1 Service de Chirurgie Gynécologique and 2 Service de Gynécologie Obstétrique, Assistance PubliqueHôpitaux de Paris, CHU CochinSaint Vincent de Paul, 75014 Paris and 3 Unité INSERM 149, CHU CochinSaint Vincent de Paul, Paris, France
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Abstract |
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Key words: complications/laparoscopy/laparotomy/randomized clinical trials/surgery
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Introduction |
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Analysis of the risk of complications is an essential part of the evaluation of any surgical procedure (Chapron et al., 2001). Four important multicentre observational studies were published recently (Jansen et al., 1997
; Härkki-Siren and Kurki, 1997
; Chapron et al., 1998
; Härkki-Siren et al., 1999
). These works, with a large number of patients in each series, allow the mean risk of complications in gynaecological laparoscopic surgery to be estimated at 3.2 per thousand procedures. However, it is impossible to tell from these studies (Härkki-Siren and Kurki, 1997
; Jansen et al., 1997
; Chapron et al., 1998
; Härkki-Siren et al., 1999
) whether or not the technique is accompanied by a greater risk of complications than traditional abdominal surgery (laparotomy). Prospective randomized clinical trials (RCT) are generally recognized as being the most reliable method for evaluating the efficacy of therapies (Byar et al., 1976
). However, the problem with RCT in the field of surgery is the limited number of subjects in each group. The small number of patients in each group does not allow any difference with respect to the risks of complications to be revealed because of their low incidence. This is why we decided to carry out this meta-analysis of prospective RCT. The main question addressed in this meta-analysis was whether the risk of complications with laparoscopic surgery is greater than that observed with laparotomy for patients who need to be operated for a benign gynaecological pathology. To the best of our knowledge, this work is the first to be centred specifically on this question.
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Materials and methods |
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Methological grading
The methodology of each trial was assessed independently by two authors (C.C. and A.F.) according to a score based on established criteria (Chalmers et al., 1981; Dickersin and Berlin, 1992
) (maximum score = 22 points; A = very good methodology: 1622 points; B = moderate methodology: 1015 points; and C = inadequate methodology: <10 points). Disagreements were resolved by discussion with a third epidemiologist (F.G.).
Outcome definition
The main outcome measure was the existence of any complication related to the procedure reported by the authors of the study. Complications were classified as either major or minor complications. Major complications were defined as one or more of the following criteria adapted from those previously published (World Health Organization, 1982; Härkki-Siren and Kurki, 1997
; Chapron et al., 1998
): (i) life-threatening perioperative condition (for example: pulmonary embolism, deep phlebitis, cardio-respiratory arrest, haemorrhage requiring transfusion, peritonitis etc.); (ii) risks of major functional sequelae or events resulting in temporary inability to return to normal working life for at least 3 months (for example: bladder injury liable to result in vesico-vaginal fistula; ureter injury; bowel injury liable to require the installation of an artificial anus; upper genital tract infection liable to result in a risk of extensive pelvic adhesions; adnexectomy, etc.); (iii) major additional surgical procedure during the same or a second anaesthesia (procedures involving the bowel, the major vessels or the urinary tract). Conversion to laparotomy was not considered as a major additional procedure, nor were repeat operations for abdominal wall complications. The minor complications were any complications that did not meet the above criteria (for example: transient high fever, defined as a temperature >38°C on two consecutive measurements 24 h after surgery; urinary tract infection; wound or vault haematoma; wound infection; haemorrhage without transfusion etc.). Secondary criteria were defined as the following: need for transfusion whatever the reason; need for reoperation; need for repeat hospitalization.
