Evaluation of the (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared to patients 'treated' with conventional best care.
ID
Source
Brief title
Condition
- Peripheral neuropathies
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complaints (Norfolk QoL-DN).
Secondary outcome
Quality of life (EQ-5D5L, 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.
Background summary
RESEARCH QUESTION: Evaluation of the (cost-)effectiveness of surgical
decompression of compressed lower extremity nerves (LEND surgery) compared to
non-surgical, conventional care.
HYPOTHESIS: Our hypothesis is that the surgical treatment of compression
neuropathies in the lower extremity results in relief of complaints and gain in
peripheral nerve function, which may result in less sensory loss and the
detrimental effects associated with this, such as diabetic foot ulceration and
amputations and the associated costs. LEND surgery is expected to be
incrementally cost-effective compared to current best care. STUDY DESIGN:
Multicenter randomized controlled trial. Comparison of the (cost-)effectiveness
of LEND surgery compared to current non-surgical care. STUDY
POPULATION / DATA RESOURCES: Adult patients with diabetes with neuropathy
complaints and compression neuropathies in the lower extremity.
INTERVENTION: decompression of compressed lower extremity nerves.
USUAL CARE/COMPARISON: Conventional non-surgical care.
OUTCOME MEASURES Complaints (Norfolk QoL-DN), quality of life (EQ-5D5L, SF-36),
plantar sensation, incidence of ulcerations/amputations, balance and gait and
electrodiagnostic parameters, 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 between baseline and
follow-up)(1; 2). Adjusting for an anticipated 25% lost to follow-up renders
our total study size to be 344 patients (129*100/75 = 172 patients per group).
Between 28 and 40 patients will be included per center (11 participating
centers in total). The primary analysis will be performed by using repeated
measurements ANOVA (change in Norfolk-QoL-DN between baseline and follow-up).
Patients will be analysed according to the intention-to-treat principle.
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.
BURDEN / RISK: Time investment per patient is on average 10 hours for the total
study period. The risks are related to the surgery itself (wound healing
problems and hemorrhage) and are accepted as generally being a low.
TIME SCHEDULE Start: Start inclusion of patients: September 2019. Last
follow-up: September 2024
Study objective
Evaluation of the (cost-)effectiveness of surgical decompression of compressed
lower extremity nerves (LEND surgery) compared to patients 'treated' with
conventional best care.
Study design
A stratified randomized (1 to 1) controlled trial comparing LEND surgery
(intervention) with current best care (control strategy). Patients and controls
have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 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.
Randomization is stratified for participating hospital. Outcome assessors are
blinded to group assignment.
Intervention
In the intervention group, a surgical release of at least the tibial and common
peroneal nerves, additional decompressions of the superficial and deep peroneal
nerves can be carried out when compressed. The contralateral leg will be
operated three months later.
Study burden and risks
Negligible risk. Low impact on patients participating', only have to full in
some questionnaires (± 10h for total study duration per patient).
Heidelberglaan 100
UTRECHT 3508 GA
NL
Heidelberglaan 100
UTRECHT 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Having diabetes mellitus (type 1 or 2) Patients (> 17 and < 76 years old)
Symptoms of neuropathy (assessed with the MNSI, scoring > 3) A bilateral Tinel
sign at the tarsal tunnel (n. tibialis posterior) Sufficient circulation to
heal lower-extremity incision (by palpating the peripheral arteries of the
foot: a palpable dorsal pedis artery or posterior tibial artery is needed). In
case of non-palpable arteries a pedal Doppler arterial waveform is evaluated. A
toe brachial index is performed when the Doppler signal is not triphasic·
Minimal or controlled pedal oedema (assessed with inspection and physical
examination) Being fit for surgery Compliant with instructions for their own
care* Intact protective sensation (cutaneous threshold <10 g monofilament) at
the plantar side of the foot (plantar hallux and fifth toe) Written informed
consent
Exclusion criteria
DFU(s) or amputation(s) in history, active radicular syndrome or neurological
disease interfering with sensation of the feet, as assessed in the interview
and screening questionnaire (e.g. HIV and chemotherapy induced neuropathy)
Previous surgery at lower extremity nerve compression sites Active Charcot foot
Not able to understand written and oral instructions (i.e. insufficient command
of Dutch language) Being incompetent (incapacitated) Current enrollment in a
clinical trial which involves surgery of the lower extremity or medical drug
trials investigating the effects on neuropathy symptoms. HbA1c level > 11% at
baseline Pregnant women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68312.041.19 |
| Other | NL7664 |