At-Home Bowel Stimulation

Official title

At-Home Bowel Stimulation: A Prospective Cohort Study

Overview

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.

Interventions

• Other 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

Primary outcome measures

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

Secondary outcome measures (2)

• Return to normal bowel function [Time frame: 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 [Time frame: From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Cleveland Clinic Florida — Weston

Identifiers

NCT: NCT07574437 · 24-1049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