Surgical trial data capture software for the operation, the surgeon and the recovery

Surgical trials compare operations, techniques, devices, timing (early versus delayed), pathways of care, or surgery against non-operative management. They differ from drug trials in four ways that matter for data. The intervention is delivered once, by a person whose skill varies. It is rarely blindable. Harms appear as complications across the perioperative period. And the primary outcome is often a patient-reported function measure collected months later. The CONSORT extension for non-pharmacological treatments, first published in 2008 and updated in 2017, asks trials to report how the intervention was standardised between providers, how adherence to that standardisation was assessed, the volume and experience of the surgeons, and the attempts made to limit bias where blinding was not possible. A data model that captures those items makes reporting straightforward.

The practical advice is to put the surgeon and the centre on every operative record. Give each surgeon a coded ID, record their experience with the technique in the way the protocol defines (for example, cases performed or years), and keep a surgeon-level lookup that does not change per participant. By-site filtering and exports then carry the variables to the statistician, who decides how to handle clustering by surgeon in the analysis. The delegation log template is a starting point for documenting who was authorised to do what.

Randomization often happens before surgery with a delay to the operation, and the delay itself can matter. Record the date of randomization, the date of surgery and any crossovers or cancellations, since a participant randomized to one technique who receives another is a deviation to be classified. The protocol deviation severity classifier helps think through severity, and clinical trial randomization software covers allocation and stratification (for example by centre or surgeon).

Surgical outcomes studies commonly grade complications with the Clavien-Dindo classification: grade I for minor deviations from the normal course managed without drugs beyond simple ones, grade II for complications needing drug treatment, grade IIIa and IIIb for those needing intervention without or with general anaesthesia, IVa and IVb for life-threatening single or multi-organ complications, and grade V for death, with a suffix for complications persisting at discharge. Some protocols collapse subgrades. Build the grade as a dropdown on a repeating complication form, alongside the date, the description, the action taken and whether the event is related to the procedure, and let the protocol define the window (for example 30 or 90 days).

Do not confuse complications with expected recovery. Pain on day one is not an adverse event in most protocols, while a wound infection is a complication. State the rule in the protocol and make the form guide staff, using hints and edit checks that raise a query when a grade is entered without a date. Serious events follow the usual route: the SAE report form and adverse event reporting software. Concomitant medicines such as anticoagulants or antibiotics are a repeating table on the concomitant medications form.

Every change carries a field-level audit trail with timestamp, user, old value, new value and reason. That is useful when a complication grade is revised after adjudication. If your protocol has an adjudication committee, you can give members access to the forms they need and nothing else through role-based access.

Long-term function is the endpoint most surgical trials care about, and it is collected from the patient. ePRO tasks open from a phone link, with reminders and windows, so patients who have gone home are not asked to attend a visit just to answer a questionnaire. For registry-style follow-up design, see EDC for orthopedic outcomes registries and EDC for registry studies. Work out window width with the visit window calculator.

Blinding is limited: surgeons know what they did, and patients often know too. Trials therefore blind the assessor who rates the wound, reads the imaging or tests function, and the analyst. Capture serves blinded roles masked views, so the assessor form can be completed without arm values, as described in blinded and unblinded role management. Where blinding of patients is impossible, record that fact and the steps taken to limit bias, since the reporting extension asks for it.

Multi-centre surgical trials need site-level participant numbering, QR-code enrollment, a site coordinator portal and by-site exports. See multi-site clinical trial management. Source data verification can be set per field; see source data verification.