Multicentric National Italian Analysis of Textbook Outcome in Colorectal Cancer Surgery

NCT07718919 | Completed

• 1 other identifier: ATOCSS
• Study Type: observational
• Target: 6,129
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the third most common malignancy worldwide, with more than 1.9 million new cases reported annually. Survival among patients with CRC depends on several factors, including disease stage at diagnosis, the patient's clinical condition, tumour characteristics, and treatment modalities. Despite advances in surgical techniques, active involvement in clinical, translational, and basic research, and improvements in perioperative care, substantial disparities in short- and long-term outcomes persist across healthcare providers and countries. To reduce these variations and improve the quality of cancer care, several metrics have been used to evaluate hospitals, therapeutic approaches, and surgical outcomes. In response to these needs, a composite measure known as "Textbook Outcome" (TO) was developed. It encompasses multiple favourable outcomes and requires patients to meet all essential quality-of-care criteria for a given procedure. TO serves as an effective predictor of survival and is recognised as an indicator of the quality of hospital care. This study aims to investigate the value of TO as an indicator of clinical outcomes and quality of care in the surgical treatment of colorectal cancer. The primary objective is to assess the achievement of Textbook Outcome criteria in colorectal cancer surgery performed by Italian surgeons. Textbook Outcome is defined by the fulfilment of six key parameters: in-hospital survival, defined as the absence of death during hospitalisation or within 30 days after surgery; radical resection, defined as an R0 resection with at least 12 lymph nodes examined; absence of reoperation; absence of an unplanned stoma; absence of major adverse events, classified according to the Clavien-Dindo criteria as grade III or higher, within 30 days after surgery; and a hospital length of stay of 14 days or less without unplanned readmission. The simultaneous achievement of all six parameters constitutes the optimal outcome, defined as Textbook Outcome. The secondary objective is to assess the consistency with which surgeons meet TO criteria during colorectal surgery and to identify patient- and procedure-related factors associated with failure to achieve TO. Through a detailed analysis of these factors, the study aims to identify the variables influencing TO failure and to determine which aspects of clinical practice or patient characteristics represent the main barriers to meeting these quality standards. The usefulness of TO as a quality indicator in the surgical management of colorectal cancer will also be evaluated by examining which individual unmet components are most frequently associated with unfavourable clinical outcomes, with particular attention to the different clinical presentations of the disease. The study will include all adult patients admitted to the participating surgical departments with a diagnosis of colorectal cancer between 1 January 2022 and 31 December 2024. Patient data will be analysed retrospectively. Demographic characteristics, comorbidity status, clinical and radiological findings, treatment strategies, and 30-day morbidity and mortality will be evaluated. Data will be entered into an online database between 1 January 2025 and 31 May 2025. The study will last 12 months: the first five months will be dedicated to data collection and the subsequent seven months to data analysis. The study is scheduled to begin in January 2025 with the commencement of data collection. The sample size required to achieve 80% statistical power, with a margin of error of ±5% at a 95% confidence level, is 324 patients. Continuous variables not following a normal distribution will be expressed as medians with interquartile ranges (IQRs), whereas normally distributed continuous variables will be reported as means with standard deviations (SDs). The Mann-Whitney U test will be used to compare non-normally distributed continuous variables between groups. Normally distributed continuous variables will be compared using the independent-samples t-test or one-way analysis of variance (ANOVA), as appropriate. Categorical variables will be reported as frequencies, and proportions will be compared between groups using the χ² test. Survival curves will be estimated using the Kaplan-Meier method and compared using the log-rank test. Prognostic factors for survival will be assessed using multivariable Cox proportional hazards regression. Statistical significance will be set at a two-sided P value of \< .05.

Conditions

Colo-rectal Cancer

Keywords

colorectal cancer surgery; Textbook outcomes; Quality of care metrics; Risk factor analysis

Outcome Measures

Primary Outcomes (1)

• to assess the TO criteria during colorectal cancer surgeries in Italy

  TO is defined by six criteria: hospital survival (no mortality during hospitalization or within 30 days post-resection), radical resection (R0 resection with a minimum of 12 lymph nodes examined), absence of reintervention, no unplanned stoma, no significant adverse outcomes (as defined by the Clavien-Dindo classification) within 30 days post-resection, and a hospital stay of 14 days or less without unplanned readmission. Achieving all six criteria constitutes a "textbook outcome".

  From enrollment to 30 days post resection

Study Arms (1)

consecutive adult patients candidate for elective surgery

consecutive adult patients (aged 18 years and older) admitted to participating surgical departments with a diagnosis of CRC. Inclusion criteria: (i) An ASA class \< IV, indicating patients who are in relatively good health and can tolerate major surgery. (ii) Histologically confirmed diagnosis of colorectal carcinoma, ensuring that only patients with verified malignant disease are included. (iii) Absence of distant metastases (M0 stage), allowing the study to focus on patients eligible for curative surgery. (iv) Patients who underwent curative resection, encompassing both elective and emergency surgical cases. (2) Exclusion criteria: (i) Patients who are preoperatively, intraoperatively, or postoperatively staged as M1, indicating the presence of distant metastases, as these cases typically involve palliative rather than curative treatment strategies. (ii) Patients with a history of prior colectomy. (iii) Patients who underwent palliative treatments

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

all consecutive adult patients (aged 18 years and older) admitted to participating surgical departments with a diagnosis of colorectal cancer submitted to colorectal cancer surgery

You may qualify if:

• Adults aged 18 years or older at the time of diagnosis.
• An ASA (American Society of Anesthesiology) classification of less than 4, indicating patients who are in relatively good health and can tolerate major surgery.
• Histologically confirmed diagnosis of colorectal carcinoma, ensuring that only patients with verified malignant disease are included.
• Absence of distant metastases (M0 stage), allowing the study to focus on patients eligible for curative surgery.
• Patients who underwent curative resection, encompassing both elective and emergency surgical cases.

You may not qualify if:

• Patients who are preoperatively, intraoperatively, or postoperatively staged as M1, indicating the presence of distant metastases, as these cases typically involve palliative rather than curative treatment strategies.
• Patients with a history of prior colectomy, as previous surgeries may complicate the assessment of current treatment outcomes.
• Patients who underwent palliative treatments, as the study aims to evaluate curative-intent surgeries.

Sponsors & Collaborators

• Academy of Applied Medical and Social Sciences, Poland: lead
• Associazione Chirurghi Ospedalieri Italiani: collaborator

Study Sites (1)

ACOI

Cagliari, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

IT (1)