Human Reproduction, Vol. 17, No. 5, 1334-1342,
May 2002
© 2002 European Society of Human Reproduction and Embryology
Laparoscopic surgery is not inherently dangerous for patients presenting with benign gynaecologic pathology. Results of a meta-analysis
1 Service de Chirurgie Gynécologique and 2 Service de Gynécologie Obstétrique, Assistance Publique–Hôpitaux de Paris, CHU Cochin–Saint Vincent de Paul, 75014 Paris and 3 Unité INSERM 149, CHU Cochin–Saint Vincent de Paul, Paris, France
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Abstract |
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BACKGROUND: Laparoscopic surgery presents a large number of advantages over laparotomy. The goal of this work was to check whether these benefits outweigh any greater risk of complications. METHODS: The study design was a meta-analysis of published data from prospective randomized clinical trials (RCT). For the period 1966 to June 2000 we searched Medline and Cochrane Controlled Trial Registers and asked the investigators for further details. Meta-analysis was carried out with the Cochrane review manager software RevMan 4.1. RESULTS: A total of 27 prospective RCT including 3611 women (1809 treated by operative laparoscopy and 1802 treated by laparotomy) were enrolled in the meta-analysis. The overall risk of complications was significantly lower for patients operated by laparoscopic surgery [relative risk (RR) 0.59; 95% confidence interval (CI) 0.50–0.70]. There was no statistically significant difference concerning the risk of major complications with respect to the approach used (RR 1.0; 95% CI 0.60–1.65). The risk of minor complications was significantly lower for patients operated by laparoscopic surgery (RR 0.55; 95% CI 0.45–0.66). Concerning the risks of readmission, second procedure and blood transfusion, there was no difference between the two groups. Identical results were found when we performed a sensitivity analysis including or excluding studies according to the methodological score. Subgroup analysis according to how serious the surgery was (minor, major, advanced) showed a significant increase in the risk of transfusion for advanced procedures performed by laparotomy. CONCLUSIONS: Laparoscopic surgery is not inherently dangerous for patients presenting benign gynaecological pathologies. The potential risk of complications should no longer be advanced as an argument against using laparoscopic surgery rather than laparotomy for an operation when the indication allows the choice.
Key words: complications/laparoscopy/laparotomy/randomized clinical trials/surgery
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Introduction |
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Laparoscopic surgery has developed considerably over the past 15 years in gynaecology. Standard laparoscopic surgery techniques have now been established for a number of benign gynaecological pathologies [ectopic pregnancy (EP), benign ovarian cyst (BOC), salpingoneostomy, myomectomy, hysterectomy etc.]. In the case of adnexal pathology, notably EP and BOC, in certain countries laparoscopic surgery has become the surgical treatment of reference (Pierre, 2000
). Although laparoscopic surgery presents undeniable advantages over laparotomy [less cosmetic impairment; less post-operative pain (Murphy et al., 1992; Mais et al., 1996a; Yuen et al., 1997; Ferrari et al., 2000); 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 shorter recovery period (Murphy et al., 1992; Olsson et al., 1996; Yuen et al., 1997; Ferrari et al., 2000)], certain authors (Grimes, 1992; Hopkins, 2000) still express reservations concerning this surgical approach. One criticism made against laparoscopic surgery is that the technique involves risks of complications that would not have been observed if the operation had been carried out using an open procedure (Hopkins, 2000).
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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Literature search
In order to identify all published RCT comparing the laparoscopy with laparotomy as the approach for gynaecological surgical procedures, Medline and the Cochrane Controlled Trials Register were searched for the period 1966 to June 2000. Randomized Controlled Trial and `laparoscopy' crossed with the following MESH terms: `ovarian diseases/surgery'; `ovarian cysts/surgery'; `hysterectomy'; `urinary incontinence, stress/surgery'; `prolapse/surgery; `gynaecological surgical procedures'; `sterilization, tubal'; `pregnancy, ectopic/surgery'; `uterine neoplasms/surgery'; `leiomyoma/ surgery'; `endometriosis/surgery'; `Fallopian tube diseases/surgery'; `salpingostomy'; `adhesions/surgery'; `infertility, female/surgery', `ovarian neoplasms/surgery'. All titles and abstracts of the resulting studies were then screened to identify those comparing the laparoscopic with the laparotomic approach. The references of each study identified were then cross-checked for other potentially relevant studies. The search was first performed in December 1999, then updated in December 2000 in order to be thoroughly comprehensive up until June 2000.
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: 16–22 points; B = moderate methodology: 10–15 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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Trials included
The search yielded 43 studies. Out of the 43 trials identified, 16 were excluded (Table I
). The reasons for excluding these 16 studies are presented in Table I.
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The remaining 27 trials (Table II
) met the selection criteria and were included in the analysis. The methodology score and the surgical procedure in the 27 prospective RCT selected are presented in Table II.
