Selection of Surgical Technique in Rectal Cancer

NCT06442215 | Recruiting

• 1 other identifier: 2024.017
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

Rectal cancer; Surgery; Minimal invasive surgery; Oncological outcomes

Outcome Measures

Primary Outcomes (1)

• Suboptimal oncological outcomes

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

  15 postoperative days

Secondary Outcomes (2)

• Surgical and Postoperative complications

  30 postoperative days

• Overall and disease free survival

  3-years surgery

Study Arms (1)

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.

Other: Data collection

Interventions

Data collection OTHER

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

Patients undergoing elective surgery for rectal neoplasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with rectal neoplasia undergoing elective surgery during a period of time from 2017 to 2021

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, 17300, Spain

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Nuria Ortega, MD

CONTACT

972 940 200; nortega.girona.ics@gencat.cat

Lidia Cornejo, MSC

CONTACT

lcornejo@idibgi.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: April 3, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2026
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)