Abstract
Objective
To determine the long-term outcome of Peristeen’s home use.
Method
Retrospective study on the 16 first patients treated by Peristeen in the department of physical and readaptation medicine of Limoges universitary hospital, by the mean of phone interviews.
Results
Successful outcome was achieved in 62.5% patients after a mean follow-up of 2.6 years. All patients had neurogenic bowel disorders, including 75% of constipation. Most of cases of Peristeen discontinuation occurred at the treatment beginning, one month after introduction in two thirds of cases. In patients who were still using transanal irrigation (TAI), mean grade of satisfaction with the Peristeen system was 9.12/10, despite the high rate of technical problems (77.8% of cases).
Conclusion
This study highlights the limits of Peristeen’s long-term using and suggests the interest of a specific therapeutic education to Peristeen and of a systematic control consultation within the 3 first months of treatment.
Résumé
Objectif de l’étude
Déterminer le maintien à long terme de l’utilisation à domicile du Peristeen.
Méthode
Étude rétrospective sur les 16 premiers patients traités par Peristeen dans le service de médecine physique et réadaptation du CHU de Limoges, menée par entretien téléphonique individuel.
Résultats
À un recul moyen de 2,6 ans, le taux de maintien avec succès du Peristeen était de 62,5 %. Toutes les indications avaient été posées chez des patients neurologiques et dans 75 % des cas pour une constipation. La majorité des abandons du Peristeen sont survenus en début de traitement, à un mois dans deux tiers des cas. Chez les patients ayant poursuivi l’utilisation, la satisfaction par rapport au Peristeen était de 9,12 sur 10 en moyenne, malgré la fréquence des problèmes techniques (77,8 % des cas).
Conclusion
Cette étude explicite les limites au maintien dans le temps de l’utilisation du Peristeen, et donne des arguments en faveur de l’intérêt d’une éducation thérapeutique spécifique au Peristeen et d’une consultation systématique de suivi dans les trois premiers mois suivant l’introduction du traitement.
1
English version
1.1
Introduction
Peristeen is a transanal retrograde irrigation system indicated in second intention in the neurogenic bowel dysfunction management. Its action by emptying rectosigmoid has been demonstrated by scintigraphy . There is evidence of Peristeen’s efficacy on neurogenic bowel symptoms in adults , as in children , and also on the quality of life . However, the use of Peristeen is difficult to maintain over time. Although short-term trials report an important improvement of bowel disorders, long-term studies show a decreasing overall success, of 47% at 1.8 years .
In the Limoges Universitary Hospital, current clinical practice of Peristeen in the PRM department is developed since 2010. The first patients who were trained in transanal irrigation (TAI) with Peristeen received an informal education. Later, we elaborated a specific protocol of therapeutic education, which was validated in august 2011 by the institution.
The objective of this retrospective preliminary study was to determine the long-term outcome of TAI with Peristeen at home, in the sample of our first patients treated by Peristeen. We plan subsequently a prospective study on the outcome of the patients who would have benefited from the specific therapeutic education.
1.2
Method
1.2.1
Objectives
The main objective was to determine the long-term outcome of TAI with Peristeen and its predictive factors. Secondary objectives were on one hand to evaluate the severity of bowel symptoms in patients treated by Peristeen, by the Neurogenic Bowel Score (NBD score) and the Cleveland clinic score, and on the other hand to evaluate the informal therapeutic education provided in our department by a numeric satisfaction scale.
1.2.2
Population and material
This is a retrospective study performed in all patients who benefited from Peristeen in the PRM department of the Limoges hospital since 2010, id est a sample of 20 patients.
First, initial clinical data were recorded: date of Peristeen’s introduction, underlying neurological pathology, Peristeen’s indication (constipation or fecal incontinence), initial severity of bowel disorders, the anterior management of bowel dysfunction (particularly laxatives’ number and quantity), the initial efficacy of Peristeen, and modalities of Peristeen’s setting up at home.
