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

NCT06382415 | Completed

• 1 other identifier: VINCat_PDO_2
• Study Type: observational
• Target: 3,826
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Organ-Space Surgical Site Infection

Keywords

Surgical Site Infection; Rectal cancer; Rectal Surgery; Survival; Recurrence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  30 days

• Rate of surgical complications

  30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Granollers: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms; Surgical Wound Infection; Recurrence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: January 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: March 31, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)