Hum. Reprod. Advance Access originally published online on July 14, 2006
Human Reproduction 2006 21(11):2996-3000; doi:10.1093/humrep/del276
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Vaginoscopic versus conventional approaches to outpatient diagnostic hysteroscopy: a two-centre randomized prospective study
1 Service de Gynécologie, SIHCUS-CMCO, Schiltigheim and 2 Service de Gynécologie, CME Le Parc, Colmar, France
3 To whom correspondence should be addressed at: Service de Gynécologie, SIHCUS-CMCO, 19, rue Louis Pasteur, 67303, Schiltigheim, France. E-mail: olivier.garbin{at}sihcus.fr
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Abstract |
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BACKGROUND: To compare the tolerability and feasibility of the transvaginal and standard approaches in outpatient diagnostic hysteroscopy. METHODS: This randomized prospective trial was carried out in two centres to compare the transvaginal (n = 200) and conventional (n = 200) approaches during outpatient hysteroscopy. Patients were randomized by a computer-generated list. The main outcome measure was pain during the examination, measured on a visual analogue scale (VAS) graded from 0 to 10 (0 = lowest, 10 = highest). Secondary criteria were ease of instrument passage through the cervix, investigation quality and its duration. For data analysis, we used the chi-squared test or Fischer’s exact test for qualitative variables and the Mann-Whitney U-test for quantitative variables. RESULTS: Median VAS was rated at 0.5 for the vaginoscopic and 2 for the standard (P < 0.0001) approaches. The approaches did not differ significantly in investigation quality, procedure duration or ease of cervical passage (although the latter was more often easy transvaginally). CONCLUSIONS: The transvaginal approach is better tolerated than the conventional technique in outpatient diagnostic hysteroscopy.
Key words: feasibility/outpatient hysteroscopy/tolerability/vaginoscopic approach
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Introduction |
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Several years ago outpatient diagnostic hysteroscopy replaced dilatation–curettage as the reference method for uterine investigations.
Initially performed under general anaesthesia with scopes 5 mm in diameter and carbon dioxide insufflation, it can now be performed effectively and tolerated well without anaesthesia, because of technical adjustments, including a smaller hysteroscopic diameter (Cicinelli et al., 2003
) and use of saline (Nagele et al., 1996; Pellicano et al., 2003) for distention.
In conventional hysteroscopy, the speculum is used to expose the cervix and the anterior lip is grasped with forceps to permit the intracervical introduction of the hysteroscope. Bettocchi recently described a transvaginal ‘no-touch’ approach, with no instruments to expose or hold the cervix (Bettocchi, 1996; Bettocchi and Selvaggi, 1997), which is reportedly tolerated better. A recent randomized study comparing these two techniques could not demonstrate the superiority of the transvaginal approach, probably because of insufficient statistical power (Sharma et al., 2005).
This study sought to compare the tolerability and feasibility of the transvaginal ‘no-touch’ and standard ‘speculum’ approaches for outpatient diagnostic hysteroscopy.
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Materials and methods |
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This randomized prospective trial took place from 12 May 2003 to 13 September 2004 and compared the transvaginal and classic approaches for outpatient diagnostic hysteroscopy. A university hospital (SIHCUS-CMCO, Schiltigheim, France) and a regional hospital centre (CME Le Parc, Colmar, France) collaborated for this trial. Three hospital staff physicians who usually handled the outpatient hysteroscopies in these hospitals performed all procedures. The randomization, stratified by centre, was performed by a computer-generated list. After obtaining written informed consent, the women were randomly assigned to two groups using numbered sealed envelopes, stored in the physicians" offices.
This study met all French legal requirements for clinical trials and was approved by the regional medical research review committee (CPPRB) on 14 January 2003.
A preliminary prospective non-randomized study conducted in 2002 (unpublished data) included 100 patients at the same two centres and compared perceived pain during the standard (n = 50) and transvaginal (n = 50) approaches with the same scale. VAS was rated at 1.98 ± 1.86 for the vaginoscopic and 2.4 ± 2.01 for the standard approaches (P = 0.14). Its study power was 29%. This preliminary study allowed us to determine that to show a significant difference of 5% between the two methods on the VAS, we would need to enrol a sample of 400 patients.
The inclusion criterion was referral for outpatient diagnostic hysteroscopy.
Exclusion criteria were pregnancy, age <18 years, current genital infection or refusal to participate. Randomization took place after the physician verified the patient’s eligibility and obtained her informed consent. During the pre-procedure interview, patients who agreed to participate drew an opaque sealed numbered envelope from those in the physician’s office.
Outpatient hysteroscopies were performed in a specially equipped room. Patients did not receive anaesthesia or premedication. We used rigid single-flow (panoramic) hysteroscopes with a 2.7-mm diameter and an external sheath diameter of 3.5 mm (Karl Storz®, Tuttlingen, Germany) and used normal saline instillation. Instillation was performed by simple gravity, with the saline placed 1 m above the patient.
The transvaginal approach began by vaginal and cervical disinfection with swab forceps and intravaginal introduction of the hysteroscope. The external cervical os was identified and the examination then conducted as usual.
The standard approach began by using a speculum to expose the cervix, disinfecting it, grasping it with Pozzi tenaculum forceps and further disinfecting the cervix before penetrating the endocervix with the endoscope.
The primary outcome was pain during the examination. Immediately after the procedure, the patient rated the pain on a visual analogic scale (VAS), graded from 0 to 10, in an interview with the nurse, outside the doctor’s presence. Secondary criteria were ease of cervical passage (easy, difficult, impossible), investigation quality (excellent, acceptable, mediocre or unacceptable), both assessed by the operator and examination time measured by the nurse from the time of the first instrument insertion by the physician until the patient rose from the examination table. Failure was defined as the impossibility to pass the cervix.
Statistical analysis was based on the intention-to-treat principle; all patients were therefore analysed in the group to which randomization assigned them. The normality of all quantitative variables was examined by the Shapiro-Wilk test. For data analysis, we used the chi-squared and Fischer"s exact tests for qualitative variables and the Mann-Whitney-U-test for quantitative variables. All tests were two-sided with statistical significance defined as P < 0.05. Statistical analysis was performed using Statview®, version 5.
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Results |
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Population
During the 19-month study period, 479 patients had consulted for hysteroscopy in the two participating centres. Four hundred of these were randomized (83.5%). Non-inclusion occurred due to refusal of participation in the study for the most part.
Among the 400 randomized women, 200 (50%) were included in the standard approach group and 200 (50%) in the vaginoscopic approach group. Each centre included 100 patients in the transvaginal group and 100 patients in the group with the standard approach. The following statistical analysis is based on all 400 included cases (Figure 1).
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Table I reports the baseline characteristics of these 400 women according to their randomization group. The groups were comparable for age, gestity, parity, genital status and indications for hysteroscopy. They were also similar for disorders identified during the examination (Table I). They were not comparable for current medical treatment: the transvaginal group had more women with intrauterine devices (IUDs) and fewer women receiving hormone replacement treatment for menopause than the standard group (P = 0.04).
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One of the three operators performed 200 examinations, the other two 100 each.
Primary outcome
Median VAS was rated at 0.5 (0–9) for the vaginoscopic approach and 2 (0–10) for the standard approach (Table II). This difference was highly significant (P < 0.0001). Mean VASs were respectively rated at 1.49 ± 1.96 and 2.31 ± 2.15 for the vaginoscopic and for the standard approaches (P < 0.0001).
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Secondary outcomes and adverse events
Cervical passage was rated as easy more often with the transvaginal approach, 175/200 (87.8%) compared with 160/200 (79.8%), although this difference was not significant. The groups had identical failure rates, 6/200 (3%) (Table II).
The quality of the examination did not differ significantly (P = 0.22). The number of uninformative examinations was similar, as was their duration: a mean of 248 ± 82 s in the vaginoscopic and 266 ± 99 in the standard groups (P = 0.15) (Table II).
There were two cases of vasovagal syncope, both in the group with the traditional hysteroscopy. We did not have any adverse events.
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Discussion |
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Outpatient diagnostic hysteroscopy has become the reference method for exploration of the uterine cavity. It is not especially well tolerated: in some series 35% of women rated the pain as severe and 17% experience vasovagal syncope (De Iaco et al., 2000
; Cicinelli et al., 2003).
Technical modifications, especially reduction of the hysteroscope diameter, have improved both tolerance and efficacy in retrospective studies and in randomized prospective trials (Nagele et al., 1996; Cicinelli et al., 2003; De Angelis et al., 2003). Randomized studies also show that saline is better tolerated than carbon dioxide and does not impair visual quality (Nagele et al., 1996; Brusco et al., 2003; Litta et al., 2003; Pellicano et al., 2003; Shankar et al., 2004). The usefulness of anaesthetic agents is more controversial. Paracervical block seems not to reduce pain, frequently causes bleeding at the injection site and may increase the vasovagal syncope rate (Lau et al., 1999). Studies with lignocaine spray report discordant results (Lau et al., 2000; Soriano et al., 2000; Wong et al., 2000).
Bettocchi introduced the ‘no-touch’ transvaginal approach, where no instruments expose or grasp the cervix (Bettocchi, 1996; Bettocchi and Selvaggi, 1997). Several teams that have adopted this procedure report satisfactory results (Bettocchi, 1996, Bettocchi and Selvaggi, 1997; Paschopoulos et al., 1997; Cicinelli et al., 2003). Nonetheless, those retrospective and prospective studies were not randomized. A recent randomized study compared these techniques, with need for anaesthesia its principal outcome measure (Sharma et al., 2005). The trial did not find a significant difference between the groups, probably because it lacked sufficient power. It differed from ours in numerous points besides the principal outcome measure, including use of two different hysteroscopes (2.9-mm and 4-mm diameters) and frequent use of local anaesthetics and cervical dilatation. This study is to our knowledge the first prospective randomized trial to demonstrate superior tolerance of the transvaginal over the standard approach without any impairment of cervical passage or visual quality.
The conventional approach, which begins by insertion of a speculum and exposure of the cervix, is generally well accepted by patients but can be made difficult or painful by post-menopausal atrophy, vaginal malformation or vaginismus. It is rarely tolerated by virgins. Grasping the cervix with forceps is intended to exert traction to correct uterine anteversion or retroversion but may also cause discomfort or pain. The transvaginal approach begins without preliminary instrumentation; instead, the physician identifies the external cervical os, and the investigation thus starts without nociceptive sensations. This probably explains why the transvaginal approach was better tolerated in our study than the traditional approach (P < 0.001). Our mean VAS with the standard method is close to that reported by several publications that assessed pain in conventional outpatient hysteroscopy, with saline and the same scope we used. De Angelis et al. (2003) reported a mean VAS of 2.3 ± 2.1, nearly identical to our 2.31 ± 2.15. The same is true for Shankar et al. (2004), with a mean VAS of 2.6. Our rate of vasovagal syncope is similar to that reported by Perez-Medina (0.5 versus 0.6%) and lower than Cicinelli’s (2.25%) (Perez-Medina et al., 2000; Cicinelli et al., 2003). In our study, both cases of vasovagal syncope occurred in the group with the traditional hysteroscopy.
The identical failure rates show that tenaculum forceps are not necessary for the examination. We even observed a trend in favour of the ‘no-touch’ approach for ease of cervical passage. Uterine anteversion was not an obstacle in the transvaginal approach. Pressure on the abdominal anterior wall corrected uterine position and facilitated passage. Nonetheless, in pronounced retroversions, the transvaginal approach may require significant upward movement of the hysteroscope, causing pressure on the area between the clitoris and urethral meatus and inducing discomfort. Our failure rate was greater than Cicinelli’s (3 versus 0.5%) and close to the 1.7 in Perez-Medina’s series and the 2% in De Angelis’s (Cicinelli et al., 2003; De Angelis et al., 2003). Difficulties in passing the cervical os, internal or external, seem to be related more to the hysteroscope diameter than to technique (Cicinelli et al., 2003).