Then was led a medical phone interview of about fifteen minutes. After giving his or her consent, the patient was asked if he or she still used TAI with Peristeen. In case of discontinuation, the date and the reason of ceasing were clarified. In case of continuation, modalities of use were detailed: type and frequency of administration, volume of instilled water, time of irrigation exposure, time between irrigation and defecation. We enquired too about eventual technical problems or complications. Bowel symptoms were evaluated by the NBD score and the Cleveland clinic score. Grade of satisfaction with the Peristeen was assessed on a numeric box scale (range 0–10, 10 representing great improvement). Finally, other therapeutics eventually associated (laxatives, enema, abominal massage, manual evacuation) were noticed. For all patients, the interview looked for the satisfaction with the informal education received in the PRM department, by the mean of a numeric scale (0–10), and for eventual complications related to constipation (emergency consultation or hospitalization).
1.2.3
Statistical method
Quantitative variables were compared using t test of Student and qualitative variables with Fisher test.
1.3
Results
1.3.1
Description de la population
We prescribed TAI with Peristeen in 20 patients ( Table 1 ). The therapeutic test was positive in 16 cases. In four patients, treatment by Peristeen was not continued because of inefficacy in one post-traumatic paraplegic patient, of systematic burst of the balloon in two cases of flaccid perineum in cauda equina syndrome, and because of a lack of cooperation of the liberal nurse for one woman suffering from multiple scleroses with cognitive impairment. These four patients have been excluded from the study.
| Features of the population ( n = 16) | Number of patients | Percentage of patients |
|---|---|---|
| Gender | ||
| Male | 6 | 37.5 |
| Female | 10 | 62.5 |
| Symptoms | ||
| Constipation | 12 | 75 |
| Constipation + fecal incontinence | 3 | 18.75 |
| Constipation + perineal pain | 1 | 6.25 |
| Underlying neurologic pathology | ||
| Spinal cord injury | 5 | 31.25 |
| Multiple sclerosis | 4 | 25 |
| Cerebral palsy | 2 | 12.5 |
| Spina bifida | 2 | 12.5 |
| Cauda equina syndrome | 1 | 6.25 |
| Stroke | 1 | 6.25 |
| Multiple system atrophy | 1 | 6.25 |
| Type of administration | ||
| Autoadministration | 6 | 37.5 |
| Hétéroadministration | 10 | 62.5 |
Our sample of 16 patients had a mean age of 49 years and a feminine predominance (62.5%). Peristeen’s indication was constipation in 75% of cases, association of constipation and fecal incontinence in 18.75% of cases, and association of constipation and perineal pain in 6.25% of cases. In this particular case, Peristeen was effective on constipation but not on the pain.
About one third of indications (31.25%) concerned spinal cord injured patients (12.5% with paraplegia, 18.75% with tetraplegia). Other causal pathologies were multiple sclerosis, cerebral palsy, spina bifida, cauda equina syndrome, stroke and multiple system atrophy.
All patients were receiving a medical treatment for constipation before the beginning of TAI with Peristeen and consuming 1.91 laxatives on average.
The mean follow-up since Peristeen’s initiation was 31 months (SD 18.05; min 7.5 months, max 66 months).
In all cases, TAI with Peristeen was initiated within a hospitalization setting: in seven patients (43.75%) in conventional hospitalization, in six patients (37.5%) in week-hospitalization, and in 3 patients (18.75%) in day-hospitalization. All patients received an informal education to Peristeen, excepted one patient who declared have not been educated at all.
At discharge, autoadministration of Peristeen was possible in only 37.5% of cases. In case of heteroadministration (72.5% of cases, 10 patients), TAI with Peristeen was performed by a nurse for seven patients, by a member of the family for one patient, and alternately by a nurse and a family member for two patients living in institution.
There was no specific follow-up of Peristeen’s use, but the usual follow-up in the context of the underlying neurologic pathology. Patients and carers had possibility to call the department if needed. Day hospitalization was available to complete education in case of technical problems, which had been performed for one patient, in autoadministration.
A percentage of 62.5 of patients were still using Peristeen at an average follow-up of 31 months.
1.3.2
Results of patients who ceased Peristeen
Six patients of 16 discontinued TAI with Peristeen in time. Discontinuation occurred precociously after initiation, with a mean time of utilization of 5 months. Actually, two thirds of patients ceased Peristeen at 1 month, one patient at 3 months, and one patient at 23 months. The half of patients justified their discontinuation by the inefficacy of Peristeen. Two patients, using autoadministration, reported too heavy administration constraints: a too long time spent to bowel management to be compatible with his professional activity for one paraplegic patient, and a too difficult utilization with impaired hand function in the case of one tetraplegic patient. Lastly, one patient ceased TAI with Peristeen because of intolerance, notably because of vomits following administration.
In this group in which patients stopped Peristeen, one digestive complication, a subocclusive episode, occurred and required one emergency consultation.
1.3.3
Results of patients who continued TAI with Peristeen
Ten patients of 16 still maintained TAI with Peristeen at home ( Table 2 ). Mean irrigation frequency was twice a week. The mean volume of water used was 922 ml. Mean time of irrigation exposure was 20.33 min, and mean time to obtain defecation after irrigation was 18.33 min. Including installation time, time spent to bowel management remained lower than 30 min in majority of cases (60%).
| Evaluation’s criteria | Results |
|---|---|
| Mean NBD score | 6.25/47 |
| Mean score of Cleveland clinic | 0.50/20 |
| Time spent to bowel management | |
| < 30 min | 60% of cases |
| 30–60 min | 30% of cases |
| > 60 min | 10% of cases |
| Satisfaction with Peristeen | 9.12/10 |
Patients were requiring not only drugs but also additional therapeutics to bowel management: manual evacuation in 20% of cases, abdominal massages in 20% of cases too, and other type of enema in 10% of cases.
More than three quarter of patients (77.78%) reported technical problems: first of them was balloon burst (85.71%), cap break in second (42.85%), and then balloon drilling (14.28%). More than half patients who had declared a balloon burst reported the solving of this problem once the producer modified the balloon composition.
Concerning Peristeen’s tolerance, only one patient presented a complication, which was rectorragia following the first irrigations performed in her institution.
To evaluate Peristeen efficacy, we compared laxatives’ consumption (number of molecules daily consumed) before and after Peristeen introduction in the group of patients who maintained irrigations. This difference (in average, consumption of 1.66 laxatives before versus 1.4 after) was not statistically significant ( P = 0.6783). Concerning the severity of bowel symptoms, mean NBD score was 6.25/47 (6 = minor bowel dysfunction), and mean Cleveland clinic score was 0.50/20, reflecting a fecal continence practically normal. But the lack of initial references does not allow to see the bowel symptoms evolution under treatment. Moreover, in this group who maintained Peristeen, there was no complication, either consultation or hospitalisation related to digestive problem.
Finally, in these patients still treated, mean grade of satisfaction with Peristeen was evaluated at 9.12/10.
1.3.4
Comparison between patients who ceased Peristeen and patients who maintained it
In order to identify predictive factors of Peristeen’s continuation over time, we compared patients who ceased Peristeen and those who continued ( Table 3 ). We did not find any significant difference related to age ( P = 0.4078). Concerning gender, 60% of women were still using Peristeen versus 66.7% of men, but this difference was not significant ( P = 0.7897). Difference in initial laxatives consumption, reflecting initial constipation severity, was not more statistically significant ( P = 0.1770). Our results did not show any impact of underlying neurological pathology on Peristeen’s continuation. The type of administration (auto- or heteroadministration) did not appear as a predictive factor of continuation ( P = 0.2997).
| Peristeen’s use | Mean | Standard deviation | Min | Max | P | |
|---|---|---|---|---|---|---|
| Mean number of laxatives (number of molecules/day) | Discontinuation | 2.6667 | 1.5275 | 1 | 4 | 0.1770 |
| Continuation | 1.6667 | 0.8660 | 1 | 3 | ||
| Age | Discontinuation | 44.461 | 12.8865 | 29.1425 | 61.6932 | 0.4078 |
| Continuation | 51.6863 | 18.1013 | 18.0521 | 72.1507 | ||
Concerning the occurrence of digestive complication, we have to point one subocclusion episode in the group of patients who ceased Peristeen.
