Gut 1994; 35: 1121-1126

Prospective audit of the introduction oflaparoscopic cholecystectomy in the west ofScotland

G M Fullarton, G Bell, and the west of Scotland laparoscopic cholecystectomy audit group

AbstractAlthough laparoscopic cholecystectomyhas rapidly developed in the treatmentof gall bladder disease in the absence ofcontrolled clinical trial data its outcomeparameters compared with open chole-cystectomy remain unclear. A prospectiveaudit of the introduction of laparoscopiccholecystectomy in the west of Scotlandover a two year period was carried outto attempt to assess this new procedure.A total of 45 surgeons in 19 hospitalsperforming laparoscopic cholecystectomysubmitted prospective data fromSeptember 1990-1992. A total of 2285cholecystectomies were audited (a com-pleted data collection rate of 99%).Laparoscopic cholecystectomy wasattempted in 1683 (74%) patients andcompleted in 1448 patients (medianconversion rate to the open procedure17%). The median operation time in thecompleted laparoscopic cholecystectomypatients was 100 minutes (range 30-330)and overall hospital stay three days(1-33). There were nine deaths (0.5%)after laparoscopic cholecystectomyalthough only two were directly attribut-able to the laparoscopic procedure. Inthe laparoscopic cholecystectomy groupthere were 99 complications (5.9%), 53(3%) of these were major requiringfurther invasive intervention. Fortypatients (2.4%) required early or delayedlaparotomy for major complications suchas bleeding or bile duct injuries. Therewere 11 (0.7%) bile duct injuries in thelaparoscopic cholecystectomy series,five were noted during the initial pro-cedure and six were recognised laterresulting from jaundice or bile leaks.Ductal injuries occurred after a median of20 laparoscopic cholecystectomies. Inconclusion laparoscopic cholecystectomyhas rapidly replaced open cholecystec-tomy in the treatment of gall bladderdisease. Although the overall deathand complication rate associated withlaparoscopic cholecystectomy is similar toopen cholecystectomy, the bile duct injuryrate is higher.(Gut 1994; 35: 1121-1126)

Laparoscopic cholecystectomy has rapidlyemerged as the most popular treatmentoption for the patient with gall stones. 1-7

Despite the widespread acceptance of thisnew technique there have been no formalcomparisons of laparoscopic cholecystectomywith conventional cholecystectomy. Indeedthe requirement for a controlled clinicaltrial of laparoscopic cholecystectomy and opencholecystectomy has been consideredunethical.8

Only one controlled study with com-paratively small numbers has comparedlaparoscopic with a small incision 'minichole-cystectomy' and this study showed an advan-tage for the laparoscopic procedure in termsof more rapid return to normal activities.9Initial uncontrolled reviews of laparoscopiccholecystectomy have shown significantpatient benefit in terms of reduced woundpain and shortened hospital stay7 10-13 butat the expense of an increased bile ductinjury rate7 10 compared with previous datafrom conventional cholecystectomy. Theseuncontrolled studies while accumulating largenumbers of patients have been selective,assessing up to 88% only of all cholecystec-tomies performed.7 The outcome and safety oflaparoscopic cholecystectomy in treating gallstone disease therefore remain unclear.

In this report we describe a prospectiveaudit of the introduction of laparoscopiccholecystectomy in the west of Scotland. Themain aim of this study was to examine thesafety and efficacy of laparoscopic cholecystec-tomy in current surgical practice.

MethodsThe west of Scotland serves a population of2 422 130 and is covered by 15 NHS hospitals(six teaching, nine district general) and fourprivate hospitals. A group of west of Scotlandsurgeons met in September 1990 and agreedto prospectively audit all laparoscopiccholecystectomies in the region over a twoyear period. After this meeting a total of 45surgeons in 15 NHS and four private hospitalscooperated in the data collection as the west ofScotland laparoscopic cholecystectomy auditgroup. This represented 100% of the surgeonsperforming laparoscopic cholecystectomy inthe participating hospitals. Individual surgeonscontributed patient data from their firstlaparoscopic procedure until the study wasterminated in September 1992. Each surgeoncontributed patient data, however, on allcholecystectomies performed over the twoyear study period - that is, from day 1 (firstlaparoscopic procedure) to termination of

Department ofSurgery, GlasgowRoyal Infirmary,GlasgowGM Fullarton

Surgical Unit,Inverclyde RoyalHospital, LarkfieldRoad, GreenockG Bell

Correspondence to:Mr G Bell, Surgical Unit,Inverclyde Royal Hospital,Larkfield Road, GreenockPA16 OXN.

Accepted for publication30 November 1993

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study in September 1992. Data were collectedon a standard proforma but complete collec-tion of audit data was achieved by a researchnurse who visited all participating hospitals,reviewed the operating theatre record books,and completed the documentation fromindividual patient case sheets. The closecooperation between surgical units in the westof Scotland also facilitated data collection.To ensure standardisation it was agreed that

a complication should be defined as anypostoperative problem that delayed hospitaldischarge or required further treatment, orboth. These were further subdivided into:(1) major - a complication that requiredfurther open surgery or invasive intervention(radiological and/or endoscopic), or both; (2)minor - a complication that delayed dischargeor required further non-operative treatment, orboth.A conversion from laparoscopic to open

cholecystectomy was only regarded as acomplication if this was performed for urgentreasons such as haemorrhage, bile duct orbowel injury. Overall complete data collectionwas achieved in 99% of all cholecystectomiesperformed over the study period.

PATIENTSThe 45 surgeons performed a total of 2285cholecystectomies over the two year period.Laparoscopic cholecystectomy was started in1683 patients, median age 48 years (range16-87) and completed laparoscopically in1448 patients (86%). For each surgeon theproportion of patients having laparoscopiccholecystectomy was 74% (median) (range30-99). In the laparoscopic group 97% ofpatients had cholelithiasis, 2% had acalculouscholecystitis, 0-6% had gall bladder polyps,and 0-2% had suspected biliary dyskinesia. In0-2% of cases the diagnosis before operationwas not stated. The median conversion rate toopen cholecystectomy was 17% (range 0-45).

Six hundred and two (26%) patients(median age 56 years (19-88)) had opencholecystectomy as the initial procedure.The commonest reason for patients havingan open cholecystectomy was choledocho-lithiasis (27%), a requirement for other surgery(18%) followed by previous abdominalsurgery (8%), laparoscopic equipmentproblems (5%), and obesity (4%). Sixteenper cent of patients were recruited to aconcomitant 'mini'-cholecystectomy study.In 22% of cases the reason for opencholecystectomy was not stated.

Results

OPERATIVE TECHNIQUELaparoscopic dissection of the gall bladderbed was by diathermy in 95% of patients, 5O/oof patients had dissection by laser (onesurgeon).Of the 1448 completed laparoscopic

cholecystectomies 133 (9%) had operativecholangiograms performed compared with

272 of 602 patients (45°/O) having opencholecystectomy.

OPERATIVE TIMNEOf the 1448 patients completing laparoscopiccholecystectomy the median operation timewas 90 minutes (range 30-330). In the 235patients having open conversion from thelaparoscopic procedure the median operationtime was 105 minutes (30-270). The medianoperation time for open cholecystectomy inthis series was 75 minutes (range 25-345).

OPERATIVE FINDINGS

LaparoscopicOf the 1448 cases completing laparoscopiccholecystectomies, 46% had a normal lookinggall bladder; 32% exhibited signs of chroniccholecystitis; 7% of gall bladders seemedcontracted and fibrosed; 3-5% were acutelyinflamed, 2-2% had mucoceles, and 1% ofpatients had empyemata. In 8% of cases theoperative findings were not described. In 10cases there was unexpected pathology findings.These were cirrhosis (2), pelvic inflammatorydisease (2), healed duodenal ulcer perforations(2), liver metastases (1), choledochal cyst (1),hepatic cyst (1), and a Morgagni hernia (1).

Common bile duct stonesOverall 151 (10%) of patients havinglaparoscopic cholecystectomy had an endo-scopic rectrograde cholangiopancreatography(ERCP) before operation and 42 had anendoscopic sphincterotomy for bile ductstones. Thirty one patients had a postoperativeERCP for suspected retained stones (n= 22) orbile duct injuries (n=9).

