Laparoscopic myomectomy: predicting the risk of conversion to an open procedure

Jean-Bernard Dubuisson1,3, Arnaud Fauconnier1, Virginie Fourchotte1, Katayoun Babaki-Fard1, Joël Coste2 and Charles Chapron1

1 Service de chirurgie gynécologique, Clinique universitaire Baudelocque and 2 Service de Biostatistique et d'informatique médicale, Paris, France


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
BACKGROUND: Laparoscopic myomectomy (LM) has some advantages over laparotomy; however, it is reputed to be technically difficult, and the risk of conversion to laparotomy might be an obstacle in using this procedure. The aim of this study was to identify the pre-operative factors affecting the risk of conversion to an open procedure (either laparoscopic assisted myomectomy or laparotomy), and to develop a simple prediction model based on available pre-operative data with the use of multiple logistic regression. METHODS: A total of 426 women presenting with a subserous or intramural myoma measuring 20 mm or more underwent LM between March 1989 and October 1999. Of these patients, 378 had successful LM. Forty eight patients [11.3%, 95% confidence interval (CI) 8.3–14.3] had a conversion to an open procedure. A total of 265 women had adequate pre-operative ultrasonography (US) and were used for the analysis. RESULTS: The best prediction model included four pre-operative factors that were found to be independently related to the risk of conversion: size 50 mm at US (adjusted OR = 10.3; 95% CI = 2.8–37.9), intramural type (adjusted OR = 4.3; 95% CI = 1.3–14.5), anterior location (adjusted OR = 3.4; 95% CI = 1.3–9.0) and pre-operative use of gonadotrophin-releasing hormone (GnRH) agonists (adjusted OR = 5.4; 95% CI = 2.0–14.2). The regression coefficients were then scaled and rounded to integers to provide an estimate of the risk for conversion. For a given patient with selected characteristics the predicted risk varied from 0–73%. CONCLUSIONS: This prediction model provides a useful tool that enables multiple criteria to be taken into account simultaneously to help select cases for LM. GnRH agonists should been used only in selected cases. US evaluation is essential before performing LM.

Key words: conversion risk/laparoscopy/leiomyomas/logistic regression/myomectomy


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Laparoscopic myomectomy (LM) was developed at the beginning of the 1990s, for the treatment of subserous or intramural myomas (Daniell and Gurley, 1991Go; Dubuisson et al.1991Go; Nezhat et al.1991Go; Hasson et al.1992Go). This new procedure has many advantages compared with the approach by laparotomy: hospitalization and convalescence are shortened and post-operative pain reduced (Mais et al.1996Go); LM might reduce the risk of post-operative adhesions compared with laparotomy, which is a considerable advantage in young patients, especially in the context of infertility (Bulletti et al.1996Go; Dubuisson et al.1998aGo).

At present a large number of teams use this technique to remove subserous and intramural myomas. However, LM is still the subject of considerable debate: in particular the technique is reputed to be technically difficult, long, and to involve a high risk of conversion to laparotomy (Daraï et al.1996Go). Dissection of the myoma may be difficult because the cleavage plane is impossible to find, provoking bleeding. The haemorrhage may be abundant. The hysterotomy may be difficult to close because of its length, its location or bleeding. As conversion to laparotomy is more time- and cost-consuming than using laparotomy from the outset, this risk might be an obstacle for diffusion of the procedure, in particular in private practice or in non-teaching hospitals. Knowledge of the characteristics of the patients which influence the risk of conversion to laparotomy could be very helpful when making the decision to perform LM. At present, little is known about the factors related to conversion, and the indications proposed for the laparoscopic approach (diameter <9 cm and no more than two or three myomas) are mostly empirical (Dubuisson et al.1996Go).

Since 1989, we have collected systematic data on women operated on in our centre for LM. The aim of this study was to identify the pre-operative factors affecting the risk of conversion to an open procedure, and to develop a simple prediction model based on available pre-operative data to help minimize this risk.


    Materials and methods
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
All consecutive women presenting with a subserous or intramural myoma measuring 20 mm or more and undergoing LM between March 1989 and October 1999 were included in the study.

