Complications of laparoscopy: A prospective multicentre observational study

Objective To determine the incidence and describe the complications of laparoscopic procedures in The Netherlands. Design A nationwide prospective multicentre observational study. Methods Data on complications were registered from 1 January to 31 December 1994 by 72 hospitals. Any unexpected or unplanned event requiring intra-operative or post-operative intervention was defined as a complication. Complications were classified in two groups: approach and technique related complications. Complication rates were compared with these already published. Results Of 25,764 laparoscopic procedures, 145 complications occurred (rate 5.7 per 1000 [parts per thousand]); two deaths occurred. In 84 women laparotomy was necessary (rate 3.3 parts per thousand). In 83 cases (57%; 95% CI for approach = 49-65%) the complication was caused by the surgical approach; in 62 cases (43%) the technique was at fault. Haemorrhage of the epigastric vein and intestinal injury, often requiring laparotomy (90% of cases) were the most frequently observed complications. The complication rate was 2.7 parts per thousand for diagnostic laparoscopic procedures, 4.5 parts per thousand for sterilisation and 17.9 parts per thousand (chi(2) = 127; dF = 2; P < 0.001) for operative laparoscopy. The highest incidence was registered for complications occurring during laparoscopic (assisted) hysterectomy. Stepwise logistic regression analysis showed that previous laparotomy and surgical experience were associated with complications requiring laparotomy. Conclusions Most complications occurred during operative laparoscopic procedures (rate 17.9 parts per thousand). Residents in training are required to learn diagnostic laparoscopy and sterilisation and this training programme results in a fall in the risk of the complications. However, operative laparoscopic procedures are still hazardous, especially laparoscopic hysterectomy. Women with a previous laparotomy are particularly at risk.