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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013347
• Other study ID #: 08/17 OSS ComEt CBM
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: March 21, 2017

Study information

• Verified date: July 2019
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 21, 2017
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoadjuvant Chemoradiotherapy
• Rectal Neoplasms
• Rectal Tumor
• Surgery
• Surgery--Complications

Intervention

Procedure:
• Rectal Resection
Low Anterior Resection and Abdominoperineal Resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patient with low tumor regression grade	rate of low tumor regression grade (1-2)	1 week after surgery
Primary	number of patient with surgical complications	rate of surgical complications	1 month after surgery
Secondary	number of patient with anastomotic dehiscence	rate of anastomotic dehiscence	1 month after surgery