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

Completed

• Conditions: Rectal Tumor; Neoadjuvant Chemoradiotherapy; Surgery; Surgery--Complications
• Interventions: Procedure: Rectal Resection

• Registration Number: NCT04013347
• Lead Sponsor: Campus Bio-Medico University

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.

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2015-03-01
• Study Completion: 2017-03-21
• Study First Submitted: 2019-06-28
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-06
• Last Update Submitted: 2019-07-06
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late Surgery	Rectal Resection	Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy
Very Late Surgery	Rectal Resection	Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy
Early Surgery	Rectal Resection	Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy

Primary Outcome Measures

Name	Time	Method
number of patient with low tumor regression grade	1 week after surgery	rate of low tumor regression grade (1-2)
number of patient with surgical complications	1 month after surgery	rate of surgical complications

Secondary Outcome Measures

Name	Time	Method
number of patient with anastomotic dehiscence	1 month after surgery	rate of anastomotic dehiscence