Laparoscopic versus open appendicectomy: prospective randomised trial
Summary Randomised assessment of
techniques is difficult. Surgeons need time to become experienced with the methods and tend, when they have experience, to favour one or other approach. We have carried out a prospective randomised comparison of laparoscopic and conventional appendicectomy done by surgeons of comparable experience in patients with suspected acute appendicitis. Postoperative management decisions were made by surgeons other than the operating surgeon. 140 patients were randomly assigned to open (OA) or laparoscopic (LA) appendicectomy (70 each). The age, sex ratio, duration of symptoms, and proportion of patients with histologically confirmed appendicitis was similar in the two groups. Operating time was longer for LA than for OA (mean 70·3 [SD 21·9] vs 46·5 [25·9] min; p<0·001). There were no major intraoperative complications in either group. 14 (20%) patients in the LA group required conversion to an open operation. No significant differences between the groups were found postoperatively for pain score, analgesic requirement, time to reintroduction of diet, or hospital stay. 46 LA patients and 42 OA patients attended follow-up 3 weeks after surgery. Similar proportions had returned to work (36 [79%] vs 31 [74%]). The frequency of wound complications and wound pain after leaving hospital was lower after LA but not significantly so. We conclude that the postoperative course after LA and conventional OA does not differ
Lancet 1993; 342: 633-37
surgery is revolutionising abdominal and thoracic surgery. Encouraging results have been reported, especially for laparoscopic cholecystectomy, the procedure in which the greatest experience has been accumulated. 1,2 Few prospective randomised studies have been done. It has been said that it is unethical to carry out a randomised study of laparoscopic cholecystectomy3 because the surgeon must not favour one operation and informed consent must be obtained from the patient to agree to either type of treatment. The benefits of laparoscopic cholecystectomy are so obvious, it is suggested, that these criteria cannot be
However, these restrictions do not apply to the treatment of
appendicitis. Traditional appendicectomy is already minimally invasive operation peformed through a small, muscle-splitting incision. Laparoscopic appendicectomy was first described in 19804 but it was adopted by few surgeons until lately. The availability of better video systems and the vogue for laparoscopic surgery have increased interest in laparoscopic appendicectomy and there have been many enthusiastic reports. If laparoscopic treatment of appendicitis has significant advantages over acute
major operation laparoscopic approach to any also be advantageous. Thus, laparoscopic appendicectomy is a key procedure in the development of laparoscopic surgery. The rapid development that has occurred so far makes a randomised comparison difficult because appendicectomy is generally done by junior surgeons who have little experience in laparoscopic techniques. The aim of this study was to look for differences in outcome for patients with clinically diagnosed acute appendicitis randomised to either laparoscopic appendicectomy (LA) or open appendicectomy (OA) done by surgeons of similar experience. more
Patients and methods
Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong (J J T Tate FRCS, J W Dawson FRCS, S C S Chung FRCS, W Y Lau FRCS, Prof A K C Li FRCS)
Correspondence to: Prof A K C
All three surgical teams admitting adult general surgical patients to our hospital took part in the study. There were three criteria for entry of a patient: a clinical diagnosis of acute appendicitis, that a grid-iron incision in the right iliac fossa would be a suitable approach, and that the patient was suitable for laparoscopy. There were no defined contraindications to laparoscopy; it was left to the surgeons’ discretion. Thus, if a patient was thought to have appendicitis and routine appendicectomy was appropriate, they were entered in the study. Patients requiring elective, interval appendicectomy were excluded. Computer-generated blocked random numbers were used to assign the type of surgery, which was written on a card sealed in a completely opaque envelope. Envelopes were drawn sequentially by the senior duty nurse in the operating department when an operating theatre was booked-after the clinical decision to operate had been made.
