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

Rectal Cancer Clinical Trial

— PREMARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107650
• Other study ID #: 0485762
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2021
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Transanal total mesorectal excision of rectal cancer
To perform a total mesorectal excision through a transanal approach

Locations

Country	Name	City	State
Spain	University Hospital Dr. Josep Trueta of Girona	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Pere Planellas Giné

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recurrence	Rate of tumor recurrence	2 years
Secondary	Survival	Rate of survival	2 years