Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382415
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-04-19
Brief Title:
OrganSpace Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery
Sponsor:
Hospital de Granollers
Organization:
Hospital de Granollers
Study Overview
Official Title:
Effect of OrganSpace Surgical Site Infection After Rectal Cancer Resection on Five-year Recurrence and Survival Rates A Population-based Cohort Study of 2208 Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VINCat_PDO_2
Brief Summary:
In rectal cancer surgery the organspace surgical site infection OS-SSI has an impact on patients prognosis Its influence in the oncologic outcomes remains controversial The main objective is to assess the possible effect of OS-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 OS-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 154981 patients undergoing colorectal cancer surgery found that postoperative OS-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 OS-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
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 OS-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 154981 patients undergoing colorectal cancer surgery found that postoperative OS-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 OS-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None