Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis

International Journal of Colorectal Disease
S C M HeemskerkS O Breukink

Abstract

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. 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, β = 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 wil...Continue Reading

References

Jun 1, 1996·Diseases of the Colon and Rectum·F AgachanS D Wexner
Jul 6, 2000·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·C H Knowles, J E Martin
Sep 30, 2004·The British Journal of Surgery·M E D JarrettM A Kamm
Jul 23, 2005·Scandinavian Journal of Gastroenterology·Patrick MarquisOlivier Chassany
Feb 14, 2006·The Journal of Urology·Miriam BrazzelliCynthia Fraser
Jul 13, 2006·Gastroenterology·Michael A Kamm
Jan 17, 2007·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·P G DinningI J Cook
Aug 2, 2007·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Stephane RobitailUNKNOWN KIDSCREEN Group
Aug 2, 2007·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Ulrike Ravens-SiebererUNKNOWN European KIDSCREEN Group
Jul 30, 2009·Annals of Surgery·Pierre A ClavienMasatoshi Makuuchi
Feb 1, 2005·Expert Review of Pharmacoeconomics & Outcomes Research·Marc A Koopmanschap
May 1, 2008·Clinics in Colon and Rectal Surgery·Jared C Frattini, Juan J Nogueras
Feb 26, 2010·Alimentary Pharmacology & Therapeutics·J BelseyM Geraint
Mar 9, 2010·Gut·Michael A KammCor Baeten
Mar 9, 2011·Best Practice & Research. Clinical Gastroenterology·Suzanne M MugieCarlo Di Lorenzo
Apr 12, 2011·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·M HerdmanX Badia
May 21, 2011·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Hareth Al-JanabiJoanna Coast
May 25, 2011·The American Journal of Gastroenterology·Nicole C Suares, Alexander C Ford
Jun 23, 2011·Tidsskrift for den Norske lægeforening : tidsskrift for praktisk medicin, ny række·Stig NordervalBarthold Vonen
Aug 3, 2011·Nature Reviews. Gastroenterology & Hepatology·Suzanne M MugieMarc A Benninga
Dec 14, 2011·Diseases of the Colon and Rectum·Bastiaan GovaertCornelius G Baeten
Apr 4, 2012·Diseases of the Colon and Rectum·Bart P van WunnikCor G Baeten
Jul 20, 2012·Diseases of the Colon and Rectum·Héctor OrtizDonato F Altomare
Nov 6, 2012·The British Journal of Surgery·G P ThomasC J Vaizey
Feb 14, 2013·Surgical Innovation·A SharmaD Jayne
May 4, 2013·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Guido Basilisco, Marina Coletta
Dec 19, 2013·Journal of Pediatric Gastroenterology and Nutrition·M M TabbersM A Benninga
Jan 21, 2014·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Sean D SullivanWen-Yi Shau
Sep 18, 2014·European Journal of Gastroenterology & Hepatology·Vincent K DikMartijn G H van Oijen
Jan 22, 2015·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·J Martellucci
Jun 13, 2015·International Journal of Colorectal Disease·Michel BouchouchaRobert Benamouzig
Aug 25, 2015·The Cochrane Database of Systematic Reviews·Mohamed A ThahaCharles H Knowles
May 5, 2016·Gastroenterology·Fermín MearinRobin Spiller
May 5, 2016·Gastroenterology·Jeffrey S HyamsMiranda van Tilburg
Jun 14, 2016·International Journal of Colorectal Disease·Aart A van der WiltStephanie O Breukink
Aug 10, 2016·Diseases of the Colon and Rectum·Vicki PattonPhil G Dinning
Oct 26, 2016·The British Journal of Surgery·F ZerbibUNKNOWN CONSTIMOD study investigators

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NCT02931582
NCT02961465

Software Mentioned

SPSS
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