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1.
Colorectal Dis ; 22(12): 2140-2145, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32593211

RESUMO

AIM: There is an ongoing debate as to whether or not the efficacy of sacral neuromodulation (SNM) is optimized by maximizing the total number of active electrode poles (AEPs) during lead placement because there are more programming options. However, this is at the cost of increased operating time. The aims of this study were to establish if a higher number of AEPs improves SNM efficacy during the trial period and after permanent implantable pulse generator (IPG) placement and if there is there a correlation between number of AEPs and battery life of the first placed IPG. METHOD: This was a single centre retrospective cohort study of new patients with faecal incontinence who underwent SNM between 2000 and 2018. Exclusion criteria were sphincter defect > 30%, rectocele/enterocele Grade 3 or higher and incomplete records. RESULTS: In all, 288/456 (63%) patients (women 91%; mean age 58.5 ± 11.7 years) were eligible for analysis. The number of AEPs during lead placement was two (n = 42, 14.5%), three (n = 82, 28.5%) and four (n = 164, 57%). There was no association between the number of AEPs during tined lead placement and long-term efficacy. Neither the success rate of the trial phase nor the battery life after first placed IPG was influenced by the number of AEPs. CONCLUSION: In this study, the number of AEPs does not seem to influence long-term efficacy of SNM success rate during the trial phase or the battery life of the first placed IPG. However, we also suggest that at the very least there should be two AEPs at lead placement.


Assuntos
Terapia por Estimulação Elétrica , Incontinência Fecal , Eletrodos , Eletrodos Implantados , Incontinência Fecal/terapia , Feminino , Humanos , Plexo Lombossacral , Pessoa de Meia-Idade , Estudos Retrospectivos , Sacro , Resultado do Tratamento
2.
Int J Colorectal Dis ; 33(10): 1341-1348, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29934702

RESUMO

PURPOSE: The aim of the study was to assess the long-term outcome of a Malone antegrade continence enema (MACE) procedure for fecal incontinence or constipation in adults. METHODS: This retrospective single-center study assessed the long-term outcome and quality of life (QoL) of patients who underwent a MACE procedure between 2005 and 2014 at the Maastricht University Medical Centre. Success rate was quantified by using Malone's continence scale. Quality of life was assessed by validated questionnaires covering general quality of life (SF-36 and Karnofsky scale), current pain level (visual analog scale), fecal incontinence (Vaizey incontinence survey), or constipation (Cleveland Clinic Constipation Score). RESULTS: Based on patients' records, 22 out of 30 patients (73%; 95% CI 54-87%) were still using their MACE. Mean follow-up was 43 months (SD 25.9) since time of surgery. According to the Malone continence scale, the overall success rate was 37% (95% CI 20.0-53.3). Nine patients developed a postoperative complication. Eighteen out of 22 patients (13 with constipation and 5 with fecal incontinence) returned the QoL questionnaires (82% response rate). Long-term quality of life of patients with a MACE did not differ from the general Dutch population. CONCLUSIONS: In our cohort of patients with fecal incontinence or constipation, MACE resulted in a disappointed overall success rate of 37%. However, it may be indicated in patients who do not prefer more invasive surgical procedures or a definite stoma. The success and morbidity rate should be thoroughly discussed with the patients preoperatively.


Assuntos
Colostomia , Constipação Intestinal , Enema , Incontinência Fecal , Efeitos Adversos de Longa Duração , Qualidade de Vida , Adulto , Colostomia/efeitos adversos , Colostomia/métodos , Colostomia/psicologia , Constipação Intestinal/fisiopatologia , Constipação Intestinal/psicologia , Constipação Intestinal/terapia , Defecação/fisiologia , Enema/efeitos adversos , Enema/métodos , Incontinência Fecal/fisiopatologia , Incontinência Fecal/psicologia , Incontinência Fecal/terapia , Feminino , Humanos , Efeitos Adversos de Longa Duração/diagnóstico , Efeitos Adversos de Longa Duração/epidemiologia , Efeitos Adversos de Longa Duração/etiologia , Efeitos Adversos de Longa Duração/psicologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Avaliação de Resultados em Cuidados de Saúde , Dor/diagnóstico , Dor/etiologia , Medição da Dor/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/psicologia , Estudos Retrospectivos , Inquéritos e Questionários
3.
Int J Colorectal Dis ; 33(4): 493-501, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29470731

RESUMO

PURPOSE: The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. METHODS: This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, ß = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. CONCLUSIONS: The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov , identifier NCT02961582, on 12 October 2016.


Assuntos
Constipação Intestinal/fisiopatologia , Constipação Intestinal/terapia , Análise Custo-Benefício , Terapia por Estimulação Elétrica , Trânsito Gastrointestinal/fisiologia , Sacro/inervação , Estudos de Coortes , Tratamento Conservador , Constipação Intestinal/economia , Terapia por Estimulação Elétrica/efeitos adversos , Humanos , Tamanho da Amostra
4.
Colorectal Dis ; 20(2): 134-143, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28782277

RESUMO

AIM: Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults. METHOD: All patients treated with SNM for FC between 2004 and 2015 were evaluated. Outcomes of children (age 10-18 years) were compared with those for adults (≥ 18 years). The primary end-point was a defaecation frequency of three or more times per week, which is consistent with the ROME-III criteria. Secondary outcomes were quality of life (QoL; SF-36) and the Cleveland Clinic Constipation Score. RESULTS: One hundred and eighty patients (45 children, 135 adults) were eligible for SNM. The mean age was 15.8 (children) and 41.4 years (adults). One hundred and twenty-six patients received permanent SNM (38 children, 88 adults). Mean follow-up was 47 months in both groups. Defaecation frequency increased in both groups after SNM compared with baseline. Defaecation frequency in adults was higher than in children. The increased defaecation frequency was maintained during the entire follow-up period in both groups. QoL of children was impaired compared with the Dutch population with regard to bodily pain, general health and vitality. Adults had worse QoL with regard to physical functioning, bodily pain, general health, vitality and social functioning compared with the Dutch population. QoL of children did not differ from adults. CONCLUSION: Sacral neuromodulation (SNM) should be considered in children (< 18 years) with FC. However, the indication of SNM for FC remains debatable considering the limited improvements and high costs.


Assuntos
Fatores Etários , Constipação Intestinal/terapia , Terapia por Estimulação Elétrica/métodos , Adolescente , Adulto , Criança , Constipação Intestinal/fisiopatologia , Defecação/fisiologia , Feminino , Humanos , Masculino , Qualidade de Vida , Estudos Retrospectivos , Sacro/inervação , Resultado do Tratamento
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