Surgery was done under general anaesthesia. All patients received 1 g cefotaxime and 500 mg metronidazole intravenously at the time of induction of anaesthesia. Premedication was prescribed at the discretion of the duty anaesthetist and was usually omitted. Surgery was carried out as soon as possible after the clinical decision to operate. Surgery at night was not a contraindication to laparoscopic surgery. done by members of the surgical team on duty patient was admitted. Those who carried out laparoscopic appendicectomy had previous experience in this operation, laparoscopic cholecystectomy, or both, and all had attended a training course including surgery in animals. Surgeons with limited experience of the operation (fewer than 10 cases) were assisted by a more experienced colleague. Open surgery was done by surgeons with previous experience of the operation or with supervision by a more senior colleague if such experience was limited. Thus, for both types of surgery, normal training practices continued during the study. For LA, the laparoscope was sited at the umbilicus and two instrument portals placed just above the pubic tubercles. The surgeon and cameraman both stood on the patient’s left side, the surgeon having both hands free to operate. After the diagnosis had been confirmed, the appendicular artery was dissected and divided between haemostatic clips. The appendix stump was secured and divided between catgut loop ligatures (Ethibinder, Ethicon Ltd, Edinburgh, UK) and the appendix cut; the stump was not buried in most cases. The appendix was retrieved through the lumen of one of the ports whenever possible, with insertion of a wide-diameter port or a bag when necessary. Open surgery was done through a muscle-splitting incision in the right iliac fossa. The appendix stump was buried. Urinary catheterisation was not used routinely in either group of patients. A non-inflamed appendix was removed at open surgery. In patients allocated to laparoscopic surgery, a normal appendix was left when another definite cause of the patient’s symptoms was found but removed if there was uncertainty or if no abnormality was found. Saline lavage at the end of the operation was done routinely after laparoscopic surgery but less frequently after open surgery, in line with the surgeon’s normal practice. Operating time was taken as the time from induction of All surgery the day the
Table 1: Details of
around any wound or a discharge. Wound pain without signs of inflammation was not considered a complication. The log-rank test was used on the survival analysis of the main endpoint variables for the two groups (measurements of pain, reintroduction of diet, and hospital stay). Student’s t test was used to compare operating time and visual analogue scale scores. Follow-up data were compared with Fisher’s exact test.
Results the 6-month study period, 142 patients aged 12 years or over met the entry criteria; 2 declined randomisation and were excluded. 70 patients were allocated to each type of surgery. The two groups were similar in age, sex distribution, body weight, and classification of
occupation (table 1). The proportions of patients with histological acute appendicitis (80%) or perforation (17%) were the same in both groups. The operative diagnoses are listed in table 2. The proportion of false-positive diagnoses based on macroscopic appearances was similar for both groups. Similar proportions of patients had normal-looking appendices; another possible cause for their symptoms was found more frequently in the LA group but this difference was not statistically significant. In 1 patient, randomised to OA, caecal diverticulitis was diagnosed and limited right hemicolectomy was done. Another patient in the OA group anaesthesia to the administration of a reversal agent; anaesthesia with a normal appendix was subsequently diagnosed as was induced in the operating room with the patient on the having acute cholecystitis. operating table, in keeping with our normal practice. Each surgeon Laparoscopy was uncomplicated in all patients despite was free to convert a laparoscopic procedure to an open one or to previous surgery in 5 (Pfannenstiel incision in 1, lower extend the wound during open surgery. midline incision in 4). The appendix was visualised either Postoperative care was as the normal practice of the admitting directly or as an inflammatory mass at the pole of the team. Standard analgesia was prescribed to all patients (1 mg/kg caecum in all but 1 patient, in whom the inflamed appendix pethidine intramuscularly every 3 h on demand or 1 g paracetamol was closely adherent to the back of the terminal ileum. The by mouth every 4 h on demand). A treatment course of 3 or 5 days of intravenous antibiotics was prescribed in patients with a perforated appendix was successfully removed from 51 patients and appendix. deliberately left in 5; conversion to open surgery was Every patient was visited at the same time each day by one of two required in 14 (20%). Thus, attempted LA was successful observers to record progress. The number of doses of pethidine in 51 (78%) of 