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

Pere Planellas Giné323 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

323

Conditions

Rectal Cancer

Interventions

Transanal total mesorectal excision of rectal cancerPROCEDURE

To perform a total mesorectal excision through a transanal approach

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)

Evaluation of the quality of mesorectum as optimal or suboptimal (international consensus defines three grades of resection: Group 1: including mesorectal resection, good quality Group 2: intramesorectal resection: moderate quality Group 3: resection in the muscularis propria, poor quality). Investigators will group patients into two groups: optimal mesorectum (group 1) and suboptimal mesorectum (group 2-3).

Time frame: 30 days

Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

Time frame: 30 days

Secondary Outcomes

Recurrence

Rate of tumor recurrence

Time frame: 2 years

Survival

Rate of survival