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

The NICE Trial is an observational study that’s looking at a newer robotic surgery approach for certain non-cancer diseases of the left side of the colon and rectum. The main question is whether the NICE procedure (which uses a robot and removes the tissue through the rectum) has similar safety to standard methods, by measuring how many people develop a surgical site infection within 30 days after surgery. It’s being done at multiple centers in the United States and will follow patients for up to 6 months to also look at recovery and longer-term bowel function and quality of life. At this time, results have not yet been published.

To be eligible, adults 18 and older with benign left-sided colon disease (like diverticulitis) who are planned for a robotic left colectomy or rectosigmoid resection and can have a primary connection of the bowel (no planned diverting stoma) may be considered. The surgeon must have extensive experience with the NICE procedure (at least 20 prior cases). Exclusions include urgent surgery, known cancer, prior pelvic radiation or colorectal surgery, significant baseline bowel problems, high frailty, ongoing infections requiring other antibiotics, and certain other health conditions. Participants will undergo the NICE procedure, follow an enhanced recovery program, and complete surveys about recovery, bowel function, and quality of life at 30 days, 3 months, and 12 months. Data are kept private, not shared outside the study team, and procedures are video-recorded for quality control.

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.