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

Area of Science:

• Gastroenterology
• Surgical Oncology
• Minimally Invasive Surgery

Background:

• Full-thickness laparoendoscopic excision (FTLE) is used for complex, unresectable colonic polyps.
• Current studies lack standardized endpoints, hindering definitive conclusions on FTLE efficacy.
• A common data set is needed to improve research quality and clinical practice development.

Purpose of the Study:

• To define the most appropriate endpoints for research on FTLE of colonic polyps.
• To establish a consensus on a core outcome set for FTLE research.
• To facilitate standardized reporting and clinical practice advancement.

Main Methods:

• A Web-based Delphi Questionnaire was employed, informed by a systematic literature review.
• Outcomes were categorized into general, complication, technical, and histopathology domains.
• International specialists prioritized outcomes using a 5-point Likert scale over two rounds.

Main Results:

• Thirty-three international specialists participated, completing two rounds of the Delphi survey.
• Eight key endpoints were identified as most important across the four domains.
• These include reoperation, anastomotic leak, mortality, secure closure, macroscopic completeness, cancer presence, margin clearance, and en bloc specimen production.

Conclusions:

• A provisional consensus on essential outcome measures for FTLE research has been achieved.
• Widespread adoption of these endpoints will enhance reporting consistency.
• Standardization will accelerate the development and refinement of FTLE techniques in clinical practice.