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

July 6, 2019 updated by: Vincenzo La Vaccara, Campus Bio-Medico University

Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015 were retrospectively analysed.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early Surgery
Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
Late Surgery
Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
Very Late Surgery
Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patient with low tumor regression grade
Time Frame: 1 week after surgery
rate of low tumor regression grade (1-2)
1 week after surgery
number of patient with surgical complications
Time Frame: 1 month after surgery
rate of surgical complications
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patient with anastomotic dehiscence
Time Frame: 1 month after surgery
rate of anastomotic dehiscence
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 6, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 6, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/17 OSS ComEt CBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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