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Laparoscopy and laparoscopic surgery
ARTICLE IN PRESS Current Obstetrics & Gynaecology (2004) 14, 115–122
www.elsevier.com/cuog
Laparoscopy and laparoscopic surgery John Koninckxa, Philippe Koninckxb, Enda McVeighc,* a
Nuffield Department of Obstetrics and Gynaecology, University of Oxford, UK Centre for Surgical Technologies, Catholic University of Leuven, Belgium c Department of Obstetrics, Gynaecology, Assisted Conception Unit, Women’s Centre, University of Oxford at The John Radcliffe Hospital, Oxford OX3 9DU, UK b
KEYWORDS laparoscopy; laparoscopic surgery; minimal access surgery
Summary Today, many procedures that previously required a laparotomy can now be carried out by laparoscopy. The benefits of minimal access surgery have been well recorded; they include less post-operative morbidity, shorter duration of hospital stay and a faster return to work. It is advances in technology, specifically in fibre optics and camera arrays, that have made the relatively recent rapid progress in laparoscopic surgery possible. Operative laparoscopy, however, requires a high degree of technical skill and training. & 2004 Published by Elsevier Ltd.
In minimal access surgery, it is the combination of small instruments and magnification that enables surgical precision. This degree of precision is often difficult to obtain by the ‘traditional’ laparotomy route, as magnification is not available and the surgeon’s hands and large surgical instruments often obscure the operative field. The precision attained during laparoscopic surgery becomes extremely important when the gynaecologist is treating conditions such as endometriosis or adhesions, and of course in the surgical management of infertility. Unfortunately, few major gynaecological procedures are performed laparoscopically. The reason for this is that major laparoscopic surgical procedures are difficult for most gynaecological surgeons to master. The gynaecologist must perform many simple laparoscopic procedures to develop the skills necessary to perform the more complex operations. They must perform these procedures on a regular basis to develop and maintain expertise. As a result, unfortunately, most gynaecological surgery for benign disease is still per*Corresponding author. Tel.: þ 44-1865-221-002. E-mail address: [email protected]. ac.uk (E. McVeigh). 0268-0890/$ - see front matter & 2004 Published by Elsevier Ltd. doi:10.1016/j.curobgyn.2003.12.011
formed by laparotomy, although experts throughout the country agree that the vast majority could safely and efficiently be performed laparoscopically.
Medicolegal As the volume of laparoscopic procedures increases, so does the number of actions for negligence against the surgeon. Complications following laparoscopic surgery may arise from poor technique, poor judgement, inadequate instrumentation or misadventure. Most complications have occurred during operative laparoscopic procedures (rate 17.9/1000). However, as more diagnostic laparoscopic procedures (complication rate 2.7/1000) and sterilization procedures (complication rate 4.5/1000) are carried out, it is these simple procedures that tend to account for most of the overall litigation. A Cochrane database comparison of laparoscopic sterilization compared with mini-laparotomy concluded that there was no difference in major morbidity between the two groups (Fig. 1). Minor morbidity was significantly less in the laparoscopy group [Peto odds ratio 1.89; 95% confidence
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J. Koninckx et al.
Table 1 Major complications per 1000 operative laparoscopies. hCG, human chorionic gonadotrophin.
Figure 1 Setup for endoscopy.
intervals (CI) 1.38, 2.59), and the duration of operation was about 5 min shorter in the laparoscopy group (WMD 5.34; 95% CI 4.52, 6.16). Litigation following laparoscopic sterilization may result due to a complication of the procedure or, more often, as a result of failure of the technique. Although we all almost universally advise patients of the risk of failure of the procedure and the potential complications of the operation, such a disclaimer does not prevent legal action because the surgeon owes a duty of care to the patient, and inappropriate or unacceptable surgery will therefore result in litigation. Appropriate preoperative planning, correct patient selection and the use of suitably skilled surgeons carrying out or supervising the procedure should decrease the litigation following this and other laparoscopic procedures. Table 1 lists the major complications that occur with operative laparoscopies. The majority of complications arise because of: (a) difficulties obtaining a pneumoperiteum; (b) bleeding, usually as a result of accessory trocars; or (c) problems with ectopic pregnancies. Most complications of minimal access surgery can be avoided with good technique. Where patients are known to be at risk, they must be fully informed of all complications, and the operation should be carried out by a senior, appropriately trained surgeon. A 9-year survey of seven French laparoscopic centres including 29 966 diagnostic and operative laparoscopies showed similar results to those in Table 1. As might be expected, this survey found that the complication rate correlated significantly with the complexity of the procedure (P ¼ 0.0001), with one out of four of the complications not being diagnosed during surgery. This survey also showed that increased experience of the surgeons had three consequences: a statistically significant decrease in the number of bowel injuries (P ¼ 0.0003); a significant decrease in the number
By instrument Verres needle Large trocar Accessory trocar Electocautery Laser Pneumoperitoneum
2.7 2.4–2.7 2.5–6.0 0.5–2.8 1.2 7.4
By site of injury Vessel/bleeding Bowel Genitourinary Nerve Uterine perforation
2.6–11.0 0.6–2.0 0.6–1.6 6.1 3.7
Other indicators Death Hospitalization 472 h Hospital readmission Persistent beta-hCG titres Infection Febrile
0.05–0.3 4.2–27.0 3.1–5.0 63.2–144.0 1.4–6.5 2.0
of conversions to laparotomy (P ¼ 0.01); and a change in the way that complications were managed, with more being managed by laparoscopy (P ¼ 0.0001).