65 patients. The reasons for conversion to given during the previous 24 h was recorded. A visual analogue open surgery were local inflammatory adhesions in 8 scale (10 cm horizontal line without graduations) was completed by patients (including 3 with abscesses), inflammation the patient to indicate the general level of pain and nausea (separate involving the base of the appendix or the caecal wall in 2, an scores) during the previous 24 h. Reintroduction of diet was inflamed retroileal appendix that could not be found under defined as the ability to tolerate an oral fluid intake of at least 100 laparoscopy in 1, and technical difficulties in 3 (camera mL/h (fluid diet) or normal hospital meals (solid diet). The length of hospital stay was the number of days after surgery (day 0) spent failure, inability to retract caecum, gangrenous appendix in the general surgical ward. Any patient transferred to a convalescent hospital for social reasons rather than going directly home was considered to have been discharged. Patients in both groups were given similar verbal instructions to return to normal activity and to work as soon as they felt fit enough to do so. All patients were invited to attend the outpatient clinic of the treating team 2-4 weeks postoperatively. A standard questionnaire was completed by the doctor during the consultation to assess return to work and complications. No definition of return to normal activity was used but occupation was classified into three groups-sedentary, light manual, and heavy manual. The wound was examined for signs of infection. A wound complication was recorded if the patient reported a history of, or had signs of, redness
disintegrated); in all cases a muscle-splitting, left-iliac fossa incision was used. A fourth cannula, in addition to the standard three, was required in 2 patients (3%) for an additional instrument. A large portal or a bag was necessary for extraction of a swollen appendix in 16 (31%) of the 51 patients in whom LA was successful. At OA, the standard incision required extension with muscle division in 5 patients because of either an unusual anatomical position of the appendix or difficult mobilisation in the presence of advanced inflammation. The patient with caecal diverticulitis had a separate midline incision. Thus, the standard grid-iron incision was
inadequate in 6 (9%) patients. LA was done by 10 different surgeons who each treated a mean of 7-0 (SD 4-7) patients and OA by 13 surgeons who treated 5-4 (2-8) patients. 8 surgeons did operations in both groups; laparoscopic operations were generally done by surgeons of more senior grade but all patients were treated by non-consultant staff. Mean operating time was significantly longer for LA than for OA (70-3 [21.9] vs 46-5 [25’9] min, p <0-001). There were no major intraoperative complications among patients in either group.
statistically significant differences for postoperative pain, reintroduction of diet, or hospital stay (table 3). 7 patients in each group had complications in hospital that delayed discharge or necessitated additional treatment (table 3). Acute bronchospasm in 1 patient (LA group) precipitated overnight admission to the intensive therapy unit but he recovered and went home 4 days after the operation. 2 OA-treated patients developed cough productive of purulent sputum; both recovered with additional physiotherapy only. Patients with fever (> 38°C) for longer than 2 days postoperatively (2 LA, 4 OA) underwent abdominal ultrasonography; only 1 patient (24-year-old man) had a positive finding, a small pericaecal fluid collection after LA, which yielded 5 mL fluid on needle aspiration. All six patients improved with antibiotics for 5 days. 1 further patient continued to have right-sided abdominal pain and tenderness after OA and ultrasound scan showed an inflamed gallbladder. Open cholecystectomy was done 3 days after his appendicectomy, but this was not counted as a complication. were no
’Maximum 10. tn=46 LA, 42 OA patients VAS=visuai
Postoperative course and complications
*Days from operation to follow-up. Table 4: Results at follow-up
Similar proportions of the LA and OA groups were available for follow-up at an average of 3 weeks postoperatively. No data were available for patients who did not attend; because our hospital has a large catchment area, patients may consult a local clinic rather than return to the hospital. Among these patients, the sex and age distribution and proportion with a histologically inflamed appendix did not differ significantly between the OA and LA groups. Similar proportions of patients attending for follow-up had returned to work (table 4). Residual wound discomfort was less common after LA, but not significantly so. A slightly, but not significantly, higher proportion of OA patients had wound complications (24 vs 150,/0)’ Analysis of the same factors when the patients were placed in subgroups according to sex and occupation showed no
significant differences. Discussion This study was undertaken within
