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

Korábbi kezelés

• Contraindication for surgery and/or general anesthesia.
• Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)

Más betegség

• Subjects with benign disease
• Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
• Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
• LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).

Egyéb

• Interventional Cohort
• Known pregnancy or lactation.
• Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
• Participation in another interventional study during the xBar system usage. Historical Cohort

• Interventional Cohort
• Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
• Expected anastomosis within 10 cm from the anal verge
• Usage of drain during the surgery (to be confirmed during the surgery)
• Willing and able to comply with the study follow up and able and agree to provide informed consent.
  • Historical Cohort
• Adults aged ≥21 years at the time of surgery.
• Underwent a low anterior resection (LAR) for malignant colorectal disease.
• 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.