Difficulties with obtaining and maintaining a pneumoperitoneum Difficulties in establishing a satisfactory pneumoperitoneum can occur, particularly in obese patients. Superficial introduction of the needle can lead to extraperitoneal insufflation and emphysema, which can dissect the peritoneum from the posterior rectus sheath and limit entry into the peritoneal cavity. If the standard umbilical entry fails because of the patient’s obesity, or the approach is inappropriate because of previous abdominal surgery or the presence of a large pelvis mass (including pregnancy), alternative techniques can be used. These include open laparoscopy, passage of the needle through the posterior culdu-sac or the uterine fundus, introduction in the left upper quadrant or supra-pubic insertion with or without visualization with an extraperitoneally placed laparoscope. Surgeons carrying out laparoscopic surgery should familiarize themselves with these different methods so that the most appropriate can be used as necessary.
ARTICLE IN PRESS Laparoscopy and laparoscopic surgery
The loss or partial loss of the pneumoperitoneum during surgery can result in an increased risk of complications. The resulting loss of the operator’s view of the field can result in an inability to secure haemostasis or repair trauma to the bowel which is now closer to the operative field. This loss of the pneumoperitoneum may be the result of defective equipment (e.g. leaking trocar valves) or due to the continuous suction necessary to remove blood/ smoke from the pelvis. The development of high flow insufflators capable of insufflating up to 30 l/ min has proved to be essential for certain procedures, especially those involving the use of lasers where continuous smoke extraction is necessary.
Injury to bowel when creating pneumoperitoneum or during insertion of trocar Inadvertent injury to the bowel on insertion of the Veress needle or trocar should be avoided in patients without a history of previous surgery. Obese patients, thin patients and those who have had previous abdominal surgery are most at risk. Bowel injury by the Veress needle is usually insignificant and closes spontaneously, but unrecognized injury with a trocar can lead to faecal peritonitis and potential death. Confirmation of peritoneal entry by the Veress needle can be obtained by a number of tests. The syringe test is the most popular; this involves attaching a 10-ml syringe filled with saline to the Veress needle, and injecting 5 ml into the peritoneal cavity. The syringe plunger is then withdrawn. No aspirate should be obtained if the needle is in the correct place as the fluid will have dispersed between loops of bowel. If the needle lies in the abdominal wall, clear fluid will be obtained, but if the aspirate is stained red or brown, perforation of the bowel or a blood vessel has probably occurred.
Vascular injuries Whereas some gastrointestinal injuries at laparoscopy may be unavoidable, the majority of injuries to the great vessels of the abdomen and pelvis should be avoidable. The usual sites of trauma to the large vessels are the terminal aorta near its bifurcation and the common iliac arteries. The vena cava and the iliac veins may also be lacerated and may be more difficult to repair. In thin women, the distance between the umbilicus and the aortic bifurcation may be less than 3 cm, and the
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umbilicus is directly over the bifurcation in 53% of women. The Veress needle and the trocar should be inserted with the patient in a flat position and not in the Trendelenberg position, since this displaces the umbilicus upwards, brings the common iliac vessels closer to the horizontal plane, and decreases the distance between the umbilicus and the aortic bifurcation. Injury to the deep epigastric vessels is the most common vascular injury at operative laparoscopy. Deep epigastric vessels are adjacent to the umbilical ligament and beneath the lateral margin of the rectus muscle. The deep epigastric vessels can be seen through the laparoscope intra-abdominally. Placement of trocars lateral to these regions will minimize the risk of injury.
Ectopic Pregnancy It is now accepted that minimal access surgery provides the best and most efficient method of treating ectopic pregnancies (RCOG Grade A recommendation). However, gynaecologists in the UK have been slow to establish laparoscopic management of ectopic pregnancies as standard practice. A conservative estimate of the overall percentage of cases managed laparoscopically in the UK is 35%. A recent audit on the management of ectopic pregnancy in a Scottish teaching hospital showed that only 62% of cases were managed laparoscopically compared with over 90% in France. This disappointingly low rate in the UK is most likely to be the result of a lack of training among junior staff. Hospitals have addressed this issue by: (a) identifying experienced surgeons willing to be available to train and supervise juniors; and (b) establishing emergency gynaecological clinics with vaginal ultrasound and serum beta human chorionic gonadotrophin measurements. Where these measures have been taken, the result is that the vast majority of ectopic pregnancies can be managed during normal working hours with senior input readily available.
Training Training in general obstetrics and gynaecology has changed significantly over the past 10 years. With the introduction of the Calman training system, and more recently the European Working Time directives, trainees have made significant gains but they have also lost some important aspects of training. They now have more humane working
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hours along with a structured training and appraisal programme. However, these changes have resulted in less exposure to clinical problems. Trainees have also lost the close working relationships they once had with individual consultants as the NHS service has become increasingly consultant based as opposed to consultant led. Training in laparoscopic surgery varies considerably across the UK. Twenty years ago, most consultant gynaecologists could perform practically all operations in gynaecology. Today, however, with the increase in minimal access surgery, a significant proportion of senior gynaecologists have limited experience in this area. This results in an inability to ‘train’ their juniors in these procedures. In 1994, the Royal College of Obstetricians and Gynaecologists (RCOG) published the report from its Working Party on ‘Training in Gynaecological Endoscopic Surgery’. The report was produced partly because endoscopic surgery was becoming an increasingly important component of gynaecological surgery, and partly because of surgical complications resulting from these procedures. The Working Party felt that training in endoscopic surgery would begin with conventional open surgery, and then subsequently proceed to laparoscopic surgical techniques. If trainees did not demonstrate an aptitude, they should not progress. The award of a certificate of completion of specialised training (CCST) at the end of 5 years of general training would include a statement that competence up to a certain level in endoscopic surgery had been achieved. In 1994, the various laparoscopic and hysteroscopic procedures were divided into four levels, with the skills required for Levels 1 and 2 being assessed at the place of work by the MRCOG trainer as an integral part of the formative and summative assessment for the membership examination. The acquisition of skills for Level 3 and 4 procedures was not necessarily a prerequisite for the membership examination or CCST. Those who wished to attain the necessary skills would be expected to attend RCOG-recognized advanced courses, obtain expert supervision by a preceptor recognized by the RCOG, and be involved in compulsory audit. Currently, the RCOG is changing this classification with the introduction of a new Level 1, which will be Basic-level Endoscopy (previously classified as Levels 1 and 2). This will be concerned with basic diagnostic and elementary operative hysteroscopic and laparoscopic techniques. Every candidate for the MRCOG examination must demonstrate knowledge and practical competence in procedures at this level. They must attend an approved course
