Laparoscopic surgery: Current status, issues and future developments

Laparoscopic surgery: Current status, issues and future developments

General Laparoscopic surgery: Current status, issues and future developments A. Cuschieri Scuola Superiore Sant’Anna di Studi Universitari, Pisa, It...

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General

Laparoscopic surgery: Current status, issues and future developments

A. Cuschieri Scuola Superiore Sant’Anna di Studi Universitari, Pisa, Italy Correspondence to: A. Cuschieri, Scuola Superiore Sant’Anna di Studi Universitari, Piazza dei martiri della liberta n.33, 56127, Pisa, Italy Email: [email protected]

Laparoscopic surgery has come a long way since its introduction two decades ago. In essence it represents a new era of technology-dependent surgical interventions, and to some extent its future progress depends on the growth of interventional technologies and devices (facilitative, enabling and additive). Laparoscopic surgery has had a signicant impact on all surgical disciplines and is now rmly embedded in routine surgical practice. There remain, however, several outstanding issues that need to be addressed. These concern mainly quality assurance, training, resource allocation, assessment of competence and tiers of laparoscopic surgical practice in line with the changing situation facing the next generation of surgeons Keywords: Laparoscopic surgery, existing practice, future advances Surgeon, 1 June 2005, 125-138

INTRODUCTION Without going into the details of the history of laparoscopic surgery, as this always rufes feathers amongst the few European surgeons involved in the early nineteen eighties in ground breaking pioneering work, it is generally agreed that laparoscopic surgery emerged when it did because the enabling technology permitting this approach had nally matured. Laparoscopic surgery was born of progress and gradual advances in the image-chain technologies occurring over a 30-year period extending from 1950 to 1980. Several optical scientists including Hopkins were involved in this seminal development. Once introduced, laparoscopic surgery has stimulated and will continue to drive technological advances, at least for the foreseeable future. It does represent a historical surgical watershed, ushering a new era (that can be set fairly narrowly at the mid 1980s) of technology-dependent surgery. It is difcult to conceive of any surgical advance that has caused such impact, controversy, problems, concerns and medico-legal litigation. Yet despite its growing problems, it has, inside two decades, altered surgical practice to an extent that has exceeded the expectations of the early pioneers. There is no surgical specialty that has not been inuenced by the new approach © 2005 Surgeon 3: 3; 125-138

and laparoscopic surgery is now rmly embedded in routine surgical practice. Some would say it has matured but some key issues concerning patient care remain unresolved.

DEFINITIONS The term minimally invasive surgery (MIS) was introduced by John Wickam to describe the emerging therapeutic approach designed to minimise the traumatic insult to the patient by surgical and allied interventional procedures. Although still in widespread usage it has undoubtedly served to promulgate the concept of the new therapeutic approach, there are, in my view, some inherent problems with this terminology. In the rst instance, it is semantically incorrect, as to invade is absolute, but more importantly, it carries connotations of ‘minor procedures’ and increased safety. A better terminology, which I have advocated, is minimal access surgery (MAS), as the benet results in large (but not exclusive) measure from reduction of the trauma of the open wound access to the surgical eld associated with conventional open surgery. The alternative term, endoscopic surgery, somehow lacks sufcient conceptual impact but is nonetheless scientically accurate. The subdivisions of MAS were described in 1992 as laparoscopic, thoracoscopic, perivisceral (nowadays referred to as extraperitoneal), The Royal Colleges of Surgeons of Edinburgh and Ireland

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endoluminal and arthroscopic.1 Perhaps more important than these semantic issues is the realisation by surgeons that radiological and exible techniques are, or should be, part of the armamentarium of the modern surgeon as we move to closer and closer interaction between interventional radiology, interventional exible endoscopy and endoscopic surgery. Surgeons would do well to embrace holistically the practice of minimal access therapy (MAT) rather than minimal access surgery. As alluded above, the benet of laparoscopic surgery is not related simply to small abdominal port wounds. The issue is far more complex and has been insufciently researched. The factors that merit serious consideration in this respect include: (i) exposure and cooling of the intestinal loops with the risk of intestinal bacterial translocation, (ii) desiccation injury to the abdominal contents, (iii) absorption of bacterial lipopolysaccharide from the operating room air by the exposed peritoneal surfaces, (iv) absence of forceful retraction (v) and delicate micro-dissection with the ne-tipped laparoscopic instruments. If, as demonstrated by the elegant seminal experimental studies of Watson et al (1995), absorption of translocated bacterial polysaccharide by the exposed serosal surfaces from the operating room air occurs during open surgery, then it could account, at least in part, for the reduced acute phase and cytokine response conrmed by several studies encountered after laparoscopic, as distinct from open surgery.2 The experiments by Watson et al (1995) also showed diminished peritoneal macrophage FITC-eCandida albicans ingestion with air laparoscopy and laparotomy, compared with controls and CO2 laparoscopy. These ndings correlated with a signicant decrease in CD11b expression. Other in vitro and in vivo animal studies have shown that CO2 causes intracellular acidication of peritoneal macrophages, which in turn suppresses production of tumour necrosis factor (TNF) in response to exposure to lipopolysaccharide.3 Experiments involving dogs have shown that peritoneal endotoxin is absorbed by the subserosal lymphatics.

