1 Centre for Minimally Invasive Surgery, Department of Gynecological Sciences and Perinatology, Policlinico Umberto I La Sapienza Università di Roma and 2 First Clinic of Medical Statistics and Biometry, Department of Experimental Medicine and Pathology, Università di Roma La Sapienza, 00161 Rome, Italy
3 To whom correspondence should be addressed: Via G. Del Monte, 13 int. 13, 00197 Rome, Italy. e-mail: cdeangelis{at}tiscalinet.it
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Abstract |
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Key words: compliance/mini-hysteroscopy/office hysteroscopy/pelvic pain/side-effects
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Introduction |
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For these reasons, numerous studies have been carried out in the last decade on the use of local anaesthesia such as paracervical (Finikiotis et al., 1992; Vercellini et al., 1994
; Cicinelli et al., 1998
), intracervical (Broadbent et al., 1992
) or transcervical (Zupi et al., 1995
; Cicinelli et al., 1996
; Cicinelli et al., 1997
; Lau et al., 2000
) anaesthesia; lignocaine spray (Davies et al., 1997
; Zullo et al., 1999
; Soriano et al., 2000
); eutectic mixture of local anaesthetics (EMLA) cream (Stigliano et al., 1997
) before office hysteroscopy; however, its efficacy as a pain-relieving method has not been definitely proven (Wieser et al., 1998
).
The main purpose of our Gynecological Endoscopy Unit has always been to diminish the level of pelvic pain or discomfort felt by the patient during office hysteroscopy in order to make this procedure acceptable and well tolerated; our aim was to make it pain-free and therefore widespread as against its presently limited application in Italy.
An Italian multicentre study (Tantini et al., 2000) evaluated the use of diagnostic and operative hysteroscopy as well as the number of hysteroscopies performed in Italian Gynecological Units every year. A total of 394 Operative Units in public hospitals (50.5% of the departments in our country) and 50 Operative Units in private clinics (27.4%) were surveyed. The results demonstrated that diagnostic and operative hysteroscopies had never been performed in 21.1 and 40.8% of the samples respectively. Within the last study year only 5.7% of the Units had carried out >500 examinations, whereas <300 and <100 procedures per year had been performed by 82.4 and 48% of the Units respectively.
In our previous study, we had investigated the use of an electrical nerve stimulation device as a pain-relieving method during hysteroscopy. The data were extremely positive with reference to the reduction of the level of pelvic pain during office hysteroscopy and greater acceptability of the procedure by the patients (De Angelis et al., 2003).
The aim of the present study was to compare two endoscopes of different calibresa traditional 5 mm Hamou I hysteroscope and a smaller 3.3 mm hysteroscopein order to evaluate the level of pelvic pain, the incidence of side-effects, haemodynamic parameters (heart rate, systolic and diastolic pressure) and the image quality.
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Materials and methods |
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A randomized computer-generated list was used to allocate the subjects into two groups, A and B, of 105 and 102 patients respectively (Figure 1). In group A, diagnostic hysteroscopy was performed by means of a 4 mm traditional optic Hamou I Storz (Tuttlingen, Germany) with a 5 mm thick outer diagnostic sheath; the patients in group B were treated by means of a 2.7 mini-hysteroscope (Circon, USA) with a 3.3 mm diagnostic sheath.
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With the patient lying in a lithotomic position, a bimanual pelvic examination was perfomed; the cervix was then visualized through a small-size vaginal speculum. At this point the hysteroscope was introduced into the uterine cavity without dilating the cervix or using a tenaculum. No pharmacological preparations or local anaesthesia were administered before the examination.
In both groups, hysteroscopy was performed using a 270 W metal halide light source and a 3-CCD Microdigital IIIe enhanced camera (Circon). Once the instrument entered into the uterine cavity, CO2 was delivered by means of an automatic, constant-flow and variable-pressure hysteroflator (Storz, Germany) with a mean flow rate of 2530 ml/min and a 100 mmHg intrauterine pressure limit. The hysteroscopic procedure was not brought to an end in five cases in the Hamou hysteroscope group and in two cases treated with the mini-endoscope (Figure 1).
The indications for hysteroscopy were the same for both groups: abnormal uterine bleeding (AUB) in pre- and post-menopausal age, AUB following HRT; ultrasound indications (endometrial thickening pattern, endometrial polyps); infertility; abnormal cytology; monitoring of the endometrium (tamoxifen therapy, HRT, previous hyperplasia); cervical polyps; post-surgery assessment; and others.
The level of pelvic pain was rated according to a 010 cm visual analogue scale (VAS: 0 = no pain, 13 mild pain, 47 moderate pain, 810 severe pain). Before performing office hysteroscopy, the patients obstetric and gynaecological history was recorded, and both basal blood pressure and heart rate were measured. At the very end of the procedure, the patient was asked to measure the level of pain she had experienced on a VAS. Also the presence of side-effects like shoulder pain, nausea, vomiting, bradycardia (bpm <60), dizziness was recorded, and blood pressure and heart rate were measured again at the end of the examination.
The doctor interviewing the patients was different from the examiner and blinded to the study: as a pain analogue scale she used a plastic ruler with a mobile cursor that the patient would move along a non-graduated line from no pain to extreme pain. The back of the ruler was graduated from 0 to 10 and divided into cm and mm, so that when the patient moved the cursor it would read a precise objective numerical value.
The duration of the procedure(s) and the CO2 flow used during hysteroscopy were evaluated in each group.
All examinations were performed by the same operator (C.D.).
Statistical analysis
A computer-generated randomization list was applied without any restriction, using a Basic program which applies the DOS random function connected to the computer clock. Initially a descriptive analysis of all the variables was made in order to single out any possible abnormal or incorrect data. The mean, being a variable that does not require the normality of the data, was compared using the non-parametric MannWhitney test. The Z-test was applied to compare the proportions. The 2-test was used to evaluate the association of categorical or nominal variables. The BMDP software (release 7, 1993) was used for the statistical analysis. P < 0.05 was considered significant.
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Results |
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The indications for hysteroscopy in both groups were: AUB in pre- and post-menopausal age, abnormal uterine bleeding with HRT (25%); ultrasound findings (endometrial thickening pattern, endometrial polyps) (37%); infertility (6.5%); abnormal cytology (1.5% = three cases with cytological finding of macrophages and hystiocytes with a pathologists indication for an endometrial examination); monitoring of the endometrium (tamoxifen therapy, HRT, previous hyperplasia) (10.5%); cervical polyps (3.5%); post-surgery assessment (12%); and others (4%).
The evaluation of the level of pain the patient had felt during office hysteroscopy on a 10 cm VAS gave some very significant results [group A, mean 4.6 ± 2.2; group B, mean 2.3 ± 2.1; (P < 0.0001) MannWhitney test] (Figure 1, Figure 2). The level of pelvic pain, the main limiting factor to the large-scale use of hysteroscopy, was halved by the use of mini-endoscopes as compared with traditional hysteroscopes.
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As to the incidence of nausea, shoulder pain and dizziness, no statistically significant differences were observed between the groups.
No cases of bradycardia (bpm <60) were seen in group A whereas five cases occurred in group B where the frequency rate decreased temporarily to 56 bpm (Table II). Four of these patients recovered spontaneously without the use of any medication, but the remaining case required the administration of 0.5 mg atropine i.v.
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Systolic and diastolic pressure increased in both groups (systolic pressure: group A, 131.6 versus 134.6 mmHg; group B, 126.9 versus 135.1 mmHg; P = 0.125, MannWhitney test; diastolic pressure: group A, 82 versus 83.7 mmHg; group B, 80 versus 85.5 mmHg, P = 0.84, MannWhitney test) probably as a result of pelvic pain or emotional stress, but these data were not statistically significant.
