World J. Surg. 21, 529 –533, 1997 WORLD Journal of SURGERY © 1997 by the Socie ´te ´ Internationale de Chirurgie Original Scientiﬁc Reports Risks of the Minimal Access Approach for Laparoscopic Surgery: Multivariate Analysis of Morbidity Related to Umbilical Trocar Insertion Julio Mayol, M.D., Ph.D., Julio Garcia-Aguilar, M.D., Ph.D., Elena Ortiz-Oshiro, M.D., Ph.D., Jose A. De-Diego Carmona, M.D., Ph.D., Jesus A. Fernandez-Represa, M.D., Ph.D. Department of Surgery I, Hospital Universitario San Carlos, C/Martin-Lagos S/N, 28040 Madrid, Spain Abstract. The objective of this study was to determine the morbidity associated with trocar and needle insertion for laparoscopic surgery and to identify risk factors for complications. Data from a prospectively collected database of all laparoscopic operations performed at a major teaching hospital over a 4-year period were analyzed. In 203 patients closed laparoscopy (Veress needle plus blind trocar insertion) was used to establish the pneumoperitoneum. Open laparoscopy with a Hasson’s trocar was performed in 200 patients. A total of 1206 operative trocars were inserted (mean  SD 2.99  0.4). Sixty-nine percutaneous punctures for cholangiography or liver biopsy were carried out. Of the 403 patients undergoing laparoscopic surgery, 20 (5%) had developed complications speciﬁcally related to the access to the abdominal cavity after a minimum follow-up of 3 months, abdominal wall hematoma being the most frequent (n  8, 2.0%), followed by umbilical hernias (n  6, 1.5%) and umbilical wound infection (n  5; 1.2%). The rate of penetrating injuries was 0.2% (n  1). Of 20 complications, 15 (75%) were related to the umbilical insertion site. Female sex and closed laparoscopy were associated with umbilical morbidity by univariate analysis. In a multivariate analysis, closed laparoscopy was the only factor associated with these complica- tions (odds ratio  6.0; p  0.04). Age, gender, obesity, diabetes mellitus, previous abdominal surgery, and the speciﬁc procedure had no inﬂuence. In conclusion, gaining access to the peritoneal cavity for laparoscopic surgery may cause severe complications, most of which are related to the umbilical trocar. Although closed laparoscopy can be safely used, open laparoscopy is associated with a lower morbidity rate; therefore its utilization is recommended. Laparoscopic surgery has developed rapidly over the last few years, and many surgical procedures formerly carried out through large abdominal incisions are now performed laparoscopically. Reduction of the trauma of access [1] by avoidance of large wounds has been the driving force for such development. How- ever, the insertion of neddles and trocars necessary for the pneumoperitneum and the performance of the procedure are not without risk [2]. Traditional diagnostic laparoscopy has been associated with a well studied morbidity [3], the incidence of which ranged from 0.14% to 0.60%. The technical modiﬁcations imposed by surgical laparoscopy are obvious (e.g., number and size of trocars, location of insertion sites, specimen retrieval), and therefore morbidity may be substantially modiﬁed. Complications such as retroperi- toneal vascular injury, intestinal perforation, wound herniation, wound infection, abdominal wall hematoma, and trocar site mestastasis have been reported [3– 8], but the overall incidence of complications related to trocar insertion for gastrointestinal lapa- roscopic surgery has not been critically assessed. The objective of this study was to determine the incidence of complications speciﬁcally related to insertion of sharp devices through the abdominal wall of patients undergoing gastrointesti- nal laparoscopic surgery and to identify factors related to the development of such complications. Patients and Methods All patients who underwent laparoscopic surgery at a major teaching hospital during a 4-year period were included in this study. The pneumoperitoneum was established by either Veress needle (closed laparoscopy) or Hasson’s trocar insertion (open laparoscopy). The choice between procedures was made by each surgeon based on his or her clinical judgment. Gastric and bladder decompression with a nasogastric tube and a Foley catheter were routinely done prior to access to the abdominal cavity. The closed technique comprised a blind percutaneous puncture with a disposable Veress needle. After insertion, Palmer’s and water drop tests were performed to conﬁrm its intraperitoneal placement. The neddle was then connected to the insufﬂator, and CO 2 was supplied to the abdomen until the intraabdominal pressure had risen to 12 mmHg. A semicircular incision in the umbilicus was fashioned, and a 10 mm trocar with a protective safety shield was blindly inserted. The open procedure [2] was carried out as follows: A semicir- cular incision in the inferior border of the umbilicus was made and the subcutaneous tissue dissected. The fascia was then grasped with two Kocher clamps and lifted to separate these layers from the underlying viscera. The fascia and peritoneum were incised with scissors to gain access to the peritoneal cavity. The fascial defect was secured by passing two single stitches on both sides of the incision. Afterward the Hasson’s trocar was inserted and attached to both sutures. Subsequently, the insufﬂator was con- nected to the trocar and the pneumoperitoneum was established. Disposable operative trocars with protective safety shields were inserted in standard fashion through small skin incisions. The Correspondence to: J.A. Fernandez-Represa, M.D., Ph.D.