At laparoscopic cholecystectomy ninepatients had stones identified by operativecholangiography. Three patients hadconversion to open cholecystectomy with ductexploration. Six patients had postoperativeERCP with four having stones confirmed bythis examination and cleared after endoscopicsphincterotomy.

HOSPITAL STAYThe patients having completed laparoscopiccholecystectomy were discharged fromhospital after three days (range 0-72)compared with nine days (range 1-177) inthose having open cholecystectomy.

RETURN TO WORK OR NORMAL ACTIVITESPatients returned to work or normal activitiesat a median of 12 days (1-144) afterlaparoscopic cholecystectomy compared with35 days (2-161) after open cholecystectomy.

REASONS FOR CONVERSION TO THE OPENPROCEDURE (n=235)The requirement for conversion to an open

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TABLE I Reasons for conversion to open cholecystectomy(n=235) (%o)

Urgent (n=29) Elective (n=206)

Haemorrhage 21 (72) Adhesions 74 (36)Bile duct damage 5 (17) Acute inflammation 45 (22)Bowel injury 3 (10) Ill defined anatomy 45 (22)

Obesity 12 (6)Insufflation problems 12 (5)Instrument failure 5 (2 5)Gall bladder leak 5 (2 5)Duct stones 3 (15)Others 5 (2 5)

cholecystectomy was divided into 'urgent' and'elective' categories. 'Urgent' conversionswere designated for laparoscopic procedureswhere a complication (bile duct damage,haemorrhage or trocar/instrument inducedorgan damage) had occurred necessitatingimmediate conversion. 'Elective' conversionswere designated for laparoscopic procedureswhere it was deemed safer to convert toopen procedure because of intra-abdominaladhesions, severe inflammation, access orinstrument problems or the presence of bileduct stones on operative cholangiography.Of the 29 patients having 'urgent' conver-

sions, 21 had bleeding as the primary reasonfor conversion (Table I). Five patients had bileduct injuries and three had bowel injuriesnoted at the time of laparoscopic cholecystec-tomy leading to conversion.There were 206 'non-urgent' conversions

to open cholecystectomy (Table I). Thecommonest reasons were intra-abdominaladhesions (36%), acute inflammation (22%),and ill defined anatomy (22%) (Table I).

MORTALITYThere were 14 deaths (0-6%) in the 2285cholecystectomies performed over the studyperiod. Nine deaths (0-5%) occurred afterlaparoscopic cholecystectomy although four ofthese occurred in patients who had conversionsto the open procedure (Table II). Five patients(0-3%) died after laparoscopic cholecystec-tomy alone (Table II). Of these only one couldbe directly attributable to the laparoscopicprocedure.

Five patients (0-8%) died after opencholecystectomy.

TABLE II Mortality after laparoscopic cholecystectomy (n= 9) (0-5%)

Daysafteroperation Cause ofdeathAge

Laparoscopic (n=5)78 5 Left ventricular failure60 6 Myocardial infarct, died 24 hours after emergency coronary

artery bypass graft and mitral valve replacement68 2 Myocardial infarct, gastric carcinoma62 Operative Trocar induced aortic perforation71 44 Bile leak, pulmonary embolismConversion from laparoscopic to open (n= 4)71 6 Conversion due to adhesions, peritonitis secondary to small

bowel perforation79 8 Conversion due to poorly visualised anatomy, pneumonia65 3 Conversion due to poorly visualised anatomy, myocardial

infarct55 8 Conversion due to haemorrhage, acute pancreatitis sec-

ondary to impacted bile duct stoneMedian68 (55-78) 6 (0-44)

COMPLICATIONSThere were 99 complications (59%/o) notedin 1683 patients undergoing laparoscopiccholecystectomy (Table III). The complicationwas deemed major in 53 patients (3o/%) with29 patients (1 7%) requiring urgent conversionfor haemorrhage, bile duct or bowel injury(Table III). Of the remaining patientswith major complications, 11 required delayedlaparotomy for bile duct injuries (4), peritonitissecondary to bowel injury (3), haemorrhage(2), or strangulated incisional hernias (2).Overall, therefore, 40 patients (2-4%) requireda laparotomy for complications developingduring or after laparoscopic cholecystectomy.Forty six patients had minor complications(2.8%) after laparoscopic cholecystectomy(Table III).

