Design, development, and evaluation of a novel retraction device for gallbladder extraction during laparoscopic cholecystectomy.

Background: A source of frustration during laparoscopic cholecystectomy involves extraction of the gallbladder through port sites smaller than the gallbladder itself. We describe the development and testing of a novel device for the safe, minimal enlargement of laparoscopic port sites to extract large, stone-filled gallbladders from the abdomen.
Methods: The study device consists of a handle with a retraction tongue to shield the specimen and a guide for a scalpel to incise the fascia within the incision. Patients enrolled underwent laparoscopic cholecystectomy. Gallbladder extraction was attempted. If standard measures failed, the device was implemented. Extraction time and device utility scores were recorded for each patient. Patients returned 3-4 weeks postoperatively for assessment of pain level, cosmetic effect, and presence of infectious complications.
Results: Twenty (51 %) of 39 patients required the device. Average extraction time for the first eight patients was 120 s. After interim analysis, an improved device was used in 12 patients and average extraction time was 24 s. There were no adverse events. Postoperative pain ratings and incision cosmesis were comparable between patients with and without use of the device.
Conclusion: The study device enables safe and rapid extraction of impacted gallbladders through the abdominal wall.