Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery

Study Overview
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Brief Summary
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Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated. Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; >57 days).

Detailed Description
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Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.

Official Title
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Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery

Conditions
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Neoadjuvant Chemoradiotherapy, Rectal Tumor, Surgery, Surgery--Complications

Intervention / Treatment
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* Procedure: Rectal Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015. To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Surgery<br>Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy | Procedure: Rectal Resection<br>* Low Anterior Resection and Abdominoperineal Resection<br>|
| Late Surgery<br>Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy | Procedure: Rectal Resection<br>* Low Anterior Resection and Abdominoperineal Resection<br>|
| Very Late Surgery<br>Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy | Procedure: Rectal Resection<br>* Low Anterior Resection and Abdominoperineal Resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient with low tumor regression grade | rate of low tumor regression grade (1-2) | 1 week after surgery | 
| number of patient with surgical complications | rate of surgical complications | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient with anastomotic dehiscence | rate of anastomotic dehiscence | 1 month after surgery |