SEX AND CONVERSION RATEThe overall conversion rate from laparoscopicto open cholecystectomy was higher in malepatients 69/326 (21%) compared with femalepatients 166/1357 (12%) (p<0002) (X2 test).The complication rates, however, after laparo-scopic cholecystectomy were similar in women(6%) compared with men (5%).

BILE DUCT INJURIESThere were 11 (0 7%) bile duct injuries in thisseries of laparoscopic cholecystectomies(Table IV), five of these were recognisedintraoperatively and this resulted in immediateconversion to the open procedure with eitherhepaticojejunostomy or primary duct repairand T tube drainage being performed. Insix patients the bile duct injury was onlyrecognised postoperatively by the developmentof a biliary fistula (n=4) or progressivejaundice (n=2). In four of these patientslaparotomy was performed at a median ofseven days (range 6-30), after initial cholecys-tectomy with either biliary-enteric bypass orsimple repair being performed. Two patientswith bile duct strictures were treated byendoscopic biliary stent insertion (Table IV).The 11 bile duct injuries were incurred by

10 surgeons (nine consultants, one seniorregistrar) after a median of 20 laparoscopiccholecystectomies (range 3-51). Operativecholangiography was performed in two ofthese patients and this was after the ductalinjuries had occurred. Two bile duct injuries(0-3%) occurred in patients having an opencholecystectomy.

DiscussionLaparoscopic cholecystectomy has beenrapidly accepted by patients and surgeonsas the preferred procedure for the treatmentof gall stones.1-5 10-14 Its progression has beenunchecked by the usual constraints of assess-ment by controlled clinical trial because of itswidespread, largely unchallenged, acceptanceby the surgical profession. The advantages oflaparoscopic cholecystectomy include reducedwound pain, lack of scarring, and reduced

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TABLE III Complications of laparo.in 1683 patients

Major (n=53)Urgent conversions:HaemorrhageBile duct injuryBowel injury

Bile duct injuriesBile collectionsIncisional herniasPeritonitis (bowel injury)HaemorrhageSubphrenic abscessCholangitisMinor (n=46)Wound infectionWound haematomaMinor bile collectionsUrinary retentionUrinary tract infectionChest infectionsRetained stonesPneumothoraxAtrial fibrillationTotal

hospital stay with earlier i

normal activity. The majo:laparoscopic procedure relahigher bile duct injury rateopen procedure.7 10

In this large prospectiv4scopic cholecystectomy inScotland population wesome questions relating tefficacy of laparoscopic c}this series we have collectcall cholecystectomies perfsurgeons in the participatundertake laparoscopic chois therefore a true reflectionpractice during each surgto laparoscopic cholecystecollection was aided by theand geographical location ain the west of Scotland.

It is clear from this studlaparoscopic surgery for girapid and probably nOverall 74% of patientsdisease in this seriescholecystectomy with this fiin those surgeons with mclaparoscopic experience.The benefits of laparos

tomy are clear from this atwere discharged home fromlaparoscopic cholecystecto

TABLE iv Bile duct injuries after laparoscopic cholecystectomy (n=

Age Presentation Duct injury Treatment

37 Post operative jaundice CHD transection Hepaticojeju23 Post operative bile leak CBD stricture Choledochoc64 Post operative jaundice CHD clipped Hepaticojeju41 Post operative bile leak CBD and right HD Suture repai:

lacerations50 Post operative bile leak CBD stricture Endoscopic54 Bile leak CBD stricture Endoscopic34 Intraoperative recognition CBD transected Hepaticojeju38 Intraoperative recognition CBD laceration Repair with '63 Intraoperative recognition CBD laceration Repair with26 Intraoperative recognition CBD/cystic duct junc- Repair with'

tion laceration62 Intraoperative recognition Minor CBD laceration Drainage

Median age 38 years (23-64). CHD=common hepatic duct, HD=hepmon bile duct.

scopic cholecystectomy with most patients returning to work or normalactivities by 12 days. We have recently