our normal hospital practice. We sought to avoid a comparison of one or two experienced and enthusiastic laparoscopic surgeons with the everyday results achieved by junior surgical trainees. The study started when we had sufficient experience of the procedure and adequate numbers of trained staff and does not represent our initial experience in LA. In simple terms of postoperative recovery, we found that LA had little or no advantage over conventional OA. Several large series of LA have drawn the unanimous conclusion that the procedure is better than OA.6-lo These studies all had inadequate or non-existent data on patients treated conventionally to support their conclusions. Of three comparative studies,i’-13 all with relatively small numbers of patients, two showed a slight advantage for LA and one a more striking benefit. Our review of our initial 50 LA cases compared with almost 100 conventional operations11 showed significantly earlier reintroduction of diet and shorter hospital stay but, as we stated, these advantages could be due to case selection because the study was non-randomised. There was no significant difference in postoperative analgesic requirement. A fully randomised study from Dublin showed a 1 day reduction in hospital stay for the LA group, which was statistically significant.12 That study did not attempt to measure postoperative pain although, subjectively, it was less after LA. The third study, 13 from a different hospital in Dublin, found significant differences in favour of LA, notably less need for analgesia (by a factor of five) and shorter hospital stay (2-2 vs 4-8 days).14 These results are at odds with our own results and those from the other Dublin study. 12 It is difficult to ensure absence of bias in determining postoperative recovery, especially "fitness for discharge". If a surgeon believes that laparoscopic surgery is
her attitude to patients and their be influenced. In this study, management may postoperative management was decided by several different surgeons, excluding the surgeon who did any individual operation. However, the type of operation each patient had had was known. When comparing hospital stay with our earlier experience," we found the results for LA were the same whereas OA patients were discharged sooner than before. A significant difference that had existed in the first study was lost. It seems knowledge of the type of operation was ignored and all patients having appendicectomy were managed similarly with the expectation that it was safe to follow a more rapid postoperative return to normal activities. Thus, the nature of the disease rather than surgical technique was the rate-limiting factor. Without a reduction in hospital stay, the longer operating time and likely higher capital and maintenance costs of laparoscopic equipment suggest that LA is a more expensive treatment. The operating time for a new laparoscopic procedure will improve with time, but the improvement may be modest (for example, a 20 % reduction after 100 laparoscopic cholecystectomiesl5). Perhaps because training of junior surgeons continued during this study, we observed no improvement compared with our previous experience.11 Both the Irish comparative studies reported that operating time was similar for the two types of surgery12,13 but it is not clear whether all surgeons were of similar experience. Reports of very short operating times may be misleading-some may exclude time taken to set up equipment, establish a pneumoperitoneum, and carry out diagnostic laparoscopy When these factors are included, appendicectomy will probably take a surgeon longer by the laparoscopic procedure. An appendix that is quickly and easily removed by way of the laparoscope would be easy to remove by conventional surgery also. Our finding of similar proportions of patients who had returned to work at follow-up shows that there is no delayed benefit either. However, our follow-up data are relatively crude and the proportion of patients who did not attend is high, although we believe the results given are representative. A more detailed survey of patient recovery, including home visits, was undertaken by Attwood and colleagues in their randomised study;12 they found that LA-treated patients did recover more rapidly after leaving hospital. There is also the benefit of a better cosmetic result in most patients after LA. Whether these social benefits justify an increased hospital cost is open to debate. Diagnostic laparoscopy is promoted as being especially beneficial in female patients. 16-19 In this study, the proportion diagnosed to have pelvic disease was similar in the two groups but appendicectomy was avoided in a higher proportion of such patients randomised to LA than to OA. It is not clear whether this difference represents an advantage; the risks from appendicectomy once the patient is already anaesthetised are low and are probably no greater than the risk of complications directly attributable to laparoscopy.20 Also, there can be no confusion if the appendix has been removed and symptoms recur in the future. If disease of the appendix or other viscus is not recognised, a "normal" laparoscopy may falsely reassure the clinician after the operation. Saving the appendix for future reconstructive use by plastic surgeons and urologists2l is likely to benefit a very small number of patients. However, surgeons tend to keep appendicectomy incisions as small as possible, which limits the scope to diagnose other disorders, and it seems likely that diagnostic
