Mini-Scissor Versus Bipolar Twizzle in Ambulatory Hysteroscopic Metroplasty: A Prospective Randomized Study

Abstract

Objective: The goal of this study was to compare mechanical (cold scissor) and electrosurgical metroplasty (bipolar twizzle) in terms of feasibility and pain scoring during ambulatory-based hysteroscopic metroplasty for short, narrow-based uterine septae. Materials and Methods: Forty women, with recurrent abortions or infertility, with short narrow-based septae <2 cm diagnosed by transvaginal ultrasound and hysterosalpingogram (HSG) were included in the study. The patients were randomized into two groups of 20 patients each. In group A, metroplasty was performed with a cold mini-scissor (mechanical resection). In group B, metroplasty was performed with a bipolar twizzle (electrosurgical resection). None of the patients were given anesthesia or analgesia. Metroplasty was scheduled in the early proliferative phase of each patient's menstrual cycle, without pharmacologic preparation. The Versascope® hysteroscopy system was used. Through the expanding plastic collapsible channel, insertion of a 7-Fr semirigid mechanical instrument (the mini-scissor) or a 5-Fr bipolar electrode (the twizzle) was performed, allowing ambulatory metroplasty to be performed. All patients had postoperative HSGs 3 months later, after exclusion of pregnancy, to evaluate objectively the complete resection of their septae. Results: No significant difference was found between both groups in terms of operative time and fluid deficit (12.68±2.08 versus 12.08±2.62) and (519±118.59 versus 480±106.01), respectively. Pain scores were significantly higher in the bipolar twizzle group than in the mini-scissor group. The pain scores had (4.01±0.68 versus 6.98±1.28) a p significance of <0.05. Conclusions: Ambulatory-based hysteroscopic metroplasty, using either a mini-scissor or bipolar twizzle, is a safe and effective procedure. Electrosurgical electrodes induce significantly higher pain scores than mechanical cold instruments, necessitating careful instrument selection when treating patients in whom more pain is anticipated (e.g., previous cesarean section, chronic pelvic pain, or anxious or menopausal women). If an electrosurgical electrode is the only available device, a preoperative analgesic is recommended, especially for such patients. (J GYNECOL SURG 30:147)

Introduction

The uterine septum is the most common structural anomaly of the female reproductive system.¹ This conditions results from fusion defects of the Müllerian ducts. Failure of resorption of the intervening septum causes the anomaly. Apoptosis has been proposed as the mechanism by which the intervening septum resorbs.² Septate uterus is associated with the worst reproductive outcomes of all congenital uterine anomalies, including recurrent first- or second-trimester miscarriages, intrauterine growth restrictions, abnormal fetal presentations, premature deliveries, and infertility.³ The well-addressed theory is vascular compromise caused by the septum's fibrous tissue hindering fetal development, in turn, causing the development of deficient estrogen and progesterone receptors and inadequate endometrial maturation. As pregnancy advances, the septum can mechanically compromise the available space for fetal growth, leading to miscarriage, abnormal fetal positioning, or preterm delivery.⁴

There is no doubt that hysteroscopic metroplasty is the “gold standard” for uterine septum treatment. Many studies have concluded that there was improvement in pregnancy rates in women with poor obstetric histories after these women underwent hysteroscopic metroplasty.^3,5–7 However, its role in patients with otherwise unexplained infertility is still not clear.⁸

In the early years of hysteroscopic metroplasty, replacing the historical metroplasty performed via laparotomy, or septal incision by scissors followed by use of a resectoscope with a knife monopolar electrode were nearly the only methods of septal incision being implemented. In the last decade, advancements have been made in hysteroscopic techniques, instrumentation, and understanding of indications for the procedure.⁹ There were two major advancements: (1) introduction of bipolar electrosurgical systems and (2) manufacturing of small-size hysteroscopes. These advancements enabled an increasing number of gynecologic pathologic conditions that had been conventionally treated in the operating room to be treated safely and effectively in an ambulatory office-based setting.¹⁰

In the ambulatory setting with miniaturized hysteroscopes, versapoint bipolar electrodes, mini-scissors, or laser energy¹¹ can now be used. Different studies have compared the different methods of septal incision, using a resectoscope as the usual standard comparison arm.^12–14 The wide variation in the lengths and widths of womens' uterine septae,¹⁵ makes a comparison between the resectoscope and ambulatory office-based hysteroscopy biased. The current authors believe that a thick broad-based septum may necessitate using a resectroscope as the ideal choice to accomplish the procedure safely and effectively. However, in patients who have short narrow-based septae, not necessitating resectoscope use, the different available ambulatory-based techniques need to be compared.

