Selection of Surgical Technique in Rectal Cancer (NCT06442215) | Clinical Trial Compass
UnknownNot Applicable
Selection of Surgical Technique in Rectal Cancer
Spain333 participantsStarted 2024-04-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Suboptimal oncological outcomes
Timeframe: 15 postoperative days
Trial details
NCT IDNCT06442215
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta