An observational study in Diverticulitis, Surgical Site Infection and Surgical Site Infections, sponsored by The Methodist Hospital Research Institute. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by The Methodist Hospital Research Institute · Observational
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.
Background and Rationale The Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) procedure represents an emerging innovation in minimally invasive colorectal surgery. It combines robotic intracorporeal anastomosis (ICA) with natural orifice specimen extraction (NOSE), typically transrectal, to avoid the need for an abdominal extraction incision. This approach may reduce surgical site trauma, postoperative pain, opioid use, and rates of incisional hernias.
Intracorporeal anastomosis has been widely studied in right-sided colectomies, with consistent evidence showing reduced surgical site infections (SSIs) and improved recovery. However, application to left-sided resections introduces unique challenges. The bacterial density in the left colon and rectum, combined with transrectal manipulation, may increase the risk of deep or organ-space SSIs. While early single-center experiences suggest the NICE procedure may be safe and effective, multicenter validation in a broader clinical setting is needed.
Study Objectives The primary objective of this study is to determine the 30-day incidence of surgical site infections (superficial, deep, and organ-space) in patients undergoing robotic left-sided colorectal resections using the NICE procedure. Secondary objectives include assessment of intraoperative technical performance, perioperative complications, postoperative recovery, and longer-term functional and quality of life outcomes.
Study Design This is a prospective, multicenter, observational cohort study enrolling patients undergoing elective robotic-assisted left colectomy or rectosigmoid resection for benign colorectal disease. All procedures will use the standardized NICE technique. Participating surgeons must have performed at least 20 prior NICE procedures. The study will run over a 24-month accrual period, with each patient followed for at least 6 months postoperatively.
Study Procedures Surgical intervention involves robotic left-sided resection with intracorporeal anastomosis and transrectal specimen extraction. All sites will follow a standardized Enhanced Recovery After Surgery (ERAS) protocol tailored to robotic colorectal surgery. Operative videos will be collected for quality control, ensuring adherence to the defined NICE procedural steps.
Postoperative follow-up includes in-person or remote assessments at 30 days, 3 months, and 12 months. Functional outcomes will be measured using validated questionnaires: Wexner score for fecal incontinence, LARS score for bowel dysfunction, and PROMS-10 for health-related quality of life.
Data Collection and Oversight Clinical data will be collected prospectively using REDCap, a secure, HIPAA-compliant electronic data capture system. All patient data will be pseudonymized. A centralized coordinating center will oversee data integrity, standardization, and site compliance. Surgical cases will be video recorded to ensure procedural fidelity.
Each site must consecutively enroll eligible patients and maintain compliance with protocol-defined ERAS standards. Surgeons will be credentialed based on review of unedited operative videos prior to participation.
Outcomes The primary outcome is the 30-day SSI rate, including superficial, deep, and organ-space infections. Secondary outcomes include intraoperative variables (e.g., operative time, blood loss, conversion rate), postoperative recovery (opioid use, length of stay, complications, readmissions, reinterventions), and long-term outcomes such as hernia formation and bowel function.
Patient-reported outcome measures will be collected preoperatively and at designated follow-up intervals. These include the Wexner score, LARS score, and PROMS-10, allowing for longitudinal evaluation of continence, function, and quality of life.
Sample Size and Statistical Considerations The study is powered to detect non-inferiority in SSI rates compared to conventional techniques. Assuming a historical SSI rate of 5% and a non-inferiority margin of 5%, a sample size of at least 224 patients provides 80% power with a 5% alpha. To accommodate multivariate modeling and variability across sites, the planned enrollment target is 300-400 patients.
Data will be analyzed using multilevel logistic regression to account for center and surgeon-level effects. Sensitivity analyses will be conducted to test robustness of findings. Descriptive and inferential analyses will be used to evaluate changes in quality of life and functional outcomes over time.
Significance This trial aims to provide high-quality evidence on the safety and performance of the NICE procedure for left-sided colorectal surgery. If non-inferiority is demonstrated, the findings may support broader adoption of this technique, with implications for faster recovery, reduced SSI risk, and improved patient experience. By incorporating video-based quality control and standardized ERAS pathways, the study ensures procedural consistency and real-world applicability of results.
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's planned enrollment of 300 is above the median of 250 across 15 observational studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →The Methodist Hospital Research Institute is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 18 (64%) have results posted.
Compared within Diverticulitis, Colonic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diverticulitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 Criteria
Patients diagnosed with cancer or disease are not eligible for the study. This includes:
Systemic 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 30 days post-surgery
Long-Term Outcomes: Hernia, Bowel Dysfunction, Fecal Incontinence
Monitors incidence of incisional hernia, long-term bowel dysfunction, and persistent fecal incontinence following the NICE procedure.