Data extraction and analysis
Two authors (C.C. and A.F.) independently extracted data from the papers retrieved and corroborated their findings. Disagreements were resolved by discussion with a third epidemiologist (F.G.). For each study, we submitted all abstracted data systematically to the corresponding author of the study so that he could approve the results or inform us what changes should be made. On each occasion this was required, investigators were asked for clarification about incomplete data reported. This methodology enabled us to gather any data missing from the prospective RCT. In cases of duplicate publication the most up-to-date data were selected, after asking the corresponding author for the study. We also asked for details about the randomization method if not adequately specified in the manuscript. With a computerized data collection form, we then exported the data to RevMan 4.1, from Cochrane Collaboration's program for preparing and maintaining Cochrane reviews. We used a fixed effect model according to the Peto method (Ysuf et al., 1985) to calculate summary relative risks (RR) and 95% confidence intervals (CI). RR are calculated to compare laparoscopic surgery to laparotomy. Continuous outcomes were analysed for individual studies as weight mean difference (WMD) and 95% CI after calculating a pooled SD for the two groups. Inverse variance methods were used to pool WMD by using the fixed effect model. We tested heterogeneity between trials using
2-tests for all analyses, with P
0.05 indicating significant heterogeneity. When heterogeneity arose between the results of the studies, we used a random effects model according to a published method (Dersimonian and Laird, 1986
). All calculations were done with the Cochran review manager software program RevMan 4.1 (Clarke and Oxman, 2000
).
Subgroup analysis and sensitivity analysis
Because the frequency of complications might vary according to different parameters, we performed subgroup analysis according to how serious the surgical procedure was. Operations were classed in one of three groups (minor, major and advanced laparoscopic surgery) according to a classification method published previously (Chapron et al., 1998). Tubal ligation was classified as minor laparoscopic surgery. Major laparoscopic surgery covered operations for which the laparoscopic surgical technique and indications have been well-defined (EP, pelvic inflammatory disease, polycystic ovaries, BOC, salpingoneostomy etc.). Advanced laparoscopy included those operations for which the operative technique and/or indications are currently being evaluated, so that we considered the following as advanced laparoscopic surgery: hysterectomy, myomectomy, lymphadenectomy, bladder neck colposuspension, tubal sterilization reversal, treatment of genital prolapse and retroperitoneal endometriosis.
To test how meticulous the review was, we performed a sensitivity analysis including or excluding studies according to the methodological score.
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Results |
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Meta-analysis
Overall analysis
For the 27 selected prospective RCT, the overall rate of complications was significantly lower for patients operated by laparoscopic surgery (RR 0.59; 95% CI: 0.500.70) (Figure 1). There was no significant heterogeneity between trials (Figure 1
). Using sensitivity analysis, these results are also observed if we excluded the six series (Letchworth et al., 1980
; Sitompul et al., 1984
; Phipps et al., 1993
; Taner et al., 1994
; Nitke et al., 1996
; Kunz et al., 1996
) classified C (Table III
).
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Subgroup analysis
The meta-analysis results when taking into account how serious the laparoscopic surgery procedure was, are summarized in Table V . For each group of operations (minor, major and advanced laparoscopic surgery), the overall risk of complications is significantly lower for patients operated by laparoscopic surgery. The risk of major complications for each group of operations does not differ significantly according to whether the patient was operated by laparoscopic surgery or by laparotomy, while for each group of operations the risk of minor complications is significantly lower for the patients operated by laparoscopic surgery. Patients who underwent advanced procedures ran a significantly lower risk of blood transfusion in the group operated by the laparoscopic route. Concerning the secondary outcomes, the only significant result is the lower risk of blood transfusion in the group of patients who underwent an advanced procedure by laparoscopic surgery (RR: 0.47; 95% CI: 0.230.93) (Table V
).
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Discussion |
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The originality of this meta-analysis lies in the fact that we did not compare any particular type of operation but instead all the procedures used in benign gynaecological surgery, thus permitting the type of approach to be compared independently of the indication. Two points arising from the meta-analysis show that this comparison is meaningful: firstly, the effects followed the same trend in all studies included except for two (Raju and Auld, 1994b; Falcone et al., 1999
); secondly, the results are the same for minor, major and advanced laparoscopic procedures. This latter point seems to us important in that our meta-analysis is liable to broaden the previous findings of the WHO trial (World Health Organization, 1982
) to include major and advanced laparoscopic procedures.
