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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06957236
Status
Enrolling By Invitation

Conditions

  • Clinical Trials
  • Colorectal Surgery
  • Diverticulitis
  • Diverticulitis Colon
  • Diverticulitis, Colonic
  • Diverticulitis; Perforation, Bowel
  • Robotic Surgical Procedures
  • Surgical Site Infection
  • Surgical Site Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: NICE Procedure Cohort
    This cohort includes patients undergoing elective left-sided colectomy or rectosigmoid resection for benign disease using the robotic Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) procedure. The procedure involves robotic intracorporeal anastomosis and transrectal specimen extraction. No comparator or control group is used. Data collected will assess surgical site infection rates and recovery outcomes.

Primary Outcome Measure

30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure [ Time Frame: 30 days post-surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-

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By research site
Houston Methodist Hospital· Houston, TX

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