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

C

Campus Bio-Medico University of Rome

Status

Completed

Conditions

Surgery
Neoadjuvant Chemoradiotherapy
Surgery--Complications
Rectal Tumor

Treatments

Procedure: Rectal Resection

Study type

Observational

Funder types

Other

Identifiers

NCT04013347
08/17 OSS ComEt CBM

Details and patient eligibility

About

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).

Full 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.

Enrollment

167 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 2015.

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

Trial design

167 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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