Ricciardi, Raffaele MD; Lanzone, Antonio MD; Tagliaferri, Valeria MD; Di Florio, Christian MD; Ricciardi, Luigi MD; Selvaggi, Luigi MD, PhD; Guido, Maurizio MD, PhD
Hysteroscopy was developed as a diagnostic procedure for directly studying the cervical canal and uterine cavity and visualizing benign lesions such as endometrial polyps and myomas. Currently, this technique is considered the gold standard for diagnosing and treating intrauterine diseases.1 Technical advances have focused mainly on miniaturizing the instruments to perform operative procedures and to reduce classic patient discomfort resulting from cervical canal dilatation and anesthesia.2,3 New miniaturized instruments facilitate the surgical treatment of intrauterine diseases using an innovative approach: “see and treat.” The diagnostic and surgical procedures can be combined into one clinical procedure that is feasible in an outpatient setting because anesthesia and cervical dilatation are not required. This “philosophy” was first proposed by Bettocchi et al4 more than a decade ago. To date, the continuous-flow hysteroscope is used as a diagnostic and operative device. The 5-French operating channel enables the use of very small mechanical instruments (eg, scissors, biopsy cups, graspers, and corkscrews), leading to a more well-tolerated procedure; nevertheless, the use of miniaturized instruments may be a restrictive factor for treating large uterine lesions.5
With the development of hysteroscopic instrumentation, a bipolar electrosurgery system, GYNECARE VERSAPOINT, was first used in the office setting in 1997, an innovation in outpatient operative hysteroscopy.6 The 5-French bipolar electrodes enabled the treatment of large intracavitary lesions with short surgical times and low complication rates. However, several studies suggested that these surgical procedures were limited to endometrial lesions of less than 2 cm and be performed only when surgical time does not exceed 15 minutes.7 Therefore, traditional hysteroscopy with hospitalization and anesthesia is the most used procedure for lesions of more than 2 cm.
Recently, Gubbini et al developed a 16-French resectoscope that integrates the diagnostic and therapeutic steps of hysteroscopy with potentially significant cost saving. The small size of the instrument (16-French) allows operative procedures to be performed without vaginal instruments (speculum and tenaculum) and cervical dilatation, reducing the risk of complications. The 13-French electrified and cold loops are used for several operative procedures, including the treatment of endocervical pathologies (polyps, adhesions, or myomas).
To estimate the use of the new 16-French resectoscope as an alternative hysteroscopic device, we performed a randomized comparative study of three different hysteroscopes (22-French resectoscope, 15-French hysteroscope, 16-French resectoscope) for treating uterine lesions.
MATERIALS AND METHODS
From January 2010 to June 2011, we enrolled women (age, 18–75 years) who were affected by endometrial polyps or grade 0 submucous myomas of less than 3 cm diameter. Exclusion criteria were therapy with gonadotropin-releasing hormone agonists before surgery, cervical canal stenosis, histologic diagnosis of cancer after diagnostic hysteroscopy, painful symptoms experienced during diagnostic hysteroscopy, severe hypertension, cardiovascular disease or respiratory disease, and multiple lesions or lesions of more than 3 cm. After obtaining informed consent, patients eligible for the study were randomized to treatment with one of three hysteroscopes with the help of a computer-generated randomization system.
The 22-French resectoscope kit included a 22-French rotatable outer sheath, a 2.9-mm 0° high-density telescope, and a 16-French 90° monopolar loop electrode. The 16-French Office Continuous Flow Resectoscope Line GUBBINI included a 16-French continuous-flow rotatable double sheath of 194 mm, a 2.9-mm 0° high-density autoclavable telescope with an overall length of 300 mm, and a 13-French 90° monopolar loop electrode. The continuous-flow office hysteroscope kit (15-French hysteroscope) consisted of a single-flow office hysteroscope. The scope was composed of a rigid rod lens system with a diameter of 2 mm and a 30° view. The outer sheath has an oval profile and is 5 mm in diameter with an incorporated 5-French operative channel. Mechanical instruments (scissors, biopsy cups, graspers, and corkscrews) and bipolar loops were used to perform the procedures.
The diagnosis and staging of uterine diseases were established by transvaginal ultrasonography and diagnostic hysteroscopy 1 month before surgery. To avoid interoperator variability, all procedures were performed by the same surgeon (R.R.), and for women of fertile age, hysteroscopy was performed during the early follicular phase of the menstrual cycle.
Surgical treatment using the 22-French resectoscope involved cervical canal dilatation and, consequently, required local anesthesia. Paracervical anesthesia was administered by injection of 20 mL of 1.5% mepivacaine chlorohydrate into the vaginal fornix. The anesthetic was delivered in divided doses through a 2- to 4-gauge V-block needle lateral to the cervix at the 3 o'clock and 9 o'clock positions at the junction of the cervix and vagina. Hegar dilatators up to 8 mm in diameter were used. Because of the smaller diameter of the outer sheath, the 16-French resectoscope and 15-French hysteroscope did not require cervical dilatation and, therefore, anesthesia was not required.