LAPAROSCOPIC APPROACHES Since its introduction, laparoscopic surgery has progressed to embrace several approaches. The classical total laparosocpic approach with positive pressure capnoperitoneum is still the most widely used as it provides the best exposure. Small gains in post-operative pain and cosmesis have been reported by use of 2-3mm instruments and 5mm laparoscopes, needlescopic laparoscopic surgery. However, the marginal cosmetic benet is offset by increased difculty in execution resulting from the inherent exibility of these ne instruments, when compared with the orthodox 5mm and 10mm instruments. The gas-less laparoscopic approach (GLA) was introduced for a variety of reasons, by different groups, for different indications and using different technologies. The term is of course scientically incorrect, as in all the techniques used, air enters the peritoneal cavity and the intra-abdominal pressure is equal to the atmospheric pressure. Hence, the correct terminology is isobaric laparoscopic approach (IBLS), used by gynaecological surgeons but rarely found in the reported surgical literature. The advantages of IBLS are several and include absence of adverse cardiovascular haemodynamic changes caused by positive pressure insufation, absence of hypercapnia and adrenergic response and elimination of risk of CO2 embolism, 126

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especially in trauma patients.4 In elective cases, the most common indication for use of IBLS is surgery of moderate severity (cholecystectomy, anti-reux surgery) in patients with ischaemic heart disease, as these patients may not tolerate the sudden fall in stroke volume and cardiac index encountered in laparosocpic surgery with positive pressure capnoperitoneum.5 In essence, all technologies used for IBLS can be categorised into four groups depending on the nature of the mechanics of the lift: Point, Linear, Curvilinear and Planar. The Point and Linear abdominal wall lift systems are exemplied by the Laparolift/ Laparofan and the Keckstein Storz lift. They carry two major disadvantages, which have detracted from their widespread use in routine surgical practice. In the rst place, they create a tenting cone effect with medial deviation of the anterolateral abdominal parieties without any distension; hence providing restricted exposure and workspace. The second consideration has been largely overlooked. These devices are inserted intraperitoneally and in providing abdominal wall lift, exert long and sustained compression on the parietal peritoneum of the anterior abdominal wall, causing ischaemic damage at the lift site.5 The Laparolift provides abdominal wall lift by subcutaneously inserted specially designed curvilinear needles. On evaluation in a randomised controlled trial (RCT) comparing it with the total laparoscopic approach using positive-pressure capnoperitoneum, it was shown to be free of any parietal injury or increased post-operative discomfort, but rendered the surgery more difcult, as indicated by increased number of manipulations to complete the operation because of the reduced exposure compared with that provided by positive-pressure capnoperitoneum.6 These advantages could be overcome by insufating CO2 at low pressures (4mm-8mmHg). The latest technology for IBLS comprises the Dundee NiTi shape memory subcutaneous rods and the vacuum system developed by Udwadia. The Dundee system has been in development for several years and is due for clinical testing. It consists of two long NiTi 4mm rods, which are inserted through lateral stab wounds. The external ends of the rods are docked into sliding rails attached to the rail bar of the operating table on either side. The subcutaneous rods arch (lifting the abdominal wall) as the holding rails are ratcheted medially from both sides. Hand-assisted laparoscopic surgery (HALS) has been developing over the past 10 to 15 years. The rst device was reported in 1995.7 Since then the technology has progresses considerably and there are now a number of hand-assist disposable devices which are in use, although none is without problems, and the search for the best design continues. They permit the insertion of the hand of the surgeon or assistant into the insufated peritoneal cavity without loss of the positive-pressure capnoperitoneum. Several studies have now conrmed that HALS does not reduce signicantly the advantages of total laparoscopic surgery.8-11 In my view, HALS should be restricted to certain operations, but in these it carries several advantages: (i) increased efciency of execution due to retraction and exposure by the internal assisting hand, (ii) immediate control of any major bleeding, (iii) reduced retractor inicted injuries and (iv) facilitation of specimen/ organ removal. Specic instrumentation has been developed for use by the internal hand during HALS. These include the Dundee Multitool and the Pisa disposable graspers. The indications for © 2005 Surgeon 3: 3; 125-138

TABLE 1a. CLINICAL INDICATIONS FOR HALS Operations for large masses, e.g. massive splenomegaly Operations that entail removal of multiple organs Operations necessitating intact specimen removal Radical resections for large solid cancers For operations expected to be difcult for whatever reason When the patient’s condition requires a rapid intervention because of comorbid disease As an alternative option to open conversion in the presence of difculties encountered during a planned laparoscopic operation Limited experience of the surgeon in the execution of a major laparoscopic operation – ensuring a safe prociency-gain curve

TABLE 1b.SPECIFIC OPERATIONS THAT BENEFIT FROM THE HALS APPROACH (GENERAL AND VASCULAR SURGERY) Splenectomy for massive splenomegaly Distal pancreatectomy for large cystic, islet cell tumours Radical gastrectomies for cancer Subtotal 3-stage oesophagectomy and oesophago-gastrectomy Total colectomy Low anterior resection for serosally-invisible tumours Excision of retroperitoneal tumours Abdominal aneurysm and reconstructive aorto-iliac surgery Right hepatic resections

the use of HALS are subject to several clinical variables. These and the specic operations in general and vascular surgery that benet from the HALS approach are outlined in Table 1. To some, it may seem a surprise that Table 1b includes low anterior resection ‘for serosally invisible tumours’. The reason for this viewpoint is that the assisting internal hand enables the exact location of the tumour and hence the safe application of the linear stapler for transection that is undoubtedly well clear of the tumour. In the author’s opinion this is uncertain with the total laparoscopic approach. The HALS does carry a number of constraints: the surgeon is anchored to the patient with his spine in lordosis as his internal hand is at a lower level that the external hand, especially when this is holding standard length laparoscopic instruments. In addition, there is encroachment of the external workspace, hindering ideal positioning of the instrument ports. The full ergonomic implications of HALS are described elsewhere. Laparoscopically-assisted surgery is of particular reference to resections of segments of the gastro-intestinal tract. The dissection and mobilisation of the gastrointestinal segment is carried out by the total laparosocpic approach but the resection and restoration of the continuity of the gastrointestinal tract is performed through a small (4cm to 5cm) appropriately place wound. It is most commonly used in colonic resections.12

