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

NCT06957236 | Enrolling By Invitation

• 1 other identifier: PRO00038141
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Natural Orifice Specimen Extraction; Intracorporeal Anastomosis; Robotic Colorectal Surgery; Left Colectomy; Rectosigmoid Resection; Benign Colorectal Disease; Diverticulitis; Minimally Invasive Surgery; Surgical Site Infection; Surgical Outcomes; Robotic Surgery Outcomes

Outcome Measures

Primary Outcomes (1)

• 30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure

  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.

  30 days post-surgery

Secondary Outcomes (20)

• Long-Term Outcomes: Hernia, Bowel Dysfunction, Fecal Incontinence

  Up to 6 months post-surgery

• Stool Contamination Grade During NICE Procedure

  During surgery

• Estimated Intraoperative Blood Loss

  During surgery

• Total Operative Time

  During surgery

• Success Rate of Intracorporeal Anastomosis

  During surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from multiple high-volume colorectal surgery centers across the United States that routinely perform robotic-assisted procedures. All participating sites follow a standardized Enhanced Recovery After Surgery (ERAS) protocol and are required to have surgeons experienced in the NICE procedure. The study population will consist of patients scheduled for elective robotic left-sided colectomy or rectosigmoid resection for benign disease, treated in real-world, non-super-selected surgical practice settings.

You may qualify if:

• \. Diagnosis: Patients must be diagnosed with benign left-sided colon and rectosigmoid disease, including diverticulitis and benign colon neoplasia.
• \. Age Requirement: Patients aged 18 years or older. 3. Cancer-Free: There must be no evidence of cancer or metastatic disease in the patients. This includes:
• 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.
• \. Informed Consent: Participants must be able to understand and willing to sign a written informed consent form.
• \. Treatment with NICE: Patients who undergo surgical treatment specifically with the NICE procedure.
• \. Surgeon Experience: The patients should be treated by surgeons who have performed at least 20 NICE procedures.

You may not qualify if:

• Urgent or emergent procedure
• Patients diagnosed with cancer or metastatic disease are not eligible for the study. This includes:
• Known genetic predisposition to colorectal cancer
• First-degree family history of colorectal cancer
• Any concern about colorectal cancer
• 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
• Patients with a high ASA of 4 or more and clinical frailty score of 8 or more
• 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
• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diverticulitis; Surgical Wound Infection; Diverticulitis, Colonic

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Study Officials

• Eric M Haas, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Muhammed Elhadi, MBBCh

  The Methodist Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Colon & Rectal Surgery

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 4, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)