Operative hysteroscopy for infertility using normal saline solution and a coaxial bipolar electrode: a pilot study

H. Fernandez1, A. Gervaise and R. de Tayrac

Department of Obstetrics and Gynaecology, Antoine Béclère Hospital, AP-HP, 157, Rue de la Porte de Trivaux, 92140 Clamart Cedex, France


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
The efficacy and safety of a coaxial bipolar electrode surgical system used to treat surgically remediable infertility conditions was investigated. After gaining initial experience with 50 patients with perimenopausal menorrhagia, 40 infertile patients with submucous myomas (n = 12), uterine septum (n = 12), uterine adhesions (n = 11), and uterine hypoplasia (n = 5) were treated. Bipolar electrodes were inserted through a `5' French operating channel of a 5.5 mm hysteroscope without cervical dilatation. Three electrodes were used: ball, twizzle and spring. Power settings ranged from 50 W (desiccation mode) to 200 W (vapour cut mode). Normal saline was used as the distension medium. All the procedures were completed within 30 min using a 1 l bag of normal saline solution. No episodes of cervical laceration, uterine perforation, haemorrhage, fluid overload or thermal injury occurred. Mild cramping, vaginal bleeding and vaginal discharge were common during the first week. No patients were readmitted. This new surgical approach appears to be well tolerated, safe, and is an effective alternative to conventional hysteroscopic surgery in the treatment of intrauterine lesions.

Key words: bipolar electrode/hysteroscopic surgery/normal saline solution


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Operative hysteroscopy for infertility includes resection of uterine septa, lysis of synechiae, hysteroscopic metroplasty in diethylstilboestrol syndrome and resection of submucous leiomyomata. Monopolar electrodes or Nd:YAG laser fibres delivered through operating hysteroscopes are used for these procedures (Neuwirth and Amin, 1976Go; Hamou, 1993Go; Donnez and Nisolle, 1994Go). Hyponatraemia and subsequent cerebral oedema caused by the glycine media, frequently used during monopolar hysteroscopic surgery, is the most serious complication (Bieber and Loffer, 1995Go; Siegler, 1995Go). Moreover, operative hysteroscopy requires cervical dilatation with the added risk of cervical laceration and uterine perforation, particularly in infertile nulliparous patients with small cervices and uterine cavities. The use of instrumentation of a size >5 mm in such patients is often problematic.

In order to decrease these complications, we used a new coaxial bipolar electrode surgical system, effective in saline solution, through the `5' French (5F) operating channel of a 5.5 mm hysteroscope.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Bipolar system
The Versapoint® bipolar vaporization system (Gynecare; 92787 Issy-Les-Moulineaux, France) consists of a dedicated bipolar electrosurgical generator and three types of electrodes (spring, twizzle and ball). The twizzle and ball electrodes provide precise and controlled removal of tissue by vaporization.

Each electrode consists of an active electrode located at the tip and a return electrode located on the shaft, separated by a ceramic insert. Only tissue in contact with the active electrode involved in the electrical path circuit will be desiccated or vaporized. Similar to other electrosurgical equipment, the generator is designed to be located outside the sterile field with adjustment of settings performed by ancillary operating staff. The generator provides five modes of operation (waveforms) and different power settings between 1 and 200 W. The selected mode of operation and the power setting is indicated on the generator display. The vaporize and blend acronyms of vapour cut, `VC1', `VC2', `VC3' and Blend, `BL1' and `BL2' waveforms are assigned the traditional `cut' (yellow pedal) and are used to vaporize and excise tissue. The `DES' acronym for desiccate waveform is assigned to the traditional coagulation mode (blue pedal) and is used for haemostasis. There is only ~1 mm2 area of collateral damage to tissue. The generator is connected to the electrode via a flexible cable. The electrodes are designed for insertion down the 5F working channel of the 5.5 mm hysteroscope (Karl Storz GmbH & Co, Tuttlingen, Germany).

When the electrode type is connected to the generator, a key feature of the system is its ability to detect the type of electrode attached and to adjust automatically the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. We used, for this reproductive surgery, 130 W. Normal saline in a 1 l bag as the distension medium. Each bag was then adapted in an automatic rotary pump (Hamou-Endomat; Karl-Storz). The flow rate was then constant at no more than 400 ml/mm. Monitoring was performed by measurement of the difference between fluid consumption and aspiration.

Patients
To gain experience with this new system, we first treated 50 patients with endometrial polyps and submucous myomata who had experienced perimenopausal menorrhagia. After this initial learning experience, we treated 40 patients with surgically remediable lesions associated with infertility between 1 January 1999 and 1 February 2000.

Uterine pathology was documented either by hysterosalpingography or transvaginal sonography and diagnostic hysteroscopy.

In this pilot study, the inclusion criteria were hysteroscopic surgical correction of submucous myomata with a size <2 cm (n = 12), uterine septum (n = 12), intrauterine adhesions grade III (according to the European Society of Hysteroscopy: Wamstefer and De Block, 1993) (n = 11) and uterine hypoplasia (n = 5) defined by T-shaped uterus.

No patient had previous uterine surgery. Moreover, all patients underwent investigation of infertility including hormonal evaluation on day 3 of the cycle (FSH, LH, oestradiol), which was normal in all cases, and partner sperm analysis. Five patients had male infertility. Ten patients also had a hysterosalpingography showing tubal or peritubal abnormalities. No endometrial suppressive treatment was given preoperatively. Patients with acute cervicitis and active pelvic inflammatory disease were excluded.

Hysteroscopy was first performed to confirm the uterine lesion and then the electrode was used to vaporize or excise these lesions. Visualization was not affected by the creation of bubbles or tissue debris, which were always absent. The hysteroscopic metroplasty consisted of incising the lateral spurs to obtain an enlargement of uterine size and an improvement in uterine shape.

In this study, general anaesthesia was systematically performed. Twenty-five patients required concurrent laparoscopy for visualization of the pelvic organs and a chromotubation test. In the other 15 patients, 10 laparoscopies had been previously performed in other surgical departments and five were not indicated because of associated male infertility, with indication for intracytoplasmic sperm injection.

Post-operative hysteroscopy was systematically indicated after treatment of intrauterine adhesions (n = 11) and uterine hypoplasia (n = 5) due to the risk of post-operative synechiae. In one case we performed a post-operative hysteroscopy because the initial septum was particularly large.


    Results
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Forty patients, median age 33 ± 3.9 years (range 26–39) were treated with this new bipolar system on an outpatient basis. The results are presented in Table IGo. Follow-up observation ranged from 4 to 58 weeks with none lost to follow-up. No patient required cervical dilatation before the introduction of the hysteroscope.


View this table:
[in this window]
[in a new window]
 
Table I. Results from treatment of 40 patients with new coaxial bipolar electrode system
 
All the procedures were completed within 30 min. There were no major complications such as cervical laceration, uterine perforation, haemorrhage, fluid overload or thermal injury. No secondary documented complaints occurred. Mild cramping in the first couple of days and vaginal discharge during the first week were common. No patients needed readmission.

All the procedures were completed using a 1 l bag of normal saline solution. The amount of saline absorbed systemically ranged from 100 to 300 ml. Diuretics were never required. Leakage of fluid around the hysteroscope was frequently observed.

Among the 25 concurrent laparoscopies, 15 identified normal pelvic anatomy, five periadnexial adhesions (score AFS 1 and 2; American Fertility Society, 1985), three endometriosis (score AFS 1 and 2) and two hydrosalpinx which required neosalpingostomy.

Seventeen patients had a systematic post-operative control hysteroscopy at 2 months. No synechiae were observed and no second surgery was indicated. During this short follow-up period, 10 normal intrauterine ongoing pregnancies (25%) occurred with no recurrence of abortion.


    Discussion
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Current techniques of operative hysteroscopy used for treating infertility such as removal of submucous myoma, metroplasty and Asherman's syndrome use a monopolar electrosurgical system. The distension medium is usually sorbitol and glycine; this limits the operative time in order to decrease the incidence of fluid overload, which may lead to hyponatraemia and subsequent cerebral oedema and death. In contrast with the bipolar electrosurgical system, the normal saline used has ion concentrations similar to human plasma and may reduce electrolyte changes and hyponatraemia. However, if there is excessive absorption of saline solution, pulmonary and brain oedema and even death may still occur (Vilos, 1999Go). Therefore, the total amount of saline solution must be closely monitored and recorded at the end of the procedure, just as with the use of sorbitol or glycine.

A second advantage of the bipolar electrode system is that cervical dilatation is not required. Such dilatation is often difficult in nulliparous women with a stenotic cervix. Avoiding cervical dilatation should prove advantageous in reducing the risk of cervical laceration and uterine perforation and in post-operative analgesia requirements.