J. Koninckx et al.
and be observed and declared competent by a preceptor. These skills should be acquired during all gynaecological training programmes. The new Level 2 will be Intermediate-level Endoscopy (previously classified as Level 3). This level will be concerned with intermediate-level procedures in laparoscopic surgery involving the tubes, ovaries, mild peritoneal endometriosis and laparoscopic-assisted hysterectomies. Demonstration of competence in these areas is not compulsory, but it is expected that all who undertake this type of minimal access surgery can demonstrate that they have been appropriately trained in the procedures they undertake, and have attended an appropriate course and have been accredited competent by an approved RCOG preceptor. These techniques require additional skills above those acquired in routine training, and are best achieved as a special-interest module in an appropriate surgical centre as part of the Calman training programme. Level 3 is proposed to be set as Advanced-level Endoscopy (previously classified as Level 4), that will encompass a number of different areas: oncology, urogynaecology, reproductive medicine and pelvic dysfunction. Due to the expertise needed in each area, it has been suggested that it would be ‘both inappropriate and impractical to expect any individual to become competent in all areas’. There is, as yet, no agreed mechanism for training and accreditation in any of these advanced endoscopic procedures. Each of these groups requires complex surgical, particularly laparoscopic, skills that need considerable time to acquire. One possible way of obtaining this training would be to start it as a ‘special-interest module’ inside general Calman training or the relevant subspeciality training, and then, in the case of Level 3, to continue the training post-Calman/ subspecialization completion. As at other levels of training, RCOG-approved preceptors and courses should be identified. The numbers requiring such specialized training would be small and should perhaps be provided on a national basis. Training should be from within a given subspeciality, but with help, where appropriate, from other specialities.
Laparoscopic training: virtual reality as an option for the future? Recent studies investigating the effectiveness of computer-based virtual training models have been encouraging. These experimental settings show a
ARTICLE IN PRESS Laparoscopy and laparoscopic surgery
high-quality surgeon–computer interface and might be useful in assessing the laparoscopic skills of a surgeon. Another development that is closely related to this virtual technique is the use of microsurgical robots in laparoscopy, although because of the limited availability and high costs involved, this application remains experimental.
Laparoscopic hysterectomy Hysterectomy remains one of the most common gynaecological inpatient procedures. Since most hysterectomies are performed for benign conditions, the choice of route almost entirely depends upon the surgeon’s skill and experience. Avoiding a laparotomy in the appropriately chosen patient is without doubt beneficial. The best route for carrying out a hysterectomy is probably still vaginal. However, in those patients where a vaginal hysterectomy is contra-indicated or not technically possible, the default should be a laparoscopic approach. The first laparoscopic hysterectomy using only laparoscopic techniques was performed in 1988 by Harry Reich. Other milestones are shown in Table 2. Total laparoscopic hysterectomy can be a technically difficult procedure to perform. A number of alternative laparoscopic techniques to perform all or some of the hysterectomy have therefore been introduced to simplify the procedure, but retain the major advantages of the approach, i.e. avoidance of a laparotomy wound. The advantages of this approach have been well documented, but the laparoscopic route has been little used by general gynaecologists to date. Although it has been possible to reduce the laparotomy rate for hysterectomy to 10% in some units, there is evidence from the UK (Table 3) and the USA that more than 70% of all hysterectomies are still being performed by laparotomy.
Table 2
Milestones in hysterectomy.
First vaginal hysterectomyFLangenbeck (1810) First abdominal hysterectomyFClay (1843) Cautery to cervical stumpFKeith (1880) Definition of subtotal techniqueFKelly(1896) Low transverse incisionFPfannenstiel (1900) MyomectomyFBonney (1920) Total hysterectomyFRichardson (1929) Dominance of total hysterectomyF(1940s50s) Endometrial ablationFde Cherney, Hamou (1980s) Laparoscopic hysterectomyFReich (1988) Intra-uterine levonorgestrelF(Nilsson, 1977) (1990s)
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Table 3 RCOG UK Hysterectomy Audit. All hysterectomy operations in UK October 1994FSeptember 1995 in 343 hospitals B36 000 hysterectomy procedures B3% laparoscopic B20% vaginal
Laparoscopic surgery and endometriosis The diagnosis of endometriosis is based on the presence of endometrial-like tissue outside the uterine cavity. Clinically, three entities can be distinguished: peritoneal implants, endometriotic cysts and deep nodular lesions. Laparoscopy and biopsy remain the gold standard for diagnosis; however, the skill of the surgeon is crucial to achieving an accurate diagnosis. The surgeon who does not perform laparoscopic surgery routinely will certainly diagnose typical endometriotic lesions, but risks missing a substantial amount of subtle disease. The laparoscopic surgeon should therefore adhere to a systematic approach and meticulous method of evaluating the pelvis to assure complete diagnosis of endometriosis. The laparoscope affords the surgeon the capability of altering the field of view, depending upon the proximity of the laparoscope to the tissue (Figs. 2 and 3). The definitive treatment of endometriosis for both pelvic pain and fertility is through laparoscopic excision or vaporization of the endometriotic tissue. For fertility, this was demonstrated through the Canadian Collaborative Group in Endometriosis who carried out a randomized controlled trial to determine whether laparoscopic surgery enhanced fecundity in infertile women with minimal or mild endometriosis. They concluded that laparoscopic resection or ablation of minimal and mild endometriosis enhances fecundity in infertile women (cumulative probabilities, 30.7% in the treated group and 17.7% in the untreated group). Clinically, the most difficult form of endometriosis to diagnosis and treat is deep infiltrating endometriosis. Koninckx described three types of lesion, as follows (Fig. 4). Type 1Fa large lesion in the peritoneal cavity, infiltrating conically with deeper parts becoming progressively smaller. It has been suggested that this type of endometriosis is caused by infiltration. Type 2Fthe main feature in this type of lesion is that the bowel is retracted over the lesion, the latter becoming situated in the rectovaginal septum, although not really infiltrating it.
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J. Koninckx et al.
Figure 4 Different types of deep nodules.
Figure 2 Rokitansky syndrome.
Figure 5 liver.
Endometriosis on the diaphragm above the
Figure 3 Uterine adhesions.
Type 3Fthe deepest and most severe lesions. They are spherically shaped, situated deep in the rectovaginal septum, and are often only visible as a small typical lesion at laparoscopy. This lesion is often more palpable than visible, originates from the rectovaginal septum tissue, and consists essentially of smooth muscle with active glandular epithelium and scanty stroma. Laparoscopic excision of this severe form of endometriosis requires significant skill (Figs. 5 and 6). It is essential that the patient’s bowel is appropriately prepared before the operation as there is a significant possibility that the rectum will have to be opened to excise the disease completely. It is therefore likely that this degree of skill will only exist in a small number of centres nationally. These centres should therefore be identified to allow regional and national referral. In line
Figure 6 Bilateral ovarian endometriomas.
with Clinical Governance, centres undertaking this highly skilled surgery should produce figures to demonstrate the numbers of cases being performed, along with their success and complication rates.
ARTICLE IN PRESS Laparoscopy and laparoscopic surgery
Laparoscopic surgery and infertility management The success rates, based upon clinical pregnancies, of assisted reproductive technologies (ART) have improved over the last 10 years. Operative endoscopy has also, however, made significant advances, thereby ensuring its place in the ongoing management of infertility (Figs. 2 and 3). ART bypasses pelvic pathology to attempt to obtain a pregnancy. Surgical approaches, however, improve natural fertility by correcting pathological conditions, for example endometriosis and adhesions. By correcting them, the patient improves their fertility and also potentially improves other related symptoms such as pain. After surgery, couples can have unlimited attempts to conceive naturally without being subject to the risk of multiple pregnancies and ovarian hyperstimulation, stress and cost associated with ART.
Laparoscopic surgery in gynaecological oncology Over the last decade, laparoscopic surgery has become an acceptable alternative for the treatment of women with early-stage endometrial carcinoma. Several studies have attested to the feasibility and safety of laparoscopic surgery among select groups of women with endometrial carcinoma. These studies have found laparoscopic surgery to be associated with excellent surgical outcome, shorter hospital stay, earlier recovery and improved quality of life compared with traditional surgery performed through laparotomy. Few studies published to date have reported on the survival of women with endometrial carcinoma after laparoscopic surgery, and with only one exception, these reports were retrospective reviews of select groups of patients. These data show no significant differences in 2- and 5-year overall survival or disease-free survival when comparing laparoscopic with laparotomic treatment. Among the reported, likely advantages of the laparoscopic surgical technique are a reduced blood loss and transfusion rate, and a higher lymph node harvest. One of the concerns raised about the laparoscopic technique is that a higher incidence of positive peritoneal cytology is noted among women with low-risk endometrial carcinoma who were treated with laparoscopy, but the clinical significance of this finding is questionable since it appears to have no significant effect on the survival rate.
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Conclusion Over the past 20 years, technology has allowed minimal access surgery to progress at a rapid rate. The development of superior light sources and microchip video cameras has resulted in superior imaging of the operative field, allowing everincreasing precision, far greater than could be expected at open surgery. Current work on the use of three-dimensional technology, integrated minimal access theatre suites, new methods of suturing and new generations of lasers will continue to advance the field. However, the major challenge facing laparoscopic surgery is training. Unlike the general gynaecologist of 20 years ago, current gynaecologists would not and should not be expected to be able to undertake most gynaecological operations. The establishment of an approved national training programme with a small number of audited, specialized centres to which the most complex cases are referred will hopefully be established soon. Through training and audit, the confidence and experience both inside the profession and within the public will grow, resulting in the eventual ‘norm’ being a minimal access approach.
Practice points Benefits * Less post-operative morbidity, shorter hospital stay and quicker return to work * Magnification allows for greater surgical precision * Most procedures that are carried out through a laparotomy can now be performed by laparoscopy
*
*
*
*
Problems Operative laparoscopy, however, requires a higher degree of technical training and skill A lack of skill or training can result in increasing medicolegal claims Solutions A revised structured training programme by the Royal College of Obstetricians and Gynaecologists The development of regional centres for more advanced surgical cases
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Further reading Asch R, Studd J. Progress in reproductive medicine. In: Nezhat CR, Nezhat F, Nezhat CH, editors. New York: Parthenon Publishing; 1996. Cofman RS, Diamond MP, De Cherney A. Complications of laparoscopy and hysterscopy. Oxford: Blackwell Scientific Publications; 1993. Kononickx PD. Deeply infiltrating endometriosis. In: Brosens I, Donnez J, editors. Endometriosis: research and management. New York: Parthenon Publishing; 1994. p. 437–46.
