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

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 Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Transanal total mesorectal excision of rectal cancer

• Study Type: Observational
• Enrollment (Actual): 323

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17007
    • University Hospital Dr. Josep Trueta of Girona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients affected of mid-low rectal cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk patients; Patients with high risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed	Procedure: Transanal total mesorectal excision of rectal cancer; To perform a total mesorectal excision through a transanal approach
Low risk patients; Patients with low risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pere Planellas Giné

Publications and helpful links

General Publications

• Planellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):271-280. doi: 10.1097/SLA.0000000000005161.
• Planellas P, Salvador H, Cornejo L, Buxo M, Farres R, Molina X, Maroto A, Ortega N, Rodriguez-Hermosa JI, Codina-Cazador A. Risk factors for suboptimal laparoscopic surgery in rectal cancer patients. Langenbecks Arch Surg. 2021 Mar;406(2):309-318. doi: 10.1007/s00423-020-02029-0. Epub 2020 Nov 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 0485762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No