1.3.5
Satisfaction with education
Fifteen patients of 16 benefited from informal education to Peristeen’s use within the PRM department. Global satisfaction with this education was 8.66/10 in average. No patient expressed any suggestion to improve this education.
1.4
Discussion
Four of the 20 patients who tried TAI with Peristeen during hospitalization discontinued the treatment before discharge. On one hand, trials in two patients presenting a flaccid perineum due to cauda equina syndrome, failed because of a systematic balloon burst since the balloon did not resist to the inflation needed to the anal canal obstruction. Today, perhaps the modification of the balloon composition would make TAI with Peristeen successful in these patients. On the other hand, one patient good responder to Peristeen had to cease irrigations because her liberal nurse refused arguing a too long time of administration. Since January 2012, the French quotation of care related to Peristeen increased. Now, nurses’ fees include not only realization of enema but also therapeutic interventions, which represents 30.40 euros per irrigation. So theoretically there is no more financial limit to TAI with Peristeen by liberal nurse at home. Moreover, Coloplast proposes training to TAI with Peristeen for liberal nurses.
Our follow-up of 2.6 years of TAI with Peristeen is the longest of the literature. Indeed, few studies reported this long-term follow-up: 1.6 years for Faaborg concerning follow-up of TAI modes different from Peristeen, and 1.8 years for Christensen concerning TAI partially performed with Peristeen. Similarly to our study, these authors reported most of discontinuation in the beginning of the treatment, within the first three months. Early discontinuation of Peristeen may be attributed either to an inappropriate indication either to a true inefficacy. In our study, we noticed one indication probably inadequate, in a young spastic paraplegic patient who had asked TAI with Peristeen as alternative to manual evacuation whereas his bowel function was quite efficient. He rapidly ceased Peristeen because of the augmentation of the time spent to bowel management for a similar efficacy compared to manual evacuation. The indication of TAI with Peristeen is not to replace manual evacuation. Moreover, in our group of patients who maintained TAI with Peristeen, 20% still required manual evacuation.
Furthermore, it is interesting to note that in our 6 patients who ceased Peristeen, there were two women suffering from cognitive impairment due to multiple sclerosis. Cognitive troubles might have limited acceptance and compliance to TAI.
Predictive factors of successful outcome of TAI have been described in literature : male gender, mixed symptoms, and prolonged colorectal transit time. In our study, gender did not appear as a significant predictive factor ( P = 0.7897). Factors correlated with positive outcome have been precised by Christensen : neurogenic bowel dysfunction, anal insufficiency as underlying pathology, low rectal volume at urge to defecate, low maximal rectal capacity, and low anal squeeze pressure increment. Peristeen’s efficacy varies according to the type of symptoms – 63% of success in case of constipation and 68% in case of fecal incontinence – and according to the underlying neurological pathology – 62% of successful outcome in case of spinal cord injury, 67% in case of spina bifida, and 50% in case of multiple sclerosis .
If Peristeen’s efficacy remains insufficient despite an appropriate indication, the algorithm of adaptation of TAI developed by Christensen can be useful.
Considering our results, the development of a systematic follow-up by the prescriber doctor and eventually by a specialized nurse seems to be interesting within the first three months of TAI with Peristeen, for reevaluation and therapeutic adaptation, in order to limit treatment discontinuation.