A pre-operative work-up was carried out including: abdominal and transvaginal ultrasonography (US); examination of the uterine cavity either by diagnostic hysteroscopy or by hysterosalpingography; and pre-operative haemoglobin concentrations. Gonadotrophin-releasing hormone (GnRH) agonists were sometimes used, depending on the operator's decision, and usually indicated for anaemia and low haematocrit. Treatment consisted of i.m. administration of leuporelin depot (Enantone® LP 3.75 mg; Takeda, Puteaux, France) or triptorelin depot (Decapeptyl® LP 3 mg; Ipsen Biotech, Paris, France) every 4 weeks for 1–6 months prior to LM.

The technique of LM was described previously (Dubuisson et al.2000aGo). Hysterotomy is carried out directly on the prominent part of the myoma using a low voltage electrode (monopolar scissors or hook). Enucleation is made along the cleavage plane separating the myoma and the surrounding myometrium. Haemostasis of the myometrium is achieved progressively using precise bipolar coagulation of the small vessels. The hysterotomy is usually closed in one sero-muscular layer using separate stitches of vicryl 2/0, 0 or 1 (Polyglactine® 910; Ethicon, Neuilly, France). The hysterotomy is sutured in two layers when the myoma is located deeply, or the uterine cavity is opened. Myoma extraction is usually performed by the suprapubic route either directly or using the electric morcellator (Steiner et al.1993Go) depending on the size of the myoma. During the study period LM were performed by 17 surgeons. One of them (J.B.D.) performed more than 50 procedures (n = 285), four of them 11–50 procedures and 12 of them less than 10 procedures.

After each operation, the following data were systematically collected and entered into a database: indication for myomectomy; number of myomas; intra-operative characteristics of each myoma: type (intramural, subserous, or pedunculated), clinical size (measured at laparoscopy), and location of the myomas; presence of adnexal adhesions; associated operative procedures. As the database did not take pre-operative US data into account we had to collect this retrospectively by reviewing charts. The pre-operative US investigations took place in many different centres and some of them did not provide accurate information about the myomas. Therefore, we decided to include in the analysis only those women for whom the US investigation was adequate. Criteria for adequate US were the following: measurement of the diameter of the entire uterus (length, thickness and width), number of myoma and at least the characteristics of the dominant myoma: type (intramural, subserous, or pedunculated), size, and location. Uterine volume was calculated by using the formula for an ellipsoid (0.524xlengthxthicknessxwidth) (Sudik et al.1996Go).

Laparoscopic-assisted myomectomy (LAM) was defined as the use of a minilaparotomy (<5 cm length) to perform either enucleation of the myoma or uterine closure (Nezhat et al.1994Go; Tulandi and Youseff, 1997Go). In our institution we always try to perform the myomectomy entirely by laparoscopy, and therefore recourse to LAM was considered as conversion. Conversion to laparotomy was defined as the need for a standard laparotomy at any time during the procedure, either because of complications or technical difficulties. Women with conversion to LAM together with those who had a conversion to laparotomy were considered as a failure of the laparoscopic approach and were further termed as conversion to an open procedure. Patients who had conversion to an open procedure were compared with the others.

Statistical analyses
Pearson's {chi}2-test was used for the qualitative variables, and Student's t-test for the quantitative variables. Subsequently, logistic regression analysis (Hosmer and Lemeshow, 1989Go) was used to construct a prediction model for conversion to an open procedure. All variables associated with conversion to an open procedure at the threshold of P < 0.10 in the univariate analysis were then tested in a multiple logistic regression model. The final model included only variables independently associated with conversion to an open procedure at the threshold of P < 0.05. Two statistics based on the comparison of observed and predicted values, Hosmer and Lemeshow goodness-of-fit test (Hosmer and Lemeshow, 1989Go) and Harrell's c-index (Harrell et al.1984Go) were used to identify the best predicting model. Certain variables were grouped in order to reduce the number of classes. The parameter values for the final model were estimated by the maximum likelihood method; the adjusted odds ratios and their confidence intervals (CI) were calculated from the model's coefficients and their standard deviations. The reference class was the class for which the risk for conversion was lowest. In order to provide a simple-to-use estimate of the risk for conversion for a given patient with selected characteristics, the regression coefficients of the final model were finally scaled and rounded to integers, according to Cole (Cole, 1993Go). All analyses were performed with SAS software (SAS Institute Inc.).


