Accuracy of hysterosalpingography and laparoscopic hydrotubation in diagnosis of tubal patency

FERTILITY AND STERILITY Copyright

©

Vol. 63, No.5, May 1995

1995 American Society for Reproductive Medicine

Printed on acid·free paper in U. S. A.

Accuracy of hysterosalpingography and laparoscopic hydrotubation in diagnosis of tubal patency

Babatunde Adelusi, F.R.C.O.G.* Lulu Al-Nuaim, M.R.C.O.G.* Dorothy Makanjuola, F.R.C.R.t

Tariq Khashoggi, Arab Board* Noori Chowdhury, M.P.H.* Dustan Kangave, M.S.t

King Khalid University Hospital, Riyadh, Saudi Arabia

Objective: To compare the diagnostic accuracy of two methods of assessment oftubal patency, viz, hysterosalpingography (HSG) and laparoscopic hydrotubation. Design: One hundred four infertile women who were investigated with both HSG and laparoscopy in King Khalid University Hospital were selected for the study. Complete history offactors that may predispose to tubal occlusion was obtained. Patients with problems of ovulatory failure or poor semen analysis that may contribute to their infertility were excluded. Results: The overall agreement between the two methods was 62.5%. However, the diagnostic accuracy ofthe two methods differed significantly. Conclusion: It would appear that laparoscopic hydrotubation, despite its invasive nature, had an edge in diagnostic accuracy when compared with HSG. It would be advantageous to subject patients in whom HSG has shown tubal blockage to laparoscopy or any of the newer techniques of hysteroscopy or sonographic hydrotubation. Fertil Steril 1995;63:1016-20 Key Words: Hysterosalpingography, laparoscopic hydrotubation, diagnostic accuracy

Tubal pathology due to pelvic adhesive disease has been reported to account, either totally or in part, for infertility in up to 50% of investigated couples (1-3). This is because of the vital role played in sperm and ovum transport by the ciliary and muscular activities ofthe fallopian tubes (4,5). Hence, the diagnostic evaluation of the tubes often is limited to whether these are patent or nonpatent (4). The two diagnostic procedures currently used for evaluation of tubal patency are hysterosalpingography (HSG) and laparoscopic hydrotubation (6-8). Each option has certain advantages, disadvantages, and limitations. Although HSG is accepted as a noninvasive procedure, it is performed without any sedation or anesthesia and, therefore, the patient is

Received June 24, 1994; revised and accepted December 5, 1994. * Department of Obstetrics and Gynaecology. t Reprint requests: Babatunde Adelusi, F.R.C.O.G., Department of Obstetrics and Gynaecology, King Khalid University Hospital, P.O. Box 7805, Riyadh 11472, Saudi Arabia (FAX: 966-1467-1993). :j: Department of Radiology. § Biostatistics Division, College of Medicine Research Center. 1016

Adelusi et al. Diagnosing tubal patency

not relaxed. In addition, the patient is exposed to a contrast medium (4, 9). Hence, the rate of tubal spasm at the cornua and, therefore, false positive tubal blockage, is said to be higher than usual (10). On the other hand, laparoscopy is an invasive procedure, which, even though allows it pelvic visualization, is not without risks (11). Various studies have reported agreement of the two techniques, with results varying from 55% to 76% (12-14). Indeed, it is reported that the only discrepancy between the results of the two procedures lay in the identification of peritubal adhesions at laparoscopy (13, 14). To evaluate the accuracy of each of these two procedures, HSG and laparoscopy, in identifying tubal blockage, we analyzed the infertility patients who were assessed and managed at the King Khalid University Hospital over a 5-year period and in whom both procedures were performed as part of their infertility evaluation. The results of the tubal patency tests with these two procedures were compared and analyzed statistically. MATERIALS AND METHODS

From 1988 to 1992, 104 infertile women who were investigated with both HSG and laparoscopy in King Fertility and Sterility

Khalid University Hospital were included in the study. These women underwent diagnostic HSG, followed by laparoscopy within a period of 6 months, as part of their infertility workup. All patients had a history of infertility of 2e: 1 year duration, whether primary or secondary, before being investigated. For each patient, a complete history was taken, including the presence of any factor that may predispose to tubal occlusive disease especially with regards to past history of sexually transmitted diseases (STDs) or pelvic inflammatory disease. All patients with factors, such as ovulatory failure or poor semen analysis, that may be contributory to their infertility were excluded from the study. Hysterosalpingogram was performed under sterile conditions with the tenaculum cannula technique, during the first 10 days ofthe menstrual cycle. When indicated in patients with irregular menstrual cycles or patients with amenorrhoea, a negative pregnancy test result was obtained before the procedure. Mter cannula placement, routine spot films were obtained under fluoroscopic guidance. The standard views obtained include a scout view of the pelvis, an anteroposterior underfilled view of the uterus, filled view of the fallopian tubes, and a delayed (5 to 10 minutes) anteroposterior view ofthe pelvis, to evaluate the character of the peritoneal spill. Oblique views of the tubes and uterus also were obtained whenever necessary. Six to 10 mL of the water-soluble contrast (60% iodine wtlvol) usually was adequate for examination. Findings charted from the films include tubal occlusion and its location, whether proximal or distal salpingitis isthmica nodosa, hydrosalpinx, fimbrial occlusions, spillage, whether free or loculated, and uterine abnormalities such as Asherman's Syndrome, bicornuate uterus, cervical incompetence, leiomyoma, adenomyosis among others. Whenever the tube was absent or not visualized, as in cases of spasm at the cornua or postsalpingectomy for ectopic pregnancy, the tube was regarded as blocked for ease of analysis. Laparoscopy with dye hydrotubation was performed in a fully equipped operating room, under general anaesthesia, and after adequate premedication. Laparoscopic technique was standard (7), with little modification according to local facilities and the operator's personal preference and experience. Methylene blue dye solution was used for laparoscopic hydrotubation. In addition, to the observation of tubal patency with free spill of methylene blue in the peritoneum, the appearances of the various pelvic structures (fallopian tubes, ovaries, uterus, peritoneal flimsy adhesions, and other abnormalities) also were evaluated. The results were analyzed and Vol. 63, No.5, May 1995

aOTH

LEFT TUBE BLOCKED

'6Q6,")

BOTH TUBES BLOCKED

23(22'") RIGHT TUBE BLOCKED

A

eoTH TUBES BLOCKED

"l"~

LEFT TUB!: BLOCKED 3'")

3a(35,")

'311

B Figure 1 Tubal patency as determined by laparoscopy (A) and HSG (B).

compared for both techniques using various statistical methods.

RESULTS The ages of the patients recruited into the study varied from 20 to 45 years (mean 30.5 years). There was no significant relationship between patients' ages and tubal blockage, whether with HSG or laparoscopy. Similarly, parity, type of infertility (primary or secondary), or location of tube (right or left), did not have any significant relationship with tubal blockage. However, when tubal blockage was related to the possible associated causative factors, some relationship was found with both techniques. For example, one (50%) of two patients with a history of STD and all three (100%) of those with usage of an intrauterine contraceptive device (IUCD) had blocked tubes on HSG. Similarly, with laparoscopy, both (100%) patients with history of STD, both (100%) patients with appendicitis, and 2 of 3 (66.7%) patients with usage of an IUCD had blocked tubes. The figures are too few for statistical analysis, however. An evaluation of the status of the tubes as assessed by each of the two techniques is shown in Figure 1. Laparoscopy identified 54 (52%) of the patients with both tubes patent, 23 (22%) with both tubes blocked, 11 (11%) with the right tube blocked, and 16 (15%) with the left tube blocked. (Fig. 1A) On the other hand, HSG identified 41 (39%) of the Adelusi et al. Diagnosing tubal patency

1017

BOTH TUBES MTENT

80TH TUBEI BLOCKED

ONE lUBE BlDCKED

TUBAL PATENCY

Figure 2 Comparative diagnostic accuracy of tubal patency by laparoscopy and HSG.

patients with both tubes patent, 36 (35%) with both tubes blocked, 14 (13%) with the right tube blocked, and 13 (13%) with the left tube blocked (Fig. IB). Figure 2 shows a comparative accuracy to identify tubal patency as demonstrated by laparoscopy and HSG. Whereas laparoscopy showed that both tubes were patent in 51.9% of cases, HSG identified both tubes as patent in 39.4% of cases. There was agreement between laparoscopy and HSG in only 31.7%. Similarly, agreement between the two methods in terms of bilateral tubal blockage was 16.3% of cases and, in terms of unilateral blockage, there was agreement in only 14.5% of cases. Table 1 shows the distribution of tubal patency tests by laparoscopy and HSG as expressed in percentages of the total. All data were subjected to statistical analysis, using Kappa Statistics, McNemar's test ofs~metry, and test of marginal homogeneity, to examme whether the marginal proportions differed significantly. There was an overall agreement between the two techniques in 62.5% of cases. Of the 62.5% in which the two procedures showed agreement, however, the percentages along the leftto-right diagonal show that either test indicated that both tubes were patent in only 31.7% of cases, both tubes were blocked in 16.3% of cases, and one tube (regardless of whether it was right or left) was indicated to be blocked in 14.5% of cases. Kappa measure of reliability for the frequencies along the left-toright diagonal, which is analogous to a correlation ~oefficient, was very low (K, 0.453), thus implying Imperfect agreement between the two test results.

McNemar's test of symmetry, which tests whether the frequencies off the left-to-right diagonal of Table 1 differ significantly from those expected to occur by chance alone, indicated that the two methods yielded results that were significantly at variance (P ~ 0.0488). For instance, according to HSG, observabon to the right of the diagonal showed that 12.5% case~ h~d both tubes blocked, whereas laparoscopy had mdICated that both tubes were patent in these patients. In contrast, observation to the left of the diagonal showed only 1.9% of cases had both tubes blocked on laparoscopy, whereas HSG had indicated that both tubes were patent. A test of marginal homogeneity showed that the marginal proportions also differed quite significantly (P = 0.0247). This difference is brought out ~learly w?en the various figures in the correspondmg margmal proportions have been compared. Laparoscopy method identified 51.9% of cases having both tubes patent as compared with only 39.4% of cases by HSG. On the other hand, HSG identified 34.6% of.cases as having both tubes blocked, as compared wIth only 22.1% by laparoscopy. However, each method identified 26.0% with one tube blocked. Table 2 shows the additional pathologies observed at laparoscopy and HSG. In 50 (48.1%) of cases, there were no abnormalities on laparoscopy. Pelvic adhesions (20.2%), ovarian cysts (7.7%), polycystic ovarian disease (6.7%), and uterine fibroids (3.8%) were the commonest pathologies. Combinations of pelvic pathologies were observed also. However inability to identify salpingitis isthmica nodosa ~as consistently apparent. As ~n advantage, HSG identified some other pathologies that were not identifiable by laparoscopy. There were no abnormalities found in 77 (74%) cases. Irregular uterine cavity (9.6%), congenital uterine abnormalities (8.7%), cervical incompetence (2.9%), and uterine fibroids (1.9%) were the most common abnormalities found. DISCUSSION

Apart from the advantages, disadvantages and limitations of each of the two methods for the e;alua-

Table 1 Percentage Tubal Patency as Demonstrated by Hysterosalpingography and Laparoscopic Hydrotubation* Hysterosalpingography Laparoscopic hydrotubation Both tubes patent Both tubes blocked Right tube blocked Left tube blocked Total

Both tubes patent 33 2 2 4 41

Both tubes blocked

(31.7) (1.9) (1.9) (3.8) (39.4)

13 17 3 3 36

(12.5) (16.3) (2.9) (2.9) (34.6)

Right tube blocked

Left tube blocked

Total

6 (5.8) 2 (1.9) 6 (5.8) 0(0.0) 14 (13.5)

2 (1.9) 2 (1.9) 0(0.0) 9 (8.7) 13 (12.5)

54 (51.9) 23 (22.1) 11 (10.5) 16 (15.4) 104 (100)

denotes'nu~ber~disc~ss:~~no:ete~t.p

= 0.0488; margmal

* Kappa measure, reliability = 0.453; McNemar test of symmetry X2 = 11133 de ees f f homogeneity, X2 = 9.374, degrees of freedom = 3, P = 0.0247. Boldfade 1018

Adelusi et al. Diagnosing tubal patency

d

-

.

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Table 2

Pathologies Observed by Laparoscopy and HSG

Pathology Laparoscopy No abnormalities Pelvic adhesions Ovarian cysts Polycystic ovarian disease Uterine fibroids Adhesions + ovarian cyst Uterine anomalies (bicornuate) Endometriosis Adhesions + polycystic ovarian disease Tubo-ovarian mass Uterine fibroid + polycystic ovarian disease Uterine fibroid + ovarian cyst Enlarged ovary Total HSG No abnormalities Irregular uterine cavity Congenital anomalies (septate, bicornuate) Cervical incompetence Fibroids Filling defects Irregular cervix Syncechae + filling defects + irregular uterine cavity Total

No. of cases*

50 (48.1) 21 (20.2) 8 (7.7) 7 (6.7) 4 (3.8) 4 (3.8) 2 (1.9) 2 (1.9) 2 (1.9) 2 (1.9) 1 (1.0) 1 (1.0) 1 (1.0) 104 (100) 77 10 9 3 2 1 1

(74.0) (9.6) (8.7) (2.9) (1.9) (1.0) (1.0)

1 (1.0) 104 (100)

* Values in parentheses are percentages.

tion of tubal patency in infertility, both laparoscopy and HSG have been reported to show agreement in 55% to 75% of cases (12-14). Indeed, it was postulated that the only discrepancy between the two methods lay in the identification of some peritubal adhesions at laparoscopy (13, 14). The results of the present study, showing an overall 62.5% agreement (31. 7% patency, 16.3% bilateral blockage, and 14.5% unilateral blockage), would tend to be in consonance with these other studies (13). However, despite this agreement, this study has shown that the two methods yielded results that were significantly at variance. The percentages off the left-to-right diagonal in Table 1 showed the disparities between the results of the two methods. If there were perfect, or near perfect, agreement between the two methods, the percentages in the upper right hand of the diagonal (Table 1) would be approximately equal to those in the lower left hand ofthe diagonal. On the contrary, the percentages in the upper right hand depicting laparoscopy demonstrations were relatively higher than those in the lower left hand depicting HSG results. Similarly, other pairwise comparisons of percentages in Table 1 would tend to demonstrate this lack of symmetry in the two test results, except at the level of unilateral left tubal blockage. This lack of perfect agreement was strengthened by the low value for K Vol. 63, No.5, May 1995

