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Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.
Heemskerk, Stella C M; Dirksen, Carmen D; van Kuijk, Sander M J; Benninga, Marc A; Baeten, Coen I M; Masclee, Ad A M; Melenhorst, Jarno; Breukink, Stéphanie O.
Afiliação
  • Heemskerk SCM; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands.
  • Dirksen CD; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
  • van Kuijk SMJ; School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands.
  • Benninga MA; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands.
  • Baeten CIM; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
  • Masclee AAM; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands.
  • Melenhorst J; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
  • Breukink SO; Department of Pediatric Gastroenterology, Emma Children's Hospital/Amsterdam University Medical Center, Amsterdam, The Netherlands.
Ann Surg ; 279(5): 746-754, 2024 May 01.
Article em En | MEDLINE | ID: mdl-37991178
OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Terapia por Estimulação Elétrica / Tratamento Conservador Limite: Adolescent / Adult / Humans Idioma: En Revista: Ann Surg Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Holanda

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Terapia por Estimulação Elétrica / Tratamento Conservador Limite: Adolescent / Adult / Humans Idioma: En Revista: Ann Surg Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Holanda