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Sponsor study identifier
interventional
67
1 country
2
Study Start
February 21, 2017
Actual (reported)Primary Completion
July 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit) constipation is of suboptimal quality. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group. Objective: The main objective of this study is to assess the effectiveness of SNM compared to personalized conservative treatment (PCT), in patients with idiopathic slow-transit constipation who are refractory to conservative treatment. The secondary objectives are assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT. Hypothesis: Based on previous research we hypothesize that SNM will be more effective than PCT in terms of a significantly higher proportion of patients having treatment success at 6 months. Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a prospective cohort study. Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic slow-transit constipation refractory to conservative treatment. Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of two phases. In the screening phase an electrode is inserted near the third sacral nerve and connected to an external stimulator. If the screening phase is successful (average defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the buttocks of the patient. If not successful, patients receive conservative treatment. The control intervention is PCT. This is the best and least invasive alternative to SNM. PCT consists of medication and/or retrograde colonic irrigation. Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months. Furthermore, cost-effectiveness and budget-impact will be estimated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2016
Actual (reported)November 11, 2016
Actual (reported)February 21, 2017
Actual (reported)July 31, 2021
Actual (reported)December 31, 2021
Actual (reported)Treatment success at 6 months
Treatment success is defined as an average defecation frequency of ≥ 3 a week based on a patient-reported defecation diary over a period of 3 weeks
6 months
Defecation frequency
1 and 3 months
Proportion of patients with a 50% reduction in the proportion of defecations with straining
Baseline, 1, 3 and 6 months
Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation
Baseline, 1, 3 and 6 months
Constipation severity
Baseline, 1, 3 and 6 months
Fatigue
Baseline, 1, 3 and 6 months
SNM starts with a screening phase. In this phase a tined lead is inserted into the third sacral foramen and attached to an external stimulator, after which the patient enters a four-week stimulation test period. If the screening phase is successful (defecation frequency (DF) ≥3 a week), the external stimulator is changed for a pacemaker that is implanted in the buttocks. If the screening phase is unsuccessful (DF \<3 a week), the lead is explanted. Patients in the intervention group are asked to limit the use of additional conservative treatments for constipation (such as laxatives and colonic irrigation) to what is necessary to relieve (the most severe) complaints. What is necessary to relieve complaints is determined by the patient.
Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX, Netherlands
Groene Hart Ziekenhuis
Gouda, South Holland, 2800 BB, Netherlands
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
Stéphanie O Breukink, Dr.
Maastricht University Medical Centre+
Carmen D Dirksen, Prof. dr.
Maastricht University Medical Centre+
67 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2016
First Posted
November 11, 2016
Study Start
February 21, 2017
Actual (reported)The control group will receive the best and least invasive alternative treatment, which is personalized conservative treatment (PCT). PCT includes, a combination of laxative/medication use and/or colonic irrigation, depending on the preferences of the patient. Use of PCT will be documented.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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van Wunnik BP, Peeters B, Govaert B, Nieman FH, Benninga MA, Baeten CG. Sacral neuromodulation therapy: a promising treatment for adolescents with refractory functional constipation. Dis Colon Rectum. 2012 Mar;55(3):278-85. doi: 10.1097/DCR.0b013e3182405c61.
Heemskerk SCM, Rotteveel AH, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, van Kuijk SMJ, Dirksen CD, Breukink SO. 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. Int J Colorectal Dis. 2018 Apr;33(4):493-501. doi: 10.1007/s00384-018-2978-x. Epub 2018 Feb 22.
Heemskerk SCM, Dirksen CD, van Kuijk SMJ, Benninga MA, Baeten CIM, Masclee AAM, Melenhorst J, Breukink SO. Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial. Ann Surg. 2024 May 1;279(5):746-754. doi: 10.1097/SLA.0000000000006158. Epub 2023 Nov 23.
Primary Completion
July 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
June 13, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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