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Table 5 Incidence of key adverse events, by specific adverse events, reported in the ARIEL gynaecological surgery registry (n=2,882)

From: Use of icodextrin 4% solution in the reduction of adhesion formation after gynaecological surgery

Adverse event Number of events [n (%)]
  Laparoscopy 2,069 patients Laparotomya 813 patients
Cardiac events 1 (0.1) 2 (0.3)
Fluid imbalance problems 13 (0.6) 3 (0.4)
 Vulval oedema 10 (0.5) 2 (0.3)
 Abdominal wall oedema 2 (0.1) 0 (0.0)
 Hypovolaemic shock 0 (0.0) 1 (0.1)
 Ankle oedema 1 (0.1) 0 (0.0)
Haematological events 21 (1.0) 11 (1.4)
 Bleeding 16 (0.8) 7 (0.9)
 Haematoma 3 (0.1) 0 (0.0)
 Pulmonary embolism 1 (0.1) 2 (0.3)
 Thrombosis 0 (0.0) 2 (0.3)
 Decreased haemoglobin 1 (0.1) 0 (0.0)
Ileus 3 (0.1) 8 (1.0)
Pain 21 (1.0) 14 (1.7)
Predicted irrigation/instillation eventsb 39 (1.9) 13 (1.6)
 Abdominal discomfort 3 (0.1) 2 (0.3)
 Abdominal distension 8 (0.4) 1 (0.1)
 Abdominal pelvic collections 7 (0.3) 2 (0.3)
 Port/wound leakage 21 (1.0) 8 (1.0)
Respiratory events 0 (0.0) 3 (0.4)
Septic/infective events 16 (0.8) 22 (2.7)
Surgical/technical events 19 (0.9) 16 (2.0)
Wound healing problems 3 (0.1) 10 (1.2)
Other 20 (1.0) 11 (1.4)
  1. aIncludes laparoscopies converted to laparotomies (n=96)
  2. bPredicted irrigation/instillation events are inevitable events when a fluid is used and are, therefore, not adverse events as such