Clinical trial · Observational
Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery
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
NCT06382415CI-TRIAL-00077075VINCat_PDO_2completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Organ-Space Surgical Site Infection | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients operated on rectal cancer
- description
- 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.
Primary outcomes (2)
- measure
- Rate of overall cancer recurrence
- timeFrame
- 5 years (from date of the surgical procedure until 5 years post-surgery)
- description
- 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.
- measure
- Overall survival
- timeFrame
- From date of the surgical procedure until the date of death, assessed up to 5 years
- description
- Overall survival (OS) was defined as the time from surgery to death by any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.