Time frame: Up to 6 months post-surgery
Stool Contamination Grade During NICE Procedure
Assesses the degree of fecal contamination encountered intraoperatively using a standardized grading scale. Scale Components and Interpretation: Degree of Contamination (Severity of contamination encountered): * 1 = Mild (Minimal stool, easily managed with minimal delay) * 2 = Moderate (Requires additional cleaning, minor to moderate delays) * 3 = Severe (Substantial contamination, extensive cleaning and procedural delay required) Higher scores indicate worse contamination. Quality of Contamination (Consistency of stool): * Liquid = Easily aspirated * Semi-formed = Partially cleared with aspiration * Solid = Requires transrectal/manual clearing Degree of Evacuation (Effectiveness of stool clearance): * Complete = All visible stool removed * Semi-complete = Minimal residual stool * Incomplete = Moderate residual stool
Time frame: During surgery
Estimated Intraoperative Blood Loss
Records the estimated blood loss in milliliters during the NICE procedure as documented by the surgical team.
Time frame: During surgery
Total Operative Time
Measures the total duration of the NICE procedure from skin incision to closure, reported in minutes.
Time frame: During surgery
Success Rate of Intracorporeal Anastomosis
Captures whether the intracorporeal anastomosis (ICA) was successfully completed as intended using the robotic platform.
Time frame: During surgery
Success Rate of Transrectal Specimen Extraction
Measures whether the surgical specimen was successfully extracted through the rectum without conversion to transabdominal extraction.
Time frame: During surgery
Incidence of Intraoperative Complications
Reports the occurrence of intraoperative complications such as rectal tear, sphincter injury, or conversion to open surgery.
Time frame: During surgery
Total Opioid Use Within 30 Days Post-Surgery
Measures the cumulative opioid consumption during the first 30 days following surgery, expressed in morphine milligram equivalents (MME).
Time frame: 30 days post-surgery
Length of Hospital Stay
Measures the number of days from the date of surgery to the date of discharge, assessing early recovery and discharge readiness.
Time frame: 30 days post-surgery
Overall Postoperative Complication Rate
Proportion of patients who experience one or more postoperative complications, including minor and major events, within 30 days of surgery.
Time frame: 30 days post-surgery
Reoperation or Re-intervention Rate
Proportion of patients who require unplanned surgical reoperation or interventional procedures (e.g., drainage) within 30 days post-surgery.
Time frame: 30 days post-surgery
Readmission Rate Within 30 Days
Percentage of patients who are readmitted to any hospital for any cause within 30 days following the index surgery.
Time frame: 30 days post-surgery
Postoperative Mortality Rate
Percentage of patients who die from any cause within 30 days following the surgical procedure.
Time frame: 30 days post-surgery
Use of Transrectal Wound Protector
Documents whether a wound protector was used during transrectal specimen extraction as part of the NICE procedure.
Time frame: During surgery
Type of Intracorporeal Anastomosis Staple Line
Classifies the anastomosis as either crossing or non-crossing staple line configuration.
Time frame: During surgery
Oversewing of Anastomosis
Indicates whether the anastomosis was reinforced with oversewing after stapling.
Time frame: During surgery
Performance of Mesenteric Shaving
Captures whether mesenteric shaving was performed on the specimen during the NICE procedure.
Time frame: During surgery
Change in Wexner Score for Fecal Incontinence
Evaluates changes in the Wexner score from baseline at 3 and 12 months to assess the severity and frequency of fecal incontinence following the NICE procedure. The Wexner score assesses the ability to control gas, liquid, and solid stool, the need for protective garments, and the impact on lifestyle. Scale Range: 0 (no incontinence) to 20 (complete incontinence); Higher scores indicate worse fecal incontinence.
Time frame: Baseline, 3 months, 12 months
Functional Outcomes: LARS Score
The Low Anterior Resection Syndrome (LARS) score assesses bowel dysfunction including incontinence, frequency, and urgency following low anterior resection. Evaluates changes over time. Scale Range: 0 to 42; Scores 0-20 indicate no LARS, 21-29 minor LARS, and 30-42 major LARS. Higher scores indicate worse bowel dysfunction.
Time frame: Baseline, 3 months, 12 months
Health-Related Quality of Life: PROMS-10 Score
PROMS-10 captures patient-reported physical, emotional, and social well-being using a 10-item questionnaire. Monitors change in health-related quality of life over time. Scale Range: 0 to 40; Higher scores indicate better quality of life.
Time frame: Baseline, 3 months, 12 months
Plan to share: No — Individual participant data (IPD) will not be shared outside the study team due to privacy concerns and the multicenter observational nature of the study. Although data are pseudonymized, the complexity and volume of surgical video and clinical data could still risk indirect identification. Data access is restricted to investigators approved by the study's steering committee to ensure confidentiality and ethical compliance.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2026, 14 months after the start.
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