STUDY OBJECTIVE: To determine the safety of a new radially expanding access device compared with complication rates associated with sharp laparoscopic cannulas. DESIGN: Prospective, multicenter study (Canadian Task Force classification II-1). SETTING: Free-standing and hospital-based ambulatory surgery centers. PATIENTS: Two hundred twelve women undergoing various laparoscopic procedures and followed over 44 months. INTERVENTION: Five hundred forty-one radially dilating access devices were used exclusively for laparoscopic abdominal wall access. MEASUREMENTS AND MAIN RESULTS: No major vascular injury, abdominal wall bleeding, intestinal injury, bladder or ureteral injury, liver trauma, or postoperative incisional hernia occurred. One patient developed a postoperative mesenteric hematoma probably caused by a venous injury from the Veress needle. Of the 541 radially expanding access cannulas placed, only 6 (1%) slipped, despite absence of fascial anchoring devices. CONCLUSION: Radially dilating abdominal access devices may reduce laparoscopic complications, lessen a surgeon's exposure to liability, and improve patient outcomes while reducing facility costs. (J Am Assoc Gynecol Laparosc 6(1):79-84, 1999)
STUDY OBJECTIVE: To determine the safety of a new radially expanding access device compared with complication rates associated with sharp laparoscopic cannulas. DESIGN: Prospective, multicenter study (Canadian Task Force classification II-1). SETTING: Free-standing and hospital-based ambulatory surgery centers. PATIENTS: Two hundred twelve women undergoing various laparoscopic procedures and followed over 44 months. INTERVENTION: Five hundred forty-one radially dilating access devices were used exclusively for laparoscopic abdominal wall access. MEASUREMENTS AND MAIN RESULTS: No major vascular injury, abdominal wall bleeding, intestinal injury, bladder or ureteral injury, liver trauma, or postoperative incisional hernia occurred. One patient developed a postoperative mesenteric hematoma probably caused by a venous injury from the Veress needle. Of the 541 radially expanding access cannulas placed, only 6 (1%) slipped, despite absence of fascial anchoring devices. CONCLUSION: Radially dilating abdominal access devices may reduce laparoscopic complications, lessen a surgeon's exposure to liability, and improve patient outcomes while reducing facility costs. (J Am Assoc Gynecol Laparosc 6(1):79-84, 1999)