Despite continued evolution of both laparoscopic instruments and techniques, injury to intra-abdominal structures continues to be a common, yet potentially avoidable complication of laparoscopy. Many of these injuries are related to the blind placement of the Veress needle or sharp primary trocar into the abdomen when performing a technique referred to as “closed” laparoscopy. Although “open” laparoscopy (where the peritoneal cavity is opened before placing a blunt trocar into the abdomen) has been successful in avoiding major vessel injury, bowel injuries with this technique have not been eliminated. 1,2 In response, trocars were developed for laparoscopy, termed “optical-access trocars.” These trocars were designed to decrease the risk of injury to intra-abdominal structures by allowing the surgeon to visualize abdominal wall layers during placement, and only two serious complications have been reported in the medical literature with their use. 3–5 Two “optical-access” trocar systems are available: one uses a blade that strikes the fascia and peritoneum under laparoscopic visualization (Visiport, United States Surgical, Norwalk, CT); the other system has a conical clear tip that is rotated under laparoscopic vision as it penetrates the fascia and peritoneum (Optiview, Ethicon Endo-Surgery, Cincinnati, OH).
A complication at one of our hospitals associated with an optical-access trocar demonstrated to us that the use of optical-access trocars did not always avoid injury to intra-abdominal organs. An optical-access trocar was placed in preparation for laparoscopic cholecystectomy in a 24-year-old pregnant woman at 23 weeks' gestation. During the initial port placement, the optical-access trocar penetrated the uterine fundus into the amniotic cavity. Within 1 week of this complication, the woman experienced preterm labor and underwent a vaginal delivery. Her fetus died within 1 hour of birth because of complications associated with extreme prematurity.
Because few complications while using optical-access trocars have been reported in the medical literature, we searched for alternative sources for such reports. The Food and Drug Administration (FDA) operates databases designed for the reporting of adverse outcomes associated with medical devices, called Medical Device Reporting (MDR) and Manufacturer and User Facility Device Experience (MAUDE). The following is a report of the complications derived from these two databases since the introduction of optical-access trocars in 1994.
MATERIALS AND METHODS
We reviewed the medical literature published before and after FDA approval of optical-access trocars in 1994. We searched MEDLINE from 1994 to December 2000 using PubMed (http://www.nlm.nih.gov). The following key words and subject terms were searched: “optical-access trocars,” “Visiport,” “Optiview,” and “trocar injury.” All languages and publication types were included. Bibliographies of pertinent articles and reviews were searched for additional references. Relevant textbooks and foreign-language articles were also reviewed.
When few reported complications were found using the search techniques described above, we searched MDR and MAUDE databases. These voluntary reporting systems maintained by the FDA for tracking adverse medical events can be accessed through the FDA web-sites http://www.fda.gov/cdrh/mdrfile.html (MDR) and http://www.fda.gov/cdrh/maude.html (MAUDE). An on-line search was performed to obtain information by using the search words “Visiport” and “Optiview.”
The MEDLINE search from 1966 to December 2000 revealed two small series describing the use of the Optiview trocar with a total of five minor complications in 106 cases. 3,4 In addition, we found one report of two cases of vena cava injury using the Visiport trocar in preparation for laparoscopic cholecystectomy. 5
A review of the MDR and MAUDE databases revealed 79 additional cases involving complications associated with the use of optical-access trocars that have occurred since 1994. Of these 79 cases, 57 were reported through the MDR database and 22 were reported through MAUDE. These complications occurred when laparoscopy was performed for both general surgical and gynecologic procedures (Table 1).
Major vascular injury, defined as injury to aorta, vena cava, or the iliac vessels, was the most frequently reported major injury, occurring in 37 cases (Table 2). Six of these major vessel injuries involved simultaneous injury to bowel, and two resulted in patient deaths. Twenty cases involved injury of other vessels, and two of these resulted in death. A total of 24 cases of bowel injury occurred, including the six cases of combined major vessel/bowel injuries. The Optiview trocar was used in 26 cases, and the Visiport trocar in 53 cases.
The results of this study indicate that the use of optical-access trocar systems for laparoscopy is associated with a risk of injury to intra-abdominal vessels and organs despite the rarity of reports of such injuries in the medical literature. Rather than only two major complications over the last 7 years as suggested by a review of MEDLINE, at least 82 serious complications (including the case briefly presented in this paper) have occurred in the United States during this time period according to the data available in the MDR and MAUDE databases.
Unfortunately, data from these databases lack sufficient details to clearly establish a causal relationship between these injuries and use of these trocars. In addition, the relative or absolute degree of risk of these instruments is impossible to determine for two reasons. The first reason is that the number of cases performed with either of the two optical-access techniques during this time period is unknown. However, the reported rate of major vessel and bowel injury reported using a standard closed technique is approximately three in 100,000 cases and 26 in 100,000, respectively. 6 In light of the 37 major vessel injuries and 24 bowel injuries contained in the present report, a total of approximately 1,200,000 (37 × 100,000 ÷ 3) such procedures would have had to have been performed with this technique during the reporting period for the risk to be equivalent to the standard closed technique for major vessel injury, and 92,000 (24 × 100,000 ÷ 26) procedures respectively for bowel injury. The second reason the relative or absolute degree of risk cannot be established is that there is no way to determine if the complications have been under-reported because reporting in this system is voluntary.
This type of data does not allow for an accurate comparison of injury rates between standard trocars and optical-access trocars, as the complications are reported voluntarily and the actual numerators and denominators remain unknown. Although the degree of risk or serious complication remains uncertain, it is clear that the use of optical-access trocars does not avoid serious injury to intra-abdominal structures. The actual safety of these techniques will have to be determined by large studies of their use in practice with an accurate record of the associated complications.
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