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

NCT06957236 · The Methodist Hospital Research Institute · Updated 8 May 2025

What is being tested
Not stated
For
Diverticulitis; Surgical Site Infection; Surgical Site Infections; Colorectal Surgery; Robotic Surgical Procedures; Clinical Trials; Diverticulitis, Colonic; Diverticulitis Colon; Diverticulitis; Perforation, Bowel
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 300 people. The full rules are on the registry page.
Where
United States
When
Starts or started 2 April 2025, ends 30 Dec 2026. Registered 4 May 2025.
Results
None posted yet.

In the researchers' words

The goal of this observational study is to learn if a new surgical technique, called the NICE procedure, is as safe as standard methods for treating benign left-sided colon and rectal diseases in adults. The main question it aims to answer is: Does the NICE procedure lead to similar or lower rates of surgical site infections (SSIs) within 30 days compared to traditional surgery? Researchers will gather information from hospitals across the country to evaluate how well this procedure works when performed by experienced surgeons in everyday clinical settings. Participants will: Have surgery using the NICE procedure, which uses a robotic platform and removes the specimen through a natural opening (the rectum). Be monitored for any infections or complications after surgery. Complete surveys to track their recovery, bowel function, and quality of life for up to 6 months. This study may help improve recovery, reduce pain, and lower infection risk in future colorectal surgeries.
ClinicalTrials.gov, NCT06957236

Sites

  • Houston Methodist HospitalHouston, Texas, United States