Introduction: Clinical trials are fundamental to advancing all areas of medicine. Despite their importance, trials are often expensive and time-consuming due to the need for extensive human resources, with limitations in cohort sizes and potential biases from loss of follow-up. Smart pill bottles (SPBs) offer a promising innovation by automating data collection, which could reduce costs and improve the granularity and accuracy of data. This technology may provide a more efficient alternative to traditional methods, streamlining data acquisition in clinical research. Objectives: This proof-of-concept study aims to assess the feasibility of using smart pill bottles (SPBs) to collect data on opioid consumption in a postoperative setting, comparing their cost-efficiency and data quality to traditional methods. We hypothesize that SPBs will be readily adopted by users and enable the collection of highly granular data with fewer missing data points, while reducing the costs associated with human resource-based data collection. Material and Methods: This single-center, single-arm trial will enroll 69 patients aged 18 and above undergoing major abdominal surgery via laparotomy. Following recruitment, patients will complete web-based questionnaires assessing pain, comorbidities, and quality of life. Postoperatively, patients will receive an SPB, the Thess Therapy Smart System manufactured by Thess Corporate (France) and provided by AppMed Inc. (Canada) to monitor opioid consumption at home for up to 90 days. At the end of the study period, participants will use the web-based platform to complete the same questionnaires, an opioid compliance checklist and a product satisfaction survey. The primary outcome will be the percentage of patients who successfully use the SPB throughout the study period. Secondary outcomes will include the extent of automated data collection, data granularity, project costs, the incidence of persistent opioid consumption, and patient satisfaction with the SPB. Trial registration: clinicaltrials.gov (July 25th, 2024). Unique protocol ID: 2025-3801. NCT number: NCT06522698.

Dr Pascal Laferrière Langlois declares ownership interest in private companies unrelated to this work (Divocco Medical and Divocco AI). Other authors declare no competing interests.

NCT06522698

The author(s) received no specific funding for this work.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Research Ethics Committee of the CIUSSS de l'Est-de-l'Ile-de-Montreal (Universite de Montreal) gave ethical approval for this work. (Comite d'ethique de la recherche (CER) du CIUSS de l'Est-de-l'Ile-de-Montreal in French)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

No datasets were generated or analyzed during the current study. All relevant data from this study will be made available upon study completion. Any additional data such as the patient consent form or questionnaires will be made available upon reasonable request to the corresponding author.