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Selection of Surgical Technique in Rectal Cancer

Recruiting
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
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Suboptimal oncological outcomes15 postoperative days

Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection

Secondary Outcome Measures
NameTimeMethod
Overall and disease free survival3-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 complications30 postoperative days

Conversion to open surgery and anastomotic dehiscence rates

Trial Locations

Locations (1)

Hospital Universitari Dr. Josep Trueta de Girona

🇪🇸

Girona, Spain

Hospital Universitari Dr. Josep Trueta de Girona
🇪🇸Girona, Spain
Nuria Ortega, MD
Contact
972420200
nortega.girona.ics@gencat.cat

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