Predicting surgical techniques for rectal cancer patients
Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · NCT06442215
This study is trying to find out which rectal cancer patients might do better with less invasive surgery compared to traditional surgery, based on their individual risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 333 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Girona) |
| Trial ID | NCT06442215 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive model to identify patients with rectal neoplasms who are at high risk for poor surgical outcomes, particularly in the middle and lower thirds of the rectum. By analyzing data from patients scheduled for anterior resection with mesorectal excision, the study seeks to determine which individuals may benefit from minimally invasive surgery versus those who may require an open surgical approach. The goal is to optimize surgical techniques based on individual patient risk factors, ultimately improving oncological outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with adenocarcinoma of the rectum scheduled for anterior resection.
Not a fit: Patients with colorectal tumors of histology other than adenocarcinoma or those requiring complex multivisceral resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better surgical outcomes for patients with rectal cancer by tailoring surgical approaches to individual risk profiles.
How similar studies have performed: While this approach is novel in its specific predictive modeling for rectal cancer, similar studies have shown promise in optimizing surgical techniques based on patient characteristics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision. * Age ≥ 18 years. * Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy. * Initial stage T1-T4a. Any N. Any M. * Intention for R0 resection. Exclusion Criteria: * Colorectal tumor with histology different from adenocarcinoma. * Synchronous colon tumor. * Benign pathology or adenoma. * Tis. * T4b or oncological multivisceral resections. * History of neoplastic colorectal surgery or local excision or TAMIS. * Perforated or obstructive rectal neoplasm.
Where this trial is running
Girona
- Hospital Universitari Dr. Josep Trueta de Girona — Girona, Spain (RECRUITING)
Study contacts
- Study coordinator: Nuria Ortega, MD
- Email: nortega.girona.ics@gencat.cat
- Phone: 972 940 200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Neoplasms, Rectal cancer, Surgery, Minimal invasive surgery, Oncological outcomes