Proof-of-concept for intervention to prevent post-operative ileus in patients undergoing ileostomy formation

This study was approved by the Institutional Review Board at the University of California, San Francisco (UCSF): Study Number 18-26677. Reporting guidelines as outlined in the Standards for Quality Improvement Reporting Excellence (SQUIRE) 2.0 were followed.

Enhanced recovery after surgery pathway at our institution

An enhanced recovery after surgery (ERAS) pathway was implemented at our institution for all patients undergoing abdominal colorectal surgery in 2014. Prior to implementation of this pilot intervention, the pathway included day-to-day guidance on multimodal pain control, fluid administration, activity level, nutrition, and other nursing treatments (e.g., foley removal, chewing gum, shower) for patients undergoing different colorectal operations. Per our standard ERAS pathway, patients undergoing ileostomy formation received Lactated Ringers in 5% Dextrose solution at 50 ml/h intravenously on post-operative day (POD) 0, which was discontinued on POD1 if patients did not show clinical signs of volume deficit (e.g., tachycardia or orthostatic hypotension, oliguria, or acute elevation in blood urea nitrogen [BUN] or creatinine [Cr] meeting the criteria of acute kidney injury [AKI]). We define tachycardia as > 100 beats per minute; orthostatic hypotension as systolic blood pressure decrease of at least 20 mmHg or diastolic blood pressure decrease of at least 10 mmHg within three minutes of standing; oliguria as urine output < 0.5 mL/kg/h; and AKI as increase in serum creatinine by ≥ 0.3 mg/dL within 48 h, or increase in serum creatinine to ≥ 1.5 times baseline, or urine volume < 0.5 mL/kg/h for 6 h (KDIGO clinical practice guideline for acute kidney injury 2012). Patients were restricted to a clear liquid diet not to exceed 2 L in a 24-h period on POD0 and advanced to a low-residue diet on POD1 if no nausea was present.

Pilot intervention

Our pilot intervention consisted of three adjustments to this protocol for patients undergoing new ileostomy formation (either end ileostomy or diverting loop ileostomy). The first adjustment was to administer furosemide (Lasix) 10 mg intravenously on POD1 if the patient’s net fluid balance was greater than 500 mL, ileostomy output was less than 1.5 L, and kidney function, as measured by BUN and creatinine, was at the patient’s baseline. The second was a change in diet advancement to a new protocol of restricted clear liquids on POD0, a full liquid diet on POD1, and a low residue diet on POD2. The third was intubation of the stoma with a red Robinson catheter on the morning of POD1 if ileostomy output was < 100 mL since operation. No changes in pain control, activity level, or other nursing treatments were made to the ERAS protocol for these patients as part of our pilot intervention.

Information about the new protocol was shared with the attendings on the service, residents rotating on the service, and advanced practice providers who are permanently assigned to the colorectal surgery service. To ensure compliance with the changes, we updated our official internal protocol documents circulated to faculty, clinical staff, and trainees rotating on the colorectal surgery service; provided an in-service to faculty and clinical staff on the colorectal surgery service; included a visual reminder (Fig. 1) in the team workroom; and incorporated the new guideline into sign-out between the outgoing and incoming chief surgical resident on the rotation to disseminate to the rest of the team. Furthermore, the nurse practitioners, who are consistent members of the team, were asked to reinforce these protocols. The attending surgeons also continually reinforced the ERAS adjustment with the team and kept track of all patients who participated in the pilot.

Fig. 1figure 1

Visual reminder of ERAS adjustment disseminated to clinical staff and posted in team workroom, original

Study population and comparison group

The pilot period included 58 non-emergent procedures between August 13, 2020 and June 1, 2021 that included formation of an ileostomy in which the pilot intervention was employed. The baseline comparator period included all consecutive patients who had elective or urgent (i.e., non-emergent) abdominal colorectal surgery that included formation of an ileostomy by a board-certified colorectal surgeon from July 1, 2015 to June 30, 2020. These were patients on the standard ERAS pathway without pilot intervention. Procedures with ileostomy formation were identified by querying a prospectively-maintained database using current procedural terminology (CPT) codes that included ileostomy formation. Patient charts associated with cases identified through the query were reviewed to confirm they included ileostomy formation.

Outcome measures

Our primary outcome of interest was the development of POI. Secondarily, we assessed stoma output and net fluid balance as of POD2; post-procedure length of stay [LOS]; direct cost of hospitalization; and 30-day readmissions.

Study variables

Demographic, intraoperative, and select outcome (LOS, direct cost of hospitalization, and 30-day readmissions) data for both time periods were obtained from an automated ERAS report from our electronic medical record (EMR). Chart review was performed for all ileostomy formation cases in both time periods to identify daily fluid balance, ileostomy output, and whether the patient developed POI. During the patient’s hospitalization, onset of POI was defined clinically by the primary team based on the findings of post-operative nausea and vomiting, abdominal distension, and/or imaging suggesting POI and treated by restricting diet and placing a nasogastric (NG) tube. For the study, patients with POIs were identified by reviewing each patient’s chart to identify documentation of POI or, in the absence of explicit documentation of POI in a patient’s chart, evidence of ileus-specific intervention such as prolonged NPO status (POD3 or longer) or post-operative NG tube placement.

Data analysis

SAS V9.4 (SAS Institute, Cary, NC, USA) was used to summarize these variables via simple descriptive statistics and compare pilot data to our institution’s baseline data consisting of patients who had an ileostomy formation between July 1, 2015 and June 30, 2020. Two sample t tests were used to compare continuous variables and Fisher’s exact tests were used to compare categorical variables. Logistic regressions were used to evaluate the association between POI and covariates.

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