No % Incidence shown that such clear patient benefits areaccompanied by direct cost savings to hospitalsby adopting laparoscopic cholecystectomy.'5

21 1-2 The overall morbidity associated with3 0-2 laparoscopic cholecystectomy (6%) is similar6 0 4 compared with the open procedure, which has4 0-2 reported morbidity rates of 5-25%.16-19 In3 0 18 this series, 53°/o of our complications were1 006 important requiring therapeutic intervention1 0-06 with either further surgery or interventional8 05 radiology; haemorrhage being the commonest7 04 complication requiring urgent conversion to7 004 the open procedure. The commonest minor5 0 4 complication in this series was wound4 0o2 infection, which occurred despite antibiotic3 0 18 prophylaxis. Some complications noted are3 018 unique to laparoscopic surgery. Three patients

in this study had visceral damage relatedto cannula insertion after induction of the

return to work or pneumoperitoneum. These injuries may ber drawback of the avoided by the insertion of the initial portites to its apparent under direct vision as with the Hassoncompared with the cannula - that is, open laparoscopy.20 The four

complications of incisional hernias through ae audit of laparo- cannula site can also be avoided by directa defined west of fascial closure at completion of laparoscopy.hoped to answer The major concern relating to laparoscopicto the safety and cholecystectomy has been the increased bileholecystectomy. In duct injury rate compared with the opened data in 99% of procedure. Although this was higher at 0-5%ormed by all the in a large series of laparoscopic cholecystec-ing hospitals who tomies7 compared with the figure for openolecystectomy. This cholecystectomy of 0-0.4%18 19 21-23 theof cholecystectomy overall duct injury rate remains unknown butweons introduction of concern.2426 In our series the bile duct-ctomy. The data injury rate is also significantly higher than theclose cooperation previously established figure for open cholecys-

)f the surgical units tectomy. Bile duct injuries occurred duringopen cholecystectomy caused by dissection in

Ly that the trend to poorly visualised areas with unclearall stone disease is anatomy27-29 and such factors seem to pertainiow unstoppable. in the laparoscopic procedure.with gall bladder Certain patterns of bile duct injury duringhad laparoscopic laparoscopic cholecystectomy are emerging.igure rising to 88% Firstly, excessive cystic duct traction may tent:re than two years the common bile duct and lead to misidentifi-

cation of this structure for the cystic duct with;copic cholecystec- clipping or resection of the common bile ductadit. Most patients and often right hepatic artery injury.30hospital after their Secondly, inadvertent clipping of the bile ductmy at three days may occur during hilar bleeding and thirdly

thermal and ischaemic ductal injury through=11) (07%) either injudicious use of diathermy or excessive11) dissection of the cystic/common bile duct

Days junction.25 31 The requirement for surgeons toaoperation operate in a two dimensional field certainly

contributes to misidentification of importantLnostomy 30 structures and the recent development of threeduodenostomy 6nostomy 6 dimensional imaging may help reduce this risk.r 7 With open cholecystectomy the risk of bilestent duct injury was highest between the surgeonsstent 25th and 100th procedure23 and this earlyT tube drainage period also seems to be the laparoscopists mostT tube drainage vulnerable with a bile duct injury at a medianT tube drainage of 20 procedures noted in the current study.

The role of operative cholangiography in,atic duct, CBD=com- prevention of bile duct injuries in open

cholecystectomy is unclear although most

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Prospective audit of the introduction of laparoscopic cholecystectomy in the west of Scotland 1125

authorities accept that an accurate biliary 'roadmap' is at least likely to offer some help in theirprevention.24 25 32 In this series it is notablethat operative cholangiography was performedin only 9%/o of patients having laparoscopiccholecystectomy compared with 45% of opencholecystectomy patients showing a change insurgical practice. In addition, of the 11 ductalinjuries after laparoscopic cholecystectomyonly two had operative cholangiography andthis was performed after the injury had beenproduced. In a newly developing proceduresuch as laparoscopic cholecystectomy, whichseems to carry an increased risk of bileduct injury it seems sensible that morefrequent operative cholangiography should beperformed particularly if the anatomy is in anyway unclear.The avoidance of bile duct injury during