Materials and Methods

Objective

The aim of this study was to compare mechanical (cold-scissor) with electrosurgical metroplasty (bipolar twizzle) in terms of feasibility and pain scoring during ambulatory hysteroscopic metroplasty of short narrow-based uterine septae.

Patients

The study included 40 patients, after they provided informed consent. The patients were selected from the outpatient clinic of the Shatby Maternity University Hospital, in Shatby, Alexandria, Egypt. The study was conducted from October 2010 to February 2012. Selection criteria were: age 20–45; no prior hysteroscopic intervention; and short narrow-based septum <2cm diagnosed by transvaginal ultrasound and hysterosalpingogram (HSG), and confirmed by diagnostic hysteroscopy during resection. All cases with the following criteria or findings were excluded from the study: long- and wide-based septae; having an episode of bleeding; active cervical or uterine infection; and/or cervical malignancy. In addition, all patients in whom a vaginoscopic approach was difficult and requiring tenaculum application, patients with stenosed cervices necessitating general anesthesia, and/or patients with long septae requiring an estimated time of >30 minutes of ambulatory or office metroplasty were also excluded.

The selected patients were randomized preoperatively using a computer-generated randomization sheet into two groups of 20 patients each. Group allocation was concealed in an opaque envelope, which was opened at the time of each woman's procedure. Group A metroplasty was performed with a cold mini-scissor (mechanical resection). Group B metroplasty was performed using a bipolar twizzle (electrosurgical resection).

Procedures

None of the patients received anesthesia or analgesic medication. Metroplasty was scheduled in the early proliferative phase of each woman's menstrual cycle, without pharmacologic preparation. A Gynecare Versascope™ hysteroscopy system (Ethicon, Gynecare, Johnson & Johnson) was used for all procedures. The diameter of the telescope is 1.8 mm, with a working length of 18 cm, a view direction of 0°, and a field of view of 75°. This device's disposable outer sheath has a diameter of 3.5 mm and an expanding plastic collapsible channel. This channel allows the insertion of a 7-Fr semirigid mechanical instrument (e.g., a mini-scissor) or 5-Fr bipolar electrodes (twizzle or versapoint or vaporizing electrode are all synonyms terms for one of these electrodes), allowing office or ambulatory operative procedures to be performed. The twizzle is used for precise and controlled vaporization (resembling cutting). It consists of an active electrode located at the tip of the instrument and a return electrode located on the instrument's shaft, separated by a ceramic insert. Once the electrode is connected to the generator, the generator automatically adjusts to the default setting (vapor cut VC1 and 100 W).

Each patient's uterine cavity was distended with saline at a constant inflow pressure. A Hamou Hysteromat was used to ensure an intrauterine pressure of 35 mm Hg, with a flow rate of 150 mL/minute. Fluid deficit was recorded by measuring the difference between the infused and drained fluid. The outflow port of the versascope and the drained fluid from the vagina were collected in a plastic graduated container, so little fluid was lost in the drapes. The operative time was calculated from the start of the vaginoscopy (minute of introducing the versascope through the interoitus) until the withdrawal of the versascope.

In each patient, a vaginoscopic approach (nontouch introduction) was used. The septum was incised, starting from its lower margin and proceeding forward with progressive horizontal incisions. In group A, a mini-scissor was inserted into the expandible channel of the versascope, performing a mechanical resection. In group B, a bipolar twizzle was introduced performing an electrosurgical resection. All procedures were performed by the same hysteroscopist. In all patients, the procedure was ended depending on the surgeon's experience with recognizing myometrial muscle fibers and blood vessels.

A single dose intraoperative intravenous antibiotic was given according to hospital protocol. All patients were discharged to go home on the same day as the procedure. Operative data, including operative times, fluid deficits, and complications (e.g., fluid overload, bleeding, incomplete resection, or perforation) were recorded. Immediately after the procedure, each patient was asked to access the pain score on a visual analogue scale (VAS).

All patients had postoperative HSGs 3 months later, after exclusion of pregnancy, to evaluate the complete resection of the septum objectively.

Statistics

Data were fed to the computer using the Predictive Analytics Software (PASW Statistic 18). The distributions of quantitative variables were tested for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. A D'Agostino test was used if there was a conflict between the two previous tests. Quantitative data were described using range, mean, and standard deviation. Association between categorical variables was tested using a χ-square test. Significance test results were quoted as two-tailed probabilities. Significance of the obtained results was judged at the 5% level.

Results

Of the 40 included patients, 70% were nullipara and 30% were multipara, 82.5% were symptomatic (having infertility, recurrent miscarriages, or premature births), and 17.5% were asymptomatic.

Both groups were compared with respect to age, duration of marriage, gravidity and parity, and symptoms; no statistical differences were found (Table 1).

Table 1.

Comparison Between Both Groups Regarding Age, Gravidity, Parity, and Presentation

Characteristics	Group A (mini-scissor) n (%)	Group B (bipolar twizzle) n (%)	Test of significance
Age
20–30	11 (55%)	12 (60%)	χ²=0.98
31–40	6 (30%)	6 (35%)	p=0.24
41–45	3 (15%)	1 (5%)
Range	21–43	22–42	t=0.85
Mean±SD	32.5±4.65	35.2±6.25	p=0.29
Gravidity & parity
Nullipara	13 (65%)	15 (75%)	χ²=0.96
Multipara	7 (35%)	5 (25%)	p=0.28
Range	0–3	0–2	t=1.42
Mean±SD	1.77±0.62	1±0.25	p=0.096
Presentation
Infertility	5 (25%)	7 (35%)
Miscarriage	6 (30%)	5 (25%)	χ²=0.68
Premature birth	6 (30%)	4 (20%)	p=0.33
Asymptomatic	3 (15%)	4 (20%)

SD, standard deviation.

With respect to operative time and fluid deficit, group A had a shorter operative time and a lower fluid deficit than group B, but the difference did not reach the level of significance (Tables 2 and 3). No major complications (i.e., uterine perforations, fluid overloads, or vasovagal episodes) were noted in either group.

Table 2.

Comparison Between Both Groups Regarding Operative Time

Operative time (min)	Group A (mini-scissor)	Group B (bipolar twizzle)
Range	9–16	8–14
Mean±SD	12.68±2.08	12.08±2.62
	t=1.06
	p=0.25

p is significant at ≤0.05.

min, minutes, SD, standard deviation.

Table 3.

Comparison Between Both Groups Regarding Fluid Deficit

Fluid deficit (mL)	Group A (mini-scissor)	Group B (bipolar twizzle)
Range	350–720	379–750
Mean±SD	519±118.56	480.6±106.01
	p=0.144

p is significant at ≤0.05.

SD, standard deviation.

In group A, the mean VAS score was 4.01 (range 3–5), and, in group B, it was 6.98 (range 4–8). A significant statistical difference was found in pain scores, with higher pain scores in the electrosurgically resected group (group B) than in the mechanically resected group (group A; Table 4).

Table 4.

Comparison Between Both Groups Regarding the VAS

Pain scores	Group A (mini-scissor) n (%)	Group B (bipolar twizzle) n (%)	Test of significance
0 (no pain)	0 (0%)	0 (0%)
1–3 (mild pain)	13 (65%)	0 (0%)	χ²=2.11
4–6 (moderate pain)	7 (35%)	14 (70%)	p=0.025^*
7–10 (severe pain)	0 (0%)	6 (30%)
Range	3–5	4–8	t=2.06
Mean±SD	4.01±0.68	6.98±1.28	p=0.013^*

p is significant at ≤0.05.

=significant.

VAS, visual analogue scale; SD, standard deviation.

HSG was performed 3 months later, after exclusion of pregnancy, and showed complete resections with no residual problems in all cases in both groups.

Discussion

Ambulatory and office-based operative hysteroscopy is being performed in progressively increasing numbers worldwide. To achieve the optimum efficacy, safety and the best patient tolerability, three points should be considered. These are (1) proper indication, (2) good patient selection, and (3) appropriate instrumentation. For example, a long- or wide-based uterine septum is a main limitation for office metroplasty, as the operative time is extended, lowering the patient's tolerability for undergoing the procedure.^16–18

In the current study, of the 40 included patients, 17.5% were asymptomatic. In accordance with other research findings—and considering the feasibility, minimal morbidity, and cost effectiveness of hysteroscopic metroplasty—it is believed that it should be done in all cases of uterine septae.¹⁹ This prophylactic metroplasty could prevent miscarriage, preterm labor, or abnormal presentations, even in patients with no prior fertility problems.²⁰ Meanwhile, other researchers accept the fact that any surgical procedure, regardless of its invasiveness, needs to be founded in objective evidence for proper indications. Thus, metroplasty for asymptomatic septa is still debatable.

In the current study, only patients with short narrow-based uterine septae <2cm were included, to ensure tolerability and completion of the procedure. In all patients, a vaginoscopic approach (nontouch technique) was adopted. This follows the recommendation of the researchers in two studies,^21,22 that vaginoscopic approach results in significant improvement of patient tolerability. If tenaculum application was needed or cervical stenosis was found necessitating general anesthesia, the patient was immediately eliminated from the study. A new patient was added into the study and was allocated to the same group from which the previous patient had been exempted. This protocol of selection ensured that there would be no anesthetic or analgesic needs in the patients who were in the study.

Forty women were divided at random into two groups. In both groups, hysteroscopic metroplasty was started midway between the anterior and posterior uterine walls. This was accompanied by immediate retraction of the incised part to become a part of the corresponding uterine surface. If the patient was assigned to group A, the mini-scissor (mechanical metroplasty) was used. The scissor handles were rotated and maintained in the plane of the uterine cavity, facilitating the resection without burrowing into the myometrium. If the patient was assigned to group B, the bipolar twizzle (electrosurgical metroplasty) was used. Although use of a bipolar electrode allows tissue vaporization with less bleeding, the electrode generates gas bubbles that may impede proper vision. All of the procedures were performed by the same hysteroscopist, who stopped resection once healthy myometrium was reached; this was known by the occurrence of minimal bleeding and/or pain perception by the patient.²³

In the current study, the operative time and fluid deficit were less in group B (bipolar twizzle) than in group A (mini-scissor), but the difference did not reach the level of statistic significance. No major complications (e.g., fluid overloads, uterine perforations, hemorrhaging, or vasovagal episodes) were recorded in either group.

With respect to pain scores (on the VAS), a statistically significant difference was detected between the two groups. Patients in group B (bipolar twizzle) had higher pain scores than patients who underwent mechanical metroplasty (mini-scissor). This could be explained by the transmission of bipolar thermal energy as soon as the resection started, causing stimulation of the adjacent uterine wall. Although the bipolar electrosurgical system does not require dispersive return electrodes and does not generate stray currents,⁹ the close proximity of the resected septum to the uterine wall causes the uterine wall to be affected by the localized energy generated, causing the perception of pain. In mechanical resection, direct stimulation of the uterine wall occurs only when the resection is almost complete as a result of direct mechanical contact with the myometrium.

The need for anesthesia or analgesia for performing hysteroscopy is still controversial. Many factors explain the lack of agreement on this issue depending on the instruments used, the approach of entry, indication, the operator's skill, and the patient's characteristics.²⁴ In a study conducted by Bettochi et al., the researchers used a special technique in their center, based on their observation that the default setting of the versapoint generator causes more discomfort, when the operative procedure is done in an office setting without analgesia or anesthesia.²⁵ Bettochi et al. adapted the generator setting to the mildest vapor-cutting mode (VC3) instead of VC1 and reduced the power setting to 50 W instead of 100 W. These researchers concluded that this allows working more closely to the myometrium with less discomfort.²⁵

The current authors' findings are similar to those of Bettochi et al. in a later study.²⁰ The researchers analyzed 4863 cases performed with mechanical instruments (scissor or grasping forceps) in an office setting without analgesia or anesthesia. The procedures were performed without discomfort in 71.9%–93% of the patients. The researchers concluded that operative office hysteroscopy with excellent patient satisfaction is possible, provided that this is used for the correct indication.²⁰

Moreover, in a recent study by Wortman et al., 414 operative hysteroscopies were performed in an office-based setting, with parenterally administered moderate sedation, and the researchers concluded that even major operative procedures could be performed with a high degree of safety and patient satisfaction in an office-based setting.²⁶

In two previous studies,^12,13 office electrosurgical metroplasty was compared to resectoscopy using a monopolar knife or a Collin's loop. The researchers concluded that office-based metroplasty is as effective as resectoscopy. However, the current authors perspective is that the wide variation in uterine septae length and width makes not all procedures involving the septae suitable for office or ambulatory settings; this concept takes into account the feasibility of the procedure in terms of completion and patient tolerability. In the current study, follow-up HSG performed 3 months later, showed complete resections with no residual problems in all cases in both groups. However, this particular scheduling for HSG 3 months postoperatively was arranged in accordance with the postoperative follow-up timing cited in previous articles,^23,25 which included information about following patients undergoing metroplasty. This does not constitute evidence that such scheduling is the best time to perform the HSGs, based on what is known about uterine healing following metroplasty, which heals uniformly within 4 weeks.

Conclusions

From the current study's results, it can be concluded that ambulatory-based hysteroscopic metroplasty, using either a mini-scissor or a bipolar twizzle, is a safe and effective procedure. Electrosurgical electrodes induce significantly higher pain scores than mechanical cold instuments, necessitating careful instrument selection when operating on with patients in whom more pain is anticipated (e.g., those with previous caesarean sections or chronic pelvic pain, or who are anxious or in menopause). If an electrosurgical electrode is the only available device, a preoperative analgesic is recommended especially for patients in whom more pain is expected to occur.

Footnotes

Disclosure Statement

The authors have no conflicts of interest.

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