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NCT Number: NCT02961582

Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Surgery

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre, Maastricht, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Neuromodulation

Device

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 names: Medtronic Interstim Therapy System

Personalized Conservative Treatment

Other

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 names: Care as usual

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch National Health Care Institute
  • Medtronic

Registry information

Official study title

Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 11, 2016
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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