Selection of Surgical Technique in Rectal Cancer
- Conditions
- Rectal Neoplasms
- Registration Number
- NCT06442215
- Lead Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 333
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suboptimal oncological outcomes 15 postoperative days Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection
- Secondary Outcome Measures
Name Time Method Overall and disease free survival 3-years surgery 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.
Surgical and Postoperative complications 30 postoperative days Conversion to open surgery and anastomotic dehiscence rates
Related Research Topics
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Trial Locations
- Locations (1)
Hospital Universitari Dr. Josep Trueta de Girona
🇪🇸Girona, Spain
Hospital Universitari Dr. Josep Trueta de Girona🇪🇸Girona, SpainNuria Ortega, MDContact972420200nortega.girona.ics@gencat.cat