statistic (K = 0.453) based on the data along the leftto-right diagonal in Table 1. Although there was overall agreement of 62.5% in this study, similar to those of other studies (13, 14), the percentages of 31. 7%, 16.3%, and 14.5% for both tubes patent, both tubes blocked, and one tube blocked (regardless of whether it was right or left), respectively, are quite low. This would imply that there was relatively poor agreement between the results of specific aspects of tubal patency tests demonstrated by the two methods. Indeed, the marginal percentages in Table 1 are quite informative and also are supportive of the above findings as shown by the significant difference in the marginal homogeneity (P = 0.0247). It would appear from these results that laparoscopic hydrotubation, despite its invasive nature, has an edge in its diagnostic accuracy as compared with HSG. It is plausible to explain the lower percentage of tubal patency tests obtained by HSG as being due to the state of the patients, who are not relaxed enough, and their exposure to contrast medium (4, 9) to which they react, with the resultant tubal spasm at the proximal end of the tubes, therefore causing possible false positive tubal blockage (10). The added advantage of visualization of other intrapelvic pathologies that may be the cause of infertility in many instances, especially with regards to intrapelvic adhesions, polycystic ovarian disease, and endometriosis, among others, would tend to favor the use of laparoscopy in the evaluation of tubal patency. The advantage of HSG in visualizing some intrauterine anomalies cannot be overlooked, however, especially in the identification of such pathologies as salpingitis isthmica nodosa. Because HSG is as old as infertility investigation itself, the use of laparoscopic hydrotubation should be the norm only in those patients in whom HSG has demonstrated tubal blockage. Whenever HSG has demonstrated tubal patency with free flow of dye, subjecting the patient to laparoscopic hydrotubation again may not be necessary. However, the newer methods of hysteroscopy and sonographic hydrotubation (15, 16) also may be used in the evaluation of tubal patency in the infertile woman. Indeed, this is more so in those women in whom HSG has indicated that the tubes are blocked, so as to enhance the accuracy of tubal patency. REFERENCES 1. Arronet GH, Eduljee SY, O'Brien JR. A nine-year survey of fallopian tube dysfunction in human infertility: diagnosis and therapy. Fertil Steril 1969;20:903-18. 2. Onifade A, Adelusi B, Kolawole JT. Tubal patency in infertility in Nigeria. J Trop Obstet Gynecol 1985;5:25-30. 3. Harrison RF. Pregnancy successes in the infertile couple. rnt J FertiI1980;25:81-7. Adelusi et al. Diagnosing tubal patency

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4. Seibel MM. Work-up of the infertile couple. In: Seibel MM, editor. Infertility a comprehensive text. Norwalk (CT): Appleton and Lange, 1990:1-21. 5. Tufekci EC, Girit S, Bayirli E, Durmusoglu F, Yalti S. Evaluation of tubal patency by transvaginal sono-salpingography. Fertil Steril 1992;57:336-40. 6. Pontifex G, Trichopoulos D, Karpathios S. Hysterosalpingography in the diagnosis of infertility: (statistical analysis of 3,437 cases). Fertil Steril 1972;23:829-33. 7. Streptoe PC. Laparoscopy in gynecology. London: Livingstone Ltd., 1967. 8. Peterson EP, Behrman SJ. Laparoscopy of the infertile patient. Obstet Gynecol 1970;36:363-7. 9. Richman TS, Biscomi GN, de Cherney A, Polan ML, Alcebo LO. Fallopian tubal patency assessed by ultrasound following fluid injection. Radiology 1984; 152:507 -10. 10. Ismajovich B, Wexler S, Golan A, Langler L, David MP. The accuracy of hysterosalpingography versus laparoscopy in the evaluation of infertile women. Int J Gynaecol Obstet 1986;24:9-12.

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11. Donnez J, Langerock S, Lecart CI, Thomas K. Incidence of pathological factors not revealed by hysterosalpingography but disclosed by laparoscopy in 500 infertile women. Eur J Obstet Gynecol 1982; 13:369-75. 12. Keirse MJN, Vandervellen R. A comparison ofhysterosalpingography and laparoscopy in the investigation of infertility. Obstet Gynecol 1973;41:685-8. 13. Swolin K, Rosencrantz M. Laparoscopy vs. hysterosalpingography in sterility investigations. A comparative study. Fertil Steril 1972;23:270-3. 14. Gabos P. A comparison of hysterosalpingography and endoscopy in evaluation oftubal function in infertile women. Fertil Steril 1976;27:238-42. 15. Henig I, Prough SG, Cheatwood M, Delong E. Hysterosalpingography, laparoscopy and hysteroscopy in infertility: a comparative study. J Reprod Med 1991;36:573-5. 16. Mitri FF, Andronikou AD, Perpinyal S, Hofmeyr GJ, Sonnendecker EWW. A clinical comparison of sonographic hydrotubation and hysterosalpingography. Br J Obstet Gynaecol 1991;98:1031-6.

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