Rectal CancerVINCat_PDO_2NCT06382415
Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery
An observational study of Rectal Cancer and Organ-Space Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Organ-Space Surgical Site Infection
- How many people
- 3,826 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2011to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer, Organ-Space Surgical Site Infection
- Keywords
- Surgical Site Infection, Rectal cancer, Rectal Surgery, Survival, Recurrence
- Medical subject headings
- Rectal Neoplasms, Surgical Wound Infection, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall cancer recurrence
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.
Measured: 5 years (from date of the surgical procedure until 5 years post-surgery)
Overall survival
Overall survival (OS) was defined as the time from surgery to death by any cause.
Measured: From date of the surgical procedure until the date of death, assessed up to 5 years
Secondary outcomes (2)
Rate of Organ-space surgical site infection
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
Measured: 30 days
Rate of surgical complications
Postoperative complications were classified in accordance with the Clavien-Dindo Classification
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català d'Oncologia
- Responsible party
- Principal investigator, Josep M Badia, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382415
- Sponsor's protocol ID
- VINCat_PDO_2
- Acronym
- VINCat_PDO_2
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06382415
- Acronym / sponsor ID
- VINCat_PDO_2 / VINCat_PDO_2
- Conditions
- Rectal Cancer, Organ-Space Surgical Site Infection
- Keywords
- Surgical Site Infection, Rectal cancer, Rectal Surgery, Survival, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,826 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Institut Català d'Oncologia
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on rectal surgery for rectal cancer in Catalonia, Spain.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Rate of Organ-space surgical site infection
Time frame: 30 days
Rate of surgical complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Organ-Space Surgical Site Infection, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of overall cancer recurrence (time frame: 5 years (from date of the surgical procedure until 5 years post-surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.