Transection of the liver parenchyma with an ultrasound dissector or a stapler device: results of a randomized clinical study.

BACKGROUND: Perioperative hemorrhage and postoperative bile leakage are severe complications of liver surgery. They may be related to the techniques used to divide the tissue. We designed a randomized clinical trial to compare the cavitron ultrasonic surgical aspirator (CUSA) and an endoscopic stapler device applied in routine clinical hepatic surgical practice.
METHODS: All consecutive patients admitted for elective hepatic resective surgery--at least bisegmentectomy of the liver--were assessed for enrollment in the study. A total of 100 patients were subsequently randomized. There was a good balance between the study groups concerning issues that may be of relevance for the perioperative and postoperative courses. The primary objective of the study was to achieve an approximately 25 % reduction in perioperative blood loss and postoperative bile leakage. Secondary outcome variables were operating time, general postoperative morbidity, length of hospital stay, and direct medical costs.
RESULTS: The amount of perioperative or postoperative blood loss did not differ significantly between the two groups. We observed a trend toward shorter transection and operating time for patients in whom staplers were used, but the difference did not reach statistical significance. The postoperative courses were close to identical in the respective study arms with no difference in bile leakage rates or in the total morbidity profiles. The direct medical costs were nonsignificantly lower in the group where staplers were used for liver transection.
CONCLUSIONS: The results show that the use of endoscopic vascular staplers in liver surgery is feasible and safe. It offers an attractive alternative for division of the liver parenchyma during routine hepatic surgery, being comparable to the use of CUSA without adding extra costs.

RCT Entities:   Population Interventions Outcomes