Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial

Study Overview
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Brief Summary
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This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.

Detailed Description
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Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.

Official Title
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Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial

Conditions
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Rectal Cancer, Gastric Adenocarcinoma

Intervention / Treatment
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* Other: Carnoy's solution
* Other: 10% neutral buffered formaldehyde


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Rectal Cancer: Long course neoadjuvant chemoradiation Low anterior resection with total mesorectal excision Inclusion Criteria - Colon Cancer: - Rectosigmoidectomy Inclusion Criteria - Gastric Cancer: Gastric adenocarcinoma Subtotal gastrectomy D2 lymphadenectomy Exclusion Criteria - Rectal Cancer: Previous surgery Incomplete neoadjuvant chemoradiation Refuse to sign the informed consent T4b and/or Multivisceral resection Exclusion Criteria - Colon Cancer: Previous surgery Neoadjuvant chemoradiation Refuse to sign the informed consent T4b and/or Multivisceral resection Exclusion Criteria - Gastric Cancer: Distant metastasis Previous upper abdomen radiotherapy Previous surgery over stomach or omentum Refuse to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10% neutral buffered formaldehyde<br>Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes. | Other: 10% neutral buffered formaldehyde<br> <br> |
| Experimental: Carnoy's solution<br>Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes. | Other: Carnoy's solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node yield | Primary outcome will be the total number of lymph nodes dissected in each specimen | 10 days - accessed with the pathological report for each specimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissection duration | Secondary outcome will be measured in minutes, counting from the start to the end of the dissection | 10 days - accessed with the pathological report for each specimen |