Surgical Site Infection Outcomes in Natural Orifice Intracorporeal Anastomosis and Extraction (NI… (NCT06957236) | Clinical Trial Compass
By InvitationNot Applicable
Surgical Site Infection Outcomes in Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) Procedure - The NICE Trial
United States300 participantsStarted 2025-04-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Urgent or emergent procedure
. Patients diagnosed with cancer or metastatic disease are not eligible for the study. This includes:
. Patients with an ongoing infection other than diverticulitis (e.g., pneumonia) or taking antibiotics unrelated to diverticulitis.
. Patients with a history of pelvic radiation
. Patients with prior anorectal surgery or prior colorectal surgery
. Patients with fecal incontinence, outlet obstructive defecation, anismus, or levator spasm at baseline are excluded from the study
. Any procedure in which a primary anastomosis is not feasible or diversion of the fecal stream is anticipated
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure