Transvaginal Hydro Laparoscopy: Preliminary Assessment of Cost-Effectiveness

Transvaginal hydro laparoscopy (THL) is a new approach to pelvic anatomic evaluation in the infertile woman. In this procedure a dilating trocar is inserted through the osterior vaginal wall for endoscopic pelvic examination. Normal saline is used to float the bowel out of the pelvis so that one can evaluate the distal Fallopian tubes, ovarian surfaces, pelvic sidewalls, and the cul-de-sac. The THL procedure makes in-office pelvic endoscopy, hysteroscopy, and dye hydrotubation a reality.[1]

For many years there has been a debate over the accuracy of hysterosalpingography (HSG) when compared to laparoscopy as the gold standard. False positive and false negative rates for HSG are in the range of 15-38% and 13-57%, respectively. In a meta-analysis of studies comparing HSG to laparoscopy, Swart reported that HSG had a sensitivity of .65 and a specificity of .83.[2] The author's conclusion was that HSG was good for diagnosing tubal obstruction but poor at predicting peritoneal pathology. Most authors recommend 3 to 10 months of therapy following a normal HSG because of the expense of laparoscopy, which can account for as much as 70% of the cost of the infertility work-up.[3]

This article discusses the role of THL and HSG in the cost-effective evaluation of infertility.

Emerging Endoscopic Therapies

New diagnostic technologies that may improve the accuracy and cost-effectiveness of infertility services are being explored. Currently, couples have a basic evaluation involving semen analysis, HSG, and postcoital and ovulatory testing. If the HSG is normal, couples undergo various therapies, including intrauterine insemination and ovulation induction prior to laparoscopy. Chlamydial antibody testing can help in detecting those patients who have a higher likelihood of tubal disease and who should undergo laparoscopy sooner.

Hysteroscopy, in our hands, has been more accurate than HSG for diagnosing submucosal fibroids and polyps. Office diagnostic hysteroscopy can be done with minimal discomfort and is sometimes recommended even after a normal HSG. Sonohysterography (SHG) has been shown to be very accurate in uterine cavity evaluation.[4] SHG may be of value in diagnosing tubal obstruction, and can be incorporated into a screening ultrasound examination. Diagnostic microlaparoscopy[5] and THL are new endoscopic advances for minimally invasive, visual pelvic evaluation.

Microlaparoscopy has been proposed as a cost-effective method to obtain accurate pelvic anatomic information. Microlaparoscopy can be performed in the office with conscious sedation for diagnostic purposes. The need for Trendelenberg position, CO2 insufflation, and organ manipulation makes microlaparoscopy an uncomfortable procedure for many patients.

THL is performed in dorsal lithotomy position, and uses a fluid distending medium as opposed to CO2. Generally patients can tolerate this procedure with less discomfort than microlaparoscopy. The pelvic structures tend to float in the fluid, so the scope can be guided around the surface of the organ of interest. In expert hands THL can be performed with only local anesthesia and no significant sedation.[1] For the physician with less experience, THL may require IV or oral conscious sedation.

Indications/Contraindications of THL

Preceding laparoscopy, couples usually undergo 3 to 10 months of therapy. These therapies involve both monetary and emotional costs. Approximately 50% of apparently normal infertile patients undergoing laparoscopy will have pelvic pathology.[6]

Endometriosis, which affects 25-35% of infertile women, is associated with a lower monthly pregnancy rate. Laparoscopic treatment of minimal or mild endometriosis significantly improves the pregnancy rate compared to expectant management.[7] Women with moderate to severe distal tubal adhesions, whether from advanced stages of endometriosis, infection, or prior surgery, may be better served by in vitro fertilization (IVF) than operative laparoscopy. THL is a diagnostic endoscopic procedure with greater accuracy than HSG and can be done in the office with conscious sedation. Initial or early evaluation with THL, as a more precise critical pathway, may help reduce fertility costs.

Substituting THL for HSG in the infertility work-up requires combining THL with diagnostic hysteroscopy and dye hydrotubation. Patients who would not be candidates for THL are those with a pelvic mass, a fixed retroverted uterus, or suspicion of an obliterated cul-de-sac. Women with an enlarged uterus filling the pelvis would also not be candidates. A vaginal infection should be treated before attempting THL, and transvaginal sonography should be performed before considering THL. Contraindications found on ultrasound include submucosal fibroids, endometrial polyps, endometrioma, dermoid, suspected ovarian neoplasia, or any other pelvic mass that suggests the need for operative intervention. Since blood can obscure the view, THL may not be possible in the presence of hemoperitoneum. THL may not be advisable in morbidly obese patients. In the initial infertility evaluation, THL, hysteroscopy, and dye hydrotubation are feasible in the majority of patients.