We used a Valleylab Force FX electrosurgical generator for the procedures performed with the 16-French resectoscope and 22-French resectoscope as well as a GYNECARE VERSAPOINT electrosurgical system for the 15-French hysteroscope. The Valleylab system was set up with a monopolar circuit, an output power of 45 W, and a cut waveform. The VERSAPOINT system was set up with a VC1 waveform and an output power of 100 W.
The distension medium used for the 22-French and 16-French resectoscope procedures was sorbitol mannitol, which was usually instilled from a bag wrapped in a pressure bag connected to a manometer and pumped to 150–200 mm Hg. All procedures performed with the 15-French hysteroscope used a saline distension medium (NaCl 0.9%) instilled at the same pressure.
The side effects of the surgical procedures that we measured included vagal symptoms such as lipothymia, severe hypotension, and sweating; severe nausea and vomiting as well as an electrolyte imbalance and overload syndrome. The side effects of anesthesia included vasovagal syncope, laceration of the vaginal mucosa, systemic toxicity of the local anesthetic, parametrial hematoma, and paracervical or subgluteal abscesses.
The following parameters were evaluated and considered as primary outcomes in our study: surgical time, degree of patient discomfort according to the visual analog scale, volume of the distension medium delivered, and discharge time. In the group of women treated with the 22-French resectoscope, the surgical time included the initiation of anesthesia and cervical canal dilatation with Hegar dilators. In the other two groups, the surgical time began with the vaginoscopy.
To verify patient acceptability, the degree of discomfort that each patient experienced during the procedure was assessed soon after the end of the procedure (1–5 minutes) using a visual analog scale with a rating scale of 0 (no discomfort) to 10 (severe discomfort). The volume of distension medium used was evaluated as the difference between the amount of liquid in the sac at the beginning of the procedure and the amount left over at the end of the procedure.
Patients treated with the 22-French resectoscope were discharged after resolution of the effects of anesthesia. In the remaining two groups, the discharge was influenced by the duration of painful symptoms such as abdominal discomfort or cramps.
The Kolmogorov–Smirnov test revealed that the data had an abnormal distribution (P>.05). The mean and standard deviation of bond strengths were calculated. Data were normalized by replacing them with the log of their values and compared by one-way analysis of variance. Multiple comparison tests were performed using Tukey's test.
The analysis between groups by lesion size was performed by two-way analysis of variance. Multiple comparison test was performed with the Bonferroni post test. The statistical significance was set at P<.05.
Power calculation was based on previous reports identifying the minimal clinically important differences for all parameters. Assuming an adequate delta value for each parameter, our sample size allows us to have a 95% statistical power (α=0.05, two-tailed) for all the comparisons performed (post hoc statistical power using Graph Pad StatMate 2 statistical software). The study protocol was approved by the institutional review board of the Department of Obstetrics and Gynecology of the Università Cattolica del Sacro Cuore, Rome, Italy.
Of 451 patients enrolled in the study, 401 underwent randomization (Fig. 1). Fifty patients were excluded from the randomization: 26 did not meet the inclusion criteria and 24 declined to participate. One hundred twenty-seven patients were randomized to the 22-French resectoscope group, 142 patients were randomized to the 16-French resectoscope group, and 132 patients were randomized to the 15-French hysteroscope group; the 15-French hysteroscope was equipped with an operative channel of 1.8 mm.
Table 1 shows the baseline characteristics of the enrolled patients. None of the women experienced severe complications or side effects during and soon after the procedure. We observed only a few cases of minimal or mild nausea.
Table 2 shows the surgical and postoperative data related to the entire group of 401 patients. Overall, the time to discharge did not exceed 2 hours for all the procedures. As expected, we observed a significant reduction in the surgical and discharge times in the group treated with the 16-French resectoscope compared with the group treated with the 22-French resectoscope (P<.01 for both parameters). Interestingly, a significant reduction was observed in all the studied parameters in the group treated with the 16-French resectoscope compared with the group treated with the 15-French hysteroscope (P<.01 for all parameters). We observed a significant decrease in surgical time, distension medium used, and visual analog scale scores in the 22-French resectoscope group compared with the 15-French hysteroscope group (P<.01 for all three parameters).
