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Aim: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection., Methods: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected., Discussion: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy., Trial Registration: NCT05010850., (© 2024 Association of Coloproctology of Great Britain and Ireland.)

Background: Adequate tissue oxygenation and perfusion remain fundamental to safe bowel resection surgery. Near infrared (NIR) imaging using indocyanine green has proven itself superior to clinical evaluation alone in assessing bowel perfusion, but requires expensive equipment not readily available in many centers., Methods: We studied the IntraOx device (Vioptix Inc, Newark, CA USA), a handheld, tissue oxygen saturation assessment tool, to assess whether tissue bed oxygen saturation (StO2) is comparable to NIR assessment of bowel viability. Patients undergoing elective colon resection for benign and malignant disease were included. After choosing a clinical margin (CM) and dividing the mesentery, StO2 was measured at 5-cm intervals along the colon. A tissue oxygen saturation margin (TOM) was assigned where StO2 dropped off by at least 10 percentage points. NIR perfusion was then assessed to determine NIR margin (NIRM). Intraoperative and postoperative data were collected., Results: 32 consecutive patients undergoing colectomies were analyzed. IntraOx sensitivity was 90.6%, specificity was 94.3%. The mean StO2 difference across the NIRM was 23.1%. In all but one case, the TOM matched the NIRM. In 3 cases, the TOM and NIRM concurred, but were a mean of 3.3 cm proximal to the CM and altered the surgical plan. At 4-week follow-up, no significant complications were reported., Conclusions: The IntraOx device consistently identified a margin of significant saturation "drop-off" which correlated with the findings on NIR perfusion and clinical assessment. These early data indicate that StO2 measurement may be equivalent to NIR assessment of bowel perfusion. In addition, the IntraOx device may be a more cost-effective solution for surgeons looking for adjunctive evaluation of bowel viability. More study is warranted in a larger group of patients to confirm these preliminary findings and to judge the impact of StO2 assessment on reducing anastomotic leaks., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Aim: Anastomotic dehiscence is a devastating complication. Inadequate blood supply is felt to be the prevailing cause. This study describes the use of near infrared imaging to evaluate transanally anastomotic tissue perfusion following low anterior resection., Method: Twenty patients undergoing low anterior resection for benign and malignant disease were studied. After completing the anastomosis, indocyanine green (ICG) was injected via a peripheral intravenous catheter. An endoscopic near infrared imaging system (Pinpoint, Novadaq, Canada) was then used transanally to visualize mucosal perfusion of the colon, rectum and the anastomotic staple line., Results: All patients underwent a technically successful ICG angiogram. The angiogram was abnormal in four patients. Two of these had a protective loop ileostomy and showed no sign of anastomotic breakdown. The other two patients were found on CT scan to have a peri-anastomotic collection consistent with anastomotic leakage. Both were managed conservatively with resolution., Conclusion: This study confirms that transanal ICG angiography is feasible and provides imaging of mucosal and anastomotic blood flow. The technique warrants further study in a larger group of patients to assess its ability to identify defects in tissue perfusion that may lead to anastomotic breakdown., (© 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.)