Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer (PREMARE)

Pere Planellas Giné

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Transanal total mesorectal excision of rectal cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03107650

0485762

Details and patient eligibility

About

Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection.

In a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.

Enrollment: 323 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.
• Age ≥ 18 years
• Histology of adenocarcinoma or adenoma
• With or without neoadjuvant chemoradiotherapy
• TNM classification: T2 or T3, any N stage or M stage
• Intention of resection R0

Exclusion criteria

• TNM classification: T1 or T4.
• Complicated rectal cancer or emergency surgery.
• Previous major colorectal surgery

Trial design

323 participants in 2 patient groups

High risk patients

Description:

Patients with high risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed

Treatment:

Procedure: Transanal total mesorectal excision of rectal cancer

Low risk patients

Description:

Patients with low risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed