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Uterine septum dissection using mini-hysteroscopy with a bipotrode 5 Fr bipolar electrode versus monopolar resectoscopy with a unipolar knife

a randomized-controlled study

Youssef, Hamed M.a; Elshamy, Mageda; Shokeir, Tareka; Goda, Hosama; Warda, Osamaa; Magdy, Ahmedb

Author Information
Evidence Based Women's Health Journal: August 2014 - Volume 4 - Issue 3 - p 117-121
doi: 10.1097/01.EBX.0000453186.89383.54
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Abstract

Introduction

Septate uterus is one of the most common forms of congenital uterine malformations that affect female reproductive health negatively 1. The incidence of congenital uterine malformations has been reported to be as high as 3–4% in the general female population 2,3 and to be significantly higher in patients with infertility and recurrent pregnancy loss 3,4. Septate uterus results from incomplete resorption of the paramesonephric mullerian ducts during the first trimester of pregnancy. The absorption of the septum normally initiates at the level of the uterine cervix and continues upwards in the direction of the uterine fundus. Depending on the size of the septum, the uterine cavity may be affected only partially, as in case of an incomplete septate uterus, or it may be divided into two separate components including two cervices and eventually a vaginal septum, as in case of a complete septate uterus 3,4.

A uterine septum affects female reproductive health in three ways: (i) obstetric complications, (ii) recurrent miscarriages, and (iii) infertility 5. Although clinical studies consistently show a poorer obstetric outcome in patients with septate uterus compared with women without uterine anomalies 5,6, the literature on septate uterus as the primary cause of female infertility is controversial. Fedele et al.7, for example, were the first to postulate that a septate uterus may influence fertility by hindering embryo implantation. This hypothesis was based on histological samples obtained during operative hysteroscopy showing the following ultrastructural alterations in the septal endometrium compared with endometrium of the lateral uterine wall: (i) a reduced number of glandular ostia, (ii) irregularly distributed ciliated cells with incomplete ciliogenesis, and (iii) a reduction in the ciliated to nonciliated cell ratio. These factors are believed to cause the poor response to estrogens in the septal mucosa as normal serum estrogen levels were found in all patients. Others reported inadequate uterine vascularization leading to subsequent abnormal placentation in women with a septate uterus 8. Moreover, clinical studies in women with a septate uterus reported an increased content of muscle tissue as well as an increased and uncoordinated contractility of the uterine septum 9.

However, Sparac et al. 9 found no differences in vascularization assessed by transvaginal color Doppler ultrasound comparing endometrium and uterine septum. In another study, histological examination of uterine septum biopsies from three different sites of the septum, namely the basis, the midpoint, and the tip, showed no differences in terms of muscle tissue and vessel density compared with biopsies from the left posterior aspect of the uterus 10.

Hysteroscopic evaluation has been considered by some to be the ‘gold standard’ in the diagnosis of intrauterine anomalies 11,12. Also, many prospective randomized studies concluded that office hysteroscopy, saline injection sonography, and hysterosalpingography were statistically equivalent in the evaluation of the uterine cavity in infertile women 13.

The septum can be divided by hysteroscopic scissors, electrosurgery (monopolar or bipolar), or laser fibers under local, general, or no anesthesia at all 14. A residual septum of less than 1 cm does not appear to have an adverse effect on reproductive outcomes 15. Bettocchi et al. 14 performed 154 hysteroscopic evaluations of septated uteri using the vaginoscopic approach without anesthesia or analgesia. To date, no randomized-controlled trial has compared septal resection using a reusable bipolar electrode with the conventional monopolar knife in terms of safety and efficacy; hence, we sought to carry out this study.

Patients and methods

The protocol of this study was approved by the Local Ethical Committee in Mansoura Faculty of Medicine, Egypt. A verbal and written consent was obtained from all cases before starting the study. Our study included 84 patients with evident incomplete uterine septa proved by hysteroscopy, and attending the Outpatient Gynecologic Clinic at Mansoura University Hospital or the Mansoura Fertility Care Unit with a complaint of unexplained infertility or repeated miscarriages from June 2005 to January 2010. Complete information on hormonal status, patency of fallopian tubes, and the result of the partner’s semen analysis was available for all cases. Cases were allocated randomly to two groups by selecting a closed envelope containing the procedure to be performed. Group A included 42 women, who were subjected to the conventional hysteroscopic surgery using a 26 Fr resectoscope with a unipolar knife. Group B included 42 women who underwent resection with a 4-mm diameter hysteroscope with a bipotrode 5 Fr reusable bipolar electrode. The patients were followed up for a period of 24 months including the first 6 months after surgery.

Surgical technique

All operations were performed as an inpatient surgery in group A and in four cases in group B, in whom cervical dilatation was needed. Thirty-eight cases from group B were operated upon as outpatients. We did not use any form of long-term pretreatment with gonadotropin releasing hormone agonists or preoperative intravaginal administration of misoprostol. All procedures were performed in the early follicular phase of the menstrual cycle by the same operator (the first author). The aim of the procedure was to create a triangular and symmetric uterine cavity, which was achieved in 39 cases in group A and 40 cases in group B. The severity of postoperative pain was evaluated using a visual analogue scale. In our series, we did not insert an intrauterine device postoperatively, and we advised the patients to use combined oral contraceptives for three months after surgery. Reseptoplasty was needed in five cases, three cases in group A and two cases in group B, because of bleeding during the procedure.

Monopolar resectoscope

After cervical dilation with Hegar’s dilators up to a width of 10 mm, an operative hysteroscope (Storz 10 mm Fiberoptic Resectoscope; Storz GmbH, Tuttlingen, Germany) was inserted. The uterine cavity was distended with a 1.5% glycine solution with a continuous irrigating flow. The hysteroscope’s knife was placed in contact with the septum and an incision was made perpendicular to the septum using coagulation-cut current (Fig. 1).

F1-1
Figure 1:
Monopolar resectoscopy.

Septum dissection with a bipotrode 5 Fr bipolar electrode

A small-diameter hysteroscopy with a bipotrode 5 Fr reusable bipolar electrode (made of semiflexible stainless steel, which is autoclavable and reusable) was used (Richard Wolf, Germany). The current was coagulation-cut. The distension media were saline solution. The principal advantage of this technology is that cervical dilatation, general anesthesia, and the use of a reusable electrode can be avoided, and a saline solution was used, which is nontoxic, easily metabolized, and also less expensive than conventional hypotonic nonelectrolyte solutions (Fig. 2).

F2-1
Figure 2:
Bipotrode 5 Fr bipolar electrode.

Follow-up

All the patients were advised to become pregnant after 6 months from septoplasty. This was followed by a period of follow-up for 18 months, during which the reproductive outcome parameters of pregnancy, abortion, preterm delivery, and live birth rate were assessed. Complete follow-up was available for 78/84 (92.9%) patients. Four patients from group A and two from group B were lost to follow-up (Fig. 3).

F3-1
Figure 3:
Participant flowchart.

Statistical analysis

Statistical analysis was carried out using the statistics package for the social sciences (SPSS 17; SPSS Inc., Zonguldak Karaelmas University, Zonguldak, Turkey). The Student t-test and the χ2-test were used to compare the parametric and nonparametric data. P value less than 0.05 was considered significant.

Results

A total of 112 participants with incomplete uterine septum were evaluated. Twenty-eight participants were excluded from the study because of different causes (eight cases involved male factor infertility, seven cases involved ovarian factor infertility, seven cases involved tubal factor infertility, and six refused to participate in the study). The sociodemographic data of the groups studied (age, BMI, duration of infertility) were comparable (Table 1). In terms of the operative parameters, general anesthesia and cervical dilatation were used in all cases of group A and in four cases of group B. Both operative time and volume of the fluid used for uterine distention were statistically significant greater in group A than in group B (25.4±3.2 and 15.6±2.2 min, P<0.001, and 710.4±120.4 and 1103±350.5 ml, P<0.001, respectively) (Table 2).

T1-1
Table 1:
Sociodemographic data of the studied groups
T2-1
Table 2:
Operative data

Severity of pain was evaluated using a visual analogue scale, which consisted of a two-sided ruler with a 10 cm linearity linking two points at one extreme, indicating a completely pain-free state, the other as the worst imaginable pain; the women included in our study were instructed to mark a spot on this line to indicate the intensity of their pain 16, 0=pain free and 10=worst imaginable pain. There was no significant difference between both groups in the need for analgesia and time to rescue analgesia (Table 3). Reseptoplasty was needed in five cases, three cases in group A and two cases in group B, because of bleeding during the procedure and all the procedures were performed without complications. There was no statistically significant difference between both groups in reproductive outcome parameters (Table 4).

T3-1
Table 3:
Pain severity using a visual analogue scale
T4-1
Table 4:
Reproductive outcome

Discussion

It is well established that in patients with recurrent abortion, hysteroscopic metroplasty significantly improves the subsequent reproductive outcome irrespective of the hysteroscopic technique used 17,18. Comparable results have been found with the use of a fiberoptic laser, a resectoscope, and scissors in retrospective studies with small series, but no randomized-controlled trials have been conducted as yet 17,18. Hysteroscopic correction of an incomplete uterine septum is justified before in vitro fertilization; also, patients with unexplained infertility might benefit from hysteroscopic metroplasty 19,20. Thanks to restoration of the anatomy of the uterine cavity, the placentation process would have a better chance of developing properly.

Incidental finding of a septate uterus is not an indication for a surgical intervention in the absence of infertility or adverse obstetrical performance 21. However, some women with unexplained infertility may have a septate uterus and no other cause of infertility, and they have a significantly higher probability of conceiving after removal of the septum than patients with idiopathic infertility 11. It is well known that biological tissue contains a more or less high concentration of electrolytes, making it sufficiently conductive to electrosurgical treatment. The thermal effect of a high-frequency current is used to separate (cutting) and coagulate tissues (desiccation of tissues). The high-frequency currents must be used on humans as low-frequency currents can stimulate nerve and muscle cells in the currents flow because of electrochemical processes (electrolysis). These effects are small enough to be disregarded with frequencies above 100 kHz 13.

It has been shown that hysteroscopy with concomitant laparoscopy is considered to be the gold standard for the diagnosis and treatment of the septate uterus. Some advise a hysteroscopic resection of the uterine septum and sparing of the double cervix whenever present and this itself is quite sufficient to improve the reproductive outcome and manage recurrent abortion, if any 22.

Conventional hysteroscopic surgery uses a monopolar electrocautery system in which the current passes from the active electrode through the patient’s body toward the return plate. The distension media used are glycine 1.5% or sorbitol–mannitol (nonelectrolyte irrigation fluid). This system is potentially dangerous as the electrons flow through the body, beyond the surgeon visual control, before it can return to the generator. In bipolar electrosurgery, the current flow through the tissue is restricted to the area under visual control of the surgeon. Saline solution can be used as a distension medium because there is no risk of current dispersion. The generator produces a high initial voltage spike that establishes a voltage gradient in a gap between the bipolar electrodes 22. There is also electron impact dissociation of water molecules into exited fragments of H+ and OH ions. Bottom line is rupture of cell membranes, which translates into visible cutting. Clinically, there is a precise tissue effect with minimal collateral damage and the depth of coagulation is determined principally by the electrode configuration and by the system design as well as by the technique used by the operator (time and pressure of contact) 13.

Bipolar technology was introduced in the hysteroscopy field with resectoscopic loops and electrodes adaptable to mini-hysteroscopes. The use of isotonic saline as a distension medium and the proximity of electrodes reduce the risk of electrolyte imbalance and electrical burns. Delivering an electrosurgical device throughout mini-hysteroscopes avoids cervical dilatation, limiting damage to the uterine wall.

The safety and efficacy of bipolar surgery, with respect to monopolar instrumentation, need to be established. The main progress achieved with the introduction of bipolar devices is probably represented by a safe shift of inpatient procedures to the office, leading to saving of medical costs. In this field, evidence-based answers are required.

Hysteroscopic septum resection using a bipolar versapoint system has been found to be an effective and safe approach for the removal of septum and significantly improves the live birth rates, and future fertility is not impaired 23. Moreover, Lin et al. 22 studied the reproductive outcome following resectoscope metroplasty in women with a complete uterine septum with double cervix and vagina and found improved pregnancy outcomes in women with primary infertility or a history of pregnancy loss associated with a complete uterine septum with double cervix and vagina.

To date, few cases of uterine rupture during pregnancy after hysteroscopic metroplasty have been reported in the literature 24–27. None of these procedures was performed in an office setting and two were complicated by uterine perforation during the metroplasty, whereas three were performed using rigid scissors. Undoubtedly, uterine rupture during pregnancy after hysteroscopic metroplasty is a rare event, irrespective of the method used 26. In accordance with other authors, we believe that office hysteroscopic metroplasty, in awake patients, can alert the surgeon as soon as the muscular tissue is reached, causing the patient pain. In that instant, the metroplasty must be stopped irrespective of the length of the septum left. The results of our study indicate the possibility of achieving a safe, complete removal of uterine septa in most cases using mini-hysteroscopy with a bipotrode 5 Fr bipolar electrode. Selvaraj and Selvaraj 23 have reported the effectiveness and the safety of using a bipolar versapoint system in septoplasty, but it was a retrospective study including a small number of patients. The main advantage of the Bipotrode is that it is made of semiflexible stainless steel, which is autoclavable and reusable; thus, it results in low cost per case

Conclusion

Septal resection with a 4-mm diameter hysteroscope with the reusable bipotrode 5 Fr bipolar electrode presents some advantages in comparison with monopolar resectoscopy. The use of saline as a distension medium, avoiding general anesthesia, can increase the feasibility of an outpatient intervention to improve the clinical outcome and to decrease medical costs.

Acknowledgements

Conflicts of interest

There are no conflicts of interest.

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Keywords:

bipotrode 5 Fr bipolar electrode; hysteroscopy; monopolar; uterine septum

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