Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Cervical Radiculopathy

Treatments: Procedure: Discharge on the day of surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03979443

1540/2019

Details and patient eligibility

About

FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion (ACDF) procedure.

Full description

To determine whether early discharge (outpatient care) is noninferior to inpatient care, the investigators will randomize 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that early discharge is not significantly worse (inferior) than the current care in terms of change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, within statistical variability, by a margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to health care system. Secondary outcomes in the study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS), sickness absence days, return to previous leisure activities, and complications.

Patients who are eligible for the trial, but are not willing to undergo randomization, will be asked to be included in a simultaneous, pragmatic follow-up cohort.

Enrollment: 104 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cervical radiculopathy syndrome (CRS) unresponsive to non-operative treatment for at least six weeks or with severe progressive signs and symptoms of nerve root compression during conservative treatment of shorter duration.
2. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8.
3. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms
4. Neck Disability Index score ≥30 out of 100
5. Age between 18 to 62 years
6. No previous cervical operations
7. Currently employed
8. No co-morbidities causing a need for a sick leave
9. Provision of informed consent from the participant
10. No contraindication for randomization in postoperative check (see below)

Exclusion criteria

1. MRI finding inconsistent with patient's symptoms
2. Diagnosed osteoporosis or permanent use of oral corticosteroids
3. ACDF operation requiring plate or cage fixation with screws
4. Active malignancy
5. American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients)
6. Pregnancy
7. Abundant use of alcohol, drugs or narcotics
8. No possibility to be accompanied by an adult person over the first postoperative night after the surgery
9. Insufficient Finnish language skills
10. Distance to the closest hospital emergency more than 60 min

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

104 participants in 2 patient groups

Inpatient

No Intervention group

Description:

patients staying in the hospital for 1-3 nights after surgery

Outpatient

Active Comparator group

Description:

discharge on the day of the surgery, usually within 6-8 hours after procedure

Treatment:

Procedure: Discharge on the day of surgery