Our population reported a high frequency of technical problems (77.78% of cases), principally a balloon burst. The frequency of this problem has already been mentioned in the literature: Christensen et al. , for a 10-week trial period, described bursts of the rectal balloon in approximately one in every three patients. Conversely, a longer follow-up (4.7 years) of TAI by classic colostomy kit showed a lower rate of technical problems (43% of patients). Yet these technical problems, solved as a majority, did not hamper Peristeen’s continuation.
In our population, 62.5% of patients were still using TAI with Peristeen at 2.6 years, with a mean grade of satisfaction of 9.12/10. Our successful outcome is close to those of 63% at 1.8 years published by Christensen et al. in patients suffering from neurogenic bowel dysfunction. Furthermore, satisfaction with Peristeen of our adult patients is greater than those of 7.3/10 reported in children by López Pereira et al. .
But in opposite to other publications on Peristeen , our study did not show significant decrease of laxatives consumption. The evaluation of digestive symptoms suggested a good control of digestive function in patients who maintained Peristeen, since mean NBD score was 6.25/47 and mean Cleveland clinic score was 0.50/20. Moreover, the time spent to bowel management remained inferior to 30 minutes in most of cases (60%) . Nevertheless, retrospective nature of our study does not permit to precise the Peristeen’s impact on those parameters not recorded before treatment. Several studies demonstrated a decrease of digestive symptoms and time spent to bowel management under TAI with Peristeen.
In addition, it is interesting to note that no consultation or hospitalization for digestive complication was needed in patients still treated by Peristeen, which signs both medical efficacy and cost-effectiveness. A randomized controlled cost-effectiveness analysis had demonstrated the economical benefit of Peristeen anal irrigation, concluding to a lower total cost to society than conservative bowel management in spinal-cord injured patients.
In our study, Peristeen’s complications were rare: rectorragia occurred at the beginning of the treatment in one patient and then disappeared, and intolerance with vomits after administration led to discontinuation in another one. The long-term safety of Peristeen TAI had been demonstrated , with a low risk of bowel perforation (0.002% per irrigation); but minor transitory symptoms during defecation may be frequent (up to 60% of patients).
Although this study concerns our first patients trained to TAI with Peristeen by informal therapeutic education, mean grade of satisfaction with this education appears encouraging as evaluated at 8.66/10 in average and as patients didn’t note any endpoint to improve. The specific protocol of therapeutic education developed in our department since august 2011 would permit to improve the initial evaluation of colorectal troubles and the follow-up up of Peristeen‘s observance and efficacy; that will be the hypothesis of a future prospective study.
Due to the small size of the sample and missing data related to its retrospective nature, our study suffers from a lack of power.
1.5
Conclusion
Our study reported the longest Peristeen’s follow-up of the literature. Our results showed that satisfaction with Peristeen was excellent in patients who maintained TAI. In order to reduce the high discontinuation rate at the beginning of the treatment, it seems necessary to better select therapeutic indications and to institute a systematic follow-up within the first three months after Peristeen’s initiation. A specific and protocolized therapeutic education should improve patients’ follow-up and perhaps Peristeen’s efficacy.
Disclosure of interest
The authors declare that they have no conflicts of interest concerning this article.
2
French version
2.1
Introduction
Le Peristeen est un dispositif d’irrigation transanale (ITA) rétrograde indiqué en seconde intention dans les troubles colorectaux d’origine neurologique. Son action par l’évacuation du rectosigmoïde, démontrée par scintigraphie, permet la régularisation du transit. Son efficacité a été prouvée sur les symptômes intestinaux d’origine neurologique chez l’adulte et chez l’enfant ainsi que sur la qualité de vie . Pourtant, l’utilisation du Peristeen est difficile à maintenir dans le temps. Ainsi, alors que les essais à court terme rapportent une amélioration importante des troubles colorectaux, les études à long terme montrent une diminution du taux de réussite globale, à 47 % à 1,8 ans .
