Selection of Surgical Technique in Rectal Cancer

NCT ID: NCT06442215

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-04-03

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Data collection

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitari Dr. Josep Trueta de Girona

Girona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Nuria Ortega, MD

Role: CONTACT

972 940 200 ext. 2825

Lidia Cornejo, MSC

Role: CONTACT

Facility Contacts

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Nuria Ortega, MD

Role: primary

972420200 ext. 2825

Other Identifiers

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2024.017

Identifier Type: -

Identifier Source: org_study_id

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