P188 QUALITY ASSURANCE OF SURGICAL INTERVENTION WITHIN RANDOMIZED CONTROLLED TRIALS FOR GASTRO-ESOPHAGEAL REFLUX DISEASE

Abstract

Abstract Aim Randomized controlled trials provide level 1 evidence for surgical intervention in the treatment of gastro-esophageal reflux disease (GERD). This systematic review aimed to investigate the practice of surgical quality assurance in RCTs concerning surgical interventions in GERD. Background & Methods A systematic literature search for articles was performed in Medline, Embase, Web of Science and Cochrane library for randomized controlled trials (RCT) evaluating surgical intervention in the management of GERD. Each RCT was assesses for surgical quality assurance (SQA) using an eight-point checklist in three main areas and given a SQA score out of 8. Clinical outcomes from each trial including reoperation rates were then compared against the SQA score. Results Thirty-one publications were included compromising 5803 patients. The assurance of surgical quality was poor with the randomized controlled trials included, ranging from 3% to 68% for the factors examined: Credentialing surgeon experience before entry into the trial by; 1. Case volume – 26% (8/31) 2. Operative reports – 6% (2/31) 3. Video assessment – 6% (2/31) 4. Live operating room evaluation – 3% (1/31) Pre-trial standardization by; 5. Education of surgeons – 13% (13%) 6. Consensus for standardization – 68% (21/31) Monitoring surgical performance during the trial by; 7. Video assessment – 10% (3/31) 8. Monitoring of data – 3% (1/31) RCTs with a high SQA score had a reduced average rate of reoperation (SQA score 4 to 8 vs. 0 to 3; 0% vs. 3.19%; P<0.05). Credentialing surgeons by case volume before entry into the trial was also associated with a reduced rate of reoperation (0.04% vs. 3%; P<0.05). Conclusion Surgical quality assurance has been largely lacking in randomized controlled trials for GERD previously. High surgical quality assurance was associated with reduced reoperation rates within RCTs, highlighting the need for good SQA within these types of trials. Future RCTs in benign UGI conditions with surgical interventions should ensure SQA in three main areas: (i) Credentialing surgeon experience before trial; to ensure they are past learning curve. (ii) Standardizing the surgical technique; to ensure less heterogeneity in operative performance. (iii) Monitoring performance during trial; to ensure standard of surgical quality is maintained within the trial.