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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2017-03-21

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).

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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.

Conditions

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Neoadjuvant Chemoradiotherapy Rectal Tumor Surgery Surgery--Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Early Surgery

Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy

Rectal Resection

Intervention Type PROCEDURE

Low Anterior Resection and Abdominoperineal Resection

Late Surgery

Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy

Rectal Resection

Intervention Type PROCEDURE

Low Anterior Resection and Abdominoperineal Resection

Very Late Surgery

Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy

Rectal Resection

Intervention Type PROCEDURE

Low Anterior Resection and Abdominoperineal Resection

Interventions

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Rectal Resection

Low Anterior Resection and Abdominoperineal Resection

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes