1 Leuven Institute for Fertility and Embryology (LIFE), Leuven, 3 Genk Institute of Fertility Technologies (GIFT), Genk, 4 Department of Obstetrics and Gynaecology, Sint Jan Hospital, Brussels, Belgium and 2 Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia
5 To whom correspondence should be addressed at: Leuven Institute for Fertility and Embryology (LIFE), Tiensevest 168, 3000 Leuven, Belgium. Email: roger.molinas{at}lifeleuven.be
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Abstract |
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Key words: diagnostic/mini-hysteroscopy/office/pain/visualization
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Introduction |
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The most important challenge for the office approach is to reduce patient discomfort to a minimum. This should not be underestimated since many patients still prefer the in-patient approach believing that it will be pain free (Kremer et al., 2000). Several alternatives have been proposed for pain reduction during office diagnostic hysteroscopy, but the results are still inconclusive (Davies et al., 1997
; Nagele et al., 1997
; Wieser et al., 1998
; Wong et al., 2000
; Yang and Vollenhoven, 2002
; De Angelis et al., 2003a
). Over the last years, major technical improvements, such as the use of saline as distension medium (Nagele et al., 1996
), the availability of high-resolution mini-endoscopes (Campo et al., 1999
) and the atraumatic insertion of the instruments (Bettocchi and Selvaggi, 1997
), have led to the development of the mini-hysteroscopy. This technique avoids most traumatic uterine manoeuvres leading to a less painful and better tolerated examination (Cicinelli et al., 2003a
,b
; De Angelis et al., 2003b
) and has increased the feasibility and acceptability of the office diagnostic hysteroscopy. Therefore, it is now recommended as a first line diagnostic tool for the evaluation of abnormal uterine bleeding (AUB) (Cooper and Brady, 1999
; Loverro et al., 1999
) and infertility (Brown et al., 2000
; Nawroth et al., 2003
) and also for operative purposes (Bettocchi et al., 2004
).
The advantages of the mini-hysteroscopy have been reported in many studies (Kremer et al., 2000; Cicinelli et al., 2003a
,b
; De Angelis et al., 2003b
). Since those studies were performed by experienced surgeons and enrolled mostly patients with AUB and with previous vaginal deliveries, it remains unclear whether the same conclusions can be validated for gynaecologists at different levels of training and for patients with other indications and without previous vaginal deliveries. Therefore, this multicentre randomized controlled trial (RCT) was performed to compare the performance of office conventional hysteroscopy versus mini-hysteroscopy and to evaluate the effects of patient parity and surgeon's experience.
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Materials and methods |
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To evaluate the effect of the instrument diameter, patients were randomly assigned with a computer-generated sequence and sealed envelopes to undergo conventional hysteroscopy (group 1, n=240) or mini-hysteroscopy (group 2, n=240). To evaluate the effect of patient parity, women with (groups 1.1 and 2.1) and without (groups 1.2 and 2.2) vaginal deliveries were differentiated. To evaluate the effect of surgeon's experience, the procedures were performed by six gynaecologists with experience in hysteroscopy under general anaesthesia but with different levels of experience in office hysteroscopy, i.e. three experienced surgeons who had performed >1000 office hysteroscopies each before this study (groups 1.1.1, 1.2.1, 2.1.1 and 2.2.1) and three inexperienced surgeons who had not performed any office hysteroscopy before this study (groups 1.1.2, 1.2.2, 2.1.2 and 2.2.2). This experimental design determined a total of eight groups (n=60 in each group) and allowed us to evaluate the effect of three factors, i.e. instrument diameter, patient parity and surgeon's experience (Figure 1).
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Outcome measures
The primary outcome measure was pain, which was scored by the patient with a 10 cm visual analogue scale (VAS, 0 = no pain, 10 = intolerable pain) at the end of the procedure and in the absence of any of the staff involved. The secondary outcome measures included quality of visualization of the uterine cavity, complication rate and success rate, which were scored by the surgeon. Quality of visualization of the uterine cavity was scored with a grading system (0=no, 1=insufficient, 2=sufficient, 3=excellent). Visualization was scored as 0 when the assigned instrument had to be changed, but the patient remained in the assigned group for statistical analysis (intention to treat). Vasovagal reaction, uterine perforation, cervical lacerations and bleeding were recorded as complications. The examination was arbitrarily considered successful only when the pain score was <4, the quality of visualization of the uterine cavity was >1 and no complication occurred, since it was accepted that under these conditions, office hysteroscopy can be offered as a routine first line diagnostic procedure.
All hysteroscopic findings were recorded in a standardized pre-design form. A complete visualization of the cervical canal, uterine cavity and tubal ostia and absence of any anatomical alterations were required to categorize the examination as normal. It was considered abnormal when any major or minor abnormalities, regardless of their clinical significance, were detected. If for any reason, i.e. patient tolerance, technical or anatomical problems, no or insufficient visualization was obtained, it was stated that the examination failed to achieve a diagnosis.
Statistical analyses
Sample size was calculated based on estimates for pain scores. An SD of 2.5 cm in the 10 cm VASmm was found in pilot studies, which is consistent with recent reports (Shankar et al., 2004). To detect a difference of at least 2.5 cm (80% power, 5% significance, two-tailed test) evaluating three factors simultaneously, i.e. instrument diameter, patient parity and surgeon's experience, a sample size of at least 25 patients in each group would be needed. Statistical analyses were performed with the SAS System (SAS Institute, Cary, NC) and the Graph Pad Prism 4 (GraphPad Prism Software Inc., San Diego, CA). Multifactorial analyses were preformed with proc GLM (continuous and ordinal variables) and proc logistic (nominal and dichotomous variables). Unifactorial analyses were performed with MannWhitney and KruskalWallis with Dunn tests (continuous and ordinal variables), and Fisher's exact test (comparison of frequencies). Two-tailed P-values <0.05 were considered significant. Data are presented as means±SE unless otherwise indicated.
Results
All patients included in the study and randomly allocated to conventional hysteroscopy (group 1: n=240) or to mini-hysteroscopy (group 2: n=240) received the assigned intervention and were analysed (Figure 1). The conventional 5.0 mm hysteroscope had to be changed to a mini-hysteroscope in 83 cases, i.e. 12 in group 1.1.1, 14 in group 1.1.2, 27 in group 1.2.1 and 30 in group 1.2.2, but patients remained in the assigned group for statistical analysis (intention to treat). Although the mini-hysteroscopy system included 3.5 and 2.4 mm scopes, the latter was used only in five cases in group 2 and in 13 cases in group 1.
The ages (median, range) of patients in groups 1 (34, 2078 years) and 2 (35, 1970 years) were similar. The number of post-menopausal patients in groups 1 (n=29) and 2 (n=27) were similar. This comparability was also observed for procedures performed by experienced and inexperienced surgeons but, as expected, patients with vaginal deliveries were older and more likely to be post-menopausal than patients without vaginal deliveries (P<0.0001 and P=0.0001; Table I).
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The findings were normal in 263 cases (55%) and abnormal in 197 cases (41%), whereas no diagnosis could be obtained in 20 cases (4%). These findings were distributed similarly in groups 1 and 2, being normal in 128 (53%) and 135 (56%) cases and abnormal in 96 (40%) and 101 (42%) cases, whereas no diagnosis could be obtained in 16 (7%) and four (2%) cases, respectively. An equivalent distribution of findings was also observed according to patient parity, whereas the frequency of abnormal findings in the procedures performed by inexperienced surgeons was relatively higher (P=0.002; Table I).
Mini-hysteroscopy compared with conventional hysteroscopy was associated with less pain (1.8±0.1 versus 3.4±0.2, P<0.0001), better visualization (2.8±0.03 versus 1.7±0.1, P<0.0001) and higher success rates (208 out of 240, 87% versus 105 out of 240, 44%, P<0.0001). The complications rates were, however, similar and very low overall (four out of 240, 1.3% versus eight out of 240, 3.3%, P = NS). All complications were vasovagal reactions, whereas uterine perforation, cervical lacerations or bleeding were not reported.
In a multifactorial analysis, all outcome variables were highly influenced by instrument diameter and patient parity, and slightly influenced by surgeon's experience. Pain scores were lower with mini-hysteroscopy (P<0.0001), in patients with vaginal deliveries (P<0.0001) and when the procedures were performed by experienced surgeons (P=0.02, Figure 2). Visualization scores were higher with mini-hysteroscopy (P<0.0001) and in patients with vaginal deliveries (P<0.0001), but not affected by surgeon experience (P = NS, Figure 3). The complication rate was not affected by instrument diameter (P = NS) and surgeon's experience (P = NS), but it was lower in patients with vaginal deliveries (P = 0.02, Table I). Success rates were higher with mini-hysteroscopy (P<0.0001) and in patients with vaginal deliveries (P <0.0001), but not affected by the surgeon's experience (P= NS, Figure 4).
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The multifactorial analysis also demonstrated that the indication, which was a non-controlled factor, slightly influenced the overall results. In patients with AUB, more pain was seen (P=0.002), less visualization (P<0.05), lower success rates (P=0.02) and more abnormalities (P<0.05) than in patients with infertility.
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Discussion |
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This study demonstrates that mini-hysteroscopy induces less pain and provides better visualization than conventional hysteroscopy, probably due to the less traumatic passage through the cervical canal and the internal ostium. The differences in visualization scores were only related to the quality of visualization of the uterine cavity, rather than to the quality of image itself, since it is obvious that the 4.0 mm optic provides a better image than the 2.7 mm optic. Since the smallest fibreroptic 2.4 mm hysteroscope was required very seldom, our data indicate that the rod lenses 3.5 mm total diameter hysteroscope, combining the advantages of good optical quality and small diameter, is suitable for most cases. Although no differences in complication rates could be detected, probably due to the overall very low values, the success rates were higher with mini-hysteroscopy.
Our data also demonstrated the relative importance of patient parity and surgeon's experience. A better performance was observed in patients with vaginal deliveries and in procedures performed by experienced surgeons when conventional hysteroscopy was performed. This was not surprising since in those patients and in those surgeons, an easier access to the uterine cavity and less traumatic manoeuvres, respectively, can be expected. Interestingly, both patient parity and surgeon's experience were no longer important when mini-hysteroscopy was performed, indicating that a small diameter endoscope can counteract the difficulties determined by the anatomy and by the operator, which broadens the indications for diagnostic hysteroscopy for any patient and for any gynaecologist.
In conclusion, our data demonstrate the importance of instrument diameter, patient parity and surgeon's experience for office diagnostic hysteroscopy. They highlight the clinical relevance of correct instrument selection, especially for inexperienced surgeons and in patients in whom difficult access to the uterine cavity is anticipated. Therefore, this study confirms and extends the advantages of mini-hysteroscopy, indicating its potential as a first line office diagnostic procedure since it is associated with minimal patient discomfort, excellent visualization and very low complication and failure rates.
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Acknowledgements |
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References |
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Submitted on July 23, 2004; accepted on September 17, 2004.
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