Laparoscopy has become a valuable tool for the gynaecologist in the diagnosis and treatment of a variety of gynecological disorders. Its quicker recovery time and other advantages has benefitted countless women. Laparoscopic procedures, however, have their own associated risks and complications, and the surgeon must become thoroughly familiar with these. This awareness will help reduce patient morbidity and mortality, and potentially avoid the stress and burden of litigation, which has been increasing in recent years. Complications of gynaecologic laparoscopy include entry-related problems, and injuries to bowel, urinary tract, blood vessels, and nerves. Although some of these complications have been well described, some have emerged recently in relation to new technology and techniques. In this chapter, we discuss some of the complications of endoscopic surgery, including their incidence, prevention, and medico-legal implications, and provide a brief overview of their management.
Introduction
Laparoscopy has become an important tool for the diagnosis and treatment of a variety of gynaecological disorders. This includes laparoscopic-assisted vaginal hysterectomy, first performed by Reich in 1989, and total laparoscopic hysterectomy.
Compared with conventional hysterectomy by laparotomy, the laparoscopic approach is associated with decreased postoperative pain, blood loss, wound infection, hospital stay, and recovery time. In a meta-analysis of 27 randomised-controlled trials (RCTs), the investigators reported that laparoscopy for benign gynaecologic procedures has a 40% lower complication rate compared with laparotomy (8.9% v 15.2%), and a similar incidence of major complications (1.4%). Any complication, however, can be devastating, both to the patient and the staff involved. An increase in litigious action against healthcare providers has taken place, along with an increase in the sums of money that is awarded to plaintiffs.
Audits of hospitalised patients in several major centres in developed countries have indicated the following adverse event rates: USA (3.7%); Canada (7.5%); UK (10.8%); and Australia (16.6%). A prospective study in a tertiary referral hospital in South Africa reported an adverse event rate specific to gynaecologic admissions of 11.7%. Although most resulted in minor complications, nearly one-half were deemed preventable. In a Canadian study, the estimated mortality rate resulting from preventable adverse events is 0.66%. Clearly, efforts must be made to reduce these complications. More importantly, about one-quarter of surgical complications remain undiagnosed until after surgery. Detection of intraoperative injury during the initial surgery is, therefore, crucial.
As a surgeon gains experience, the complication rates decrease. For example, in one study spanning 9 years, adverse events requiring a laparotomy decreased significantly from 4.86 to 2.36 per 1000. A recent cohort study involving 79 surgeons carrying out 1534 laparoscopic hysterectomies, reported that ‘a significant improvement in surgical outcomes tends to continue up to approximately 125 procedures.’ Specifically, intra-operative blood loss and adverse events were significantly less frequent among experienced surgeons. When complexity of the surgery was taken into account, the complication rates increased significantly in major and advanced surgeries (4.3 and 17.45 per 1000 cases, respectively) compared with minor cases (0.84 per 1000 cases).
It is imperative that, in pre-operative planning, consultation with experienced laparoscopists or other specialists should be carried out for complex cases. One method to reduce complications early in a surgeon’s learning curve would be to use a mentoring system, whereby a new surgeon would operate with a more experienced colleague for a designated period of time.
Entry-related issues
The peritoneal cavity can be accessed in several ways. These include the use of a Veress needle, direct trocar insertion, Hasson’s technique for open laparoscopy, and the use of optical trocars, radially expanding trocars, and reusable visual access cannulas. It has been estimated that one-half of major injuries to the intestines and blood vessels are related to entry. In a large study of nearly 30,000 women who underwent various gynaecologic laparoscopies, the only death that occurred was related to an injury to the internal iliac artery during the entry procedure, and one-third of all complications were attributed to entry. Although the rate of entry-related complications is low (0.05–0.5%), the outcomes can be devastating. The overall mortality rate after such a complication is about 4%, and unrecognised bowel injury results in a 21% mortality rate.
A Dutch review evaluating 229 medical liability claims related to laparoscopic procedures in gynaecologic and general surgery over a 10-year period found that 18% of the claims were associated with complications related to laparoscopic entry. Out of 51 injured structures, 30 were bowel injuries and 18 were vascular injuries. Unfortunately, less than one-half were diagnosed perioperatively. Most of them were young women undergoing day surgeries or short-stay surgeries. Trainees were involved in 15% of claims. Evidence of informed consent was found in only 6% of the claims, and of a post-operative debriefing of the patient in only 7%.
