Chronic idiopathic constipation (CIC) is characterised by multiple symptoms and classified according to the Rome III criteria [
TAI is a type of colonic irrigation which is self-administered by the patient at home after adequate training in the technique and which differs from commercialised colonic irrigation (hydrotherapy) only in the volume and length of time the water is left in situ. It typically involves transanal insertion of a rectal catheter or cone in order to instil lukewarm water retrograde into the colon. This is achieved through various commercially available irrigation systems which have either hand controlled or mechanical pumps, in a volume ranging from 500 mL to 1000 mL depending on patients’ experience and tolerance. This is then drained naturally after a few minutes and can result in a satisfactory bowel movement.
The published literature provides very little evidence of efficacy in the CIC group and mostly reports effect in patients suffering faecal incontinence or constipation secondary to neurogenic bowel dysfunction (NBD) [
Patients who suffer from CIC are clearly a separate and distinctly different group of patients; the aetiology of the condition is completely unknown; there is evidence of its marked prevalence (14%) and chronicity [
Patients for this study were treated at the Durham Constipation Clinic (DCC), a tertiary referral centre in the North East of England receiving around 150 new patient referrals each year and with around 850 patients under follow-up. All patients prospectively give informed consent for enrolment onto an ethically approved database. This includes data of symptom and severity measures, physiological tests (transit, proctography, and physiology), and scores of symptom severity using the validated PAC-SYM [
The DCC team are experienced in using TAI as a minimally invasive technique for treating CIC after failed medical and behavioural therapies. Patients are selected for one of 3 differing forms of irrigation equipment based on patient choice and the ability of patients to manage the differing practical aspects of each type. Peristeen™ (Coloplast A/S®, Denmark), Qufora™ (MBH International A/S®, Denmark), and the Irrimatic pump™ (B. Braun Melsungen AG®, Germany) systems are all used, with the vast majority given the Peristeen™ system.
A service evaluation was designed to gain patient perspective on TAI as a treatment specific to refractory CIC. Patients under active clinic follow-up were identified through the prospective database and included if they fulfilled the Rome III criteria for functional constipation, had past or present treatment with TAI, and received TAI specifically for refractory CIC (failed all medical and behavioural therapies). Patients were excluded for any secondary causes of constipation (e.g., neurological or opioid use) or concomitant faecal incontinence. Evaluation of patients was not at specific time-points after commencement of therapy but was a snapshot of all patients who had used the therapy in our service within the preceding 12 months.
A 12-question form was designed for self-completion in clinic or via telephone interview by a team member. The form asked patients to indicate therapy commencement/cessation and total use, how they perceived response to the treatment, the number of irrigations performed on average each week, whether it improved particular CIC symptoms (stating yes or no if TAI improved), how satisfied they were with the therapy, and any adverse events or complications they encountered. Data was collected from February to June 2012. The duration of therapy was calculated from both participants answers on the actual length of time they had used it (to the nearest week) and notes entries on when it was started by the specialist nurse. The duration of therapy use was considered the main outcome measure as a surrogate marker of efficacy. The total number of irrigations for each person was calculated by participants reporting their frequency of use, which was then extrapolated over the therapy duration.
The prospective database of DCC patients’ baseline assessments was used to identify baseline predictors of long-term TAI efficacy. Patients who had completed the service evaluation had their baseline data checked on the database and these were extracted and included in the analysis if present and consistent with investigation prior to commencing TAI. PAC-SYM score, transit study time, isotope proctogram, and barium proctogram results were included as relevant indicators of symptom severity and physiological profile of constipation. Transit time was calculated according to the day 4 time on the Metcalf protocol [
148 people were identified (via database and specialist nurse records) and contacted, and 102 completed the service evaluation (69%) with consent for survey and demographic data analysis (Figure
Baseline
Number of patients | 102 |
Median age in years [range] | 45 [ |
Number of females [%] | 95 [93%] |
Number of males [%] | 7 [7%] |
Mean duration of CIC in years [SD : SE] | 21.8 [16.9 : 1.7] |
SD = standard deviation, SE = standard error.
Transanal irrigation
Presently still using TAI | 54 [53%] |
Completely stopped TAI | 48 [47%] |
Combined length of therapy weeks [years] | 6,175 [118.8] |
Mean length of therapy use in weeks [SD : SE] | 60.5 [73.2 : 7.3] |
Median length of therapy use in weeks [range] | 30.15 [ |
Combined irrigations | 21,476 |
Mean irrigations/week [SD : SE] | |
SD = standard deviation, SE = standard error.
Patient flow.
Participants reported “yes” or “no” if they believed that particular symptoms of CIC had been improved by TAI use (Table
Symptom improvement and overall satisfaction with transanal irrigation (TAI).
| |
Bowel frequency | 43 (42%) |
Clearance of rectum | 64 (63%) |
Abdominal pain | 49 (48%) |
Bloating | 50 (49%) |
General well-being | 66 (65%) |
Awareness of urge | 25 (25%) |
Spontaneous complete bowel movements (SCBMs) | 22 (22%) |
| |
No better | 34 (33%) |
Moderately better | |
Very much better | 28 (28%) |
In the Kaplan-Meier survival curve (Figure
Baseline investigations on prospective database (cohort).
Investigation | | Result |
---|---|---|
Transit study mean time (hours) [SD : SE] | 81 | 60.9 [15.6 : 1.7] |
PAC-SYM mean total score [SD : SE] | 65 | 2.23 [0.76 : 0.09] |
Baseline isotope & barium proctograms classified to FDD or no | 76 | FDD 40 |
FDD by consensus of consultant coauthors | None 36 |
Standard deviation (SD), standard error (SE), functional defecation disorder (FDD).
Kaplan-Meier survival of transanal irrigation. In this survival curve the endpoint was defined as patients’ discontinuing TAI therapy due to perceived ineffectiveness. 40 patients reached the endpoint with 62 (60.0%) censored at their current duration of use of TAI. The curve demonstrates that a significant proportion of the cohort continue with the therapy.
This boxplot compares the reported TAE therapy duration (
Adverse events reported (Table
Adverse events (AEs).
All AEs | 22/102 (21.6%) |
| |
Bursting balloons | 10 (9.8%) |
Catheters splitting | 3 (2.9%) |
| |
Rectal bleeding | 6 (5.9%) |
Painful irrigations | 3 (2.9%) |
Painful haemorrhoids | 2 (2.0%) |
New anal fissure | 2 (2%) |
Perforation | 0 (0%) |
Investigators across Europe have been reporting for 10 years that TAI is a beneficial treatment for patients suffering faecal incontinence and constipation due to a range of aetiologies [
The results in this cohort demonstrate that around 60% of patients with CIC use TAI for an extended period of time (1-2 years or more) and feel their symptoms are significantly improved. As this was a retrospective snapshot of outcomes, satisfaction rates at specific time intervals cannot be determined. However the duration of TAI therapy use is a justified outcome measure as this is a procedure which requires commitment and time (unlike drug treatments) and patients tend to discontinue ineffective treatments early. Duration of TAI therapy use is therefore a reasonable surrogate marker for efficacy.
The most severe symptoms of CIC (abdominal pain, bloating, incomplete emptying [of rectum], and bowel frequency) improved in over 42% of patients. Remarkably awareness of urge and spontaneous complete bowel movements occurred in a quarter and a fifth, respectively. No correlation was demonstrated between duration of TAI therapy use and patient age or duration of CIC, suggesting that the treatment can be just as effective in a patient who has suffered for 20 years as in someone with a six-month history. There was also no correlation between therapy duration and baseline transit time or presence of FDD suggesting that, on present evidence, the treatment can be offered to patients with any type of constipation. It might be a therapy that could be offered to community-assessed patients with only the treatment refractory referred for detailed investigations. A very slight negative correlation exists between baseline PAC-SYM severity and duration of therapy use: this does not reach statistical significance and merely reflects that patients with more severe symptoms fail treatments faster, which is hardly surprising.
There were no serious complications recorded despite over 20,000 irrigations used by this cohort. Indeed TAI has been used in our service for 7 years and the cohort studied probably represents less than a third of the total number of patients treated. We have not encountered any cases of rectal perforation or other serious complications in this time, though these problems have been reported and remain an unlikely possibility. A small proportion of patients developed new anal fissures during therapy but without a control group it is difficult to know if this is treatment related.
The exact mechanism through which TAI causes a bowel motion is unclear, although it is postulated to be due to stimulation or initiation of peristaltic waves through either stretching and/or warming the colon, and scintigraphic assessment has previously demonstrated washout to the splenic flexure [
Overall, a significant proportion of patients in this cohort are globally satisfied with the therapy, reporting marked symptom improvements and minimal complications. International expert consensus on the treatment algorithms of CIC in both Europe and the US has failed to adequately recognise the value and position of this treatment [
Our results are retrospective, uncontrolled, and possibly affected by reporting bias as patients were interviewed by clinic staff and as such should be treated with caution. A prospective controlled multicentre study is therefore required together with assessments of cost-effectiveness and qualitative studies of the experience of the procedure.
These results do add weight to a body of evidence that TAI is an effective and safe minimally invasive treatment for CIC, either definitively in some or as a bridge to other treatments. For now, the medical ethos of “first do no harm” and common sense dictate that it should be considered as an option on the CIC treatment algorithm before any form of invasive abdominal surgery.
Transanal irrigation
Chronic idiopathic constipation
Neurogenic bowel dysfunction
Functional defecation disorder
Durham Constipation Clinic
Health related quality of life
Patient assessment of constipation symptoms.
This manuscript has been presented as two separate conference presentations: Association of Surgeons of Great Britain and Ireland 90th International Surgical congress, Harrowgate, North Yorkshire, UK, 30/04/2014–02/05/2014. Tripartite Colorectal Meeting 2014, Birmingham, UK, 30/06/2014–03/07/2014.
The authors declare that they have no competing interests.
Kevin J. Etherson and Yan Yiannakou made substantial contributions to conception and design and were responsible for acquisition of data. Kevin J. Etherson, Yan Yiannakou, Ian Minty, Iain M. Bain, and Jeremy Cundall were responsible for analysis and interpretation of data, drafting manuscript and revising it critically for important intellectual content, and final approval of manuscript version to be published.
Yan Yiannakou has received an educational grant from Coloplast A/S. The authors thank Deborah Rowley-Conwy and Anne Kelly for help with data collection and Professor Charles Knowles for proofreading the manuscript and providing reliable scholarly advice.