PREMARE: Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Recurrence [2 years]
Rate of tumor recurrence
- Survival [2 years]
Rate of survival
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.
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Age ≥ 18 years
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Histology of adenocarcinoma or adenoma
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With or without neoadjuvant chemoradiotherapy
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TNM classification: T2 or T3, any N stage or M stage
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Intention of resection R0
Exclusion Criteria:
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TNM classification: T1 or T4.
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Complicated rectal cancer or emergency surgery.
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Previous major colorectal surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Dr. Josep Trueta of Girona | Girona | Spain | 17007 |
Sponsors and Collaborators
- Pere Planellas Giné
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0485762