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

NCT06957236 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-05-08

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Eric M Haas, MD · The Methodist Hospital Research Institute

  • Muhammed Elhadi, MBBCh · The Methodist Hospital Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06957236 on ClinicalTrials.gov