A third potential advantage is that this bipolar system might prevent electrosurgical genital tract burns, previously reported (Vilos et al., 1997Go, 2000Go). The return electrode must always be exposed and lie outside the sheath of the hysteroscope to complete the circuit and achieve the most efficient vaporization.

Having optimized our technique in the initial cohort of 50 patients, we were able to operate more quickly than with the usual monopolar technique. Lesions located within the lower uterine segment in close proximity to the internal os (particularly synechiae) still posed some degree of technical difficulty.

Excellent haemostasis was achieved in the vapour cut mode requiring the infrequent desiccation mode which is likely to be advantageous in infertility surgery. Total vaporization of the myomata also avoids the process of having to remove chips from the field of vision and this contributes to the decrease in operating time. All intrauterine lesions should be biopsied prior to complete vaporization to minimize the risk of missing a malignancy.

In conclusion, the Versapoint® bipolar electrosurgical system appears advantageous in infertility surgery. Those experienced with operative hysteroscopy should be able to adapt readily to this new technique. Our results confirm the preliminary experiences previously published in prospective, uncontrolled pilot studies with intrauterine pathology (Kung et al. 1999Go; Vilos, 1999Go; Lindheim et al., 2000Go), but many hundreds of patients must be operated on using this device in order to determine its safety and the degree and type of various complications. In the future, some of these operative hysteroscopies could be conducted without need of general anaesthesia using a paracervical block with or without intravenous sedation in selected patients.

This bipolar electrosurgical system may become an effective alternative to traditional modalities for infertility surgery.


    Notes
 
1 To whom correspondence should be addressed at: Department of Obstetrics and Gynaecology, Antoine Béclère Hospital, AP-HP, 157, Rue de la Porte de Trivaux, 92140 Clamart Cedex, France.E-mail: herve.fernandez{at}abc.ap-hop-paris.fr Back


    References
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
American Fertility Society (1985) Revised American Fertility Society classification of Endometriosis. Fertil. Steril., 43, 351–352.[Medline]

Bieber, E.J. and Loffer, F.D. (eds) (1995) Gynecologic Resectoscopy. Blackwell Science, Cambridge, MA, USA.

Donnez, J. and Nisolle, M. (eds) (1994) An Atlas of Laser Operative Laparoscopy and Hysteroscopy. Parthenon Publishing, London.

Hamou, J. (1993) Electroresection of fibroids. In Sutton, C. and Diamond, M. (eds), Endoscopic Surgery for Gynaecologists. W.B. Saunders, London, pp. 327–330.

Kung, R.C., Vilos, G.A., Thomas, B. et al. (1999) A new bipolar system for performing operative hysteroscopy in normal saline. J. Am. Assoc. Gynecol. Laparosc., 6, 331–336.[ISI][Medline]

Lindheim, S.R., Kavic, S., Shulman, S.V. and Sauer, M.V. (2000) Operative hysteroscopy in the office setting. J. Am. Assoc. Gynecol. Laparosc., 7, 65–69.[ISI][Medline]

Neuwirth, R.S. and Amin, H.K. (1976) Excision of submucus with hysteroscopic control. Am. J. Obstet. Gynecol., 126, 95–99.[ISI][Medline]

Siegler, A.M. (ed.) (1995) Hysteroscopy. Obstet. Gynecol. Clin. N. Am., 22, 457–471.

Vilos, G. A. (1999) Intrauterine surgery using a new coaxial bipolar electrode in normal saline solution (Versapoint*): a pilot study. Fertil. Steril., 72, 740–743.[ISI][Medline]

Vilos, G.A., D'Souza, I. and Huband, D. (1997) Genital tract burns during rollerball endometrial coagulation. J. Am. Assoc. Gynaecol. Laparosc., 4, 273–276.[ISI][Medline]

Vilos, G.A., Brown, G., Graham, G. et al. (2000) Genital tract electrical burns during hysteroscopic endometrial ablation: report of 13 cases in United States and Canada. J. Am. Assoc. Gynecol. Laparosc., 7, 141–144.[ISI][Medline]

Wamstefer, K. and De Block, S. (1993) Diagnostic hysteroscopy: technique and documentation. In Sutton, C. and Diamond, M. (eds) Endoscopic Surgery for Gynaecologists. Saunders, London. pp. 263–273.

Submitted on March 16, 2000; accepted on May 12, 2000.