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TECHNOLOGIES FOR LAPAROSCOPIC SURGERY During the past 15 years, laparoscopic surgery has been a major driving force for the development of new technologies for (i) improved imaging of the operative eld and its display to the surgeon, (ii) energised dissection, (iii) hand assisted devices and instrumentation, (iii) technologies for in situ ablation of tumours, (iv) tissue reduction and extraction systems and (v) advanced instrumentation, including hand held manipulators and telerobotic camera holders and telemanipulators (DaVinci and Zeus systems). An up-to-date review of all these technologies is outside the scope of this review but some general comments and points relating to the nature of technological advances need emphasis. In my view, in terms of minimal access surgery in general and for laparoscopic surgery in particular, technological advances fall into three categories: (i) facilitative, (ii) enabling and (iii) additive. Facilitative technologies improve the efciency of performance of the procedure and reduce the level of difculty of its execution, though not necessarily its safety. Examples of facilitative technologies include the newer high-power ultrasonic dissection systems (Ultracision and Autosonix), hand-assist devices and the cutting impedance-controlled bipolar coagulation (LigaSure). These energised dissection systems facilitate advanced laparoscopic surgical operations by reducing instrument trafc, as essentially the one energised instrument is used for the whole or most of the procedure, aided by an atraumatic grasper held in the non-dominant hand of the surgeon. It is often assumed that facilitative technologies are entirely safe technologies. This assumption is only valid if the surgeon understands the basics of the physics underpinning the functionality of the instrument and, in so doing, does not abuse the technology during laparoscopic surgery. A pertinent example of this is provided by high power ultrasonic dissection, which is in widespread use in modern laparoscopic surgery. Continuous activation at maximum power for 15 seconds or more will generate exceedingly high temperature at the jaws (>200 C), and temperature isotherms at 1.0cm away from the tip of the vibrating jaw of thermal intensity high enough to cause undoubted collateral tissue damage.13 Enabling technologies make possible certain surgical procedures, which would be impossible or very difcult without them. Enabling technologies are of course relative to specic interventions. Examples include radio frequency (RF) thermal and other physical tissue ablators used for laparoscopic in situ ablation of hepatic tumours, inatable bands for obesity surgery, linear cutting endostaplers for colorectal and upper GI surgery. Additive technologies bring sophistication to surgical manipulations but are not considered essential, although they may, as the technology advances, replace existing systems, but this seems unlikely in the near future. Additive technologies are usually expensive and hence limited only to a few centres. The best example is provided by the DaVinci system, which consists of robotic arms (up to three) into which are docked the surgical instruments and a separate operating console for the surgeon. The powerful in-built computer controls the robotic arms such that they move in the same direction as the surgeon’s hands (master-slave manipulator) as he or she operates from a gaze-down 3-D image display of the operating eld. The The Royal Colleges of Surgeons of Edinburgh and Ireland

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instruments held by the robotic arms have internal wrists, which reproduce the pronation movements during suturing.14,15 The entire set up is referred to as computer-assisted telerobotic surgery (CATS) and, indeed, the separation of the surgeon from the patient can be increased to transatlantic distances, although the wisdom and practicality of this is suspect. The advantages of CATS have been reviewed by Aurora and Thalamini (2004) and include comfortable ergonomic positioning of the surgeon (sitting down at the operating console) thus decreasing fatigue; stereoscopic vision (authors mean 3-D, as stereoscopic is not possible except in normal vision) with the possibility of 10x magnication; wrist-like manual dexterity with intuitive motion; motion-scaling and tremor elimination.14 CATS has, to date, been used for a variety of established laparoscopic operations. In all these reported studies, except perhaps for laparoscopic radical prostatectomy, there has been no evidence to suggest that the CATS execution results in a better clinical outcome than the conventional unassisted laparoscopic surgical technique. On the negative side, CATS procedures are more expensive and incur longer overall operating times. All of this indicates that CATS is advanced additive technology in evolution and the present set up has to be regarded as the rst generation of a new era of specialised tremor-free high precision surgery, which may be of particular use in endoscopic microsurgical applications.

CURRENT LAPAROSCOPIC SURGICAL PRACTICE Based on usage and published evidence, admittedly of variable quality, the spectrum of operations performed by the laparoscopic approaches can be categorised into (i) operations that have denitely improved patients outcome, (ii) operations that appear to benet the patient, and (iii) operations of current uncertain benet. The author’s attempt at allocation of the various procedures in these three categories is shown in Tables 2a, 2b and 2c. Cholecystectomy for symptomatic gallstone disease is undoubtedly the gold standard and has virtually replaced open cholecystectomy, although the morbidity and mortality (3% to 4%) after laparoscopic surgery for acute cholecystitis remains high despite increased experience and improved technology.16 There are some residual controversies regarding this commonly performed laparoscopic operation, including the need or otherwise for routine uorocholangiography. The laparoscopic treatment of ductal calculi has not had the clinical uptake it deserves despite good evidence, including one multi-centre RCT which showed similar efcacy and morbidity as the traditional (two stage management of preoperative endoscopic stone extraction followed by laparoscopic cholecystectomy) but a reduced hospital stay averaging three days.17-19 In an era of supposedly evidence-based medicine, it is indeed extraordinary where a single stage procedure, which leaves pristine the anatomy of the extrahepatic biliary tract including the sphincter of Oddi, is not used in the UK except in a minority of centres. The reasons for this are complex but include lack of the necessary laparoscopic biliary expertise in district hospitals within the UK and resistance by interventional gastroenterologists to change their practice. In this respect, there is a general misconception that the exible endoscopists will lose all the ductal stone work. This is far from being the case, as laparoscopic treatment for ductal 128