J. Koninckx et al.
Royal College of Obstetrician and Gynaecology, MAS Training Subcommittee Recommendations. Royal College of Obstetrics and Gynaecology. UK. Hysterectomy Audit; 1995. Sutton C, Diamond M, editors. Endoscopic surgery for gynaecologists. London: W.B. Saunders Company; 2000. Tulandi T, editor. Atlas of laparoscopic and hysteroscopic techniques for gynecologists, 2nd ed. London: W.B. Saunders Company; 1999.
www.elsevier.com/cuog
Laparoscopy and laparoscopic surgery John Koninckxa, Philippe Koninckxb, Enda McVeighc,* a
Nuffield Department of Obstetrics and Gynaecology, University of Oxford, UK Centre for Surgical Technologies, Catholic University of Leuven, Belgium c Department of Obstetrics, Gynaecology, Assisted Conception Unit, Women’s Centre, University of Oxford at The John Radcliffe Hospital, Oxford OX3 9DU, UK b
KEYWORDS laparoscopy; laparoscopic surgery; minimal access surgery
Summary Today, many procedures that previously required a laparotomy can now be carried out by laparoscopy. The benefits of minimal access surgery have been well recorded; they include less post-operative morbidity, shorter duration of hospital stay and a faster return to work. It is advances in technology, specifically in fibre optics and camera arrays, that have made the relatively recent rapid progress in laparoscopic surgery possible. Operative laparoscopy, however, requires a high degree of technical skill and training. & 2004 Published by Elsevier Ltd.
In minimal access surgery, it is the combination of small instruments and magnification that enables surgical precision. This degree of precision is often difficult to obtain by the ‘traditional’ laparotomy route, as magnification is not available and the surgeon’s hands and large surgical instruments often obscure the operative field. The precision attained during laparoscopic surgery becomes extremely important when the gynaecologist is treating conditions such as endometriosis or adhesions, and of course in the surgical management of infertility. Unfortunately, few major gynaecological procedures are performed laparoscopically. The reason for this is that major laparoscopic surgical procedures are difficult for most gynaecological surgeons to master. The gynaecologist must perform many simple laparoscopic procedures to develop the skills necessary to perform the more complex operations. They must perform these procedures on a regular basis to develop and maintain expertise. As a result, unfortunately, most gynaecological surgery for benign disease is still per*Corresponding author. Tel.: þ 44-1865-221-002. E-mail address: [email protected]. ac.uk (E. McVeigh). 0268-0890/$ - see front matter & 2004 Published by Elsevier Ltd. doi:10.1016/j.curobgyn.2003.12.011
formed by laparotomy, although experts throughout the country agree that the vast majority could safely and efficiently be performed laparoscopically.
Medicolegal As the volume of laparoscopic procedures increases, so does the number of actions for negligence against the surgeon. Complications following laparoscopic surgery may arise from poor technique, poor judgement, inadequate instrumentation or misadventure. Most complications have occurred during operative laparoscopic procedures (rate 17.9/1000). However, as more diagnostic laparoscopic procedures (complication rate 2.7/1000) and sterilization procedures (complication rate 4.5/1000) are carried out, it is these simple procedures that tend to account for most of the overall litigation. A Cochrane database comparison of laparoscopic sterilization compared with mini-laparotomy concluded that there was no difference in major morbidity between the two groups (Fig. 1). Minor morbidity was significantly less in the laparoscopy group [Peto odds ratio 1.89; 95% confidence
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J. Koninckx et al.
Table 1 Major complications per 1000 operative laparoscopies. hCG, human chorionic gonadotrophin.
Figure 1 Setup for endoscopy.
intervals (CI) 1.38, 2.59), and the duration of operation was about 5 min shorter in the laparoscopy group (WMD 5.34; 95% CI 4.52, 6.16). Litigation following laparoscopic sterilization may result due to a complication of the procedure or, more often, as a result of failure of the technique. Although we all almost universally advise patients of the risk of failure of the procedure and the potential complications of the operation, such a disclaimer does not prevent legal action because the surgeon owes a duty of care to the patient, and inappropriate or unacceptable surgery will therefore result in litigation. Appropriate preoperative planning, correct patient selection and the use of suitably skilled surgeons carrying out or supervising the procedure should decrease the litigation following this and other laparoscopic procedures. Table 1 lists the major complications that occur with operative laparoscopies. The majority of complications arise because of: (a) difficulties obtaining a pneumoperiteum; (b) bleeding, usually as a result of accessory trocars; or (c) problems with ectopic pregnancies. Most complications of minimal access surgery can be avoided with good technique. Where patients are known to be at risk, they must be fully informed of all complications, and the operation should be carried out by a senior, appropriately trained surgeon. A 9-year survey of seven French laparoscopic centres including 29 966 diagnostic and operative laparoscopies showed similar results to those in Table 1. As might be expected, this survey found that the complication rate correlated significantly with the complexity of the procedure (P ¼ 0.0001), with one out of four of the complications not being diagnosed during surgery. This survey also showed that increased experience of the surgeons had three consequences: a statistically significant decrease in the number of bowel injuries (P ¼ 0.0003); a significant decrease in the number
By instrument Verres needle Large trocar Accessory trocar Electocautery Laser Pneumoperitoneum
2.7 2.4–2.7 2.5–6.0 0.5–2.8 1.2 7.4
By site of injury Vessel/bleeding Bowel Genitourinary Nerve Uterine perforation
2.6–11.0 0.6–2.0 0.6–1.6 6.1 3.7
Other indicators Death Hospitalization 472 h Hospital readmission Persistent beta-hCG titres Infection Febrile
0.05–0.3 4.2–27.0 3.1–5.0 63.2–144.0 1.4–6.5 2.0
of conversions to laparotomy (P ¼ 0.01); and a change in the way that complications were managed, with more being managed by laparoscopy (P ¼ 0.0001).
Difficulties with obtaining and maintaining a pneumoperitoneum Difficulties in establishing a satisfactory pneumoperitoneum can occur, particularly in obese patients. Superficial introduction of the needle can lead to extraperitoneal insufflation and emphysema, which can dissect the peritoneum from the posterior rectus sheath and limit entry into the peritoneal cavity. If the standard umbilical entry fails because of the patient’s obesity, or the approach is inappropriate because of previous abdominal surgery or the presence of a large pelvis mass (including pregnancy), alternative techniques can be used. These include open laparoscopy, passage of the needle through the posterior culdu-sac or the uterine fundus, introduction in the left upper quadrant or supra-pubic insertion with or without visualization with an extraperitoneally placed laparoscope. Surgeons carrying out laparoscopic surgery should familiarize themselves with these different methods so that the most appropriate can be used as necessary.
ARTICLE IN PRESS Laparoscopy and laparoscopic surgery
The loss or partial loss of the pneumoperitoneum during surgery can result in an increased risk of complications. The resulting loss of the operator’s view of the field can result in an inability to secure haemostasis or repair trauma to the bowel which is now closer to the operative field. This loss of the pneumoperitoneum may be the result of defective equipment (e.g. leaking trocar valves) or due to the continuous suction necessary to remove blood/ smoke from the pelvis. The development of high flow insufflators capable of insufflating up to 30 l/ min has proved to be essential for certain procedures, especially those involving the use of lasers where continuous smoke extraction is necessary.
Injury to bowel when creating pneumoperitoneum or during insertion of trocar Inadvertent injury to the bowel on insertion of the Veress needle or trocar should be avoided in patients without a history of previous surgery. Obese patients, thin patients and those who have had previous abdominal surgery are most at risk. Bowel injury by the Veress needle is usually insignificant and closes spontaneously, but unrecognized injury with a trocar can lead to faecal peritonitis and potential death. Confirmation of peritoneal entry by the Veress needle can be obtained by a number of tests. The syringe test is the most popular; this involves attaching a 10-ml syringe filled with saline to the Veress needle, and injecting 5 ml into the peritoneal cavity. The syringe plunger is then withdrawn. No aspirate should be obtained if the needle is in the correct place as the fluid will have dispersed between loops of bowel. If the needle lies in the abdominal wall, clear fluid will be obtained, but if the aspirate is stained red or brown, perforation of the bowel or a blood vessel has probably occurred.
Vascular injuries Whereas some gastrointestinal injuries at laparoscopy may be unavoidable, the majority of injuries to the great vessels of the abdomen and pelvis should be avoidable. The usual sites of trauma to the large vessels are the terminal aorta near its bifurcation and the common iliac arteries. The vena cava and the iliac veins may also be lacerated and may be more difficult to repair. In thin women, the distance between the umbilicus and the aortic bifurcation may be less than 3 cm, and the
117
umbilicus is directly over the bifurcation in 53% of women. The Veress needle and the trocar should be inserted with the patient in a flat position and not in the Trendelenberg position, since this displaces the umbilicus upwards, brings the common iliac vessels closer to the horizontal plane, and decreases the distance between the umbilicus and the aortic bifurcation. Injury to the deep epigastric vessels is the most common vascular injury at operative laparoscopy. Deep epigastric vessels are adjacent to the umbilical ligament and beneath the lateral margin of the rectus muscle. The deep epigastric vessels can be seen through the laparoscope intra-abdominally. Placement of trocars lateral to these regions will minimize the risk of injury.
Ectopic Pregnancy It is now accepted that minimal access surgery provides the best and most efficient method of treating ectopic pregnancies (RCOG Grade A recommendation). However, gynaecologists in the UK have been slow to establish laparoscopic management of ectopic pregnancies as standard practice. A conservative estimate of the overall percentage of cases managed laparoscopically in the UK is 35%. A recent audit on the management of ectopic pregnancy in a Scottish teaching hospital showed that only 62% of cases were managed laparoscopically compared with over 90% in France. This disappointingly low rate in the UK is most likely to be the result of a lack of training among junior staff. Hospitals have addressed this issue by: (a) identifying experienced surgeons willing to be available to train and supervise juniors; and (b) establishing emergency gynaecological clinics with vaginal ultrasound and serum beta human chorionic gonadotrophin measurements. Where these measures have been taken, the result is that the vast majority of ectopic pregnancies can be managed during normal working hours with senior input readily available.
