Surgical Site Infection Outcomes in Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) Procedure - The NICE Trial

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Apr 25, 2025

Keywords

ClinConnect Summary

Background and Rationale The Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) procedure represents an emerging innovation in minimally invasive colorectal surgery. It combines robotic intracorporeal anastomosis (ICA) with natural orifice specimen extraction (NOSE), typically transrectal, to avoid the need for an abdominal extraction incision. This approach may reduce surgical site trauma, postoperative pain, opioid use, and rates of incisional hernias.

Intracorporeal anastomosis has been widely studied in right-sided colectomies, with consistent evidence showing reduced sur...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Diagnosis: Patients must be diagnosed with benign left-sided colon and rectosigmoid disease, including diverticulitis and benign colon neoplasia.
• 2. Age Requirement: Patients aged 18 years or older. 3. Cancer-Free: There must be no evidence of cancer or metastatic disease in the patients. This includes:
• • Colonoscopy with no evidence of malignant lesion in the last 12 months
• • CT scan with no concern for malignancy in the prior 6 months
• • No other clinical concern for possible malignancy 4. Surgical Eligibility: Patients must be eligible to undergo robotic left colectomy with primary anastomosis without a planned diverting stoma.
• • 5. Informed Consent: Participants must be able to understand and willing to sign a written informed consent form.
• • 6. Treatment with NICE: Patients who undergo surgical treatment specifically with the NICE procedure.
• • 7. Surgeon Experience: The patients should be treated by surgeons who have performed at least 20 NICE procedures.
• • 8. General Practice Inclusion: Patients treated by surgeons who offer the NICE procedure as part of their general surgical practice and do not super-select patients for the procedure.
• • Exclusion Criteria
• • 1. Urgent or emergent procedure
• 2. Patients diagnosed with cancer or metastatic disease are not eligible for the study. This includes:
• • Known genetic predisposition to colorectal cancer
• • First-degree family history of colorectal cancer
• • Any concern about colorectal cancer
• • 3. Patients with an ongoing infection other than diverticulitis (e.g., pneumonia) or taking antibiotics unrelated to diverticulitis.
• • 4. Patients with a history of pelvic radiation
• • 5. Patients with prior anorectal surgery or prior colorectal surgery
• • 6. Patients with fecal incontinence, outlet obstructive defecation, anismus, or levator spasm at baseline are excluded from the study
• • 7. Any procedure in which a primary anastomosis is not feasible or diversion of the fecal stream is anticipated
• • 8. Patients with a high ASA of 4 or more and clinical frailty score of 8 or more
• • 9. Patients requiring preoperative nutritional support, such as total parenteral nutrition (TPN) or enteral feeding via percutaneous endoscopic gastrostomy (PEG) or nasogastric (NG) tube within 30 days prior to surgery
• • 10. Systemic steroids used within the last 12 months or immunomodulators and biological agents used within the last 60 days prior to surgery will render the patient ineligible for the trial.
• • Preoperative antibiotics used within two weeks to treat diverticulitis are permitted.
• • Antibiotics used within 30 days before surgery for any condition other than treating an infection related to diverticulitis will render the patient ineligible for the trial.
• • 11. Regional block anesthesia (e.g., epidural and spinal) is not permitted in this trial.
• • 12. Chronic Opioid Use: Chronic use of opioids in the prior 3 months.