laparoscopic cholecystectomy may also requiremore closely regulated supervision of traineelaparoscopists particularly during their early'learning curve' period. In addition patientswith severe cholecystitis or previous abdominalsurgery may be best treated by conventionalopen cholecystectomy from the outset. Indifficult cases, however, where laparoscopy hasbeen initiated perhaps a lower threshold forconversion to the open procedure would nowseem appropriate. Retrograde dissection ofthe gall bladder in severe inflammation mayalso be helpful in decreasing the likelihood ofductal injuries.The death rate in this unselected series of

laparoscopic cholecystectomy stands at 05%/o,which is comparable with open cholecystec-tomy series. Of the nine deaths only the aorticperforation can be directly attributable to thelaparoscopic procedure, although the smallbowel perforation in the converted patientcould have been a laparoscopic injury. Bothaortic and bowel perforation are clearlytechnically avoidable complications especiallyif open laparoscopy is performed.The treatment of bile duct stones with the

advent of laparoscopic cholecystectomyremains controversial. At present thetechnique of laparoscopic common bile ductexploration and stone retrieval remains feasiblein only a few highly experienced centresworldwide. With this proviso, surgeons in thisstudy initially regarded choledocholithiasis asan indication for an open cholecystectomy.A significant number of patients with choledo-cholithiasis, however, have now been treatedby a minimally invasive combination treatmentof preoperative ERCP, endoscopic sphinctero-tomy, stone clearance, and subsequentlaparoscopic cholecystectomy. Unless bileduct exploration techniques become clearlyestablished this combination seems to be themost acceptable.We conclude that laparoscopic cholecystec-

tomy is rapidly replacing open cholecystec-tomy as the preferred treatment for patientswith gall bladder disease. In this introductoryperiod, although clear patient benefits exist,there is an increased risk of major bile ductinjury with laparoscopic cholecystectomy.More judicious patient selection, increased use

of cholangiography, and earlier conversion toopen procedure may be helpful in decreasingthe ductal injury rate after laparoscopiccholecystectomy.

We wish to thank Mrs Helen Leslie, audit nurse, InverclydeRoyal Hospital, for help in this study and Mrs Annette Bowiefor her secretarial assistance.

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32 Berci G, Sackier JM, Paz-Partlow M. Routine or selectedintraoperative cholangiography during laparoscopiccholecystectomy? Am J Surg 1991; 161: 355-60.

The west of Scotland laparoscopic cholecystectomy auditgroup: MrW R Murray, Mr CW Imrie, Mr J R Anderson, MrJ N Baxter, Glasgow Royal Infirmary; Mr P O'Dwyer, Mr GRamsay, Western Infirmary, Glasgow; Mr D Galloway, Mr AMcKay, Gartnavel General Hospital, Glasgow; Mr J S Smith,Mr D T Hansell, Stobhill Hospital, Glasgow; Mr A Litton, MrG McBain, Mr G T Sunderland, Mr J C Ferguson, SouthernGeneral Hospital, Glasgow; Mr A Mack, Mr D C Smith, Mr IS Smith, Mr G Gillespie, Mr G Gray, Mr J K Drury, Victoria

Infirmary, Glasgow. Districts: Mr P J Shouler, Mr EW Taylor,Mr J R McCallum, Vale of Leven District General Hospital,Alexandria, Dunbartonshire; Mr G Bell, Mr J J Morrice, Mr GOrr, Mr I Watt, Mr D Hamilton, Inverclyde Royal Hospital,Greenock; Mr K G Mitchell, Mr B W A Williamson, RoyalAlexandra Hospital, Paisley; Mr A D McNeill, Mr A Smith, MrW S Hendry, Mr D B Booth, Stirling Royal Infirmary, Stirling;Mr C Moran, Mr B A Sugden, Crosshouse Hospital,Kilmarnock; Mr I McKenzie, Mr M K Browne, Mr R WBrookes, Monklands District General Hospital, Airdrie; Mr JWallace, Law Hospital, Carluke, Lanarkshire; Mr H Campbell,Stonehouse Hospital, Stonehouse, Lanarkshire; Mr D GKnight, Mr J R Richards, Mr J R Goldring, Mr W 0 Thomson,Hairmyres Hospital, East Kilbride, Glasgow.

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