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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Dr. Josep Trueta of Girona

Girona, 17007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transanal total mesorectal excision of rectal cancer

Procedure

To perform a total mesorectal excision through a transanal approach

Primary outcomes

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

Time frame: 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)

Time frame: 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 outcomes

Recurrence

Time frame: 2 years

Rate of tumor recurrence
Survival

Time frame: 2 years

Rate of survival

Sponsors and collaborators

Lead sponsor

Pere Planellas Giné

Other

Registry information

Acronym: PREMARE

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Apr 11, 2017
Registry last updated: Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed