Surveillance of adverse events associated with totally implanted venous-access ports

Impact of implementing a surveillance of adverse events associated with totally implanted venous-access ports in cancer inpatients: a quasi-experimental study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57640029

Enrollment

1000

Registered

2011-01-13

Start date

2009-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cancer Cancer

Interventions

The trial does not compare treatments. The intervention is the implementation of a surveillance scheme associated with morbidity-mortality conferences. The aim is to assess the impact of this implemen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Two hospitals will participate in the study: a university hospital, and a hospital exclusively dedicated to the care of cancer patients. In each hospital, wards performing cancer intravenous chemotherapy as a usual activity will be approached and proposed the implementation of a surveillance of adverse events associated with totally implanted venous-access ports. Only patients (male or female adults above 18 years old) with totally implanted venous-access ports used for cancer chemotherapy will be included in this surveillance.

Exclusion criteria

Exclusion criteria: Wards with no, or infrequent, activity of cancer chemotherapy will not be included in the study. In wards participating in the study, patients with totally implanted venous-access ports used for other treatment than cancer chemotherapy (antibiotics, parenteral nutrition, etc.) will not be included in the surveillance.

Design outcomes

Primary

Measure	Time frame
1. Adverse events frequency 2. Number of corrective actions identified and implemented 3. Assessment of health care workers perception of the surveillance and MMC scheme Measured after a 12 month period of surveillance and 4 morbidity-mortality conferences (1 every 3 months).	—

Secondary

Measure	Time frame
1. Assessment of the repercussion of adverse events associated with totally implanted port by interview with patients 2. Description of objective consequences of adverse events (prolongation of stay, diagnostic or therapeutic procedures, port replacement, delay in the administration of chemotherapy) 3. Assessement of sensibility and specificity of adverse event identification by the surveillance Measured after a 12 month period of surveillance and 4 morbidity-mortality conferences (1 every 3 months).	—

Measure

Time frame

1. Assessment of the repercussion of adverse events associated with totally implanted port by interview with patients 2. Description of objective consequences of adverse events (prolongation of stay, diagnostic or therapeutic procedures, port replacement, delay in the administration of chemotherapy) 3. Assessement of sensibility and specificity of adverse event identification by the surveillance Measured after a 12 month period of surveillance and 4 morbidity-mortality conferences (1 every 3 months).

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Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026