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TABLE 2a. MARKER OPERATIONS THAT HAVE DEFINITELY IMPROVED PATIENT OUTCOME Staging and diagnostic laparoscopy Cholecystectomy and laparoscopic ductal stone extraction Adrenalectomy Splenectomy Anti-reux surgery Cardiomyotomy for achalasia Obesity surgery Laparoscopic colonic surgery Live donor nephrectomy

TABLE 2b. MARKER OPERATIONS THAT APPEAR TO BENEFIT THE PATIENT Laparoscopic abdominal aneurysm surgery Laparoscopic distal and central pancreatic surgery Laparoscopic left hepatic resections Laparoscopic localisation and enucleation of benign insulinomas Laparoscopic pancreatic necrosectomy Gastric and oesophageal resections Laparoscopic rectal surgery (anterior resection) Appendicetomy Laparoscopic hernia surgery

TABLE 2c. OPERATIONS OF CURRENT UNCERTAIN BENEFIT Right hepatectomy Pancreatoduodenectomy

calculi is contraindicated in patients with cholangitis, patients with severe gallstone pancreatitis and patients with signicant cardiorespiratory disease. With some operations, such as adrenalectomy and splenectomy, the benet in terms of reduced morbidity and accelerated recovery is so obvious and universally accepted by the surgical community that no RCTs are necessary and, indeed, the open approached is only justiable in specic situations such as massive splenomegaly (spleen below level of umbilicus) and large malignant adrenal masses. There is some evidence that the advent of laparoscopic surgery has resulted in an increased number of adrenalectomies for incidentalomas. Undoubtedly, from scrutiny of the many published series of endoscopic adrenalectomy, there seems to have been an increase in the resection of these incidental non-functioning adrenal tumours and there appears to be no uniformity of the size criterion for removal of these adrenal masses. Another caution has been highlighted by a reported study on quality of life in patients with Cushing’s disease. Although the benets of laparoscopic bilateral adrenalectomy for this disease are real (accelerates recovery, avoids wound healing problems and abolishes the symptoms of Cushing’s disease), these patients, as after open surgery, continue to experience poor health as measured by the SF-36, when compared with the general population.20 © 2005 Surgeon 3: 3; 125-138

Laparoscopic cardiomyotomy for achalasia and laparoscopic anti-reux surgery fall almost in the same category of benet, although there are some controversial issues concerning both these operations. Laparoscopic cardiomyotomy has replaced open surgery, thoracsosocpic cardiomyotomy, pneumatic dilatation and Botulinum toxin injection, as the results are uniformly excellent and the morbidity very low. The residual controversy regarding laparoscopic cardiomyotomy for achalasia concerns the use of additional fundoplication. Many surgeons advocate the use of an anterior Dor type of fundoplication, as they consider gastroesophageal reux to be inevitable after the procedure. This is true if the gastroesophageal mobilisation is complete and circumferential. However, if the technique used only entails anterior mobilisation of the lower oesophagus and gastro-oesophageal (O-G) junction, leaving the posterior oesophageal attachments intact, and if the muscle pillars of the myotomy are sutured to the crus on either side (for separation of the myotomy edges and xation of the oesophagus), the incidence of gastroesophageal reux after this technique of laparoscopic cardiomyotomy is 10%.21 As the body of the oesophagus is immotile in classical achalasia, fundoplication may deter from a good functional result. The results of laparoscopic fundoplication have been uniformly good and continued efcacy at ve years is now conrmed by many reports (Figure 1). There appears to be a benet in small-randomised trials for partial wraps in reducing the incidence of adverse symptoms including dysphagia. In contrast, the reported results of laparoscopic treatment of giant hiatal hernias (type III) have not been so good. There is general agreement amongst expert upper GI laparoscopic surgeons on the following components of the surgical treatment for giant hiatal hernia: (i) complete reduction and excision of the mediastinal hernial sac such that the stomach comes to lie on its own accord entirely within the abdomen, (ii) mesh repair of the diaphragmatic defect, (iii) fundoplication and (iv) anterior gastropexy. To these the author would add drainage of the mediastinum to prevent seroma formation in the mediastinum following surgery, as the repair of the diaphragm and the fundoplication prevents drainage of any accumulated mediastinal uid into the abdomen. The anterior gastropexy (to the abdominal wall) is a measure designed to reduce the incidence of recurrence in these patients. Even so, recurrence of the hiatal hernia is common and is reported in up to 30% of patients but most recurrences are small and only 3% to 5% have severe symptoms that require re-operation.22-24 There is a variety of mesh materials that can be used, and individual preference, costs and familiarity are the deciding factors in the choice by the individual surgeon. In this respect, it is sensible for the surgeon to become experienced with the use of one or (at most) two types of mesh materials for hiatal repair, as consistency improves the quality of the repair since the various materials handle and suture quite differently. The more recent bio-matrix implant made from porcine acellular noncrosslinked collagen (SIS, Cook) gives excellent results.24 It is derived from the small bowel submucosa and is available as freeze-dried mesh. This material becomes incorporated in host tissue by creeping substitution and is totally non-immunogenic. The only disadvantage is cost. Many techniques have been used for mesh repair of the hiatal defect but they roughly fall into two categories: (i) mesh is used as an on-lay buttress re-enforcement of the © 2005 Surgeon 3: 3; 125-138

Figure 1: Toupet crurally xed posterior partial fundoplication.