The examination did not take longer with the ‘no-touch’ approach. The time lost in identifying the external os is made up by the time saved in placing the speculum and tenaculum. The mean duration reported here is slightly longer than that published by Brusco (2003) (4 versus 3.12 min) and shorter than that reported by Sharma (2005), who found vaginoscopy significantly faster than the standard technique.
The principal drawback to the transvaginal approach is septic risk. The risk of pelvic infection after diagnostic hysteroscopy is certainly underestimated. A prospective study of standard hysteroscopy with CO2 reported a pelvic infection rate of 0.79% (Bracco et al., 1996). These involved Chlamydiae trachomatis infections isolated in the cervical canal. The promoter of the transvaginal approach does not recommend vaginal disinfection (Bettocchi, 1996), and some authors report no infections with this technique (Bettocchi and Selvaggi, 1997; Cicinelli et al., 2003). Perez-Medina (2000) reported two pelvic infections in the 48 h after examination in 2498 vaginoscopic examinations. Infection might nonetheless be transported by the saline or the hysteroscope from the vagina to the uterine cavity, but continuous instillation of saline, constantly washing the end of the scope, probably limits this risk. Cervical mucus, with its well-known bactericidal properties, also helps reduce infection. Our surgical procedure nonetheless begins with disinfection, with the introduction of a swab dipped in antiseptic into the vagina and up the cervix. In our experience, we have not observed infection after a vaginoscopic approach. Nevertheless, the transvaginal approach, like the standard technique, is contraindicated in women with patent genital infection (Cicinelli et al., 2003).
One study limitation is the subjectivity of the secondary criteria, necessarily assessed by the operator who knew the patient’s randomization group. Prudence is required in interpreting these non-significant results for the secondary outcome measures. Another limitation is the significant gynaecological treatment differences between the groups, with more IUDs and less hormone replacement treatment for menopause in the vaginoscopic than in the standard group. These differences, nonetheless, do not seem to have favoured the vaginoscopic approach but rather worked to its disadvantage.
With the transvaginal approach, operative hysteroscopy is possible right after or even at the same time as the diagnostic examination, without anaesthesia. This requires instruments adapted to small-diameter surgical hysteroscopes, an experienced operator, a cooperative patient and limited disease. Porreca and Bettocchi reported a series of 253 polypectomies with instruments five French in diameter (Porreca et al., 1996). This team subsequently reported two series of 501 and then 4863 women, treated for fibromas, polyps, synechiae and septa following the same procedures, with acceptable tolerance and satisfactory results (Bettocchi et al., 2002, 2004). Currently, vaginoscopy is especially indicated for the outpatient placement of hysteroscopic implants for tubal sterilization without anaesthesia (Ubeda et al., 2004)
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Conclusion |
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TopAbstractIntroductionMaterials and methodsResultsDiscussionConclusionReferences |
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This study found that the transvaginal approach is better tolerated than the conventional technique in outpatient diagnostic hysteroscopy.
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References |
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TopAbstractIntroductionMaterials and methodsResultsDiscussionConclusionReferences |
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Bettocchi S. (1996) New era of office hysteroscopy. J Am Assoc Gynecol Laparosc 3:(Suppl 4),, S4.[Medline]
Bettocchi S and Selvaggi L. (1997) A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 4:255–258.[CrossRef][Web of Science][Medline]
Bettocchi S, Ceci O, Di Venere R, Pansini MV, Pellegrino A, Marello F, Nappi L. (2002) Advanced operative office hysteroscopy without anesthesia: analysis of 501 cases treated with a 5 Fr bipolar electrode. Hum Reprod 17:2435–2438.
