Patient Management with The Insides System

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Patients with an enteroatmospheric fistula or high-output enterostomy should be closely monitored when first introduced to The Insides® System. The following points should act as a guideline to ensure successful patient outcomes. This document should be used in conjunction with The Insides® System Instructions and Technical Description and The Insides® System Setup Guide. 

Setup

Refer to The Insides® System Setup Guide for setup instructions to The Insides® System

Setting Expectations

The first week of chyme reinfusion therapy for the patient is going to be the hardest due to the discomfort of reintroducing chyme into the distal intestine, learning how to change their ostomy appliance with the Tube in situ, troubleshooting, and minor modifications to their diet. Please establish this at the beginning and continue to provide support in the initial phase of chyme reinfusion therapy. In turn, please reassure the patient that this will pass and performing chyme reinfusion therapy will provide them with many benefits.

First Time Refeeding

To provide further securement of The Insides® Tube (Tube), secure The Insides® Clip (Clip) to the outside of the ostomy appliance, over the Tube, and as close to the bottom of retention sleeve as possible. This Clip provides a second anchor point for Tube to stop it from sliding out from peristalsis. Please view How to use The Insides® Clip and Retention sleeve video and Patient applying The Insides® Clip video for further clarification.    

During the first session, use the patient's chyme to demonstrate refeeding. Refeeding with chyme provides a more realistic understanding of the time requirement, which is longer than refeeding water. Chyme must be less than eight-hours old, and the ostomy appliance should be at least one-third full.

The patient's first refeed of chyme may cause lower abdominal discomfort and bloating due to bowel distension. A small volume of chyme should be initially refed, at regular intervals, to minimise discomfort.

The volume of refed chyme will vary among patients. For example, a patient with a newly formed stoma may be able to refeed 100 mL of chyme once or twice a day, while a patient who has been defunctioned for over a year may only be able to refeed 50mL in a day. Most patients take one week to be rehabilitate their distal bowel and refeed at least 90% of their output. It is not unusual for some patients to take up to a month to establish routine refeeding, and this is due to the increased length of time that the patient has been defunctioned. Increasing a patients tolerance to refeeding is explained further below. Mild to moderate analgesia can reduce patient discomfort if required.

For efficient refeeding, the patient should sit on the edge of the bed with their feet flat on the ground or standing up with at least three points of contact for balance. This ensures all chyme is sitting at the bottom of the ostomy appliance. Ensure the Tube is straight down in the ostomy appliance so The Insides® Driver (Driver) does not have to work against bends in the Tube. Ensure the patient has a good view of the Tube and can see the chyme moving up the Tube. Support them with finding a comfortable position to hold the Driver for effective refeeding.

Day 1-2

Review The Insides™ Tube

The Tube can take up to 48-hours to settle into its natural resting position. Peristalsis may push the Tube out slightly, changing the resting position. The retention sleeve may need to be adjusted to ensure the Tube maintains a flat profile against the body. The Tube length may require additional adjustment to ensure that The Insides® Pump (Pump) is appropriately placed and not pressed against the end of the ostomy appliance.

The use of the Clip is helpful in this initial period to help keep the Tube in place and reduce movement.

The patient should feel comfortable while the Tube is in situ. Pain around the distal stoma, or significantly more Tube visible in the ostomy appliance, may signify that the Tube has slipped from underneath the fascia and is resting at skin level. If this occurs, the Tube will need to be removed and reinserted.

Increasing Refeeding Volumes and reflux

The patient should continue to refeed at very low volumes for the first few days and only increase to their own tolerance. This reduces the amount of discomfort they may get from bolusing chyme into a defunctioned intestine. Bolusing chyme stretches the luminal wall of the intestine which creates the discomfort. Please see the Frequently Asked Question: Increasing Patient Tolerance to Chyme Reinfusion for guidance on how to complete this safely. In the first week the patient may experience reflux which is chyme that has been refed but trickles back into the ostomy appliance. Reflux is not harmful but it does increase the length of time to refeed. Reflux occurs because the intestine is unable to absorb the volume of chyme that is being bolused. To reduce reflux, refeed little volumes, around 50 ml, every 2-3 minutes to assist in rehabilitating the distal intestine. Gently hold the retention sleeve on the Tube, up close to the mucosa of the stoma while reinfusing to encourage the bolus of chyme to be absorbed and reduce reflux.

Maintaining a Fluid Balance Chart

When a patient refeeds using The Insides® System (System), chyme passes through the entire gastrointestinal tract; therefore, a patient's output is calculated as follows:

Output = Volume of Vomitus + Volume of Urine + Volume of Chyme Discarded into the Toilet

 The output calculation does not include the volume of chyme, which is refed. Instruct the patient on maintaining the Patient Fluid Balance Chart, which will provide the healthcare team with an overall picture of device use and an accurate measure of the patient's fluid balance. Once the patient is home, encourage the patient to continue monitoring their fluid balance by using The Insides Log Book, that is provided in the System box.  This will provide the healthcare team visibility on the patients progress while at home.

Resume Eating

Once a patient has started refeeding, they can begin consuming food to wean off parenteral nutrition. Patients should start oral feeding slowly with small meals and it is recommended to be under the guidance of a Dietician. Once a patient starts oral feeding, their output will increase, please reassure the patient this is expected and will slow down once their distal bowel is rehabilitated and adjusting their anti-motility medication. Patients should chew their food well and avoid stringy, fibrous foods to ensure that the Pump does not block. Refer to the Dietary Recommendations for The Insides® System for more information.

