Spanish National Registry of ANAstomotic Leakage in CAncer of the REctum (ANACARE)

NCT02634112 | Unknown

• 1 other identifier: ANACARE
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Endpoint: The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center that could enable the establishment of the best standard of care. Secondary Endpoints: To determine the real incidence of anastomotic leakage according to the different locations and techniques: uniform definition of anastomotic leakage. To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR. To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR. To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and mortality. To create and validate an anastomotic leakage predictive Score.

Conditions

Anastomotic Leak

Keywords

anastomotic leakage; rectal cancer surgery; anastomotic leakage predictive score

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit

  The aim of this Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center, that could enable the establishment of the best standard of care.

  1 month

Secondary Outcomes (2)

• Incidence of rectal anastomotic leakage rate between different types of surgeon

  1 month

• Influence of different stapling devices in rectal anastomotic leakage rate

  1 month

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

It is a record of the surgical procedure performed in patients undergoing rectal cancer surgery electively, resected with curative intent and anastomosis, with or without protective ileostomy. Participating Hospitals should include all patients undergoing rectal cancer surgery CONSECUTIVE during the study period. An estimated number of centers and patients a priori is not fixed; will depend on the publicity of the record between the members of the Spanish Association of Surgeons and the commitment and involvement of the researchers involved.

You may qualify if:

• Patient with not less than 18 years.
• Patients who are to undergo surgery for rectal cancer (within 15cm from the anal margin by rigid colonoscopy), elective, resected with local curative intent (R0 and R1) and anastomosis with or without proximal stoma .
• Patient permit registration information of the surgical procedure, which has been submitted by signing the written informed consent.

You may not qualify if:

• Patients underwent the following procedures:
• No resected.
• Local resection= R2.
• Resection without anastomosis
• Patients participating in a clinical trial that would alter this trial.
• Patients who are lacking basic relevant information to complete the requested data in the registry.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead
• Johnson & Johnson: collaborator

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 17, 2015

Record last verified: 2015-12