Cost Comparisons/Cost-Effectiveness

The value of substituting THL for HSG in the initial work-up may be controversial. However, there is support that performing THL before laparoscopy reduces infertility costs. Campo reported on 70 infertility patients who underwent THL.[8] Thirty-three (47%) had no adnexal pathology and did not go on to laparoscopy. Assuming the cost of laparoscopy (anesthesiologist, hospital, surgeon) is $5,580[3] and the cost of THL is $1,000, this approach represents a savings of $114,170 ($1,631/patient). Applying this same cost model to Marcoux's[7] study on laparoscopic treatment of endometriosis provides additional considerations. Assume 30% of patients have minimal or mild endometriosis.[6] HSG costs $400, THL is $1,000, and laparoscopy is $5,580 (see Table 1).

All women with minimal or mild endometriosis will have a normal HSG; after 9 months 17.7% are pregnant (rate for untreated controls); and the rest undergo laparoscopy. THL diagnoses all patients with endometriosis, each is treated with laparoscopy, and 30.7% are pregnant at 9 months (treated rate). The cost per pregnancy is $28,585 for the HSG group and $21,457 for the THL group. These models support the economic value of THL.[6,7]

A pilot study of the cost-effectiveness of THL was conducted at our institution on 11 patients who underwent THL instead of laparoscopy. Eight patients had a previous normal HSG, one had an abnormal HSG (unilateral distal disease), and 2 had historical factors without previous HSG. THL was adequate in all patients. Based on THL findings laparoscopy was recommended in only 4 patients (36%), saving $28,060 ($2,551/patient - see Table 2). The contralateral side and the rest of the pelvis was normal in the patient with the abnormal HSG. Both of the women with no previous HSG had a normal pelvis. Three of the 8 patients with a normal HSG had a normal THL. Four of the other 5 were candidates for operative laparoscopy, and IVF was suggested for the other patient. The cost of therapy in the 5 women that had a normal HSG but an abnormal THL was $13,725 ($2,745/patient - see Table 3). If THL was used initially instead of (or in combination with) HSG, patients who would benefit from IVF or laparoscopy could be identified sooner.

Summary

There is a learning curve for THL. One must become familiar with a narrower field of vision and a view of the pelvis from a different angle. In laparoscopy we are used to a broad panoramic view. Physicians experienced in office microlaparoscopy know that with a conscious patient, there is less CO2 distention, and the panoramic view is decreased. The closeness of the pelvic organs and the smaller field of vision associated with THL are similar to the smaller field of view in hysteroscopy. A physician comfortable with in-office hysteroscopy should be able to master THL.

The THL trocar system (Figure 1) is designed to minimize the risk of complications. The occurrence of infection, puncture of the uterine parametrium, rectal perforation, and other bowel injury are thought to be similar to the risk of other transvaginal needle procedures such as ovum retrieval and culdocentesis. Careful exclusion of patients with contraindications is one way to avoid complications. It is wise to perform THL in the hospital at the time of laparoscopy to develop a comfort with the procedure before attempting it in the office.

Until recently, THL has been solely a diagnostic procedure. Instrumentation has been developed for operative applications (see CIRCON Update, below) such as treatment of minimal to mild endometriosis. Other uses of THL may include pain mapping for chronic pelvic pain, lysis of adhesions, tubal sterilization, and ovarian cystectomy.

Based on our experience, THL appears to be an efficient, cost-effective procedure that can be performed in the office setting and is well tolerated by patients. However, further prospective trials are necessary to fully assess its role in pelvic assessment for infertility.

References:

References

1. Gordts S, Campo R, Rombauts L, et al. Transvaginal hydro laparoscopy as an outpatient procedure for infertility investigation. H Repro. 1998;13:99-103.

2. Swart P, Mol BWJ, Van der Vee F, et al. The accuracy of hysterosalpingography in the diagnosis of tubal pathology, a meta-analysis. Fertil Steril. 1995;64:486-491.

3. Bates GW, Bates BR. The economics of infertility; developing an infertility managed-care plan. Am J Obstet Gynecol. 1996;174:1200-1207.

4. Gaucherand P, Piacenza JM, Salle B, et al. Sonohysterography of the uterine cavity: preliminary investigations. J Clin Ultrasound. 1995;23(6):339-348.

5. Palter SSF, Olive DL. Office microlaparoscopy under local anesthesia for chronic pelvic pain. J Am Assoc Gynecol Lap. 1996;3:359-364.

6. Speroff L, Glass RH, Kase NG. Clinical gynecologic endocrinology and infertility. Baltimore, MD: Williams & Wilkins; 1998.

7. Marcoux S, Maheux R, Berube S. Laparoscopic surgery in infertile women with minimal or mild endometriosis. N Engl J Med. 1997;337:217-222.

8. Campo R, Gordts S, Rombauts L, Brosens I. Diagnostic culdoscopy in infertility: study of 400 out-patient procedures. Infertil Reprod Med Clin N Am. 1999;161-175.

Dr. Moore is an assistant clinical professor at the University of Colorado Health Sciences Center, and medical director, Advanced Women¹s Institute, in Denver, CO.