Rectal Neoplasms
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical and Postoperative complications | 30 postoperative days | Conversion to open surgery and anastomotic dehiscence rates |
| 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. |
Countries
Spain