Figure 2a: Massive hiatal hernia (Type III).

crural repair by interrupted sutures and (ii) mesh is used to close the defect around the oesophagus without any attempt at crural approximation. There are no studies on the comparative efcacy of the two techniques but the author is rmly opposed to the rst category in large hernial defects as the crural closure can only be achieved under great tension, sometimes with obvious splitting of the longitudinal muscle fasciculi of the crura forming gaping holes on either side of the sutures. On the other hand, mesh closure of the defect around the oesophagus creates a tension-free repair, which will not disrupt with coughing or vomiting in the post-operative period (Figures 2a and b). It has been estimated that the world epidemic of obesity and morbid obesity aficts 1.7 billion people and although bariatric surgery today is the only effective therapy for morbid obesity, only about 1% receive this treatment. In a report of a recent email survey to 31 International Federation for the Surgery of Obesity The Royal Colleges of Surgeons of Edinburgh and Ireland

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(IFSO) nations and national groups to gauge extent and type of bariatric surgery practice for the year 2002-2003, 146,301 such operations were performed by 2,839 bariatric surgeons; 103,000 of these in the USA and Canada.25 In this multinational survey, 63% of the operations were performed laparoscopically and 37% by open surgery. The six most popular operations were: laparoscopic gastric bypass (26%), laparoscopic adjustable gastric banding (24%), open gastric bypass (23%), laparoscopic long-limb gastric bypass (9%), open long-limb gastric bypass (7%), and open vertical banded gastroplasty (4%). These data conrm that laparoscopic bariatric surgery has largely replaced open surgery for morbid obesity because it reduces dramatically the morbidity (predominantly pulmonary) inevitable in these patients after an extensive laparotomy. The laparoscopic approach has also lead to a novel procedure for dealing with this most common disorder by banding which has the undoubted merit of easy reversibility and, more importantly, it does not alter the anatomy and physiology of the upper gastrointestinal tract.26,27 A study on disease-specic QoL after laparoscopic banding showed signicant improvement at 12 months follow-up, which was maintained at a median of 28 months following operation. Laparoscopic banding does not promote gastroesophageal reux and appears to protect against reux provided the operation is not followed by pouch formation. The band technology has evolved into low-pressure narrow devices. The technique of insertion of the bands has improved over the past 10 years, with the pars accida replacing the initial peri-gastric technique, as it appears to reduce the slippage rate. More recently, the exact location of the band has been moved up from 1cm to 2cm below the O-G junction to the junction itself. There is now a sufciently large reported experience to conrm that laparoscopic banding performed expertly works and induces signicant weight reduction with acceptable morbidity, which occurs during the rst three years. Serious major complications such as gastric erosion are rare with experience and use of the low-pressure systems. The weight loss is, however, not as pronounced as that following laparoscopic gastric bypass, which is currently practiced to the same extent.28-30 The concern I have with this operation relates to the long-term sequelae of this unphysiological operation. Even more problematic to the long-term health of these unfortunate patients is the procedure of bilio-pancreatic diversion with duodenal switch, which induces massive malabsorption and bacterial overgrowth. Laparoscopic vertical banded gastroplasty is also practiced but only in a few centres with reported results being equivalent to gastric banding. A recent report has provided useful information on the need for laparoscopic cholecystectomy during laparoscopic morbid obesity surgery.31 In this study, if gallstones were identied by intra-operative ultrasound (IOUS), simultaneous laparoscopic cholecystectomy (LC) was performed. Patients without gallstones were put on ursodeoxycholate for six months and scheduled for follow-up with external ultrasound. During the laparoscopic operation (laparoscopic gastric bypass), gallstones were detected by IOUS in 14% of patients who were assigned to simultaneous LC. Of 189 patients with no stones identied by IOUS, 151 patients had a post-operative ultrasound at six months and 33 of these had developed gallstones (22%) or 12 sludge (8%). Eleven patients developed gallstone-related symptoms and were treated by LC (7%). The 130

