Selection of Surgical Technique in Rectal Cancer

Last updated: June 4, 2024
Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Rectal Cancer

Colon Cancer

Treatment

Data collection

Clinical Study ID

NCT06442215
2024.017
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled surgery for anterior resection of the rectum meeting oncological criteriawith mesorectal excision.

  • Age ≥ 18 years.

  • Histology of adenocarcinoma with or without neoadjuvant chemotherapy orchemoradiotherapy.

  • Initial stage T1-T4a. Any N. Any M.

  • Intention for R0 resection.

Exclusion

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 Design

Total Participants: 333
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
April 03, 2026

Connect with a study center

  • Hospital Universitari Dr. Josep Trueta de Girona

    Girona, 17300
    Spain

    Active - Recruiting

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