Intra-operative hyperspectral imaging for brain tumour detection and delineation: Current progress on the HELICoid project

Background: In 2013, the Declaration of Helsinki mandated that every research study involving human subjects must have its protocol registered in a publicly accessible database prior to the enrolment of the first patient.This systematic review assessed the number of studies published in leading journals of plastic surgery that had either published or registered a protocol with a publicly accessible database.Material and methods: All research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014 -31st March 2015 were examined.The primary outcome measure was whether each study had registered or published a protocol with any mainstream registry database.ClinicalTrials.gov,International Standard Randomised Control Trial Number (ISRCTN), WHO (World Health Organization) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed.Preliminary results Of 595 included articles, the most common study designs were case series (n¼185, 31.1%).There were 24 randomised controlled trials (RCTs, 4.0%).A total of 24 studies had a protocol registered (4.0%), although no studies had published a protocol in a journal.The most common database to register a protocol was ClinicalTrials.gov(n¼17).The study design that most commonly had a registered protocol was the RCT (n¼8 of 24, 33.3% of RCTs).Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low.There is considerable scope to improve this and relevant guidance is provided.