Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Dr. Josep Trueta de Girona
RECRUITING
Girona
Contact Information
Primary
Nuria Ortega, MD
nortega.girona.ics@gencat.cat
972 940 200
Backup
Lidia Cornejo, MSC
lcornejo@idibgi.org
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2026-04-03
Participants
Target number of participants: 333
Treatments
Patients undergoing elective surgery for rectal neoplasm
Patients diagnosed with rectal neoplasia undergoing elective surgery between 2017 and 2021 at medical centers within the national territory.
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

This content was sourced from clinicaltrials.gov