The US Food and Drug Administration (FDA) reviewed 31 fatal and 1353 non-fatal injuries resulting from laparoscopic trocars, and found that 74% of deaths resulted from blood-vessel injury. One-tenth of these deaths had occurred during gynaecologic procedures. Of interest, devices expected to improve safety, such as shielded and optical trocars were used in these fatal cases. The investigators emphasised that, when mortality occurs, the devices should be returned to the manufacturer for inspection.
Entry technique
No definitive study determining the safest method of entry has been published. Owing to the low incidence of entry-related injury, a sample of over 200,000 women undergoing closed or open-entry techniques to detect a reduction of major complications from 0.1 to 0.05% is needed. In addition, few gynaecologists use the Hasson technique compared with the closed approach, making it difficult to compare the two methods.
Open versus closed techniques
In a review of laparoscopic entry methods, the Society of Obstetricians and Gynecologists of Canada stated that ‘there is no evidence that the open entry technique is superior to or inferior to the other entry techniques currently available.’ Use of the Canadian Task Force on Preventative Health Care classification, shows that this is a level II-2C recommendation, meaning that, based on the available data from well-designed cohort or case-control studies, the existing evidence is conflicting and not clearly in favour or against a particular entry technique. A similar statement was made by the European Association for Endoscopic Surgery. They added that, ‘although open entry seemed to be associated with fewer minor complications, firm conclusions about serious complications (bowel or vascular injury) could not be made owing to the lack of participants in the RCTs’.
A meta-analysis of laparoscopic entry complications found that open entry is more likely to result in bowel injury than direct- or Veress-needle entry, but less likely to result in vascular injury. This may be because the open technique is often selected for women who are at high risk, such as those who have had a prior laparotomy, adhesions, inflammatory bowel disease, or obesity.
Direct trocar entry
It has been suggested that direct trocar entry reduces the incidence of failed pneumoperitoneum, preperitoneal insufflation, intestinal insufflations, or carbon dioxide embolism. Several studies have shown that direct entry is at least as safe as the open and Veress techniques in women who are at low risk, and it is faster. A 2002 meta-analysis including 51 retrospective and prospective studies, with a total of 850,350 laparoscopic procedures, found that the incidence of bowel injury using the Veress needle was 0.4 per 1000, using the open technique 1.1 per 1000, and using direct entry 0.5 per 1000. The incidence of bowel injury was significantly higher for the open technique compared with the others. Entry-related vascular injury rates were statistically higher when using the Veress needle (0.4 per 1000 v 0.1 per 1000 for open entry). The direct technique caused no vascular injuries, suggesting that establishment of pneumoperitoneum before placing trocars does not necessarily prevent vascular injury.
A Cochrane review in 2012 evaluated 28 RCTs involving 4860 women who underwent laparoscopy. It found that direct entry is associated with lower rates of failed entry, extraperitoneal insufflations, and omental injury. The studies, however, were underpowered to detect differences in major complications. Two RCTs indicated reductions in the time to successful peritoneal entry using direct entry compared with Veress entry.
Various trocars
Various entry technologies include the use of disposable shielded trocars, the radially expanding access system (Step, InnerDyne, Sunnyvale, Ca; VersaStep, Covidien, Mansfield, MA; and US Surgical, Norwalk, CT), and optical trocars (Endopath Optiview; Ethicon Endo-Surgery, Inc., Cincinnati, OH and Visiport; Tyco-United States Surgical, Norwalk, CT and EndoTIP; Karl Storz Endoscopy, Tuttlingen, Germany). Complication rates of the different types of trocars are presented in Table 1 .
| Type of trocar | Complications |
|---|---|
| Standard reusable trocar |
|
| Disposable shielded trocar |
|
| Radially expanding trocar |
|
| Optical access trocar |
|
Shielded trocars
Disposable shielded trocars are made with an outer sheath that retracts as the trocar is pushed through the abdominal wall, and then advances to cover the tip of the trocar when the negative pressure of the abdominal cavity is reached. This would help to prevent sharp injury to the viscera and blood vessels. Compared with the use of non-disposable trocars, less force is required to enter an insufflated abdomen, theoretically improving the surgeon’s control of the device. In an FDA review of laparoscopic complications between 1997 and 2002, of the 24 fatal complications reported that mentioned the type of trocar used, all were associated with the use of either optical trocars or disposable shielded trocars. Although this type of retrospective study does not provide evidence of safety of different entry mechanisms, these statistics highlight the fact that there is no ‘safe’ method of entry.
