Carpal tunnel release surgery in patients with carpal tunnel syndrome Surgery
Conditions
Interventions
This is a three-arm pilot multicentre study aimed at testing feasibility and informing the design of a future definitive trial comparing the outcomes of wound closure after carpal tunnel surgery (CTR)
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any adult patient (18 years or older at the time of surgery) 2. Scheduled to undergo a primary CTR during the period of recruitment 3. CTR performed through a standard open approach procedure 4. Able and willing to give consent to surgical procedure and follow-up
Exclusion criteria
Exclusion criteria: 1. Patient unable to provide informed consent 2. Revision/repeat carpal tunnel surgery 3. Adoption of a surgical approach different from the standard open incision (including extended carpal tunnel incision) 4. Additional simultaneous procedure(s) to the same upper limb 5. CTR performed in the context of trauma (non-elective procedure) 6. Patient did not receive the pre-enrolment information pack on the RCT prior to surgery 7. Patient non-English speaker 8. Patient unable to fill in questionnaires 9. Patient expresses a strong preference for one type of suture over the others when the option of different sutures is explained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of randomised patients from those eligible and approached measured using the electronic screening log at the end of the 92-day recruitment window | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Exclusion/inclusion rate measured using the SEAR (Screened, Eligible, Approached, Randomised) approach at 2 weeks follow up 2. Completion of follow-up/dropout rate (proportion completing follow-up at each time point at 2 and 6 weeks, and 3 and 6 months 3. Substitution of randomisation suture allocation, and completeness of data collection measured using the Boston Carpal Tunnel Questionnaire (BCTQ), the Patient and Observer Scar Assessment Scale, Patient Scale (POSAS 2.0), the Patient Events Questionnaire (PEQ), and the EuroQol health-related of life questionnaire (EQ-5D-5L) at 2 and 6 weeks, and 3 and 6 months The following outcomes will be explored for the proposed definitive RCT: 1. Estimate of the effect of the suture types on wound healing measured using Southampton Wound Score at 2 weeks 2. Scar quality measured using the POSAS 2.0 questionnaire at the follow-up points at 2 and 6 weeks, and 3 and 6 months 3. Functional outcomes measured using BCTSQ at each follow-up 4. Time to return to work and other normal activities measured using a patient diary and the PEQ at 2 and 6 weeks, and 3 and 6 months 5. Health economics outcomes and Health-related Quality of Life measured using the EQ-5D-5L pre-surgery, 6 weeks, and 3 and 6 months 6. Healthcare resource use over the 6-month follow-up period measured using both self-report with a bespoke set of brief resource use questions in the patient questionnaire capturing NHS healthcare resource utilisation, in primary and secondary care (administered at 6 weeks, and 3 and 6 months) and from patient diaries (completed weekly). The resource use data collected in the pilot will allow the estimation of very exploratory and descriptive healthcare resource use costs associated with each of the three treatment arms to be calculated, and only to help inform the design of the health economic analysis component of a future larger trial, and thus will not be an endpoint in their own right. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactLynn Dinsmore
Outcome results
None listed