Methods of surgical quality assurance in cervical and endometrial cancer trials: a systematic review and meta-analysis.

Abstract

Surgery quality in gynecology oncology trials varies, potentially biasing results. This systematic review examines methods for assuring surgical quality in multi-center gynecologic oncology trials and the impact on patient outcomes. A systematic search (2000-2023) was conducted in Medline, Embase, and Web of Science. Multi-center randomized controlled trials reporting on surgical endometrial and cervical cancer trials and lymph node harvest, short-term mortality, or conversion rate were included. Studies were assessed using a 10-point checklist to determine surgical quality. This was used to assess the association with variation in lymph node harvest, post-operative mortality, and conversion rate. Overall, 5963 titles and abstracts were screened for their eligibility and 10 studies reporting on 22 surgical-only arms were included for further analysis. The total number of included patients was 7434 from 366 centers. Analysis showed that standardization of surgical approach (β = -6.6, 95%, p = .043), standardization of the extent of lymphadenectomy (β = -2.432, p = .004), video assessment pre-trial (β = -3.492, p = .04) and monitoring of data including clinical outcome measures (β = -4.018, p = .009) were significantly associated with reducing variation in lymph node harvest. It also showed that standardization of the extent of lymphadenectomy (β = -0.718, p < .001) and pre-trial case/procedure volume assessment (β = -0.531, p = .049) were significantly associated with reducing short-term mortality. The regression model showed standardization of the extent of lymphadenectomy (β = -3.123, p = .034) was significantly associated with reducing conversion rate. In conclusion, the heterogeneity of surgical quality measures showed that there is no clear consensus on the approach to delivering surgical quality assurance in gynecology oncology trials. The analysis in this evidence synthesis has shown a potential association between different aspects of surgical quality assurance and clinical outcomes. Further research is required to develop a framework ensuring surgical quality deliverance in gynecology oncology trials.