One RCT of 200 participants compared direct entry using a disposable shielded trocar, direct entry using a reusable trocar, and entry using a Veress needle. The authors reported that the shielded trocar did not result in any complications (0%), compared with 22% with the Veress needle and 6% with reusable trocars, respectively (all were minor complications). Again, the study is underpowered to detect a statistically significant difference in complications.
Radially expanding trocars
The radially expanding (STEP) trocars function by using a pneumoperitoneum needle that radially expands to become a cannula of up to 12 mm in diameter. It eliminates the use of sharp trocars and their inherent risks. It expands tissue along anatomical planes, thus theoretically reducing the occurrence of incisional hernias without the need for fascial suturing, and stabilising the cannula within the abdominal wall. Although presently few trials have compared them with standard cutting trocars, several studies indicate possible benefits.
A multicentre, prospective randomised trial showed that radially expanding trocars result in a significant decrease in abdominal wall bleeding and postoperative wound complications, and a trend towards lower pain scores. Other randomised trials (but not all) also indicate that these systems reduce pain scores. In a study of 1055 cases of urologic oncology laparoscopies, however, radially expanding trocars were used in all seven cases in which trocar site hernias were subsequently diagnosed. A Canadian review also noted that, in particular, InnerDyne’s step system required more force to enter the abdomen than the traditional cutting trocars. The Canadian review, the Cochrane review, as well as the French National College of Gynecologists and Obstetricians, stated that the evidence is not sufficient to promote the radially expanding trocars as a first-line tool.
Direct optical access trocars
Direct optical access trocars are disposable visual entry systems that use a laparoscope within hollow trocar to enter the abdomen after insufflation is complete, with real-time visualisation of the abdominal layers penetrated on the way to the peritoneal cavity. Some surgeons advocate using the optical trocar without prior pneumoperitoneum in obese women. The use of this device was associated with two reported cases of aortic injury, one of which was fatal.
Optiview ®
The Optiview ® system (Ethicon Endo-Surgery, Inc., Cincinnati, OH) is inserted by twisting the handle so that the winged trocar tip dissects through layers of the abdomen as thrust is applied by the surgeon. Advantages include visualised entry and faster access than the Veress or Hasson techniques. In a retrospective study of 1187 individuals undergoing general surgery, a 0.3% complication rate, including two bowel injuries, one mesenteric vessel injury, and one trocar site hernia, were reported. In addition, the axial force applied to advance the trocar is relatively high, lacks a mechanism to prevent overshoot, and often hinders tissue recognition owing to the compression of the tissues. As of yet, the studies available do not present sufficient evidence to promote the use of optical trocars as first-line technique.
Visiport™
The Visiport™ system (Tyco-United States Surgical, Norwalk, CT) uses a trigger to advance and then immediately retract a blade 1 mm into the tissues, with visualisation using a 10-mm laparoscope. The surgeon activates the trigger only when he or she is certain of the level of the trocar. This system was used in a retrospective study of 2207 individuals undergoing bariatric surgery, and resulted in a 0.18% overall complication rate, all due to vascular injuries. It was also used in a study of 1283 urology patients. The complication rate was 0.31%, including one bowel injury, one mesenteric vessel injury, and two epigastric vessel injuries.
EndoTIP™
The EndoTIP™ (Karl STORZ Endoscopy, Tuttlingen, Germany) is a reusable optical cannula system. It is a stainless steel cannula with a thread that spirals along its outer surface. After a skin incision is made, and the fascia is exposed, the surgeon rotates the cannula clockwise so that the blunt tip of the cannula separates tissues as it is descended under direct visualisation. The potential benefits include less axial force required, the blunt tip separates tissues rather than cutting, and direct visualisation of the tissues. A study in animal models found that, compared with the use of pyramidal trocars, tissue trauma resulting from the EndoTIP™ was significantly small with less muscle damage.
Entry-related issues
The peritoneal cavity can be accessed in several ways. These include the use of a Veress needle, direct trocar insertion, Hasson’s technique for open laparoscopy, and the use of optical trocars, radially expanding trocars, and reusable visual access cannulas. It has been estimated that one-half of major injuries to the intestines and blood vessels are related to entry. In a large study of nearly 30,000 women who underwent various gynaecologic laparoscopies, the only death that occurred was related to an injury to the internal iliac artery during the entry procedure, and one-third of all complications were attributed to entry. Although the rate of entry-related complications is low (0.05–0.5%), the outcomes can be devastating. The overall mortality rate after such a complication is about 4%, and unrecognised bowel injury results in a 21% mortality rate.
