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

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Transanal total mesorectal excision of rectal cancer

• Registration Number: NCT03107650
• Lead Sponsor: Pere Planellas Giné

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Study Start: 2018-01-01
• Primary Completion: 2019-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk patients	Transanal total mesorectal excision of rectal cancer	Patients with high risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed

Primary Outcome Measures

Name	Time	Method
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)
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).

Secondary Outcome Measures

Name	Time	Method
Survival	2 years	Rate of survival
Recurrence	2 years	Rate of tumor recurrence

Trial Locations

Locations (1)

University Hospital Dr. Josep Trueta of Girona; 🇪🇸 Girona, Spain