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A total of 3611 women was enrolled in the meta-analysis. For patients operated by laparoscopic surgery (n = 1809), the mean number of patients in each study was 67.0 ± 151.9 (range 10–819). For patients operated by laparotomy (n = 1802), the mean number of patients in each study was 66.7 ± 146.5 (range 10–791). The surgical procedures carried out in these 27 prospective RCT were the following: tubal ligation (n = 5) (Meyer and King, 1975
; Letchworth et al., 1980; World Health Organization, 1982; Sitompul et al., 1984; Taner et al., 1994), ectopic pregnancy (n = 3) (Vermesh et al., 1989; Murphy et al., 1992; Gray et al., 1995), benign ovarian cysts (n = 6) (Mais et al., 1995; Mais et al., 1996b; Nitke et al., 1996; Yuen et al., 1997; Damiani et al., 1998; Morgante et al., 1998), myomectomy (n = 1) (Mais et al., 1996a), hysterectomy (n = 12) (Nezhat et al., 1992; Phipps et al., 1993; Raju and Auld, 1994b; Kunz et al., 1996; Langebrekke et al., 1996; Olsson et al., 1996; Summitt et al., 1998; Yuen et al., 1998; Falcone et al., 1999; Marana et al., 1999; Perino et al., 1999; Ferrari et al., 2000). The 27 prospective RCT were carried out in the following countries: Italy (n = 8) (Mais et al., 1995, 1996a,b; Damiani et al., 1998; Morgante et al., 1998; Marana et al., 1999; Perino et al., 1999; Ferrari et al., 2000); USA (n = 6) (Meyer and King, 1975; Vermesh et al., 1989; Murphy et al., 1992; Nezhat et al., 1992; Summitt et al., 1998; Falcone et al., 1999); UK (n = 3) (Letchworth et al., 1980; Phipps et al., 1993; Raju and Auld, 1994b); Hong Kong (n = 2) (Yuen et al., 1997, 1998); Sweden (n = 2) (Gray et al., 1995; Olsson et al., 1996); Germany (n = 1) (Kunz et al., 1996); Indonesia (n = 1) (Sitompul et al., 1984); Israel (n = 1) (Nitke et al., 1996); Norway (n = 1) (Langebrekke et al., 1996); Turkey (n = 1) (Taner et al., 1994); World Health Organization (n = 1) (World Health Organization, 1982). This last work (World Health Organization, 1982), included participation of the following centres: Bangkok, Havana, Santiago, Seoul, Singapore, Sydney, Los Angeles and London. For 23 of the studies we were able to note the rate of conversion to laparotomy. No conversion to laparotomy was observed in 14 studies (61%) while 26 conversions to laparotomy were observed in the other nine series.
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: 0.50–0.70) (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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The meta-analysis results according to the importance of the complications (major versus minor) are presented in Table IV
. The overall rate of major complications is comparable whether the patients underwent laparoscopic surgery or laparotomy (RR: 1.00; 95% CI: 0.60–1.65). The overall rate of minor complications is significantly lower for the group of patients operated by laparoscopic surgery (RR: 0.55; 95% CI: 0.45–0.66).
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The meta-analysis results of the secondary outcome (transfusion, readmission, second surgical procedure) do not differ significantly according to whether the patient was operated by laparoscopic surgery or by laparotomy (Table IV
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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: 0.23–0.93) (Table V).
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Discussion |
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Our meta-analysis of all the available prospective RCT comparing the results of laparoscopic surgery with those obtained by laparotomy shows that the overall rate of complications is significantly lower for patients operated by operative laparoscopy, whatever the importance of the surgical procedure carried out (minor, major, advanced). To our knowledge, this work is the first that has enabled such a result to be revealed. Because several prospective multicentre studies had shown a low incidence of complications for laparoscopic surgery in gynaecology (Härkki-Siren and Kurki, 1997
; Jansen et al., 1997; Chapron et al., 1998; Härkki-Siren et al., 1999), we designed a meta-analysis with a sufficiently large number of patients to enable any statistically significant difference to be revealed concerning the overall rate of complications. The lower overall rate of complications observed for patients operated by laparoscopic surgery is due to the fact that the rate of minor complications is significantly lower in the group operated by endoscopy. The explanation for this result lies in the fact that most minor complications are abdominal wall (haematoma, abscess etc.) or infectious problems (urinary infection, unexplained high fever etc.). Laparoscopic surgery involves a low risk of infection (Chapron et al., 1998) and although abdominal wall complications are indeed possible at the points where the trocars are inserted (Boike et al., 1995), it is logical to consider that the smaller size of the scars helps to reduce this risk compared with that observed with a Pfannenstiel incision or a midline laparotomy. Even if these so-called `minor' complications remain in most cases without any long-term serious consequence for the patients, it is essential nevertheless to take them into account when assessing a surgical technique. They do result in prescriptions for their treatment, and some time in rehospitalization and in reoperation that all have their cost. Another important point of this meta-analysis is that the major complications rate was exactly the same in both groups. Because major complications are rare events (Härkki-Siren and Kurki, 1997; Jansen et al., 1997; Chapron et al., 1998; Härkki-Siren et al., 1999), this meta-analysis was not designed to deal specifically with major complications as the primary outcome. However, as the 95% CI for RR of major complications varies from 0.60 to 1.65, even at the upper limit the excess risk of major complications related to laparoscopy might not exceed 1% higher than the same risk with laparotomy. This observation concerning the risk of major complications is an important point because it could have been expected that there would have been an increase in their incidence since the laparoscopic approach itself may result in major complications during setting-up (Chapron et al., 1997). Our results did not corroborate the criticisms made against laparoscopy (Grimes, 1992; Hopkins, 2000)
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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This meta-analysis was not supported by any pharmaceutical company, government agency, or other grant.
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Notes |
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4 To whom correspondence should be addressed. E-mail: charles.chapron{at}cch.ap-hop-paris.fr
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References |
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Submitted on September 27, 2001; accepted on January 1, 2002.
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