A Dutch review evaluating 229 medical liability claims related to laparoscopic procedures in gynaecologic and general surgery over a 10-year period found that 18% of the claims were associated with complications related to laparoscopic entry. Out of 51 injured structures, 30 were bowel injuries and 18 were vascular injuries. Unfortunately, less than one-half were diagnosed perioperatively. Most of them were young women undergoing day surgeries or short-stay surgeries. Trainees were involved in 15% of claims. Evidence of informed consent was found in only 6% of the claims, and of a post-operative debriefing of the patient in only 7%.
The US Food and Drug Administration (FDA) reviewed 31 fatal and 1353 non-fatal injuries resulting from laparoscopic trocars, and found that 74% of deaths resulted from blood-vessel injury. One-tenth of these deaths had occurred during gynaecologic procedures. Of interest, devices expected to improve safety, such as shielded and optical trocars were used in these fatal cases. The investigators emphasised that, when mortality occurs, the devices should be returned to the manufacturer for inspection.
Entry technique
No definitive study determining the safest method of entry has been published. Owing to the low incidence of entry-related injury, a sample of over 200,000 women undergoing closed or open-entry techniques to detect a reduction of major complications from 0.1 to 0.05% is needed. In addition, few gynaecologists use the Hasson technique compared with the closed approach, making it difficult to compare the two methods.
Open versus closed techniques
In a review of laparoscopic entry methods, the Society of Obstetricians and Gynecologists of Canada stated that ‘there is no evidence that the open entry technique is superior to or inferior to the other entry techniques currently available.’ Use of the Canadian Task Force on Preventative Health Care classification, shows that this is a level II-2C recommendation, meaning that, based on the available data from well-designed cohort or case-control studies, the existing evidence is conflicting and not clearly in favour or against a particular entry technique. A similar statement was made by the European Association for Endoscopic Surgery. They added that, ‘although open entry seemed to be associated with fewer minor complications, firm conclusions about serious complications (bowel or vascular injury) could not be made owing to the lack of participants in the RCTs’.
A meta-analysis of laparoscopic entry complications found that open entry is more likely to result in bowel injury than direct- or Veress-needle entry, but less likely to result in vascular injury. This may be because the open technique is often selected for women who are at high risk, such as those who have had a prior laparotomy, adhesions, inflammatory bowel disease, or obesity.
Direct trocar entry
It has been suggested that direct trocar entry reduces the incidence of failed pneumoperitoneum, preperitoneal insufflation, intestinal insufflations, or carbon dioxide embolism. Several studies have shown that direct entry is at least as safe as the open and Veress techniques in women who are at low risk, and it is faster. A 2002 meta-analysis including 51 retrospective and prospective studies, with a total of 850,350 laparoscopic procedures, found that the incidence of bowel injury using the Veress needle was 0.4 per 1000, using the open technique 1.1 per 1000, and using direct entry 0.5 per 1000. The incidence of bowel injury was significantly higher for the open technique compared with the others. Entry-related vascular injury rates were statistically higher when using the Veress needle (0.4 per 1000 v 0.1 per 1000 for open entry). The direct technique caused no vascular injuries, suggesting that establishment of pneumoperitoneum before placing trocars does not necessarily prevent vascular injury.
A Cochrane review in 2012 evaluated 28 RCTs involving 4860 women who underwent laparoscopy. It found that direct entry is associated with lower rates of failed entry, extraperitoneal insufflations, and omental injury. The studies, however, were underpowered to detect differences in major complications. Two RCTs indicated reductions in the time to successful peritoneal entry using direct entry compared with Veress entry.
Various trocars
Various entry technologies include the use of disposable shielded trocars, the radially expanding access system (Step, InnerDyne, Sunnyvale, Ca; VersaStep, Covidien, Mansfield, MA; and US Surgical, Norwalk, CT), and optical trocars (Endopath Optiview; Ethicon Endo-Surgery, Inc., Cincinnati, OH and Visiport; Tyco-United States Surgical, Norwalk, CT and EndoTIP; Karl Storz Endoscopy, Tuttlingen, Germany). Complication rates of the different types of trocars are presented in Table 1 .
| Type of trocar | Complications |
|---|---|
| Standard reusable trocar |
|
| Disposable shielded trocar |
|
| Radially expanding trocar |
|
| Optical access trocar |
|
Shielded trocars
Disposable shielded trocars are made with an outer sheath that retracts as the trocar is pushed through the abdominal wall, and then advances to cover the tip of the trocar when the negative pressure of the abdominal cavity is reached. This would help to prevent sharp injury to the viscera and blood vessels. Compared with the use of non-disposable trocars, less force is required to enter an insufflated abdomen, theoretically improving the surgeon’s control of the device. In an FDA review of laparoscopic complications between 1997 and 2002, of the 24 fatal complications reported that mentioned the type of trocar used, all were associated with the use of either optical trocars or disposable shielded trocars. Although this type of retrospective study does not provide evidence of safety of different entry mechanisms, these statistics highlight the fact that there is no ‘safe’ method of entry.