The small calibre hysteroscope required a higher mean CO2 flow than the traditional hysteroscope (group A, 35.05 ± 2.8; group B, 37.18 ± 4.24 ml/min; P = 0.0016, MannWhitney test). The duration of the procedure was just as long in both groups (group A, 133.6 ± 59.9 s; group B, 130.93 ± 72.64 s; P = NS, MannWhitney test).
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Discussion |
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Even the failure rate of outpatient hysteroscopy is less than half (2%) with the mini-hysteroscope compared with the traditional 5 mm hysteroscope (5%). This means that in at least three cases out of 100 patients, we do not need the operating theatre to perform diagnostic hysteroscopy under general anaesthesia.
The image quality provided by the mini-endoscope with a lens system (2.7 mm) is almost as high as that of the traditional hysteroscopic optics (4 mm) in terms of luminosity, outline definition and width of the visual field.
However, the use of mini-optics did not allow a good observation of the uterine cavity in 5% of the cases. Actually the diameter of the instrument was too small for the specific anatomic conditions of the uterus: a wide open cervical canal, a notably thickened endometrium, and the presence of blood inside the uterine cavity. In these cases, a greater optical lens (5 mm) had to be used to satisfactorily bring the examination to an end.
The advantage of using mini-optics is self-evident if we consider the patients compliance: in most examinations only a slight pain or simply a feeling of discomfort during or at the end of the examination (mean pelvic pain 2.3 ± 2.1 in the 010 VAS) is reported, which is comparable to the level of pain felt during transvaginal ultrasound. Sometimes the worst discomfort is linked only to the introduction or withdrawal of the speculum.
It can be inferred from the above that the great diagnostic advantages of the endoscopic technique and the extremely high acceptance and tolerability by the patients may widen the use of the procedure, as is certainly desirable for the hysteroscopic technique. However, the use of mini-optics entails a suitable pre-training with traditional hysteroscopic optics, which is certainly more indicated to acquire the necessary operative skills and the correct spatial orientation.
Another limitation to the use of mini-optics is its high costs: even though the initial costs do not differ very much, mini-endoscopes are more delicate and wear out more easily than large-calibre instruments, thus requiring more frequent substitutions.
Last, but not least, the higher incidence of bradycardia in the mini-optic group observed in our study must be considered. Such a result was very surprising: actually the smaller calibre and consequently the reduced trauma at the level of the internal uterine os should have led to a lower stimulation of Frankenausers ganglion at the beginning of the vagal stimulus point, and therefore to a lower depression in the cardiac frequency.
Other mechanisms are evidently at work. As found in this study and in a previous investigation (Yang and Vollenhoven, 2002), there is no direct correlation between the level of pain reduction and a lower incidence of bradycardia: a progressive reduction in the level of pelvic pain felt during the endoscopic examination does not correspond to a lower negative stimulus on the cardiac frequency.
We have put forward various assumptions to explain this behaviour. First, the use of a 4 mm Novak cannula in 40% of the cases might have given rise to the vaso-vagal activation. However, in the remaining 60% of the cases, only hysteroscopy with mini-optics had been performed. This means that there is a different cause for bradycardia.
Second, based on the CO2 flow data, we noted that there was a significant difference against the use of mini-optics versus traditional optics (a higher flow for the former). It is then possible that higher CO2 pressure and flow velocity might be required to maintain the CO2 flow constant. Hence it can be assumed that the uterine cavity distends more rapidly and abruptly, with a higher stimulation on the sensitive nerve fibres on the uterine wall. This would somehow produce a vaso-vagal activation.
Finally, as a last assumption, a chemical stimulating effect of CO2 on the nervous ends (see phrenic reflection in laparoscopy for comparison) rather than a mechanical distention of the uterine walls can be considered. In this case, a different outcome should be reached with the use of a liquid as a means to distend the uterine cavity.
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Acknowledgement |
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References |
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Submitted on March 25, 2003; resubmitted on June 16, 2003; accepted on July 28, 2003.