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majority of patients (70%) remained gallstone-free at the time of ultrasound follow-up. As this study has demonstrated a relatively low incidence of symptomatic gallstones, routine LC in patients without gallstones at the time of bariatric surgery is not indicated, but chemoprophylaxis with ursodeoxycholate is advisable. Laparoscopic colorectal surgery has, more than any other procedure, created extreme controversy and debate. For many years it has found little favour amongst colorectal cancer surgeons and the establishment. Now that the concerns have been disproved by a large reported experience including randomised clinical trials, and the benets to patient outcome are acknowledged, in some countries including the UK, where surgical coloproctology is a recognised separate surgical specialty, few of the established specialist consultant surgeons are trained to do it, and certainly not enough to cope with the NHS needs.32-35 The proven benets of laparoscopic over open colorectal surgery include better preservation of pulmonary function, less post-operative pain (especially on coughing), reduced time to restoration of GI function and reduced hospital stay. The COST trial has now conrmed that there is no adverse effect on local or distant recurrence.33 This, and other reports, have removed the concerns regarding port site deposits described in some of the early reports and now considered to have been the result of a suboptimal technique. Indeed, there is some evidence that laparoscopic surgery for colorectal cancer may increase disease-free survival in the more advanced stages of the disease. Even if we resolve the surgical manpower issue, the extra cost of laparoscopic colorectal cancer surgery reported by the Swedish group participating in the COLOR trial has to be addressed.35 If the results of this cost analysis study are transferable to the UK, and there is no reason to suppose otherwise, each colorectal cancer operation would cost an extra £1,500 to the NHS. The problem facing the expansion of laparoscopic colorectal cancer surgery in the UK is a two-edge issue: can the consultant colorectal surgeons working within the NHS be brought to the necessary level of prociency to do the operation competently, and can the NHS commit the necessary resource? In the transplant eld, laparoscopic live donor nephrectomy has been a signicant advance. In the rst instance, it has reduced the morbidity and hospital stay of the donor without compromise of the function of the transplanted kidney.36-39 Aside from this, it has resulted in a signicant increase in live kidney donations because of early recovery and better quality of life of the donor. There has been only one adverse report on laparoscopic donor harvest.38 In this retrospective UNOS database analysis, laparoscopic kidney donor procurement was reported as an independent risk factor for rejection during the rst year, particularly for recipients in the 0 to 5 years age group. Obviously further studies are needed to conrm these ndings in relation to paediatric renal transplantation. An important study has stressed the importance of pre-operative imaging of the renal vascular anatomy of the donor by spiral-computed tomo-angiography.39 Laparoscopic donor kidney procurement has also beneted dual kidney-pancreas transplantation in diabetic patients in renal failure. In these patients, the current favoured procedure, in view of its excellent results, is dual living related renal and pancreatic cadaveric transplantation. Although there have been no case control and randomised studies, there is a substantial reported experience of © 2005 Surgeon 3: 3; 125-138

laparoscopic surgery to indicate that this approach has at least the potential to reduce overall post-operative morbidity and accelerate recovery in patients with specic pancreatic disorders. The laparoscopic localisation of biochemically conrmed insulinomas by contact ultrasound scanning of the pancreas (Figure 3) has to be seen as an important advance in the management of these rare tumours although it does not obviate the need for pre-operative localisation by helical CT and endoscopic ultrasound examination.40,41 Likewise, the treatment of these tumours by laparoscopic enucleation or resection of benign insulinomas (3cm) is well-established, although it appears to be accompanied by an increased incidence of minor (low volume) pancreatic stula, which usually resolves spontaneously.42 Laparoscopic distal hemipancreatectomy for larger insulinomas, non-secreting islet cell tumours, and cystadenoma carcinoma is safe and does not appear to jeopardise cure rates in these patients. Spleen-preserving distal pancreatectomy is facilitated by the laparoscopic approach.43 Whenever possible, spleen preservation should be undertaken without sacrice of the splenic vessels (Figure 4) rather than with the Warshaw technique (where the vessels are resected with the specimen and the splenic circulation maintained via the short gastric vessels), as instances of both focal and massive splenic infarction has been reported after the latter technique. Likewise, central pancreatic resections for benign and intermediate malignancy lesions with preservation of the spleen benet from the laparoscopic approach, although the reported literature is not insubstantial.44 There has been a trend during the past 10 years to treat the complications of severe pancreatitis by endosocpic, interventional radiological and laparoscopic approaches. The relatively common pseudocysts can be managed by endoscopic insertion of stents between the gastric lumen and the cyst cavity. This approach appears to be effective in the majority of non-infected cases with minimum debris. The alternative laparoscopic drainage of these pseudocysts appears to be more denitive and is achieved by two approaches (i) transgastic cysto-gastrostomy achieved by use of endolinear cutting staplers and (ii) the infracolic cystoenterostomy through an avascular window of the transverse mesocolon to the left of the middle colic artery favoured by the author.45,46 With either technique, the laparoscopic drainage of pancreatic pseudocysts is associated with a low postoperative morbidity and an effective permanent result since this essentially surgical approach obviates the risk of bleeding and creates a wide communication, enables debridement of the cyst contents and thus minimises the risk of infection or recurrence. The more limited experience of endoscopic laparosocpic necrosectomy for infected pancreatic necrosis is suggestive of improved survival of these seriously ill patients, although there have been no case control studies.45,47 The experience in Dundee and Eindhoven has been with the use of the laparosocpic infracolic approach to the lesser sac (Figures 5a, b, c). The necrosectomy is achieved with dislocation of the infected sequestrum with pulsed irrigation of the lesser sac and piecemeal removal with curved coaxial graspers. The necrosectomy is followed by closed irrigation of the lesser sac with hypertonic dialysate using the Beger regimen. In 13 such patients from the two centres, 11 survived and made a full recovery.

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Figure 3: Laparoscopic ultrasound localisation of a 1.3cm insulinoma close to the splenic vein.

Figure 4: Spleen preserving distal hemipancreatectomy.

Figure 5a: Stage in the Dundee technique of infracolic pancreatic necrosectomy.

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Figure 5b: Stage in the Dundee technique of infracolic pancreatic necrosectomy.

Figure 5c: Stage in the Dundee technique of infracolic pancreatic necrosectomy.

