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) |