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Introduction: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch investigator-initiated randomized controlled clinical trials (RCTs). Methods: All Dutch investigator-initiated RCTs with a completion date between December 31, 2010, and January 1, 2012, and registered in the Trial Register of The Netherlands database were included. PubMed was searched for the publication of these RCT results until September 2016, and the time to the publication date was calculated. Consistency in hypothesis, sample size, and primary endpoint compared with the registry data were assessed. Results: The search resulted in a total of 168 Dutch investigator-initiated RCTs. In September 2016, the results of 129 (77%) trials had been published, of which 50 (39%) within 2 years after completion of accrual. Consistency in hypothesis with the original protocol was observed in 108 (84%) RCTs; in 71 trials (55%), the planned sample size was reached; and 103 trials (80%) presented the original primary endpoint. Consistency in all three parameters was observed in 50 studies (39%). Conclusion: This study shows that approximately one out of four Dutch investigator-initiated RCTs remains unpublished 5 years after initiation. The observed low overall consistency with the initial study outline is a matter of concern and warrants improvements in trial design and assessment of trial feasibility.

Prehabilitation before colorectal cancer (CRC) surgery is promising to prevent complications and to enhance recovery, especially in patients aged 70 or older or in patients with an American Society of Anaesthesiologist (ASA) physical classification score 3–4, for whom surgery is associated with higher postoperative complications and long-lasting adverse effects on functional performance. A cohort study was conducted in a large teaching hospital in Alkmaar, the Netherlands. Fifty CRC patients (≥70 years or ASA 3–4) underwent multimodal prehabilitation between September 2020 and July 2021. The reference group comprised 50 patients (≥70 years or ASA 3–4) from a historical cohort receiving CRC surgery without prehabilitation (March 2020–August 2020). The primary outcome was 90-day postoperative complication rate. Secondary outcomes were length of stay, 90-day readmission and mortality rates and functional outcome in the prehabilitation group. One patient in the prehabilitation group decided not to undergo surgery. Of the remaining 49 patients, 48 (98.0 %) received prehabilitation for at least 3 weeks. Of these patients, 32.7 % developed postoperative complications, compared to 58 % in the reference group (p = 0.015), and none were readmitted, in contrast to 6 reference group patients (12.0 %, p = 0.012). Length of stay and mortality did not differ significantly. Six weeks postoperatively, all functional outcomes in the prehabilitation group were significantly higher than at baseline. Prehabilitation reduced postoperative complications and improved short-term functional outcomes in older and high-risk patients receiving CRC surgery. Further research should investigate the maintenance of long-term enhanced lifestyle and the effects of tailor-made programs. [ABSTRACT FROM AUTHOR]