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Selection of Surgical Technique in Rectal Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06442215
Acronym
TECARE
Enrollment
333
Registered
2024-06-04
Start date
2024-04-03
Completion date
2026-04-03
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

Rectal cancer, Surgery, Minimal invasive surgery, Oncological outcomes

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.

Interventions

OTHERData 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Suboptimal oncological outcomes15 postoperative daysSurgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection

Secondary

MeasureTime frameDescription
Surgical and Postoperative complications30 postoperative daysConversion to open surgery and anastomotic dehiscence rates
Overall and disease free survival3-years surgeryRecurrence of the tumoral disease at the pelvic level and distant recurrence is defined as s the recurrence of the disease in other distant organs.

Countries

Spain

Contacts

Primary ContactNuria Ortega, MD
nortega.girona.ics@gencat.cat972 940 200
Backup ContactLidia Cornejo, MSC
lcornejo@idibgi.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026