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Trial record 1 of 2 for:    NCT02961582
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Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation

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ClinicalTrials.gov Identifier: NCT02961582
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Dutch National Health Care Institute
Medtronic
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Constipation Surgery Device: Sacral Neuromodulation Other: Personalized Conservative Treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Sacral Neuromodulation Device: Sacral Neuromodulation

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.

Other Name: Medtronic Interstim Therapy System

Personalized Conservative Treatment Other: Personalized Conservative Treatment
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.
Other Name: Care as usual




Primary Outcome Measures :
  1. Treatment success at 6 months [ Time Frame: 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


Secondary Outcome Measures :
  1. Defecation frequency [ Time Frame: 1 and 3 months ]
    Defecation frequency based on a patient-reported defecation diary over a period of 3 weeks

  2. Proportion of patients with a 50% reduction in the proportion of defecations with straining [ Time Frame: Baseline, 1, 3 and 6 months ]
    The proportion of defecations with straining is derived from the data in the 3 week defecation diary. The reported proportion of defecations with straining is compared with the proportion of defecations with straining at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with straining and 2) <50% reduction in the proportion of defecations with straining.

  3. Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation [ Time Frame: Baseline, 1, 3 and 6 months ]
    The proportion of defecations with a sense of incomplete evacuation is derived from the data in the 3 week defecation diary. The reported proportion of defecations with a sense of incomplete evacuation is compared with the proportion of defecations with a sense of incomplete evacuation at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with a sense of incomplete evacuation and 2) <50% reduction in the proportion of defecations with a sense of incomplete evacuation.

  4. Constipation severity [ Time Frame: Baseline, 1, 3 and 6 months ]
    Displayed with the score from the Wexner constipation score (WCS).

  5. Fatigue [ Time Frame: Baseline, 1, 3 and 6 months ]
    Displayed with the score from the Fatigue Questionnaire (in Dutch 'Verkorte vermoeidheidsvragenlijst' (VVV)) .

  6. Constipation-specific (health-related) quality of life ((HR)QOL) [ Time Frame: Baseline, 1, 3 and 6 months ]
    Displayed with the score from the Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire

  7. Generic (HR)QOL [ Time Frame: Baseline, 1, 3 and 6 months ]
    In adults displayed with the score from the EQ-5D-5L and ICECAP-A In adolescents displayed with the score from the EQ-5D-5L and KIDSCREEN-27

  8. Adverse events/complications [ Time Frame: Baseline, 1, 3 and 6 months ]
    Reported by the clinician in a case report form (CRF)

  9. Resource use/costs [ Time Frame: Baseline, 3 and 6 months ]
    Health care costs, patient and family costs and costs outside the health care sector

  10. Cost-effectiveness [ Time Frame: 6 months ]
    Both from a societal and health care perspective, derived from the EQ-5D-5L scores and cost data obtained in this RCT

  11. Budget-impact [ Time Frame: 6 months ]
    From a societal, health care and health care insurance perspective, derived from the EQ-5D-5L scores and cost data obtained in this RCT



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An average defecation frequency (DF) of <3 per week based on a 3-week defecation diary (patient-reported)
  • Meet at least one other criterion of the Rome-IV criteria for idiopathic constipation based on the 3-week defecation diary (1)
  • Refractory to conservative treatment
  • Age: 14-80 years
  • Slow-transit constipation

    (1) Rome-IV criteria for idiopathic constipation:

  • Straining during ≥25% of defecations
  • Lumpy or hard stools in ≥25% of defecations
  • Sensation of incomplete evacuation for ≥25% of defecations
  • Sensation of anorectal obstruction/blockage for ≥25% of defecations
  • Manual manoeuvres to facilitate ≥25% of defecations

Exclusion Criteria:

  • Obstructed outlet syndrome (objectified by defeacography)
  • Irritable bowel syndrome (Rome-IV criteria for irritable bowel syndrome)
  • Congenital or organic bowel pathology
  • Rectal prolapse
  • Anatomical limitations preventing placement of an electrode
  • Skin and perineal disease with risk of infection
  • Previous large bowel/rectal surgery
  • Stoma
  • Coexisting neurological disease
  • Significant psychological co-morbidity as assessed subjectively by the investigator
  • Being or attempting to become pregnant during study follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961582


Contacts
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Contact: Stéphanie O Breukink, Dr. +31(0)433875492 s.breukink@mumc.nl
Contact: Stella CM Heemskerk, MSc. +31(0)433877286 stella.heemskerk@mumc.nl

Locations
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Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Stéphanie O Breukink, Dr.    +31(0)433875492    s.breukink@mumc.nl   
Groene Hart Ziekenhuis Recruiting
Gouda, Zuid-Holland, Netherlands, 2800 BB
Contact: Coen IM Baeten, Dr.    018-2505050    coen.baeten@ghz.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Dutch National Health Care Institute
Medtronic
Investigators
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Principal Investigator: Stéphanie O Breukink, Dr. Maastricht University Medical Centre
Principal Investigator: Carmen D Dirksen, Prof. dr. Maastricht University Medical Centre

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02961582     History of Changes
Other Study ID Numbers: NL57367.068.16
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht University Medical Center:
Sacral neuromodulation
Constipation
Slow-transit constipation
Surgery
Colorectal surgery
Cost-effectiveness
Quality of life
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms