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NCT06957236

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

Enrolling by Invitation
Not specifiedAges 18+Observational
The Methodist Hospital Research Institute
~300 participants
Updated 2025-05-08 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure
Measured over 30 days post-surgery

Conditions

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

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Eric M Haas, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
  • Muhammed Elhadi, MBBCh · STUDY_DIRECTOR · The Methodist Hospital Research Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • 30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure30 days post-surgery

    Measures the proportion of patients who develop surgical site infections (SSIs) categorized as superficial, deep, or organ-space within 30 days following robotic left-sided colectomy or rectosigmoid resection using the NICE procedure. Infections are classified per CDC definitions and assessed through clinical evaluation, medical records, and follow-up.