Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1658-1670 |
| Number of pages | 13 |
| Journal | Colorectal disease |
| Volume | 25 |
| Issue number | 8 |
| Early online date | 2023 |
| DOIs | |
| Publication status | Published - Aug 2023 |
Keywords
- constipation
- faecal incontinence
- functional bowel disorder
- transanal irrigation
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In: Colorectal disease, Vol. 25, No. 8, 08.2023, p. 1658-1670.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Prospective cohort study of high-volume transanal irrigation in patients with constipation and/or faecal incontinence
AU - Vollebregt, Paul F.
AU - Dekker, Lisette
AU - Han-Geurts, Ingrid J. M.
AU - Felt-Bersma, Richelle J. F.
N1 - Funding Information: P. F. Vollebregt has received honoraria from Wellspect B.V. as speaker fee. L. Dekker, I. J. M. Han-Geurts and R. J. F. Felt-Bersma have no conflicts of interest. The study was partly funded by Wellspect. Wellspect was not involved in the study design, the analyses or writing of the manuscript. We prospectively recruited 114 consecutive adult patients (≥18 years old) naive to TAI with either the Navina™ Classic or Smart system, referred by 26 different centres in the Netherlands to Wellspect HealthCare or the wholesale company Hoogland Medical between February 2018 and September 2020. Patients were referred by their treating gastroenterologist or colorectal surgeon. Prior to referral, all patients failed lifestyle/dietary adjustments and antidiarrhoeal medication or laxatives. Study information was provided to potential study patients by post at least 24 h before the first appointment with the conservative management nurse from Wellspect HealthCare or Hoogland Medical. During the first appointment with the nurse the study information was discussed and informed consent was given by the patient. Patients were considered ineligible if they were not able to understand written and spoken Dutch language. To reduce population heterogeneity, all patients had to satisfy the Rome IV criteria for functional constipation [a minimum of two or more symptoms during more than one-quarter (25%) of defaecations: (a) straining; (b) lumpy or hard stool; (c) feeling of incomplete evacuation; (d) feeling of anorectal obstruction; (e) manual manoeuvres; (f) fewer than three defaecations per week] [10] and/or the Rome IV criteria for faecal incontinence (episodes to solid or liquid stools occurring more than monthly) [11]. All participating patients underwent treatment with TAI according to routine care. Patients were allowed to decide to use either the Classic (manual pump) or Smart (electronic pump) system. During the first face-to-face visit, all patients were instructed by a conservative management nurse to start TAI daily with 500–1000 mL of water. The frequency of TAI and the volume of water were adjusted during follow-up (frequent telephone clinics). We prospectively recruited 114 consecutive adult patients (≥18 years old) naive to TAI with either the Navina™ Classic or Smart system, referred by 26 different centres in the Netherlands to Wellspect HealthCare or the wholesale company Hoogland Medical between February 2018 and September 2020. Patients were referred by their treating gastroenterologist or colorectal surgeon. Prior to referral, all patients failed lifestyle/dietary adjustments and antidiarrhoeal medication or laxatives. Study information was provided to potential study patients by post at least 24 h before the first appointment with the conservative management nurse from Wellspect HealthCare or Hoogland Medical. During the first appointment with the nurse the study information was discussed and informed consent was given by the patient. Patients were considered ineligible if they were not able to understand written and spoken Dutch language. To reduce population heterogeneity, all patients had to satisfy the Rome IV criteria for functional constipation [a minimum of two or more symptoms during more than one-quarter (25%) of defaecations: (a) straining; (b) lumpy or hard stool; (c) feeling of incomplete evacuation; (d) feeling of anorectal obstruction; (e) manual manoeuvres; (f) fewer than three defaecations per week] [10] and/or the Rome IV criteria for faecal incontinence (episodes to solid or liquid stools occurring more than monthly) [11]. All participating patients underwent treatment with TAI according to routine care. Patients were allowed to decide to use either the Classic (manual pump) or Smart (electronic pump) system. During the first face-to-face visit, all patients were instructed by a conservative management nurse to start TAI daily with 500–1000 mL of