There are several possible criticisms concerning this meta-analysis. Firstly, except for the WHO RCT (World Health Organization, 1982), all the other RCT included were not designed to evaluate complication rates but simply to appreciate the benefits and feasibility of a new procedure. However, all the RCT, except one that was excluded (Burton, 1994
), paid close attention to complications, even in the trials where no complications were observed (Meyer and King, 1975
; Phipps et al., 1993
; Mais et al., 1995
, 1996b
; Nitke et al., 1996
). Furthermore, all abstracted data concerning complications were checked and, if needed, updated by the author of the original RCT. Secondly, our meta-analysis was restricted to published studies, meaning that it may be subject to publication bias. In our opinion it is unlikely that any unpublished data exist for several reasons. RCT comparing surgical procedures are rare and many difficulties are encountered when mounting meaningful trials in endoscopy (Kadar, 1993
; Cotton, 2000
), thus leading to publication even in cases of negative results. In addition, we have heard nothing in the scientific congresses over recent years to indicate the possible existence of any unpublished trial comparing the laparoscopic approach with that of laparotomy.
The risk of complications no longer appears to be a valid argument against carrying out an operation by laparoscopic surgery when the operative indication is appropriate [ectopic pregnancy (Yao and Tulandi, 1997); benign ovarian cysts (Canis et al., 2000
); total hysterectomy (Chapron and Dubuisson, 1995
)]. There are other arguments in favour of widespread use of laparoscopic surgery. The shorter hospital stay (Vermesh et al., 1989
; Olsson et al., 1996
; Yuen et al., 1997
, 1998
; Summitt et al., 1998
; Perino et al., 1999
) and recovery period (Murphy et al., 1992
; Olsson et al., 1996
; Yuen et al., 1997
; Ferrari et al., 2000
) contribute significantly to reduce costs (Murphy et al., 1992
; Ellstrom et al., 1998a
). Last, but certainly not least, one of the major advantages of laparoscopic surgery is that it results in less adhesion formation than laparotomy (Filmar et al., 1987
; Luciano et al., 1989
; Group O.L.S., 1991
; Lundorff, 1991a; Schäfer et al., 1998
). Post-operative adhesions are responsible for intestinal obstruction (Menzies, 1993
; Ellis, 1998
) and infertility (Hershlag et al., 1991
; Fox Ray et al., 1998
) requiring repeated hospitalizations (Ellis et al., 1999
) that have considerable economic impact (Ray et al., 1993
; Ivarsson et al., 1997
).
In spite of all these advantages, it has to be said that although laparoscopic surgery is frequently used in certain countries (Pierre, 2000), it is still far from widespread in others (Härkki-Siren and Kurki, 1997
; Jansen et al., 1997
; Saidi et al., 1999
; Molloy, 2001
). Two important factors that limit the spread of this operative technique are the problems encountered for training the surgeons, and the need to adapt hospital structures to the requirements of laparoscopic surgery. Indeed the risk of complications is inversely proportional to the operator's experience in laparoscopic surgery (Chapron et al., 1998
) and the hospital structures must be capable of adapting to efficient practice of laparoscopic surgery, for this also helps to keep the risk of complications to a minimum (Pierre et al., 1998
) and to reduce the costs (Bachmann et al., 1998
).
The incidence of complications is high in this meta-analysis and in particular the rate of major complications is almost three times the rate found in observational studies (Chapron et al., 1998). RCT are well known for increasing the rate of reported events and this would lead us to expect a higher rate of complication in the studies included in this meta-analysis. However, another explanation could be the difficulties encountered when performing RCT in surgery (Schulz, 1995
; Cosson et al., 1996
; Cotton, 2000
). Although the studies included in this meta-analysis were mostly performed by teams experienced in gynecological operative laparoscopy, the great majority were not the centres that pioneered these new procedures. Moreover, the time between the introduction of a new technique and the RCT may sometimes have been too short for all surgeons to acquire sufficient ability for the technique (Cosson et al., 1996
). It is important to take into account the well-established phenomenon of learning curves in laparoscopic surgery before performing comparative studies (Perino et al., 1999
); it is difficult to estimate what would be the true rate of complications with teams experienced with these techniques. Nonetheless, this meta-analysis provides useful information on the rate of complication to be expected when these techniques are introduced. We now recommend setting up stringent observational studies based on large series that will provide complementary information concerning the risks of gynaecological laparoscopic surgery (Benson and Hartz, 2000
; Concato et al., 2000
; Cotton, 2000
).
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Acknowledgements |
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Notes |
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References |
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Submitted on September 27, 2001; accepted on January 1, 2002.