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
A total of 426 women was operated on during the study period. The indications for LM and the main characteristics of the sample population are given in Table IGo. Measurement of the myoma at US underestimates the clinical size of the myoma (measured at laparoscopy) by 6 mm on average (P < 0.001). The number of myomas detected by US was lower than the number of myomas detected at laparoscopy (1.7 ± 1.4 versus 2.3 ± 1.9; P < 0.0001). Of these patients 378 had successful LM. Forty eight patients (11.3%, 95% CI 8.3–14.3) had a conversion to an open procedure (Table IGo).


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Table I. Main characteristics of the study population (n = 426)
 
In 12 cases the conversion to an open procedure was related to an intra-operative complication (haemorrhage without transfusion: eight cases; haemorrhage with transfusion: three cases; subcutaneous emphysema with hypercapnia: one case). There were no conversions for complications during setting-up. In the other cases conversions were related to technical difficulties (difficulty in achieving cleavage of the myoma: six cases, difficulty during suturing: 30 cases) without complication.

Women who had conversion to an open procedure had longer operative times (162 ± 47 min versus 124 ± 56 min, P < 0.0001), lower post-operative haemoglobin levels (10.7 ± 2.0 g/dl versus 11.5 ± 1.4 g/dl, P = 0.004) and longer hospital stays (4.2 ± 1.3 days versus 2.6 ± 0.9 days, P < 0.0001) than the women who had successful LM.

A total of 265 women had adequate pre-operative US (Table IGo) and were used for the analysis. Pre-operative characteristics of conversion to an open and successful myomectomy are given in Table IIGo. The surgeon's experience was not related to conversion to an open procedure. This risk was stable within the study period (Figure 1Go).


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Table II. Pre-operative characteristics of women with to an open procedure and with successful LM (for the 265 women with adequate pre-operative US)
 


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Figure 1. Risk of conversion to an open procedure according to the year of operation.

 
Size at US, intramural type, anterior location of the biggest myoma and pre-operative use of GnRH agonists were the only factors found to be independently related to the risk of conversion in the final logistic regression model (Table IIIGo). The predictive ability of this model was excellent (c-index = 0.87; Hosmer–Lemeshow statistic = 1.441 with six degrees of freedom, P = 0.96).


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Table III. Parameter estimates for the final model and its derived simplified models (with rounded/scaled coefficients) using logistic regression
 
Optimal scaled and rounded coefficients are given in Table IIIGo. Loss of fit, due to using scaled/rounded coefficients, was negligible. The risk of conversion to an open procedure can thus be estimated in our population by using the score computed by linear combination of the coefficient: score of conversion = 8xsize = >=50 + 6xGnRH prior to LM + 5xintramural + 4xanterior location. The risk for conversion, calculated by appropriate logistic transformation {risk for conversion = exp[–5.79 + 0.29xscore]/[1 + exp(–5.79 + 0.29xscore)]} can then been read in Figure 2Go. For example: a woman with an anterior intramural myoma of 7 cm without pre-operative use of GnRH will have a score of 8 + 5 + 4 = 17 which corresponds to a risk for conversion = 30%.



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Figure 2. Risk of conversion to an open procedure corresponding to the total points score (only possible values of the score were represented). The values A, B, C and D are displayed in Table IIIGo.

 

    Discussion
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
The risk of conversion to an open procedure after LM was higher in cases of myoma measuring more than 50 mm at US, in cases of pre-operative use of GnRH, and in cases of intramural or anterior myoma.

Our study, covering 426 patients, is one of the largest series published in terms of sample population. Furthermore, in our study the type of approach finally used for the myomectomy was collected in a prospective way, thus leading to an unbiased conversion rate of 11.3%. In many studies (Daniell and Gurley, 1991Go; Nezhat et al.1991Go; Hasson et al.1992Go; Miller et al.1996Go; Ostrzenski, 1997Go; Seinera et al.1997Go; Cittadini, 1998Go) the conversion rates are close to zero or not reported (Mettler et al.1995Go; Reich, 1995Go). One hypothesis for explaining this discrepancy is that because of their retrospective design some studies were not able to recognize all the conversions. Other teams have reported conversion rates similar to ours (10.7%) (Mecke et al.1995Go) or far higher (41.4 %) (Daraï et al.1996Go). However, the main criticism concerning our study is the retrospective collection of the US data. Because pre-operative US investigations were carried out in many different centres, for about one third of the women pre-operative US data were not appropriate. These women differed from the others in particular because they presented fewer intramural myomas and the size was smaller. An explanation for this is the fact that when a woman referred to our centre has an inadequate US we only repeat the US investigation when feasibility of the LM appears to be doubtful (i.e. symptoms or pelvic examination evocative of numerous, big and/or intramural myomas). However these differences have no repercussions because when the analysis was performed on the entire population (using the operative characteristics of the myomas) the results were practically the same (data not shown).