laparoscopy would accrue a significant advantage in suspected appendicitis with time. A large series would be
needed to show whether this theory is correct. The wound complication rate was higher than expected in our LA patients. Wound infections are not unknown after laparoscopic surgery, but it has been widely reported that they are less common than is typical for open surgery’ 1,12,22 because contact between the appendix and the wound edge is avoided. It is important to have instruments available that will achieve this objective even if the appendix is very swollen. Conversion of 20% of attempted LA procedures to open surgery compares unfavourably with the 1-2%achieved in some series.7,9 However, reports that include a high proportion of patients who had a normal appendix removed incidentally during laparoscopy should be discounted;bno surgery is technically easier in such cases. Other series include selected cases and almost all represent the work of a single surgeon or a small group of surgeons. Because of local circumstances, many of our patients present late with advanced appendicitis (3 patients requiring conversion had an established abscess at the time of surgery). Such patients were not excluded from randomisation despite our previous experience that LA is more difficult if symptoms have been present for more than 3 days.23 All our surgeons had completed formal laparoscopic training, but individual surgeons’ experience varied and up to 50% of conversions were probably due to effects of experience. In conclusion, our results have shown no difference in the early postoperative course between LA and OA. Even though the cost of laparoscopic treatment may be higher due to longer operating times and equipment costs, the ability to perform a diagnostic laparoscopy should be advantageous in the longer term and there should be a reduction in wound infection rates; we believe these are major benefits that justify a laparoscopic approach. On balance, the decision between a laparoscopic or open operation for acute appendicitis may have to be determined by the individual preferences of patient and surgeon, depending on the resources available. This study does not support widespread adoption of a laparoscopic alternative to a traditional operation based on initial enthusiastic but uncontrolled studies. We thank all the general surgery staff at the Prince of Wales Hospital for their efforts to ensure the successful completion of this study, the staff of the anaesthetic department and the operating theatres for their assistance, Mrs Linda Dawson for data processing, and Mr Denis Leung (Department of Statistical Analysis, Chinese University of Hong Kong) for statistical calculations.
References 1 2
5 6 7 8
Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med 1991; 213: 2-12. Cuschieri A, Dubois F, Mouiel J, et al. The European experience with laparoscopic cholecystectomy. Am J Surg 1991; 161: 385-88. Neugebauer E, Troidl H, Spangenberger W, et al. Conventional versus laparoscopic cholecystectomy and the randomized controlled trial. Br J Surg 1991; 78: 150-54. Semm K. Endoscopic appendicectomy. Endoscopy 1983; 15: 5-9. Tate JJT, Chung SCS, Li AKC. Laparoscopic appendicectomy: a two-handed technique. Br J Surg 1993; 80: 764. Schreiber JH. Early experience with laparoscopic appendicectomy in women. Surg Endosc 1987; 1: 211-16. Valla JS, Limonne B, Valla V, et al. Laparoscopic appendectomy in children: report of 465 cases. Surg Laparosc Endosc 1991; 1: 166-72. Nowzaradan Y, Westmoreland J, McCarver CT, Harris RJ. Laparoscopic appendicectomy for acute appendicitis. J Laparoendosc Surg 1991; 1: 247-57. The Southern
Pier A, Gotz F, Bacher C. Laparoscopic appendectomy in 625 cases: from innovation to routine. Surg Laparosc Endosc 1991; 1: 8-13.
Saye WB, Rives DA, Cochran EB. Laparoscopic appendicectomy; three years’ experience. Surg Laparosc Endosc 1991; 1: 109-15. 11. Tate JJT, Chung SCS, Dawson JW, et al. Conventional versus laparoscopic surgery for acute appendicitis. Br J Surg 1993; 80: 761-64. 12 Attwood ATK, Hill ADK, Murphy PG, Thornton J, Stephens RB. A prospective randomized trial of laparoscopic versus open 10
appendectomy. Surgery 1992; 112: 497-501. 13 McAnena OJ, Austin O, O’Connell PR, Hederman WP, Gorey TF, Fitzpatrick J. Laparoscopic versus open appendicectomy: a prospective evaluation. Br J Surg 1992; 79: 818-19. 14 McAnena OJ, Austin O, Hederman WP, Gorey TF, Fitzpatrick J, O’Connell PR. Laparoscopic versus open appendicectomy. Lancet 1991; 338: 693. 15 Goodman GP, Hunter JG. Results of laparoscopic cholecystectomy in a university hospital. Am J Surg 1991; 162: 576-79. 16 Leape LL, Ramenofsky ML. Laparoscopy for questionable appendicitis: can it reduce the negative appendicectomy rate? Ann Surg 1980; 191: 410.