Training Training in general obstetrics and gynaecology has changed significantly over the past 10 years. With the introduction of the Calman training system, and more recently the European Working Time directives, trainees have made significant gains but they have also lost some important aspects of training. They now have more humane working
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hours along with a structured training and appraisal programme. However, these changes have resulted in less exposure to clinical problems. Trainees have also lost the close working relationships they once had with individual consultants as the NHS service has become increasingly consultant based as opposed to consultant led. Training in laparoscopic surgery varies considerably across the UK. Twenty years ago, most consultant gynaecologists could perform practically all operations in gynaecology. Today, however, with the increase in minimal access surgery, a significant proportion of senior gynaecologists have limited experience in this area. This results in an inability to ‘train’ their juniors in these procedures. In 1994, the Royal College of Obstetricians and Gynaecologists (RCOG) published the report from its Working Party on ‘Training in Gynaecological Endoscopic Surgery’. The report was produced partly because endoscopic surgery was becoming an increasingly important component of gynaecological surgery, and partly because of surgical complications resulting from these procedures. The Working Party felt that training in endoscopic surgery would begin with conventional open surgery, and then subsequently proceed to laparoscopic surgical techniques. If trainees did not demonstrate an aptitude, they should not progress. The award of a certificate of completion of specialised training (CCST) at the end of 5 years of general training would include a statement that competence up to a certain level in endoscopic surgery had been achieved. In 1994, the various laparoscopic and hysteroscopic procedures were divided into four levels, with the skills required for Levels 1 and 2 being assessed at the place of work by the MRCOG trainer as an integral part of the formative and summative assessment for the membership examination. The acquisition of skills for Level 3 and 4 procedures was not necessarily a prerequisite for the membership examination or CCST. Those who wished to attain the necessary skills would be expected to attend RCOG-recognized advanced courses, obtain expert supervision by a preceptor recognized by the RCOG, and be involved in compulsory audit. Currently, the RCOG is changing this classification with the introduction of a new Level 1, which will be Basic-level Endoscopy (previously classified as Levels 1 and 2). This will be concerned with basic diagnostic and elementary operative hysteroscopic and laparoscopic techniques. Every candidate for the MRCOG examination must demonstrate knowledge and practical competence in procedures at this level. They must attend an approved course
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and be observed and declared competent by a preceptor. These skills should be acquired during all gynaecological training programmes. The new Level 2 will be Intermediate-level Endoscopy (previously classified as Level 3). This level will be concerned with intermediate-level procedures in laparoscopic surgery involving the tubes, ovaries, mild peritoneal endometriosis and laparoscopic-assisted hysterectomies. Demonstration of competence in these areas is not compulsory, but it is expected that all who undertake this type of minimal access surgery can demonstrate that they have been appropriately trained in the procedures they undertake, and have attended an appropriate course and have been accredited competent by an approved RCOG preceptor. These techniques require additional skills above those acquired in routine training, and are best achieved as a special-interest module in an appropriate surgical centre as part of the Calman training programme. Level 3 is proposed to be set as Advanced-level Endoscopy (previously classified as Level 4), that will encompass a number of different areas: oncology, urogynaecology, reproductive medicine and pelvic dysfunction. Due to the expertise needed in each area, it has been suggested that it would be ‘both inappropriate and impractical to expect any individual to become competent in all areas’. There is, as yet, no agreed mechanism for training and accreditation in any of these advanced endoscopic procedures. Each of these groups requires complex surgical, particularly laparoscopic, skills that need considerable time to acquire. One possible way of obtaining this training would be to start it as a ‘special-interest module’ inside general Calman training or the relevant subspeciality training, and then, in the case of Level 3, to continue the training post-Calman/ subspecialization completion. As at other levels of training, RCOG-approved preceptors and courses should be identified. The numbers requiring such specialized training would be small and should perhaps be provided on a national basis. Training should be from within a given subspeciality, but with help, where appropriate, from other specialities.
Laparoscopic training: virtual reality as an option for the future? Recent studies investigating the effectiveness of computer-based virtual training models have been encouraging. These experimental settings show a
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high-quality surgeon–computer interface and might be useful in assessing the laparoscopic skills of a surgeon. Another development that is closely related to this virtual technique is the use of microsurgical robots in laparoscopy, although because of the limited availability and high costs involved, this application remains experimental.
Laparoscopic hysterectomy Hysterectomy remains one of the most common gynaecological inpatient procedures. Since most hysterectomies are performed for benign conditions, the choice of route almost entirely depends upon the surgeon’s skill and experience. Avoiding a laparotomy in the appropriately chosen patient is without doubt beneficial. The best route for carrying out a hysterectomy is probably still vaginal. However, in those patients where a vaginal hysterectomy is contra-indicated or not technically possible, the default should be a laparoscopic approach. The first laparoscopic hysterectomy using only laparoscopic techniques was performed in 1988 by Harry Reich. Other milestones are shown in Table 2. Total laparoscopic hysterectomy can be a technically difficult procedure to perform. A number of alternative laparoscopic techniques to perform all or some of the hysterectomy have therefore been introduced to simplify the procedure, but retain the major advantages of the approach, i.e. avoidance of a laparotomy wound. The advantages of this approach have been well documented, but the laparoscopic route has been little used by general gynaecologists to date. Although it has been possible to reduce the laparotomy rate for hysterectomy to 10% in some units, there is evidence from the UK (Table 3) and the USA that more than 70% of all hysterectomies are still being performed by laparotomy.
Table 2
Milestones in hysterectomy.
First vaginal hysterectomyFLangenbeck (1810) First abdominal hysterectomyFClay (1843) Cautery to cervical stumpFKeith (1880) Definition of subtotal techniqueFKelly(1896) Low transverse incisionFPfannenstiel (1900) MyomectomyFBonney (1920) Total hysterectomyFRichardson (1929) Dominance of total hysterectomyF(1940s50s) Endometrial ablationFde Cherney, Hamou (1980s) Laparoscopic hysterectomyFReich (1988) Intra-uterine levonorgestrelF(Nilsson, 1977) (1990s)
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Table 3 RCOG UK Hysterectomy Audit. All hysterectomy operations in UK October 1994FSeptember 1995 in 343 hospitals B36 000 hysterectomy procedures B3% laparoscopic B20% vaginal
Laparoscopic surgery and endometriosis The diagnosis of endometriosis is based on the presence of endometrial-like tissue outside the uterine cavity. Clinically, three entities can be distinguished: peritoneal implants, endometriotic cysts and deep nodular lesions. Laparoscopy and biopsy remain the gold standard for diagnosis; however, the skill of the surgeon is crucial to achieving an accurate diagnosis. The surgeon who does not perform laparoscopic surgery routinely will certainly diagnose typical endometriotic lesions, but risks missing a substantial amount of subtle disease. The laparoscopic surgeon should therefore adhere to a systematic approach and meticulous method of evaluating the pelvis to assure complete diagnosis of endometriosis. The laparoscope affords the surgeon the capability of altering the field of view, depending upon the proximity of the laparoscope to the tissue (Figs. 2 and 3). The definitive treatment of endometriosis for both pelvic pain and fertility is through laparoscopic excision or vaporization of the endometriotic tissue. For fertility, this was demonstrated through the Canadian Collaborative Group in Endometriosis who carried out a randomized controlled trial to determine whether laparoscopic surgery enhanced fecundity in infertile women with minimal or mild endometriosis. They concluded that laparoscopic resection or ablation of minimal and mild endometriosis enhances fecundity in infertile women (cumulative probabilities, 30.7% in the treated group and 17.7% in the untreated group). Clinically, the most difficult form of endometriosis to diagnosis and treat is deep infiltrating endometriosis. Koninckx described three types of lesion, as follows (Fig. 4). Type 1Fa large lesion in the peritoneal cavity, infiltrating conically with deeper parts becoming progressively smaller. It has been suggested that this type of endometriosis is caused by infiltration. Type 2Fthe main feature in this type of lesion is that the bowel is retracted over the lesion, the latter becoming situated in the rectovaginal septum, although not really infiltrating it.
