None listed
Conditions
Brief summary
Appropriate neurogenic bowel management is critical to living well with Spinal Cord Injury (SCI). In the Sydney spinal nursing community current practice around how bowel care is delivered is divided. Some recommend daily low enemas (ie, standard micro-enemas), whilst others prefer administering the enema higher into the rectum using various pieces of equipment (i.e., high enemas). High enemas are more costly than low enemas and associated with potential complications. However, many believe that high enemas give a better bowel result and therefore the additional risk and cost is justified yet there is currently no evidence to support or refute these beliefs. Therefore, the aim of this study is to determine whether low enemas are as good or better than high enemas in people with a recent spinal cord injury.
Interventions
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 mic
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 advice determines that any change in bowel care routines require 2 weeks to establish, which is why the design of the study takes this into account. i.e. 2 weeks of the 'changed intervention' to re-establish routine and 2 weeks of the routine prior to measuring outcomes.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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)
Outcome results
None listed