One RCT of 200 participants compared direct entry using a disposable shielded trocar, direct entry using a reusable trocar, and entry using a Veress needle. The authors reported that the shielded trocar did not result in any complications (0%), compared with 22% with the Veress needle and 6% with reusable trocars, respectively (all were minor complications). Again, the study is underpowered to detect a statistically significant difference in complications.
Radially expanding trocars
The radially expanding (STEP) trocars function by using a pneumoperitoneum needle that radially expands to become a cannula of up to 12 mm in diameter. It eliminates the use of sharp trocars and their inherent risks. It expands tissue along anatomical planes, thus theoretically reducing the occurrence of incisional hernias without the need for fascial suturing, and stabilising the cannula within the abdominal wall. Although presently few trials have compared them with standard cutting trocars, several studies indicate possible benefits.
A multicentre, prospective randomised trial showed that radially expanding trocars result in a significant decrease in abdominal wall bleeding and postoperative wound complications, and a trend towards lower pain scores. Other randomised trials (but not all) also indicate that these systems reduce pain scores. In a study of 1055 cases of urologic oncology laparoscopies, however, radially expanding trocars were used in all seven cases in which trocar site hernias were subsequently diagnosed. A Canadian review also noted that, in particular, InnerDyne’s step system required more force to enter the abdomen than the traditional cutting trocars. The Canadian review, the Cochrane review, as well as the French National College of Gynecologists and Obstetricians, stated that the evidence is not sufficient to promote the radially expanding trocars as a first-line tool.
Direct optical access trocars
Direct optical access trocars are disposable visual entry systems that use a laparoscope within hollow trocar to enter the abdomen after insufflation is complete, with real-time visualisation of the abdominal layers penetrated on the way to the peritoneal cavity. Some surgeons advocate using the optical trocar without prior pneumoperitoneum in obese women. The use of this device was associated with two reported cases of aortic injury, one of which was fatal.
Optiview ®
The Optiview ® system (Ethicon Endo-Surgery, Inc., Cincinnati, OH) is inserted by twisting the handle so that the winged trocar tip dissects through layers of the abdomen as thrust is applied by the surgeon. Advantages include visualised entry and faster access than the Veress or Hasson techniques. In a retrospective study of 1187 individuals undergoing general surgery, a 0.3% complication rate, including two bowel injuries, one mesenteric vessel injury, and one trocar site hernia, were reported. In addition, the axial force applied to advance the trocar is relatively high, lacks a mechanism to prevent overshoot, and often hinders tissue recognition owing to the compression of the tissues. As of yet, the studies available do not present sufficient evidence to promote the use of optical trocars as first-line technique.
Visiport™
The Visiport™ system (Tyco-United States Surgical, Norwalk, CT) uses a trigger to advance and then immediately retract a blade 1 mm into the tissues, with visualisation using a 10-mm laparoscope. The surgeon activates the trigger only when he or she is certain of the level of the trocar. This system was used in a retrospective study of 2207 individuals undergoing bariatric surgery, and resulted in a 0.18% overall complication rate, all due to vascular injuries. It was also used in a study of 1283 urology patients. The complication rate was 0.31%, including one bowel injury, one mesenteric vessel injury, and two epigastric vessel injuries.
EndoTIP™
The EndoTIP™ (Karl STORZ Endoscopy, Tuttlingen, Germany) is a reusable optical cannula system. It is a stainless steel cannula with a thread that spirals along its outer surface. After a skin incision is made, and the fascia is exposed, the surgeon rotates the cannula clockwise so that the blunt tip of the cannula separates tissues as it is descended under direct visualisation. The potential benefits include less axial force required, the blunt tip separates tissues rather than cutting, and direct visualisation of the tissues. A study in animal models found that, compared with the use of pyramidal trocars, tissue trauma resulting from the EndoTIP™ was significantly small with less muscle damage.
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