NCT06442215 Selection of Surgical Technique in Rectal Cancer
| NCT ID | NCT06442215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
| Condition | Rectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 333 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2025-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 333 participants in total. It began in 2024-04-03 with a primary completion date of 2025-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. * Tis. * T4b or oncological multivisceral resections. * History of neoplastic colorectal surgery or local excision or TAMIS. * Perforated or obstructive rectal neoplasm.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06442215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06442215 currently recruiting?
Yes, NCT06442215 is actively recruiting participants. Contact the research team at nortega.girona.ics@gencat.cat for enrollment information.
Where is the NCT06442215 trial being conducted?
This trial is being conducted at Girona, Spain.
Who is sponsoring the NCT06442215 clinical trial?
NCT06442215 is sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. The trial plans to enroll 333 participants.