incorporation of preoperative bowel stimulation into Enhanced Recovery After Surgery (ERAS®) pathways for patients undergoing ileostomy closure.

Вмешательства

• Другое At-home bowel stimulation
  All participants will undergo a standardized preoperative bowel stimulation protocol prior to ileostomy closure. The intervention includes a total of 10 stimulation sessions performed over approximately three weeks. An initial in-person visit (≤30 minutes) with a trained research nurse will include placement of a catheter into the efferent limb of the ileostomy and performance of the first supervised stimulation as instruction. Each stimulation consists of instilling 500 mL of a thickened saline

Первичные конечные точки

• Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions [Срок оценки: Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0)]

Вторичные конечные точки (2)

• Return to normal bowel function [Срок оценки: From postoperative day 0 (ileostomy closure date) until return of normal bowel function, assessed daily during the index hospitalization, up to 30 days postoperatively.]
• Length of stay [Срок оценки: From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.]

Критерии участия

Критерии включения

\- Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy

Критерии исключения

• Underlying inflammatory bowel disease (IBD)
• Known peritoneal metastases at the time of ileostomy closure
• Inability to provide clear and informed consent
• History of subtotal colectomy or total proctocolectomy
• Planned laparotomy for ileostomy closure
• Inability to speak English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Cleveland Clinic Florida — Weston

Идентификаторы

NCT: NCT07574437 · 24-1049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