Selection of Surgical Technique in Rectal Cancer (TECARE)

Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes

Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.

Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.

Study Overview

• Status: Recruiting
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 333

Contacts and Locations

• Study Contact: Name: Nuria Ortega, MD; Phone Number: 2825 972 940 200; Email: nortega.girona.ics@gencat.cat
• Study Contact Backup: Name: Lidia Cornejo, MSC; Email: lcornejo@idibgi.org

Study Locations

• Spain
  • Girona, Spain, 17300
    • Recruiting
    • Hospital Universitari Dr. Josep Trueta de Girona
    • Contact: Nuria Ortega, MD; Phone Number: 2825 972420200; Email: nortega.girona.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing elective surgery for rectal neoplasm; Patients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory.	Other: Data collection; Collection of preoperative demographic, clinical, and radiological variables from patients who meet the inclusion criteria in order to identify possible risk factors for suboptimal surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suboptimal oncological outcomes	Surgical resection with affected margins (proximal-distal and/or circumferential < 1mm) and/or incomplete or nearly complete mesorectal resection	15 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical and Postoperative complications	Conversion to open surgery and anastomotic dehiscence rates	30 postoperative days
Overall and disease free survival	Recurrence of the tumoral disease at the pelvic level and distant recurrence is defined as s the recurrence of the disease in other distant organs.	3-years surgery

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): April 3, 2025
• Study Completion (Estimated): April 3, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Rectal cancer; Minimal invasive surgery; Oncological outcomes
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2024.017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No