Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery (VINCat_PDO_2)

May 10, 2024 updated by: Josep M Badia, Hospital de Granollers

Effect of Organ/Space Surgical Site Infection After Rectal Cancer Resection on Five-year Recurrence and Survival Rates. A Population-based Cohort Study of 2208 Patients

In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence.

Study Overview

Status

Completed

Conditions

Detailed Description

Colorectal cancer is the third most common malignancy worldwide and the fourth leading cause of cancer death in both sexes, accounting for 30-35% of all tumours originating in the rectum. Although the introduction of total mesorectal excision and the use of neoadjuvant chemoradiation have improved the oncological outcome in patients with rectal cancer operated with curative intent, the 5-year recurrence rate remains around 20%, with tumour stage being the most important prognostic factor. Other tumour-related factors, such as lymphovascular, perineural and extramural vascular invasion, as well as response to neoadjuvant treatment, have also been shown to be reliable predictors of recurrence. However, surgery-related factors, such as the quality of surgical resection as well as the occurrence of postoperative complications, may have a profound impact on these outcomes.

Anastomotic leakage is one of the most serious complications of colorectal surgery and its frequency ranges from 3 to 21% depending on the location of the tumour and the definition of anastomotic leakage used. This complication is associated with considerable morbidity and mortality and may affect quality of life. Several studies have shown that anastomotic leakage and subsequent organ-space infection (O/S-SSI) are also associated with higher rates of tumour recurrence and cancer-specific mortality. A recent meta-analysis involving 43 studies with a total of 154,981 patients undergoing colorectal cancer surgery found that postoperative O/S-SSI and anastomotic leakage had a significant negative impact on disease-free survival, local recurrence and overall recurrence. This association has also been reported after resection of liver metastases and other gastrointestinal malignancies. In addition, the severity of postoperative infection has also been correlated with increased risk of recurrence.

However, these results have not been confirmed in other studies. In our setting, the development of anastomotic leaks did not affect the risk of local recurrence, overall recurrence, overall survival or cancer-specific survival in a multicentre observational study using prospectively collected data from 1181 consecutive rectal cancer patients in 22 hospitals included in the Spanish Rectal Cancer Project. These results were consistent with data reported by national colorectal cancer registries such as those of Denmark and Sweden, among others. Therefore, the question of whether anastomotic leakage contributes to disease recurrence remains controversial and requires further research.

In an attempt to clarify this controversy, a population-based study was conducted to assess the influence of O/S-SSI on recurrence and survival outcomes in patients who had undergone curative surgery for rectal cancer in hospitals integrated in the Public Health System of Catalonia (Spain) at 5-year follow-up.

Study Type

Observational

Enrollment (Actual)

3826

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Institut Catala d'Oncologia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.

Description

Inclusion Criteria:

  • Patients > 18 years old
  • Eligible patients with tumour ≤ 13 cm from anal verge, as measured by Magnetic Resonance Imaging
  • Primary adenocarcinoma
  • Oncological resection with curative intent
  • Cancer stages: I-II-III

Exclusion Criteria:

  • Transanal local resection
  • Emergency colorectal surgeries
  • Presence of metastases found in the diagnostic process or during the surgical procedure
  • Recurrence of the disease treated before the study period
  • Non-resectable tumour or palliative surgery
  • Patients operated in private centres

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
Patients operated on rectal cancer
Patients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry and in the Catalan Infection Surveillance Program, who suffered an organ-space surgical infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of overall cancer recurrence
Time Frame: 5 years (from date of the surgical procedure until 5 years post-surgery)
Overall cancer recurrence included locoregional recurrence and systemic recurrence. Locoregional recurrence was defined as tumor linked with surgical site (anastomosis, tumor bed or mesentery), and systemic recurrence as the disease spreading to organs outside the surgical field, such as the liver, lungs, bones, or brain, confirmed histologically or by imaging.
5 years (from date of the surgical procedure until 5 years post-surgery)
Overall survival
Time Frame: From date of the surgical procedure until the date of death, assessed up to 5 years
Overall survival (OS) was defined as the time from surgery to death by any cause.
From date of the surgical procedure until the date of death, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Organ-space surgical site infection
Time Frame: 30 days
As described by the Centers for Disease Control: an infection occurring within 30 days of the surgical procedure and involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during surgery. In addition, the patient must present at least one of the following associated events: a purulent drainage from a drain placed into the organ/space
30 days
Rate of surgical complications
Time Frame: 30 days
Postoperative complications were classified in accordance with the Clavien-Dindo Classification
30 days

Collaborators and Investigators

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

Sponsor

Hospital de Granollers

Collaborators

Institut Català d'Oncologia
Institut d'Investigació Biomèdica de Bellvitge

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, 2011

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VINCat_PDO_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Restrictions apply to the availability of these data, which belong to two national databases and are not publicly available. Data was obtained from the Catalan Cancer Plan and VINCat, and are only available with the permission of their Technical Committees.

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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