To verify the effect of the size of the lesions on the effectiveness, feasibility, and safety of the three instruments, patients were redistributed into six groups according to the size of the lesion. Of the patients, 188 exhibited a single endometrial polyp or grade 0 submucous myoma that was less than 1.5 cm diameter. In this group, 61 patients were treated with the 22-French resectoscope, 67 with the 16-French resectoscope, and 60 with the 15-French hysteroscope. As shown in Table 3, the comparison between the 16-French resectoscope and the 15-French hysteroscope confirmed the results obtained by the analysis of the entire population. We observed a significant reduction in all the studied parameters in the 16-French subgroup (P<.01). In addition, the surgical time and discharge times were significantly shorter in the 16-French subgroup than in the 22-French subgroup (P<.01). Regarding the comparison between the 22-French and 15-French hysteroscopes, the visual analog scale scores and the volume of distension medium used were significantly lower in the 22-French subgroup (visual analog scale, P<.01; distension medium, P<.05) as observed in the analysis of the entire population.
The remaining 213 patients exhibited a single endometrial polyp or grade 0 submucous myoma that was more than 1.5 cm diameter. In this group, 66 patients were treated with the 22-French resectoscope, 75 with the 16-French resectoscope, and 72 with the 15-French hysteroscope. As shown in Table 4, use of the 16-French resectoscope was advantageous compared with the use of 15-French hysteroscope with respect to the surgical time, volume of distension medium delivered, time until discharge, and postoperative discomfort (P<.01 for all parameters). Regarding the comparison between the 16-French subgroup and the 22-French subgroup, we observed significant reductions in the length of the procedure and the duration of hospitalization in the 16-French subgroup (P<.01 for both parameters). Finally, the operative time, amount of distension medium used, and visual analog scale scores were significantly lower in the 15-French subgroup than in the 22-French subgroup (P<.01 for all three parameters).
To our knowledge, this randomized study is the first study (English-based search from PubMed through June 2011. The search terms “office hysteroscopy or office-based hysteroscopy,” “see and treat hysteroscopy,” “vaginoscopy or no-touch technique or vaginoscopic approach,” and “16 Fr mini-resectoscope” were used) to establish the field of action of the new 16-French resectoscope by estimating the following four parameters: amount of distension medium used, surgical time, pain perception (visual analog scale), and discharge time.
Moreover, to estimate the possible advantages of the 16-French resectoscope, we performed a randomized controlled study to compare the new 16-French hysteroscope with two other devices used. The first analysis of the entire group of patients suggested the limitations of the 15-French hysteroscope in terms of effectiveness compared with the 16-French resectoscope, although these findings can be influenced by the size of the treated lesions. Nevertheless, we observed the same results when we divided the patients on the basis of lesion dimensions.
The advantages regarding operative time can be explained by the different functionalities of the electrodes used by the two hysteroscopes. In fact, the use of classical electrodes instead of the VERSAPOINT system and mechanical instrumentation leads to an easier and faster approach to endometrial lesions irrespective of the type and the size of intracavitary lesions. Another issue is the reduction in the volume of the distension medium used during the procedure because of the reduction in surgical time.
The other variable evaluated in our study is represented by the perception of pain experienced during the hysteroscopy without anesthesia. Pain is well known to represent the primary restricting factor for the broad implementation of office hysteroscopy and the tolerance and acceptability of patients are generally influenced by the diameter of the scope.
The improvement in pain symptomatology observed in the 16-French resectoscope group compared with the 15-French hysteroscope group may have resulted from an average operative time of less than 15 minutes and the consequent lower volume of distension medium used. Taken together, these findings contribute to the reduction of the recovery time.
As we stated previously, our study aimed to estimate the effectiveness of the 16-French resectoscope for treating lesions that are generally approached only in a hospitalized setting. We obtained reassuring results in this regard. The advantages of the 16-French resectoscope over the 22-French resectoscope with regard to reducing the surgical time and halving the discharge time in the entire patient group could be explained by the absence of general anesthesia.
Regarding the analysis of pain according to the visual analog scale method, patients treated with the 22-French resectoscope were still anesthetized during the most painful period. Nevertheless, we observed a visual analog scale value that was comparable between the 22-French resectoscope and 16-French resectoscope groups.
Interestingly, these arguments can be applied to both subgroups of patients who were treated for polyps or myomas of more than 1.5 cm diameter. Thus, our study suggests that the 16-French resectoscope is suitable for lesions that are traditionally treated with a 22-French resectoscope, retaining the advantages of an outpatient setting.
In conclusion, the operative 16-French resectoscope may change the manner in which we treat patients and perform hysteroscopic procedures. Our study suggests that the 16-French resectoscope is a suitable diagnostic and operative instrument and is a better alternative than the 15-French hysteroscope for treating intrauterine lesions of less than 1.5 cm diameter. In addition, this 16-French resectoscope could permit the treatment of intrauterine lesions of more than 1.5 cm in diameter in an office setting without any type of anesthesia and without patient discomfort.