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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: Spanish National Registry of Anastomotic Leakage in Rectal Cancer Surgery. Observational, Prospective and Multicenter Study

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.


Detailed Summary:

Study Procedures:

This is a Registry of the surgical procedure performed in patients undergoing elective surgery for rectal cancer, resected with curative intent, with anastomosis, with or without protective ileostomy.

Patients will be included pre-operatively, through a website access to the study database. This inclusion could be done until the day before surgery. Participating sites must include all patients undergoing rectal cancer consecutively during the study duration (approximately 1 year).

Data will be collected until day 30 after patient´s discharge. No further follow-up is planned, except for those established by clinical practice.

The study aims to be an extensive and comprehensive registry of all patients meeting inclusion criteria for a period of one year.

An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.

An estimated number of centers and patients is not fixed a priori; will depend on the dissemination of the Registry between the members of the Spanish Association of Surgeons and the commitment and involvement of the involved investigators.

All Spanish surgeons, members or not of the Spanish Association of Surgeons, will be invited to participate.

Minimum requirements for all participants will be established, being the most important the commitment with the Registry (quality of information and regular updates).

Sponsor: Hospital Universitario La Fe

Current Primary Outcome: Incidence of anastomotic leakage in rectal cancer surgery in a Spanish National Audit [ Time Frame: 1 month ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of rectal anastomotic leakage rate between different types of surgeon [ Time Frame: 1 month ]
  • Influence of different stapling devices in rectal anastomotic leakage rate [ Time Frame: 1 month ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitario La Fe

Dates:
Date Received: September 22, 2015
Date Started: January 2016
Date Completion: November 2016
Last Updated: December 15, 2015
Last Verified: December 2015