The size of the biggest myoma (>=50 mm when measured by US) was found to be the most important predictor of conversion. Although in the univariate analysis we did find a trend between size and conversion rate (Table IIGo), when performing multiple logistic regression this trend disappears and 50 mm remains the only significant cut-off point. This cut-off point might be related to a selection bias: in case of the big myomas the surgeon decided to perform LM only when associated characteristics made them easy to remove. Because of this selection bias our data did not allow us to draw any conclusion about the maximum size of myoma to remove by LM. However, it is very likely that difficulties increase with the myoma size, for many reasons. The biggest myomas will have a highly distended perimyomatous vascularization due to compression by the myoma (Farrer-Brown et al.1971Go; Acien and Quereda, 1996Go), thus increasing the risk of peri-operative haemorrhage. The growth of certain myomas results in reorganization of the myomatous tissues and neighbouring myometrium, making the attachments of the myomas more difficult to cleave. Thirdly, the time required for LM increases with the size of the myoma (Dubuisson et al.2000aGo). Finally, as LM is based on a set of `tractions' (push/pull) in a limited space, the large dimensions of the myoma make the enucleation far more difficult. We therefore recommend that LM should only be performed for myomas not exceeding 8–10 cm (Dubuisson et al.1996Go). However other teams have far higher limits, indeed up to 15 cm (Adamian et al.1996Go; Hasson, 1996Go). In fact our results show that the upper limit that should be proposed mostly depends on other characteristics (i.e. location, depth of penetration) of the myoma. On the other hand in case of myomas measuring <5 cm, LM appears to be feasible even for deep intramural myoma with distortion of the uterine cavity. This type of intramural myoma with submucosal component, even when medium sized (3–5 cm), is likely to give rise to symptoms (Dubuisson et al.1998bGo). In these cases LM could provide an interesting alternative to hysteroscopic resection of the myoma, in particular in cases of fundal or posterior location. Indeed, these cases are difficult to treat by hysteroscopic resection and usually require repeat procedures (Wamsteker et al.1993Go; Donnez et al.1995Go).

Pre-operative treatment with GnRH agonists, whatever the duration of treatment, increased the risk of conversion to an open procedure. This result must be interpreted very carefully because this treatment was not randomly allocated but left to the surgeon's judgement. Two clinical trials where GnRH agonists were randomly allocated (Zullo et al.1998aGo; Campo and Garcea, 1999Go) showed no difference in the conversion rate. However the sample size of each of these studies was not appropriate to detect any difference in the conversion rate. We believe with others (Beyth, 1990Go; Acien and Quereda, 1996Go; Reich et al.1997Go) that pre-operative treatment with GnRH may increase difficulties in identifying and dissecting the cleavage plane between the myoma and its pseudocapsule. On the other hand, there are two main advantages for using GnRH agonists prior to LM: reducing blood loss (Zullo et al.1998aGo; Campo and Garcea, 1999Go) and correction of sideropenic anaemia in a bleeding patient (Crosignani et al.1996Go). If our result is confirmed by other studies GnRH agonists should be used with caution only in selected cases. Ultrasonography with Doppler may be useful for selecting the cases that will most benefit from pre-operative use of GnRH agonists (Zullo et al.1998bGo).

