International expert consensus on endpoints for full-thickness laparoendoscopic colonic excision.

Background: Full-thickness laparoendoscopic excision has been reported for complex endoscopically unresectable colonic polyps. However, the endpoints used in these studies vary significantly and therefore making definitive conclusions regarding the novel procedure would be improved if a common data set were adopted. This study sought to define most appropriate endpoints that should be measured and reported for research on full-thickness laparoendoscopic excision of colonic polyps.
Methods: A Web-based Delphi Questionnaire was developed using a systematic literature review of reported endpoints. Outcomes were grouped into general, complication, technical and histopathology endpoints. International specialists in laparoscopic surgery, endoscopy and transanal endoscopic microsurgery were invited to participate. The questionnaire required prioritization of outcomes on a 5-point Likert scale. Respondents were then sent a second questionnaire containing feedback on scores from round 1 and asked to re-prioritize outcomes based on the feedback received to identify a final core outcome set.
Results: A total of 33 (75% response rate) participants from 11 countries completed the round 1 Delphi of 28 proposed endpoints, and all completed the second round. Eight endpoints were rated the most important to stakeholders within the four domains--reoperation (general); anastomotic leak, mortality (complications); secure closure of the excision site, macroscopic completeness of excision (technical); presence of cancer, clearance of resected margins and en bloc specimen production (histopathology).
Conclusions: This study has developed a provisional consensus on a minimum number of feasible and clinically meaningful outcome measures to use in studies of full-thickness laparoendoscopic excision of colonic polyps. Widespread adoption will allow better reporting of the technique and more efficient development in clinical practice.