Role of Indexed Oxygen Delivery in Anastomotic Insufficiencies in Elective Laparoscopic Colorectal Resections for Cancer

Colorectal cancer is a very commonly diagnosed malignancy worldwide, and surgical resection remains the mainstay of treatment. Outcomes depend on preoperative staging, surgical quality, complication rates, and multidisciplinary care; minimally invasive techniques have reduced local and systemic complications. However, anastomotic dehiscence (AD) remains the most significant local complication. AD is a breach in the anastomotic integrity creating a communication between intra- and extra-luminal compartments. Mortality rates vary from 1.7% to 29%. Reduced oxygen delivery-pre-, intra-, or post-operatively-can contribute to AD, while adequate oxygenation improves healing. Supplemental O₂ (FiO₂ 80%) has been shown to reduce AD risk after gastric surgery. Tissue oxygen delivery can be quantified by indexed oxygen delivery (DO2I), defined as ml/min/m² and determined by cardiac output, hemoglobin, and saturation. Pulse cardiac output (CO)-Oximeter® (Masimo), allow continuous non-invasive monitoring of these parameters. This prospective observational cohort study aims to explore the correlation between intraoperative DO2I and the risk of postoperative anastomotic dehiscence, using the non-invasive technologies described.

NCT Number	NCT07099820
Lead Sponsor	Saint Camillus International University of Health Sciences
Conditions	Anastomosis; Complications, Anastomosis, Surgical, Anastomosis, Leaking, Anastomotic Leaks, Anastomotic Failure of Flap, Anastomotic Leak Large Intestine, Anastomotic Complication, Anastomotic Dehiscence in Colorectal Surgery +3 more
Enrollment	100 participants
Start Date	2020-09-01
Primary Completion	2022-08-31 (estimated)
Study Completion	2022-09-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-19