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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03107650

Acronym

PREMARE

Enrollment

323

Registered

2017-04-11

Start date

2018-01-01

Completion date

2020-07-31

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

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.

Interventions

PROCEDURETransanal total mesorectal excision of rectal cancer

To perform a total mesorectal excision through a transanal approach

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)	30 days	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).
Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)	30 days	Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

Secondary

Measure	Time frame	Description
Recurrence	2 years	Rate of tumor recurrence
Survival	2 years	Rate of survival

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026