The resection of gastric stromal tumours (GST) by the laparoscopic approach is well-documented and several techniques have been reported.48-50 Undoubtedly, stromal tumours are easily and safely resected laparoscopically, thus saving the patients a laparotomy. However, gastric stromal tumours near the O-G junction or in the pyloric antrum close to the duodenum and posterior wall lesions may pose technical problems when attempted laparoscopically. Nonetheless, the results reported in the literature laparoscopic resection of GST has become the treatment of choice. Wedge resection rather than enucleation is recommended. Gastric resections for early gastric cancer are safe and appear to benet the patient in terms of earlier recovery without compromising cure rates.51-54 Less certain are extensive D2 resections for advanced gastric and gastroesophageal cancer. Undoubtedly, the exposure of the upper stomach and hiatus is facilitated. The radicality and clinical outcome of these patients in the short-term appear to be similar to open resections, but in most series the follow-up is signicantly less than ve years. The same considerations apply to oesophagectomy for cancer when there appears to be, in the more recent larger series, a reduction in the post-operative pulmonary morbidity and reduced use of intensive care.55-59 © 2005 Surgeon 3: 3; 125-138

Figure 6: laparoscopic left hepatectomy.

Laparoscopic liver resections (Figure 6) have also been established in many centres and the results have been uniformly favourable, especially for left lobectomy and plurisegmentectomies, although right hepatectomy has been performed by the laparoscopically assisted or HALS approach.60-63 The commonly reported benets include reduced blood loss, smoother post-operative period in patients with liver disease and a shorter post-operative hospital stay. Laparoscopic left lateral lobectomy (bisegmentectomy 2-3) for tumours can be performed with relative ease and safety. In a recent case control study, 60 such laparoscopic resections using ultrasonic dissection and linear staplers and portal pedicle clamping when necessary, were compared with patients who underwent open left lateral lobectomies matched and selected from a liver resection database of open resections.63 Both groups were similar (age, type and size of the tumour presence of underlying liver disease). The ndings of this study showed that compared with equivalent open hepatic resections, laparoscopic left lateral lobectomies incurred a longer surgical time and longer portal triad clamping (39 minutes versus 23 minutes), but were associated with decreased blood loss. There were no deaths in either group, and the morbidity rates were comparable (11% in the laparoscopic and 15% in the open group). There were no major post-operative complications of hepatic resection (haemorrhage, subphrenic collection, or biliary leak) after laparoscopic resections, but some were observed in the open hepatic resections. There have been many reports of laparoscopic in situ ablation for hepatic tumours (primary and secondary), although data on detailed long-term follow-up to establish recurrence have been scanty. The technologies used include RF thermal ablation (most popular), microwave thermal ablation and cryotherapy. All reports conrm low morbidity and early recovery and some retrospective reports on ablations of deposits from colorectal cancer have indicated survival comparable with hepatic resections.64 A more recent prospective study reported on the safety of RF thermal ablation in 16 patients undergoing this ablation as an additional procedure to various colorectal procedures (loop ileostomy closure, laparoscopicassisted right hemicolectomy, laparoscopic-assisted anterior resection, open transverse colectomy, open anterior resection, The Royal Colleges of Surgeons of Edinburgh and Ireland

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open loop transverse colostomy formation).65 The only complication was a right ank abscess after laparoscopicassisted right hemicolectomy. These data indicate that RF ablation, contrary to hepatic resection, may be used with safety to treat liver metastases at the time of laparoscopic or open colonic resections. At the time of writing, the procedures of uncertain benet include pancreaticoduodenectomy and laparoscopic right hepatectomy.66-68 Even with the current technology, the total laparoscopic approach for these operations is too technically demanding to be a realistic proposition, although the HALS technique is certainly easier and reduces the operating time. The feasibility of these operations amongst experienced laparoscopic surgeons is beyond question but, at least in the author’s experience, the benets over the open approach, considering the increased surgical effort, stress and operating times, are inconsequential. Undoubtedly, these procedures should only be performed in specialised centres by surgeons who have considerable experience in advanced laparoscopic surgery and specialised expertise in major hepatic and proximal pancreatic resections. There are some who would take issue with me in listing under the category ‘Operations that appear to benet the patient’ (Table 2) procedures they consider to be of undoubted benet to the patient outcome. The basis of my categorisation used in Table 2 is on the quality of published evidence. It is for this reason that I have placed rectal surgery (anterior resection in particular) in this category as although I believe it offers the same benets as colon surgery based on many published retrospective reports, there have been no level I evidence to conrm its likely benet; undoubtedly it will come, but we must wait for it. The same applies to laparoscopic inguinal hernia repair and appendicectomy. In addressing this contentious issue, the operations listed in both categories have been chosen as ‘marker’ operations and neither category is all inclusive.

EXISTING ISSUES AND PROBLEMS Over the years, the signicant benets of laparoscopic surgery have been marred by iatrogenic injuries, which regrettably are still witnessed despite technological advances and establishment of training laboratories. It is now imperative that we seek quality assurance in the practice of laparoscopic surgery by standardising techniques and procedures, training and the establishment of prociency norms in laparoscopic surgery. Quality of care has been dened as that which ‘is expected to maximize patients’ welfare, after taking in account the balance of expected gains and losses that attend the process of care.’ Quality management requires the provision to surgeons of information on expected outcomes for specic treatments (external standards) for comparison with their own clinical results following treatment (specic laparoscopic operations in our case). Regrettably, there are no expected outcomes (external standards) for laparoscopic operations, e.g. expected morbidity and functional results after laparoscopic anti-reux surgery, outcomes after surgery for laparoscopic colo-rectal cancer, etc. These external standards in laparoscopic surgery are a prerequisite to quality assurance, dened as ‘all pre-established and systematic actions necessary to guarantee that a service satises quality requirements of beneciaries.’ We are a long way off achieving this desirable goal in laparoscopic surgery, and national and European associations © 2005 Surgeon 3: 3; 125-138