water. The frequency of TAI and the volume of water were adjusted during follow-up (frequent telephone clinics). Data were collected using a comprehensive questionnaire completed at five different time points: baseline (just before starting the first irrigation at a face-to-face visit with the conservative management nurse) and at 4, 12, 26 and 52 weeks’ follow-up. The baseline questionnaire incorporated questions on demographics, obstetric, surgical and medical history and previous treatment. Validated symptom severity and QoL scores were completed at both baseline and during follow-up, including the Rome IV criteria for functional constipation [10] and faecal incontinence [11], the Cleveland Clinic Constipation Score (CCCS; 0–30; a higher score indicates more severe symptoms) [12], the St Marks Incontinence Score (SMIS; 0–24; a higher score indicates more severe symptoms) [13], PAC-QoL (1–4; a higher score indicates worse QoL) [14], the Fecal Incontinence Quality of Life Scale (FI-QoL; 1–4; a higher score indicates better QoL) score [15] and the Bristol stool form scale [16]. QoL questionnaires (PAC-QoL and FI-QoL) were not included in the questionnaire at 12 weeks’ follow-up. Completeness of evacuation after irrigation [visual analogue scale (VAS) score], treatment satisfaction (VAS score) and side effects were also recorded at each follow-up appointment. In case of discontinuation of TAI, patients were asked to provide the main reason for discontinuation. At follow-up, irrigation parameters [frequency, volume (mL) and duration (min) of irrigation] were evaluated. The questionnaire data were collected on paper (baseline visit) or digitally via a secured data management platform (Castor) depending on patient preference. All data were stored on the data management platform. The sample size was based on the primary endpoint of the study: reduction of symptoms at 52 weeks measured using the CCCS and SMIS. According to previously published results, we estimated that patients had a median SMIS of 9 (SD 4.5) and a median CCCS of 13 (SD 4.5) at baseline [5]. Patients were divided into three groups: primary symptoms of constipation, primary symptoms of faecal incontinence and symptoms of both constipation and faecal incontinence (based on the Rome IV criteria for functional constipation [10] and/or faecal incontinence [11]; these symptoms frequently coexist [17]). A 30% scale reduction with a variance estimate conservatively set at a SD of 4.5 was considered clinically relevant. A power of 90% and a significance level of 5% was used. To detect a median change of 3.9 in the CCCS pre- versus postirrigation, 17 patients with primary symptoms of constipation had to be included. To detect a median change of 2.7 in the SMIS pre- versus postirrigation, 32 patients with primary symptoms of FI had to be included. To detect a median change of 6.6 in CCCS and SMIS pre- versus postirrigation, eight patients with symptoms of both constipation and faecal incontinence had to be included. Different studies (including a study from our centre) have reported a dropout of approximately 50% of patients after 1 year of follow-up [3, 16, 18]. Therefore, we aimed to recruit a total of 34 patients with constipation, 64 patients with faecal incontinence and 16 patients with both constipation and faecal incontinence (a total of 114 patients). All data are presented in the total group as well as per Rome IV classification. Descriptive statistics were used to report the results, including median [interquartile range (IQR)] for continuous variables. For variables with missing data, multiple imputation was performed. Clinical characteristics were compared between groups using the chi-square and Mann–Whitney U tests. Kaplan–Meier curves were plotted to show continuation rates in: (1) the total group and stratified per (2) symptom group, (3) sex and (4) device group (Navina™ Classic vs. Smart). Reduction in symptoms was only analysed in those who continued TAI at 52 weeks’ follow-up. Reduction in symptoms was measured per entire group (median, IQR) and per individual (median, IQR) to confirm that symptom improvement was not secondary to drop-out of patients with more severe symptoms. Multivariable logistic regression was used to identify independent factors associated with continuation of TAI at 52 weeks, with results presented as effect sizes (odds ratio) with 95% CIs. Statistical analysis was performed using GraphPad Prism 9.0 and R Studio. Ethical approval was granted by the VU University Medical Centre Research Ethics Committee (reference number 2017.533) on 4 January 2018. Publisher Copyright: © 2023 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.
PY - 2023/8
Y1 - 2023/8
N2 - Aim: The aim of this work was to determine the clinical efficacy of high-volume transanal irrigation (TAI) in patients with constipation and/or faecal incontinence using validated symptom and quality of life questionnaires. Method: This was a prospective cohort study of 114 consecutive patients with constipation and/or faecal incontinence (Rome IV defined) who started TAI. A comprehensive questionnaire was completed at baseline and 4, 12, 26 and 52 weeks’ follow-up. The primary objective was significant symptom reduction [≥30%; Cleveland Clinic Constipation Score (CCCS) and St Marks Incontinence Score (SMIS)] in those who continued TAI at 52 weeks. Secondary objectives were (1) continuation rates of TAI, (2) effect on quality of life (QoL) and (3) identification of predictors for continuation. Results: A total of 59 (51.8%) patients with constipation, 26 (22.8%) with faecal incontinence and 29 (25.4%) with coexistent symptoms were included. At 52 weeks, 41 (36.0%) patients continued TAI, 63 (55.2%) stopped and 10 (8.8%) patients were lost to follow-up. In those who continued TAI at 52 weeks (n = 41), no reduction of constipation symptoms was observed. Median Patient Assessment of Constipation Quality of Life scores decreased on most domains, indicating QoL improvement. Reduction of faecal incontinence occurred in 5/9 (55.6%) patients with faecal incontinence and in 3/10 (30.0%) patients with coexistent symptoms. The median SMIS per-individual decreased in patients with coexistent symptoms (2; interquartile range 0–4; p = 0.023). Median Fecal Incontinence Quality of Life scores increased in most domains, indicating improved QoL. No clinical characteristics predicted continuation. Conclusion: One-third (n = 41) of patients continued TAI at 52 weeks. In those who continued TAI at 52 weeks, symptoms of faecal incontinence (SMIS) were reduced but not constipation (CCCS). QoL related to both constipation and faecal incontinence improved. No clinical characteristics predicted continuation.
AB - Aim: The aim of this work was to determine the clinical efficacy of high-volume transanal irrigation (TAI) in patients with constipation and/or faecal incontinence using validated symptom and quality of life questionnaires. Method: This was a prospective cohort study of 114 consecutive patients with constipation and/or faecal incontinence (Rome IV defined) who started TAI. A comprehensive questionnaire was completed at baseline and 4, 12, 26 and 52 weeks’ follow-up. The primary objective was significant symptom reduction [≥30%; Cleveland Clinic Constipation Score (CCCS) and St Marks Incontinence Score (SMIS)] in those who continued TAI at 52 weeks. Secondary objectives were (1) continuation rates of TAI, (2) effect on quality of life (QoL) and (3) identification of predictors for continuation. Results: A total of 59 (51.8%) patients with constipation, 26 (22.8%) with faecal incontinence and 29 (25.4%) with coexistent symptoms were included. At 52 weeks, 41 (36.0%) patients continued TAI, 63 (55.2%) stopped and 10 (8.8%) patients were lost to follow-up. In those who continued TAI at 52 weeks (n = 41), no reduction of constipation symptoms was observed. Median Patient Assessment of Constipation Quality of Life scores decreased on most domains, indicating QoL improvement. Reduction of faecal incontinence occurred in 5/9 (55.6%) patients with faecal incontinence and in 3/10 (30.0%) patients with coexistent symptoms. The median SMIS per-individual decreased in patients with coexistent symptoms (2; interquartile range 0–4; p = 0.023). Median Fecal Incontinence Quality of Life scores increased in most domains, indicating improved QoL. No clinical characteristics predicted continuation. Conclusion: One-third (n = 41) of patients continued TAI at 52 weeks. In those who continued TAI at 52 weeks, symptoms of faecal incontinence (SMIS) were reduced but not constipation (CCCS). QoL related to both constipation and faecal incontinence improved. No clinical characteristics predicted continuation.
KW - constipation
KW - faecal incontinence
KW - functional bowel disorder
KW - transanal irrigation
UR - http://www.scopus.com/inward/record.url?scp=85161458461&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/codi.16628
DO - https://doi.org/10.1111/codi.16628
M3 - Article
C2 - 37259692
SN - 1462-8910
VL - 25
SP - 1658
EP - 1670
JO - Colorectal disease
JF - Colorectal disease
IS - 8
ER -