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Figure 4 Different types of deep nodules.
Figure 2 Rokitansky syndrome.
Figure 5 liver.
Endometriosis on the diaphragm above the
Figure 3 Uterine adhesions.
Type 3Fthe deepest and most severe lesions. They are spherically shaped, situated deep in the rectovaginal septum, and are often only visible as a small typical lesion at laparoscopy. This lesion is often more palpable than visible, originates from the rectovaginal septum tissue, and consists essentially of smooth muscle with active glandular epithelium and scanty stroma. Laparoscopic excision of this severe form of endometriosis requires significant skill (Figs. 5 and 6). It is essential that the patient’s bowel is appropriately prepared before the operation as there is a significant possibility that the rectum will have to be opened to excise the disease completely. It is therefore likely that this degree of skill will only exist in a small number of centres nationally. These centres should therefore be identified to allow regional and national referral. In line
Figure 6 Bilateral ovarian endometriomas.
with Clinical Governance, centres undertaking this highly skilled surgery should produce figures to demonstrate the numbers of cases being performed, along with their success and complication rates.
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Laparoscopic surgery and infertility management The success rates, based upon clinical pregnancies, of assisted reproductive technologies (ART) have improved over the last 10 years. Operative endoscopy has also, however, made significant advances, thereby ensuring its place in the ongoing management of infertility (Figs. 2 and 3). ART bypasses pelvic pathology to attempt to obtain a pregnancy. Surgical approaches, however, improve natural fertility by correcting pathological conditions, for example endometriosis and adhesions. By correcting them, the patient improves their fertility and also potentially improves other related symptoms such as pain. After surgery, couples can have unlimited attempts to conceive naturally without being subject to the risk of multiple pregnancies and ovarian hyperstimulation, stress and cost associated with ART.
Laparoscopic surgery in gynaecological oncology Over the last decade, laparoscopic surgery has become an acceptable alternative for the treatment of women with early-stage endometrial carcinoma. Several studies have attested to the feasibility and safety of laparoscopic surgery among select groups of women with endometrial carcinoma. These studies have found laparoscopic surgery to be associated with excellent surgical outcome, shorter hospital stay, earlier recovery and improved quality of life compared with traditional surgery performed through laparotomy. Few studies published to date have reported on the survival of women with endometrial carcinoma after laparoscopic surgery, and with only one exception, these reports were retrospective reviews of select groups of patients. These data show no significant differences in 2- and 5-year overall survival or disease-free survival when comparing laparoscopic with laparotomic treatment. Among the reported, likely advantages of the laparoscopic surgical technique are a reduced blood loss and transfusion rate, and a higher lymph node harvest. One of the concerns raised about the laparoscopic technique is that a higher incidence of positive peritoneal cytology is noted among women with low-risk endometrial carcinoma who were treated with laparoscopy, but the clinical significance of this finding is questionable since it appears to have no significant effect on the survival rate.
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Conclusion Over the past 20 years, technology has allowed minimal access surgery to progress at a rapid rate. The development of superior light sources and microchip video cameras has resulted in superior imaging of the operative field, allowing everincreasing precision, far greater than could be expected at open surgery. Current work on the use of three-dimensional technology, integrated minimal access theatre suites, new methods of suturing and new generations of lasers will continue to advance the field. However, the major challenge facing laparoscopic surgery is training. Unlike the general gynaecologist of 20 years ago, current gynaecologists would not and should not be expected to be able to undertake most gynaecological operations. The establishment of an approved national training programme with a small number of audited, specialized centres to which the most complex cases are referred will hopefully be established soon. Through training and audit, the confidence and experience both inside the profession and within the public will grow, resulting in the eventual ‘norm’ being a minimal access approach.
Practice points Benefits * Less post-operative morbidity, shorter hospital stay and quicker return to work * Magnification allows for greater surgical precision * Most procedures that are carried out through a laparotomy can now be performed by laparoscopy
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Problems Operative laparoscopy, however, requires a higher degree of technical training and skill A lack of skill or training can result in increasing medicolegal claims Solutions A revised structured training programme by the Royal College of Obstetricians and Gynaecologists The development of regional centres for more advanced surgical cases
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Further reading Asch R, Studd J. Progress in reproductive medicine. In: Nezhat CR, Nezhat F, Nezhat CH, editors. New York: Parthenon Publishing; 1996. Cofman RS, Diamond MP, De Cherney A. Complications of laparoscopy and hysterscopy. Oxford: Blackwell Scientific Publications; 1993. Kononickx PD. Deeply infiltrating endometriosis. In: Brosens I, Donnez J, editors. Endometriosis: research and management. New York: Parthenon Publishing; 1994. p. 437–46.
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Royal College of Obstetrician and Gynaecology, MAS Training Subcommittee Recommendations. Royal College of Obstetrics and Gynaecology. UK. Hysterectomy Audit; 1995. Sutton C, Diamond M, editors. Endoscopic surgery for gynaecologists. London: W.B. Saunders Company; 2000. Tulandi T, editor. Atlas of laparoscopic and hysteroscopic techniques for gynecologists, 2nd ed. London: W.B. Saunders Company; 1999.