Does the type of enema administration affect time to complete bowel care in people with recent Spinal Cord Injury?

• Register: ANZCTR
• Last refreshed on: 15 November 2021
• Main ID: ACTRN12618000221257
• Date of registration: 12/02/2018
• Prospective Registration: Yes
• Primary sponsor: Northern Sydney Local Health District
• Public title: Does the type of enema administration affect time to complete bowel care in people with recent Spinal Cord Injury?
• Scientific title: Is the time to complete bowel care as quick if not quicker using a low micro enema compared to a high micro enema in people with a recent spinal cord injury?: A non-inferiority, double blinded, cross over randomised control trial
• Date of first enrolment: 28/01/2019
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000221257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Louise Kelly

• Name: Prof Lisa Harvey

Key inclusion & exclusion criteria

Inclusion criteria: * have a complete or incomplete SCI sustained within the past six months (as defined by the International Standards for Neurological classification of SCI)
* have return of gastrointestinal tract function (ie., adequate oral intake, bowel sounds, passing flatus / stool) and are in a stable bowel care routine
* have intact anorectal reflexes as confirmed by per rectal (pr) examination
* are an inpatient at one of the participating SCI units and likely to remain there for the duration of his/her involvement in the trial (i.e., approximately 8 weeks)
* aged 16 years or over at the time of consent
* willing to participate in the trial

Exclusion criteria: * unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, or behavioural problem)
* unable to speak sufficient English to fully understand and perform required activities and complete assessments
* unable to tolerate an enema for medical reasons (i.e, contraindicated)
* have any other type of neurological condition or injury other than spinal cord injury affecting bowel function
* have an allergy to any of the ingredients used in Microlax ®
* have complications related to bowel care (eg. Autonomic Dysreflexia, haemodynamic instability)


Age minimum: 16 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Injuries and Accidents - Other injuries and accidents

neurogenic bowel;spinal cord injury;
neurogenic bowel
spinal cord injury

Neurological - Other neurological disorders

Intervention(s)

Participants are randomised into one of two treatment sequences.

Treatment sequence 1:
Participants will receive a low enema for 4 weeks then switch to high enema for 4 weeks.

Treatment sequence 2:
Participants will receive a high enema for 4 weeks then switch to low enema for 4 weeks.

Low enema:
5mL of micro enema (sodium citrate 450mg, sodium lauryl sulfoacetate 45mg and sorbitol 3.125g in 5mL) will be administered into the anal canal but not past the anorectal ring.

High enema:
5mL of micro enema (sodium citrate 450mg, sodium lauryl sulfoacetate 45mg and sorbitol 3.125g in 5mL) will be transferred into a 10ml syringe attached to a nelaton catheter cut to 10cm. The syringe will be primed to 5mL (the standard dose of the micro enema) which is then passed through the anorectal ring and administered into the rectum, but not past the inferior rectal valve (3rd valve of Housten).

This treatment will be administered by nursing and technical staff once per day.

All nursing and technical staff involved in the project will attend education on the correct procedure for enema administration and complete a competency prior to participating in the study. Compliance with this requirement will be recorded in the site specific investigator folder.

The majority of people with Spinal Cord Injury do not defecate without external stimulation / intervention, The consequences of not defecating are constipation, fecal incontinence, impaction and for some, Autonomic Dysreflexia. People with Spinal Cord Injury are highly motivated to avoid these negative outcomes are therefore adherence to treatment is expected to be high.

For these reasons, there cannot be a 'wash out' period in the traditional sense. Expert clinical ad

Primary Outcome(s)

Time to complete bowel care (assessor determined):
The time from commencement of the enema administration procedure to completion of faecal elimination as defined by an empty rectum on per rectum (pr) check. [This will be assessed 6 times: three times in week 4 post randomisation (end of phase 1) and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one time for each of the two 4-week phases.]

Secondary Outcome(s)

Spinal Cord Injury Quality of Life (SCI QoL) – Bowel Management difficulties.
This outcome captures quality of life due to bowel management difficulties. It will be measured using the SCI QoL. This is a 9-item self-report questionnaire.
Participants are required to respond to statements such as “I was frustrated by repeated bowel accidents” on a Likert Scale (1-5) anchored with the following words: “not at all”, “a little bit”, “somewhat”, quite a bit” and “very much”. [This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
]

Frequency of unplanned bowel evacuations:
This outcome captures faecal incontinence outside of regular bowel care. It will be measured using the Douglas Wong Score. This is a 5-item self-report questionnaire.
[This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.]

Perception of effectiveness of bowel care routine (Participant reported):
This outcome captures participants’ perception of the effectiveness of their bowel routines over the last 4 weeks. It will be measured using a 11-point Likert Scale (0-10), anchored at each end from “extremely ineffective” to “extremely effective”.
Participants will be asked:
How effective do you think your bowel routine has been over the last 4 weeks? Please rate on the below scale from 0 to 10 where 0 indicates "extremely ineffective" and 10 indicates "extremely effective".
[This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
]

Perception of effectiveness of bowel care routine (Nurse reported):
This outcome captures nurses’ perception of the effectiveness of their bowel routines over the last 4 weeks. It will be measured using a 11-point Likert Scale (0-10), anchored at each end from “extremely ineffective” to “extremely effective”.
The nurse will be asked:
How effective do you think your patients’ bowel routine has been over the last 4 weeks? Please rate on the below scale from 0 to 10 where 0 indicates "extremely ineffective" and 10 indicates "extremely effective".

[This will be administered 6 times: three times in week 4 post randomisation (end of phase 1), and three times in week 8 post randomisation (end of phase 2). Measurements will be averaged to attain one score for each of the two 4-week phases.
]

Time to complete bowel care (participant determined):
The time from commencement of the enema administration procedure to completion of faecal elimination as defined by an empty rectum on per rectum (pr) check. The patients will be required to use a stop watch /timer to time bowel care and enter the bowel care times into a diary. [Participants will be required to do this 12 times: six times in weeks 3 and 4 post randomisation (end of phase 1), and six times in weeks 7 and 8 post randomisation (end of phase 2). Measurements will be averaged to attain one time for each of the two 4-week phases.]

Secondary ID(s)

None

Source(s) of Monetary Support

icare

Royal North Shore Hospital

Slater and Gordon Health Care Projects & Research Funds

Secondary Sponsor(s)

University of Sydney

Ethics review

Status: Approved
Approval date: 14/06/2017
Contact:

Northern Sydney Local Health District

Results

• Results available: Yes
• Date Posted: 09/11/2021
• Date Completed: 08/07/2021