Monitoring Medication

Refeeding with The Insides® System provides a longer length of bowel for absorption. Medication toxicity is possible for patients on oral medications with a narrow therapeutic range, such as Warfarin. Closely monitor drug levels and adjust doses, where necessary, when using The Insides® System.

If the patient is using a night bag to collect night time losses to reinfuse in the morning (within eight (8) hours), short-acting-medication must be taken four (4) hours before attaching the night bag. This is to ensure the medication has transited and been reinfused down stream before attaching the night bag.

Monitor drug doses closely during the initial phases of refeeding and when the patient is discharged home as compliance is likely to drop.

Day 2-7

Weaning PN Requirements 

Close monitoring of biochemistry, renal blood levels, increasing oral feeding, and reducing the amount of chyme discarded will guide weaning off PN and IV fluids. Refer to the Suggested Chyme Reinfusion and Parenteral Nutrition Weaning Guidelines for more information. Time taken to wean off PN will be dependent on individual patient characteristics but ensuring a level of independence with the device is necessary so that patients are able to maintain high use of the device.

Monitoring Bowel Movements

Patients will likely have a bowel movement within the first two to four days of refeeding, depending on the frequency and volume of refeeding. The frequency of bowel movements is also influenced by the patient's physiology and the amount of colon that remains intact. The first bowel movement will likely have a Bristol 5 or 6 consistency, progressing towards a Bristol 3 to 4 by the end of the second week. Bowel movement consistency will be affected by Loperamide use and length of colon the patient has available for reabsorption.

Reintroducing chyme downstream may ignite a Clostridium difficile infection that was lying dormant in the colon. If this occurs, monitor the patient and treat it accordingly. Low-level colitis may be present in patients that have been defunctioned for an extended period. This complication should resolve in 2-3 weeks.

Patient Involvement and Ostomy Appliance Management

Consistently encourage and support the patient to use The Insides® System independently throughout the first week. This includes modifying their process when changing their ostomy appliance. Support and monitor the patient the first few times they change their ostomy appliance so they understand how to safely thread the ostomy appliance over and off the Tube and Pump and then when resecuring the appliance once the Pump has been changed. Allow the patient to practise and record their use to improve their understanding and refeed as part of their daily routine. A well-supported patient in the hospital will likely continue to use the device once at home.

Day 7-14

Discharging Home

Patients may be ready for discharge to home in the second week. Before discharge, ensure that the patient's blood results are trending towards normal. If the healthcare team is satisfied with the patient's progress and is adequately competent with The Insides® System, they may be discharged home. Refer to Discharge Planning Checklist to ensure a safe discharge home. Utilise the Community Referral form to assit with a smooth transition home. 

Day 14-28

Home Care Requirements

A stomal therapist trained on The Insides® System should visit the patient within 48-hours after discharge. The goal of the home visit is to address and troubleshoot any issues with the System.

Renal Monitoring

Once discharged home, the patient may become dehydrated, leading to acute renal impairment. This issue occurs most often when:

  • Device use compliance drops due to life commitments, and their net stoma losses increase.
  • The patient is not refeeding overnight or if nocturnal losses become significant.
  • The patient has ceased Loperamide, exacerbating the events above.

To address issues with dehydration and renal impairment:

  • Consider implementing regular creatinine/eGFR checks to ensure appropriate hydration.
  • The patient should pump before bed and upon waking (if within eight hours).
  • If nocturnal losses are significant, use a high output ileostomy night bag, decant into the ostomy appliance in the morning and refeed if appropriate and within eight (8) hours.
    • If the patient takes medication at night, this should be taken a minimum of four (4) hours before they attach the night bag and go to bed. This allows the medication to transit through and be refeed before the night bag is attached. This mitigates the medication being collected in the night bag and being refeed in the morning.
  • Include a bedtime dosage of Loperamide.
  • Incorporate oral rehydration solutions.

The Insides System Assessment 

The following device use and patient monitoring assessments should be conducted once the patient is discharged:

  • EQ-5D-5L Quality of Life Questionnaire
  • Monitor frequency and quality of bowel movements
  • Monitor night-time losses
  • Regular renal blood results
  • Monitoring output consistency for refeeding
  • Troubleshoot pumping issues and monitor supplies

Long-Term Management

Lifestyle Routine

At this stage, the patient will be returning to their regular routines, including returning to work, resuming household duties, and reducing visits with the stomal therapist. Compliance with the System may wain, and renal impairment may increase during this period. Regular creatinine/eGFR monitoring is crucial during this stage to negate renal impairment.

Preparing for Reversal

Proper use of The Insides® System and adequate nutrition will prepare the patient for a successful stoma reversal surgery. Increasing protein and carbohydrate stores with positive weight gain optimises recovery.

Stomal Therapist Follow-Up

Once the patient becomes independent with The Insides® System, visits from the stomal therapist will decrease. The stomal therapist will still need to visit once a month to change The Insides® Tube and conduct assessments. Regular weekly phone calls with the patient renal monitoring will continue where clinically indicated.

 

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