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Br J Surg 1989; 76: 774-79. JB, Myren CJ, Haahr PE. Randomized study of the value of laparoscopy before appendicectomy. Br J Surg 1993; 80: 922-23. Chamberlain G, Brown J. The report of the working party of the confidential inquiry into gynaecological laparoscopy. London: Royal College of Obstetricians and Gynaecologists; 1978. Wheeler RA, Malone PS. Use of the appendix in reconstructive surgery: a case against incidental appendicectomy. Br J Surg 1991; 78:
19 Olsen 20
1283-85. F, Pier A, Bacher C. Modified laparoscopic appendicectomy in surgery: a report on 388 operations. Surg Endosc 1990; 4: 6-9. 23 Tate JJT, Dawson JW, Lau WY, Chung SCS, Li AKC. Which patients should undergo laparoscopic appendicectomy? Gut 1992; 33: S16 (abstr). 22 Götz
emergency sclerotherapy for variceal
To compare octreotide with injection sclerotherapy in the treatment of acute variceal haemorrhage, patients admitted with gastrointestinal bleeding and oesophageal varices confirmed by endoscopy were randomised to receive either emergency sclerotherapy with 3% sodium tetradecyl sulphate or octreotide (50 µg intravenous bolus plus 50 µg per h intravenous infusion for 48 h). At the end of the study period (48 h), the octreotide group also had sclerotherapy to obliterate the varices. 100 patients were recruited. Demographic features including the aetiology of portal hypertension and the ChildPugh’s grading of the two groups were similar. Bleeding was initially controlled in 90% of patients by emergency sclerotherapy and in 84% by octreotide infusion (95% confidence interval 0-19·5, p=0·55). There were no significant differences between the two groups in early (within 48 h of randomisation) rebleeding (16% vs 14%), blood transfusion (3 units vs 3·5), hospital stay (5 days vs 6 days), or hospital mortality (27% vs 20%). No notable side-effects were associated with octreotide. We conclude that octreotide infusion and emergency sclerotherapy are equally effective in controlling variceal
Oesophageal varices cause about 10% of cases of acute upper gastrointestinal bleeding admitted to hospitals, yet are associated with high mortality (30-50%) compared with other causes of bleeding such as peptic ulcers. The immediate mortality is related to the severity of liver disease assessed by Child-Pugh’s classification.l Methods of controlling bleeding include vasoactive agents, balloon tamponade, and injection sclerotherapy. Vasoactive therapy with vasopressin alone is associated with an unacceptably high rate of major complications.2 Even with the best combination-terlipressin and nitroglycerin-the results are conflicting.3 Native somatostatin reduces splanchnic blood flow,4 and azygous blood flow, a measurement of collateral circulation including variceal
haemorrhage. Lancet 1993; 342: 637-41
Departments of Medicine (J J Y Sung MD, C-W Lai MD, F K L Chan MD, J W C Leung MD, C Kassianides MD) and Surgery (S C S Chung MD, M-Y Yung RN, A K C Li MD), Prince of Wales Hospital, Chinese
University of Hong Kong, Hong Kong Correspondence to: Dr Joseph J Y Sung
flow that falls with an infusion of somatostatin. In addition, the effect of somatostatin on splanchnic circulation is more substantial than that of vasopressin.s However, the very short half-life of somatostatin restricts its use because it must be given with meticulous care to ensure that the infusion is continuous. Octreotide, a synthetic analogue of somatostatin, shares four amino acids with somatostatin and these are responsible for its biological activity. Octreotide has a much longer half-life (1-2 h) than somatostatin (1-2 min) in vivo. Randomised clinical trials have shown octreotide to be more effective than placebo,6 vasopressin and balloon tamponade8 in controlling acute variceal haemorrhage with minimal side-effects. Octreotide has similar effects to somatostatin in cirrhotic patients with little or no effect on systemic vascular resistance and hepatic venous pressure gradient.9 It has variable effects on intravariceal pressure but produces a significant reduction in azygous blood flow.10 So far, very few clinical data on the efficacy of octreotide in controlling acute variceal haemorrhage have been published. We compared the efficacy of octreotide with emergency injection sclerotherapy in the control of acute variceal haemorrhage. 637