The fact that intramural myoma was an independent predictor of conversion is in agreement with the study by Daraï (Daraï et al.1996Go). The main explanation for this is the difficulty with suturing the deep hysterotomy via laparoscopy particularly, when the myoma is big. Certain authors have emphasized that LM does not provide adequate uterine repair in cases of intramural myoma (Harris, 1992Go; Nezhat, 1996Go). Indeed any technical deficiency affecting this repair may result in uterine rupture during a subsequent pregnancy (Dubuisson et al.2000bGo). It is therefore essential to respect certain rules when suturing by LM: the suture must always take up the full depth of the edges of the hysterotomy and result in total contact over the whole of the myomectomy defect in order to avoid secondary constitution of a haematoma inside the myometrium. It is sometimes necessary to make a suture in several layers. This kind of suture can be carried out by laparoscopy (Dubuisson et al.1995Go; Hasson, 1996Go; Miller et al.1996Go; Ostrzenski, 1997Go). However, i.p. sutures need surgeons who are experienced in laparoscopic surgery.

Anterior location of the main myoma was an independent predictor of conversion. An explanation for this is the fact that the anterior wall of the uterus is less accessible to the operating trocars, in particular when suturing. Curved needles must be taken through the myometrium perpendicular to the serosa incision to provide accurate hysterotomy closure. This is difficult when suturing an anterior hysterotomy. We thus recommend the use of an oblique hysterotomy.

The score proposed here is a useful tool that enables multiple criteria to be taken into account simultaneously (i.e. anterior location, size of intramural myoma, etc.) to help make a decision (Coste et al.1997Go). We have two good reasons for stating that this score can provide an acceptable estimation of the risk. Firstly, the accuracy of the final model used to construct the score was excellent in this study. Secondly, the risk for conversion was relatively independent from either the study period or the experience of the surgeon. However there are several limitations in using this proposed score for estimating the risk of conversion. Firstly, because the baseline conversion rate could vary from 0–41% in other centres (Dubuisson et al.2000aGo), the score would thus provide an absolute risk estimate only in our population. Secondly, as we did not perform any cross-validation studies, it is important to assess the predictive ability of the score in an independent sample (Coste et al.1997Go). In particular, as they are not allowed in France, we did not use any vasopressive derivatives to perform the myomectomy. Use of diluted vasopressin instillation to prevent bleeding during LM is rather common (Daniell and Gurley, 1991Go; Nezhat et al.1991Go; Hasson et al.1992Go; Mecke, 1995; Mettler et al.1995Go; Miller et al.1996Go; Seinera et al.1997Go). As 11 of the 48 conversions were related to a haemorrhage it is difficult to say if the predictive ability of the score would have been the same with the use of those drugs. Furthermore, the score does not take into account two main items of information that could play a major role in the decision to use the laparoscopic approach. Presence of an adenomyoma might increase the risk for conversion (Dubuisson et al.1996Go). As ultrasound criteria for the diagnosis of adenomyosis are available (Chiang et al.1999Go; Atri et al.2000Go), it is thus important to include a systematic search for adenomyosis during US before performing LM. It is also essential to take into account the number of myomas to be removed. The fact that few myomas were found in our patients, and in patients from other studies of LM (Nezhat et al.1991Go; Hasson et al.1992Go; Mettler et al.1995Go; Reich, 1995Go; Daraï et al.1996Go; Seinera et al.1997Go; Cittadini, 1998Go), might suggest the existence of a selection bias. Because of this selection bias we did not find any relationship between the number of myomas and the risk of conversion. It is obvious that in cases of multiple myomas the surgeon decided to perform LM only when the main myomas were moderate in size. However some external arguments lead us to recommend limiting LM to cases with two myomas at most. In the study of Daraï, where the use of LM was not restricted to cases with a low number of myomas, the conversion rate increased with the number of myomas (Daraï et al.1996Go). Furthermore, operative time and difficulties increase with the number of myomas and lead to strain for the surgeon.

Three of the four criteria from the prediction model were derived from US data. This emphasizes that US evaluation is essential before performing LM. About one third of our sample did not have adequate pre-operative US, thus particular caution must be given for performing informative US investigation.


    Notes
 
3 To whom correspondence should be addressed at: Service de chirurgie gynécologique, Clinique universitaire Baudelocque, CHU Cochin Port-Royal, 123 Bd Port-Royal, 75014 Paris, France. E-mail: jean-bernard.dubuisson{at}cch.ap-hop-paris.fr Back


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 Introduction
 Materials and methods
 Results
 Discussion
 References
 
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Submitted on January 3, 2001; accepted on March 27, 2001.





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