A systematic review of outcome reporting in early phase studies of colorectal cancer surgical innovation
Session type: Poster / e-Poster / Silent Theatre session
Early phase studies of surgical innovation are essential to evaluate new technologies prior to definitive randomised evaluation. Evaluation may be limited, however, by inconsistent measurement and reporting of outcomes. This study provides an in-depth analysis of outcomes of early phase interventions for the surgical treatment of colorectal cancer.
A systematic search identified early phase studies (first in human to pre-definitive trial) of patients who have undergone an invasive procedure to treat primary colorectal adenocarcinoma published between 2018-19. Sixty-eight search terms were combined using Boolean operators and applied to Medline and Embase databases. Included were studies where authors reported a surgical device/techniques as ‘new’ or ‘modified’. Excluded were studies of established devices/techniques. Line-by-line coding was used to identify outcomes from a random sample of included articles. Outcomes were extracted, grouped into domains, and categorised as ‘measured’, where data were collected, or ‘mentioned’, when no data were collected.
An initial 8373 records were screened, of which 816 were eligible. A random sample of 51 studies were included of which 17 self-identified as evaluating ‘new’ and 34 ‘modified’ surgical devices/techniques. Most studies were case series (25%), conducted in a single-centre setting (90%) evaluating techniques (82%). Interventions most commonly involved laparoscopic (47%) or trans-anal (27%) approaches.
Some 2429 outcomes were identified, of which 1111 (46%) were measured and 1318 (54%) only mentioned. Post-operative complications were most frequently measured (502 outcomes, 20%) and measures of intra-operative resource use least measured (3, <1%). Intra-operative advantages were frequently mentioned (170, 13%) but rarely measured (15, 1%), as were surgeon’s perception and/or experience of performing the innovative intervention (222, 15% mentioned; 19, 2% measured).
There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery, and discrepancies between outcomes mentioned and measured. This may delay effective evaluation of new technology and create research waste.