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Clinical Trials/NCT06442215
NCT06442215
Recruiting
Not Applicable

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 Trueta1 site in 1 country333 target enrollmentApril 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Neoplasms
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Enrollment
333
Locations
1
Primary Endpoint
Suboptimal oncological outcomes
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 3, 2024
End Date
April 3, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Responsible Party
Sponsor

Eligibility 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.
  • T4b or oncological multivisceral resections.
  • History of neoplastic colorectal surgery or local excision or TAMIS.
  • Perforated or obstructive rectal neoplasm.

Outcomes

Primary Outcomes

Suboptimal oncological outcomes

Time Frame: 15 postoperative days

Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection

Secondary Outcomes

  • Overall and disease free survival(3-years surgery)
  • Surgical and Postoperative complications(30 postoperative days)

Study Sites (1)

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