Safe Use and Selection of Trocars in Laparoscopy
November 1, 2006 | Healthcare Risk, Quality, & Safety Guidance
Since the introduction of minimally invasive surgery* (MIS) using laparoscopes and other endoscopes more than 20 years ago, selection of the surgical techniques used and the devices involved have been important to risk management and patient safety. The performance of MIS carries risks, and these risks are well documented. Preventing or mitigating complications presents a challenge for surgeons and healthcare facilities. ______________ * Although minimally invasive surgery is used for a number of applications, this Guidance Article focuses primarily on laparoscopy and its use for peritoneal procedures such as hysterectomy, hernia repair, tubal ligation, appendectomy, and cholecystectomy. ______________ Various methods to gain access to the abdomen for MIS are available, and the choice of a specific method depends on the surgeon's training and preference. Similarly, a variety of types of devices are used during abdominal access for laparoscopy, and selection of the devices likewise largely depends on the preference of the surgeon.
The main device used for accessing the abdomen for laparoscopy is the trocar. Trocars are instruments used in conjunction with a cannula to create an opening or port in the body, through which access to internal cavities and organs is gained. Trocar use presents a risk for the patient because the trocar insertion procedure has been associated with complications such as bleeding, internal lacerations, and death. Reports involving laparoscopic injuries indicate that trocars are involved in numerous and severe injuries, leading to liability claims against surgeons and hospitals.1,2
The U.S. Food and Drug Administration (FDA) released a report in 2005 (completed in 2003) noting that FDA had received more than 1,300 reports of patient injuries (including approximately 30 deaths) associated with the use of laparoscopic trocars from 1997 to mid-2002.3 The report noted that user error was the cause of many of the trocar device failures involved in patient injuries. ECRI's guidance article on the safe use and selection of trocars (issued in 19984 and updated in 20005) was cited by FDA.
This Guidance Article provides a description of the laparoscopic procedure employing trocar devices and reviews alternatives for trocar insertion. It describes the complications that can occur during trocar use and how these complications can be avoided. Common injuries associated with trocar use are reviewed, and malpractice claims data involving laparoscopies are presented. The discussion includes the use of trocar tip shields, which are designed to reduce the risks associated with trocar use but are not used by all surgeons for all procedures because of lack of consensus regarding the benefits of shielded-trocar use. The relative merits of reusable and disposable trocar models are also reviewed. Recommendations for risk management and patient safety are provided to help ensure that safe practices are followed in the use of trocars so that risks are reduced for all stakeholders, including patients, surgeons, and healthcare facilities.
To understand the risks of abdominal access during laparoscopy, it...