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

Campus Bio-Medico University0 sites167 target enrollmentJanuary 1, 2005

ConditionsNeoadjuvant Chemoradiotherapy Rectal Tumor Surgery Surgery--Complications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neoadjuvant Chemoradiotherapy
Sponsor: Campus Bio-Medico University
Enrollment: 167
Primary Endpoint: number of patient with low tumor regression grade
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2005

End Date

March 21, 2017

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Campus Bio-Medico University

Responsible Party

Principal Investigator

Vincenzo La Vaccara

Principal Investigator

Campus Bio-Medico University

Eligibility Criteria

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
•To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.