Bettocchi S, Ceci O, Nappi L, Di Venere R, Masciopinto V, Pansini V, Pinto L, Santoro A, Cormio G. (2004) Operative office hysteroscopy without anesthesia: analysis of 4863 cases performed with mechanical instruments. J Am Assoc Gynecol Laparosc 11:59–61.[CrossRef][Web of Science][Medline]
Bracco PL, Vassallo AM, Armentano G. (1996) Infectious complications of diagnostic hysteroscopy. Minerva Ginecol 48:293–298.[Medline]
Brusco GF, Arena S, Angelini A. (2003) Use of carbon dioxide versus normal saline for diagnostic hysteroscopy. Fertil Steril 79:993–997.[CrossRef][Web of Science][Medline]
Cicinelli E, Parisi C, Galantino P, Pinto V, Barba B, Schonauer S. (2003) Reliability, feasibility and safety of minihysteroscopy with a vaginscopic approach: experience with 6000 cases. Fertil Steril 80:199–2002.[Web of Science][Medline]
De Angelis C, Santoro G, Re ME, Nofroni I. (2003) Office hysteroscopy and compliance: mini-hysteroscope versus traditional hysteroscopy in a randomized trial. Hum Reprod 18:2441–2445.
De Iaco P, Marabini A, Stefanetti M, Stefanetti M, Del Vecchio C, Bovicelli L. (2000) Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 7:71–75.[CrossRef][Web of Science][Medline]
Lau WC, Lo WK, Tam WH, Yyuen PM. (1999) Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Br J Obstet Gynaecol 106:356–359.[Web of Science][Medline]
Lau WC, Tam WH, Lo WK, Yuen PM. (2000) Randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in oupatient hysteroscopy. BJOG 107:610–613.[Medline]
Litta P, Bonora M, Pozzan C, Merlin F, Sacco G, Fracas M, Capobianco G, Dessole S. (2003) Carbon dioxide versus normal saline in outpatient hysteroscopy. Hum Reprod 18:2446–2449.
Nagele F, Bournas N, O’Connor H, Bradbent M, Richardson R, Magos A. (1996) Comparison of carbon dioxide and normal saline for uterine distension in outpatient hysteroscopy. Fertil Steril 65:305–309.[Web of Science][Medline]
Paschopoulos M, Paraskevaidis E, Stefanidis K, Kofinas G, Lolis D. (1997) Vaginoscopic approach to outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 4:465–467.[CrossRef][Web of Science][Medline]
Pellicano M, Guida M, Zullo F, Lavitola G, Cirillo D, Nappi C. (2003) Carbon dioxide versus normal saline as a uterine distension medium for diagnostic vaginoscopic hysteroscopy in infertile patients: a prospective, randomize, multicenter study. Fertil Steril 79:418–421.[CrossRef][Web of Science][Medline]
Perez-Medina T, Bajo JM, Martinez-Cortes L, Castellanos P, Perez de Avila I. (2000) Six thousand office diagnostic-operative hysteroscopies. Int J Gynaecol Obstet 71:33–38.[CrossRef][Medline]
Porreca MR, Pansini N, Bettocchi S, Loverro G, Selvaggi L. (1996) Hysteroscopic polypectomy in the office without anesthesia. J Am Assoc Gynecol Laparosc 3:(Suppl 4),, S40.[Medline]
Shankar M, Davidson A, Taub N, Habiba M. (2004) Randomised comparison of distension media for outpatient hysteroscopy. BJOG 111:57–62.[Web of Science][Medline]
Sharma M, Taylor A, di Spiezo Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. (2005) A outpatient hysteroscopy: traditional versus the ‘no-touch’ technique. BJOG 112:963–967.[Web of Science][Medline]
Soriano D, Ajaj S, Chuong T, Deval B, Fauconnier A, Darai E. (2000) Lidocaine spray and outpatient hysterocopy: randomized placebo-controlled trial. Obstet Gynecol 96:661–664.[CrossRef][Web of Science][Medline]
Ubeda A, Labastida R, Dexeus S. (2004) Essure: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril 82:196–199.[CrossRef][Web of Science][Medline]
Wong AY, Wong K, Tang LC. (2000) Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril 73:1234–1237.[CrossRef][Web of Science][Medline]
Submitted on March 29, 2006; resubmitted on June 7, 2006; accepted on June 16, 2006.
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