Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.

The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.

The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.

Inclusion Criteria:

Interventional Cohort

1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
2. Expected anastomosis within 10 cm from the anal verge
3. Usage of drain during the surgery (to be confirmed during the surgery)
4. Willing and able to comply with the study follow up and able and agree to provide informed consent.

Historical Cohort

1. Adults aged ≥21 years at the time of surgery.
2. Underwent a low anterior resection (LAR) for malignant colorectal disease.
3. Documented colorectal anastomosis located <10cm from the anal verge, or documented tumor <10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.

Exclusion Criteria:

Interventional Cohort

1. Subjects with benign disease
2. Contraindication for surgery and/or general anesthesia.
3. Known pregnancy or lactation.
4. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
5. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
6. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
7. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
8. Participation in another interventional study during the xBar system usage. Historical Cohort

1. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).