The DeCompression (DECO) Trial: A Multi-Center Randomized Controlled Trial Studying The (Cost) Effectiveness Of Lower Extremity Nerve Decompression
Willem D. Rinkel, MD1,2; Erwin Birnie, PhD1; Manuel Castro Cabezas, MD, PhD1; J Henk Coert, MD, PhD2
1Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands, 2Utrecht University Medical Center, Utrecht, Netherlands
Introduction
The peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. The surgical treatment of compression neuropathies in the lower extremity might result in less sensory loss and the detrimental effects associated with this, such as diabetic foot ulceration and amputations. Lower Extremity Nerve Decompression (LEND) surgery is expected to be incrementally cost-effective compared to current best care.
Materials and Methods
A stratified randomized (1 to 1) controlled trial comparing LEND surgery (intervention) with current best care (control strategy) will start in January 2019. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24, 36 and 48 months. Participants will be recruited in 12 months and enrolled in the eight affiliated hospitals, in which they receive both intervention and current best care and follow-up. Randomisation is stratified for participating hospital. Outcome assessors are blinded to group assignment.
STUDY POPULATION Primary eligibility criteria are patients with diabetes with complaints of neuropathy and signs of compression neuropathies in the lower extremity.
INTERVENTION In the intervention group, a surgical release of the tibial, common, superficial, and deep peroneal nerves will be carried out. The contralateral leg will be operated three months later. USUAL CARE/COMPARISON Current best care is provided regarding diabetes regulation and cardiovascular risk management.
OUTCOME MEASURES Complaints (Norfolk QoL-DN), quality of life (EQ-5D, SF-36), plantar sensation, incidence of ulcerations/amputations and resource use during follow-up. The incremental cost-utility ratio will be estimated on the basis of the collected empirical data.
SAMPLE SIZE / DATA ANALYSIS 258 patients are needed to show a difference of 15% in quality of life (total Norfolk-Qol-DN score)(1; 2). Adjusting for an anticipated 25% lost to follow-up renders our total study size to be 322 patients (40 per center (n=8)). The primary analysis will be performed by using repeated measurements ANOVA (change in Norfolk-QoL-DN between baseline and follow-up).
COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Medical and societal costs will be evaluated, so potential restoration of function and gain in quality of life can be weighed against the incremental costs of surgery.
Results
Start: January 2019. Start inclusion of patients: March 2019. Start of intervention: March 2019. Last follow-up: March 2024.
Conclusions
This is the first randomized trial on LEND surgery with a properly defined control group and sufficient long-term follow-up to study the expediency of the intervention.
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