Au CHU de Limoges, l’utilisation du Peristeen dans la pratique clinique du service de MPR s’est développée en 2010. Les premiers patients ont appris à utiliser ce dispositif par une éducation initialement informelle. Puis nous avons mis en place une éducation thérapeutique spécifique dont le protocole institutionnel a été validé en août 2011.
L’objectif de cette étude rétrospective préliminaire était d’évaluer le maintien à long terme de l’utilisation à domicile du Peristeen sur l’échantillon de nos premiers patients traités par Peristeen. Il s’agit d’un préalable à une étude prospective qui sera réalisée sur les patients formés à l’utilisation du Peristeen par le protocole d’éducation thérapeutique spécifique afin d’en évaluer les effets sur l’efficacité et le maintien dans le temps.
2.2
Méthode
2.2.1
Objectifs et critères de jugement
L’objectif principal de l’étude était de déterminer le maintien de l’utilisation à long terme du Peristeen et les facteurs prédictifs de ce maintien. Les objectifs secondaires étaient, d’une part, d’évaluer la sévérité des symptômes intestinaux des patients traités par Peristeen, par le neurogenic bowel dysfunction (NBD) score et le score de la Cleveland Clinic et, d’autre part, d’évaluer l’éducation informelle reçue au sein du service, par une échelle numérique de satisfaction.
2.2.2
Population et matériels
Il s’agit d’une étude rétrospective menée sur l’ensemble des sujets ayant bénéficié du Peristeen au sein du service de MPR du CHU de Limoges depuis 2010, soit 20 patients.
Dans un premier temps, l’étude des dossiers médicaux a permis le recueil des données initiales, à savoir : la date d’instauration du Peristeen, la pathologie neurologique sous-jacente, l’indication du Peristeen (constipation ou incontinence), la sévérité initiale des troubles, le type de traitement antérieur des troubles intestinaux (en particulier le nombre et la quantité de laxatifs utilisés), l’efficacité initiale du Peristeen, et les modalités de mise en place de l’utilisation à domicile.
Dans un second temps, il a été réalisé un entretien médical téléphonique d’une quinzaine de minutes. Après avoir recueilli oralement le consentement éclairé des patients, le questionnaire débutait par le maintien ou non de l’utilisation du Peristeen. En cas d’arrêt du Peristeen, la date et le motif d’arrêt étaient précisés. En cas de poursuite, les modalités d’utilisation étaient détaillées : type et fréquence d’administration, volume instillé, durée de pose, délai d’efficacité. D’éventuels problèmes techniques et complications étaient également recherchés. La sévérité des symptômes digestifs était évaluée par le NBD score et le score de la Cleveland Clinic. La satisfaction par rapport au Peristeen était appréciée par une échelle numérique de 0 à 10. Enfin, les thérapeutiques éventuellement associées (laxatifs, lavements, massages du cadre colique) étaient colligées. Pour tous les patients, l’entretien renseignait également la satisfaction par rapport à l’éducation informelle reçue au sein du service par une échelle numérique (de 0 à 10), ainsi que d’éventuelles complications en lien avec la constipation à l’origine consultation ou hospitalisation.
2.2.3
Méthode statistique
Les comparaisons des variables quantitatives ont été réalisées avec le test t de Student tandis que les comparaisons des variables qualitatives ont été faites grâce au test exact de Fisher.
2.3
Résultats
2.3.1
Description de la population
Parmi les 20 patients chez qui l’indication au Peristeen avait été posée, l’essai en hospitalisation a été concluant dans 16 cas ( Tableau 1 ). Chez quatre patients, le traitement par Peristeen n’a pas été maintenu : en raison d’une inefficacité chez un patient paraplégique post-traumatique, en raison d’éclatement systématique du ballonnet dans deux cas de périnée flasque sur syndrome de la queue de cheval, et en raison du manque de coopération de l’infirmière à domicile chez une patiente souffrant d’une sclérose en plaques avec atteinte cognitive. Ces quatre patients ont été exclus de l’étude suivante.
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