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

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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Key information

Conditions

Neoadjuvant Chemoradiotherapy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Rectal Tumor Surgery Surgery--Complications

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rectal Resection

Procedure

Low Anterior Resection and Abdominoperineal Resection

Primary outcomes

number of patient with low tumor regression grade

Time frame: 1 week after surgery

rate of low tumor regression grade (1-2)
number of patient with surgical complications

Time frame: 1 month after surgery

rate of surgical complications

Secondary outcomes

number of patient with anastomotic dehiscence

Time frame: 1 month after surgery

rate of anastomotic dehiscence

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2015
Study completion: 2017
First posted: Jul 9, 2019
Registry last updated: Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed