Prospective single-arm observational study evaluating a novel imaging device to assess anastomotic site mucosal oxygen tension and its association with anastomotic complications: study protocol.

BACKGROUND

Anastomotic leaks and strictures remain major sources of morbidity following colorectal surgery, with perfusion failure playing an important role in their development. Although methods such as indocyanine green fluorescence angiography are widely used to assess intraoperative perfusion, they have notable limitations including a lack of quantitative measurement. Emerging imaging modalities capable of quantifying tissue oxygen saturation (StO₂) may offer an objective strategy for predicting anastomotic complications. This study aims to evaluate the association between mucosal StO₂ and postoperative anastomotic complications using a novel imaging device. We hypothesise that lower StO₂ will be associated with higher anastomotic complications.

METHODS AND ANALYSIS: This prospective, observational, single-arm study aims to enrol 80 adult patients undergoing colorectal anastomosis. Imaging for evaluation of mucosal oxygen saturation will be performed intraoperatively at eight predefined sites near the staple line, and postoperative outcomes will be collected through 30 days. The lowest value recorded will be used for data analysis. The primary outcome of this study will be to evaluate the association of mucosal StO₂ with anastomotic strictures and leaks.

ETHICS AND DISSEMINATION: This study was approved by the Vanderbilt University Medical Center institutional review board (IRB #250787). Results will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: NCT07467980.