Impact of video-assisted preoperative patient information on patient-reported outcomes after pancreatic resection (INFORM trial): a study protocol for a randomised controlled pilot trial.

Abstract

Introduction: Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.

Methods and analysis: The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.

Ethics and dissemination: This trial was approved by the institution's Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.

Trial registration details: German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).