Selection of Surgical Technique in Rectal Cancer

Rectal Neoplasms Clinical Trial

— TECARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442215
• Other study ID #: 2024.017
• Status: Recruiting
• Start date: April 3, 2024
• Est. completion date: April 3, 2026

Study information

• Verified date: June 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Nuria Ortega, MD
• Phone: 972 940 200
• Email: nortega.girona.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 333
• Est. completion date: April 3, 2026
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta de Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical and Postoperative complications	Conversion to open surgery and anastomotic dehiscence rates	30 postoperative days
Secondary	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