None listed
Conditions
Brief summary
Chronic constipation and faecal incontinence carry significant health and economic burdens on individuals as well as the health system. Initial treatment remains conservative including medications and dietary modifications. However should these be ineffective, guidelines recommend investigating for physiological abnormalities by anorectal physiology testing including ARM and BET. The results of these are subsequently used to guide prescription of second line management including biofeedback therapy, neuromodulation and surgical interventions which when used appropriately demonstrated positive outcomes. Given the central role of anorectal physiological testing, there remains a lack of standardisation when conducting these procedures and subsequently, we remain uncertain whether the results produced are comparable. This applies to the study protocol itself, the equipment used during testing and analysis of results. Literature has even suggested that in cases of faecal incontinence, it may be beneficial for individual units to have their own range of values for defining abnormalities. The sensory component of defaecation, namely alterations in visceral perception and rectal compliance has also become increasing studied and tested. Determining type and degree of dysfunction in these have implications on provision of treatment. Barostat methodology is now widely used to assess sensory components of defaecation but different protocols exist, mainly with varying duration and equipment for the procedure. As a result, normal cut-offs remain unclear.
Interventions
Patients referred to our Neurogastroenterology Unit who meet the diagnostic criteria of functional constipation and faecal incontinence will be asked regarding their willingness to participate in the study. Apart from the Unit’s standard protocol for ARM that the patient has been referred for, the study requires them to undergo variations in the standard BET protocol and additional sensory testing via the rapid barostat protocol.
Following informed consent, the patient will undergo standard AR
Patients referred to our Neurogastroenterology Unit who meet the diagnostic criteria of functional constipation and faecal incontinence will be asked regarding their willingness to participate in the study. Apart from the Unit’s standard protocol for ARM that the patient has been referred for, the study requires them to undergo variations in the standard BET protocol and additional sensory testing via the rapid barostat protocol. Following informed consent, the patient will undergo standard ARM for which they have been referred for using a 7-lumen water-perfused manometry catheter. Anorectal ultrasound will be performed to assess for any defects in the internal or external sphincter. Following this, procedures relating to the study will be performed as detailed below. Footstool testing: Patients will undergo the BET using a commercial balloon without a footstool as per the standard BET protocol. In addition balloon expulsion will be performed two more times with two footstools of different heights (7inches and 9 inches). Hence a total of 3 BET will be completed in each patient consecutively in a randomised order. Prior to the testing, the following parameters will be measured and recorded: • Weight • Height • True leg length as determined by measuring from the anterior superior iliac spine to the tip of medial malleolus. • Degree of hip range of motion bilaterally using a goniometer as a measure of flexibility The patient will be escorted to a private bathroom where they will attempt to push out the balloon. The angle between the lower spine and femur will be measured using a goniometer for each BET. The time taken to expel the balloon will be noted. Furthermore, the patients will be asked to rate their urge to pass the balloon, the discomfort experienced and how easy it was to pass the balloon on visual analogue scales for each BET. This information will be recorded on a form. Sensory testing: This will be tested using an infinitely compliant balloon continuously injected with air in a rapid barostat protocol which has been suggested to be a more reliable measure of sensation. An infinitely compliant balloon is a bag (glad baggie) that is not fully inflated hence at the volumes tested there is no intrinsic compliance of the balloon being recorded. This is in contrast to a rubberised balloon in which there is intrinsic compliance and therefore the measurement of compliance is partly contributed to by both the rubbery balloon and the organ (rectum) being assessed. - The patients are told to report when they first feel the sensation of the expanding balloon inside the rectum and this is recorded as the rectal sensitivity threshold. - The balloon will continue to be filled and the patient then reports when they have the urge to defecate. - The balloon again continues to be inflated until the patient reports when they cannot tolerate the inflation any further. This is recorded as the maximum tolerated volume. Following this, the balloon is rapidly deflated either at time of reported maximal tolerated volume or at a maximum volume of 300mL, whichever is reached first. If the patient experiences any intolerable discomfort during the procedure, it will be terminated immediately. This sensory assessment is identical to the method used in routine anorectal manometry with a compliant balloon, except that an infinitely compliant balloon is used.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 75 2. Females and males 3. English speakers 4. Meets diagnostic criteria for either faecal incontinence or chronic constipation 5. Willingness to give written informed consent 6. Willingness to comply with study
Exclusion criteria
1. Women who are lactating or pregnant 2. Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
Outcome results
None listed