should address this issue. Quality assurance is the only basis for valid adjudication of operator prociency for specic operations, in other words, that the surgeon is able to execute the operation consistently well to the required level as judged by norm referenced patient outcome. There is perhaps some complacency that the early bad years of laparoscopic surgery are over as a result of improved training and advances in technology for laparoscopic surgery. While the incidence of major iatrogenic disasters has decreased, it remains a problem, and as indicated from reports from the Medical Defence Union, t young patients still die as a result of surgery for benign disease. The real problem underlying such injuries sustained during laparoscopic surgery is that they are often missed, a situation rarely encountered during open surgery. The problem is of course related to training and assessment of competence in laparoscopic surgery – the two are inseparable, and yet objective assessment of technical skills is not currently sufciently and objectively addressed in any of the surgical training programmes, certainly within the UK, despite considerable research on objective methods for assessment of technical skills competence.69-71 Another issue is sufcient resource to establish dedicated operating theatres for laparoscopic surgery, which seems to be a rare occurrence within NHS hospitals. The exacting ergonomic requirements for laparoscopic surgery necessitate theatres essential for optimum execution. Diminished fatigue and stress by the operating team cannot be met by a portable stack wheeled into operating theatres designed for open surgery. More than in any other surgical activity, team spirit and skills achieved only by the group working consistently together underpins safe and smooth execution of laparoscopic surgery. The current training programme within the UK has, for a variety of reasons, become orientated towards the production of two types of surgeons: the generalist surgeon in district general hospitals and the specialist surgeon forming part of a multidisciplinary group working in major regional referral centres. Inevitably, this will translate into a two-tier laparoscopic surgical practice: general and specialised (major). The problem with this is that to date within the UK, the specialist surgeons, e.g. upper GI, hepatobiliary, pancreatic, thoracic, vascular have, with few notable exceptions, declined involvement/training in advanced laparoscopic surgery. On the positive side, some colorectal surgeons are at last waking up to the importance of the new approach for their patients.

FUTURE DEVELOPMENTS It is difcult to predict the future with accuracy. Undoubtedly, there will be further technological advances that will alter practice. The next major development is likely to be in endoluminal surgery, exemplied by the many technologies currently under evaluation for the exible endoscopic treatment of gastroesophageal reux disease (Table 3). With few exceptions in isolated centres, these techniques are currently practised by gastroenterologists; and surgeons have largely been ignoring them. Currently the best results in phase II studies have been obtained by plication techniques with 70% – 80% reux control at 12 months. If these favourable early results are conrmed by larger studies with longer follow-up including RCTs, then trans-oesophageal endoluminal plication may displace laparoscopic anti-reux surgery except perhaps in patients with hiatal hernias. The Royal Colleges of Surgeons of Edinburgh and Ireland

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TABLE 3. ENDOLUMINAL TRANS-OESOPHAGEAL REFLUX PROCEDURES: TECHNOLOGY UNDER REVIEW Injection bulking (not FDA approved) Under endoscopic/ uoroscopic guidance Collagen, PTFE paste, PMMA (Plexiglass beads) Enteryx polymer (ethylene vinyl alcohol with tantal) Endonetics implanted cylinders Endoluminal plication by endoscopic mechanical suturing EndoCinch (Bard, Billerica MA) uses outer overtube (FDA approved) ESD (Wilson-Cook Medical) endoscopic endoluminal device (FDA approved) Full-Thickness Plicator (Ndo Surgical Inc, Manseld MA) - creates single transluminal serosa to serosa plication of GO junction (not FDA approved) Boston Scientic stapling system creates a cardinal plication by 4 – biogegradeable clips Olympus stapling system uses Hiss Wizz material accentuates angle of His Stretta (Curon Medical, Sunny Vale, Ca) RF controlled lesions proximal to GO junction with balloon equipped with NiTi needle electrodes (FDA approved)

It seems likely that the current generation of operating robots, which are really master-slave manipulators based on existing industrial prototypes, will be replaced by a second generation that meets more closely the exacting requirements of laparoscopic surgery. Perhaps some of the interventions will be carried out by programmable re-congurable modular micro-robots. Certainly there is considerable research activity on both sides of the Atlantic within existing bio-robotics centres focussed specically on self-assembly micro-robots for the gastro-intestinal tract. In these systems, the patients swallows the component micro-modules which assemble automatically within the gastro-intestinal tract to form the functioning robot capable of locomotion, detection of mucosal abnormalities by appropriate sensing modules, imaging and biopsy of these lesions. In some American centres even nanorobots based on molecular machines are at the design stage.72-75 On a more immediate and practical level, the technologic advances in communications have lead to a new era of telemedicine. Established applications include telementoring and on remote outpatient management of patients with chronic medical disorders. A recent study has explored the use of the use of telerounding of surgical patients during the immediate post-operative period and reported on patient satisfaction with the system compared with orthodox hospital care.76 In this study, participating patients were entered into one of three postoperative care groups: (i) standard once daily attending bedside rounds; (ii) standard once daily attending bedside rounds and one afternoon telerounding visit; or (iii) exclusive twice daily telerounding visits. Two weeks after hospital discharge, the patients enrolled in the study had to complete a validated patient satisfaction survey with 100% response rate. The results of the survey showed that patients allotted to the telerounding arm demonstrated statistically substantial improvements in ratings of examination thoroughness, quality of discussions about medical information, post-operative care coordination, and attending physician availability even after adjusting for age differences. Whilst it is difcult to conceive total abolition 136

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of the standard post-operative clinical rounds, this study has indicated unexpected patient acceptability for telerounding as a substitute to bedside visits, and it appears to facilitate physician communication with hospitalised patients. Copyright 12 April 2005

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