Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial

Table 1 Definitions of peri- and post-operative complications

Complication	Definition
Intra-operative lesion of nerves	Clinical diagnosis and/or EMG findings
Dislocation of the catheter and/or the port chamber	Radiological finding
Incompatibility of contrast agent	Any allergic reaction against a contrast agent needing medical treatment with drugs
Thrombosis	Sonographic findings and/or phlebography
Post-operative bleeding	Clinical diagnosis during reoperation
Haematoma	Clinical diagnosis, no reoperation necessary
Disconnection or breakage of the catheter	Radiological findings, findings after explantation
Extravasation of injected fluid	Radiological findings and/or clinical diagnosis
Wound infection	Clinical diagnosis, wound has to be reopened and/or antibiotic treatment
Catheter sepsis	Two or more of the following symptoms:
	Temperature over 38.3°C or under 36°C;
	Heart rate over 90 beats per minute;
	Respiration rate over 20 breaths per minute, PaCO₂ < 32 mmHg (spontaneous breathing) or PaO₂/FiO₂ < 200 mmHg (mechanical ventilation);
	Total peripheral WBC count >12 G/L or WBC <4.0 G/L or >10% immature neutrophils (bands), regardless of total peripheral WBC count;
	Plasma C-reactive protein >2 SD above normal value and positive findings in bacteriology of the port catheter pike
Cutaneous necrosis	Clinical diagnosis and/or histological finding
Pinch-off phenomenon	Radiological findings and/or clinical diagnosis

EMG: electromyography; PaCO2: partial pressure of carbon dioxide; PaO2: partial pressure of oxygen; FiO2: fraction of inspiratory oxygen; mmHg: millimetres of mercury; WBC: white blood cells.

ISSN: 1745-6215