Transvaginal hydrolaparoscopy compared with laparoscopy for the evaluation of infertile women: a prospective comparative blind study

E. Darai1,3, L. Dessolle1, F. Lecuru2 and D. Soriano1

1 Service de Gynécologie, Hôpital Hôtel-Dieu de Paris and 2 Service de Gynécologie Hôpital Boucicaut, Paris, France


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Standard diagnostic laparoscopy is considered the gold standard to investigate tubo-peritoneal infertility. It requires general anaesthesia and full operative facilities. Due to the risk of complications, laparoscopy is frequently postponed to the final stage of infertility evaluation or even after treatment trials have failed. Transvaginal hydrolaparoscopy (THL) is based on vaginal access using a needle puncture technique and saline for distention. THL can be performed on an outpatient basis under local anaesthesia. However, little data exist concerning the accuracy of THL in comparison with laparoscopy. We conducted a prospective comparative blind trial to assess the feasibility and accuracy of THL compared with diagnostic laparoscopy in infertile women. Sixty women were assigned to undergo THL immediately prior to laparoscopy. Different operators evaluated the findings of the two procedures. In order to evaluate the accuracy of THL, findings in terms of tubal pathology, endometriosis and adhesions were analysed. The success rate of accessing the pouch of Douglas was 90.2%. Complication rate was 1.6%. THL diagnosis was correlated with that of laparoscopy in 92.3% of cases. In cases of abnormal findings by THL, there were no normal laparoscopies. Our pilot study suggests that THL is a safe and reproducible method. Retroverted uterus should be considered as a relative contraindication to THL. When a complete evaluation by THL is available, it is a highly accurate technique in comparison with the laparoscopy.

Key words: adhesions/endometriosis/hydrolaparoscopy/infertility/laparoscopy


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Diagnostic laparoscopy is considered as the investigation of choice to explore tubo-peritoneal infertility or infertility associated with endometriosis. Standard diagnostic laparoscopy for female infertility when performed in women without previous pelvic pathology or any clinical and sonographic findings may result in normal examination or pathology of doubtful clinical significance (Forman et al., 1993Go). In this context, laparoscopy should be considered a major surgical procedure due to the risk of complications (Querleu et al., 1993Go; Chapron et al., 1997Go; Jansen et al., 1997Go).

Transvaginal hydrolaparoscopy (THL) is a new procedure to explore the pelvis (Gordts et al., 1998aGo). This method is based on vaginal access using a needle puncture technique and saline for distention. It was derived from culdoscopy, a method that was abandoned when laparoscopy proved to be superior. The introduction of small diameter laparoscopes allowed re-evaluation of transvaginal access for infertility investigation. THL may improve the visualization of the pelvic organs. Vaginal access and hydroflotation allow inspection of the tubo-ovarian structures in their normal position with no need for manipulation (Gordts et al., 1998aGo; Brosens et al., 1999Go). THL can be performed on an outpatient basis under local anaesthesia (Gordts et al., 1998aGo,bGo; Watrelot et al., 1999Go). This may reduce the procedure's cost and the incidence of complications associated with general anaesthesia.

However, there are few data concerning the accuracy of THL in comparison with the `gold standard' laparoscopy in terms of tubal pathology, endometriosis, and adhesions. The aim of this study was to evaluate the feasibility and usefulness of THL as a screening tool in infertile patients in comparison with standard diagnostic laparoscopy.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Between January and December 1999, 60 consecutive women referred for diagnostic laparoscopy due to infertility at the Services de Gynécologie, Hôpital Hôtel-Dieu de Paris and Hôpital Boucicaut were prospectively enrolled into the study. The inclusion criteria were infertility of >2 years, normal ovulation, normal gynaecological and ultrasonographic examination. All patients had hysterosalpingography before entering the study; all were considered as normal except for four cases with suspicious tubal spasms. Semen analysis was normal in all of the women's partners except two, who had oligozoospermia.

All patients gave their consent after receiving a detailed explanation concerning the two procedures. The mean (±SD) age was 31 ± 6.8 years (range 21–40). Primary infertility was diagnosed in 39 women (65%) and nine women (15%) had previous pelvic or abdominal surgery.

The study was conducted on a blind setting basis. The THL was performed immediately prior to the diagnostic laparoscopy. Different operators, who were blinded to the initial findings of the THL, performed the standard laparoscopy. THL surgical reports were written immediately after the operation before performing the laparoscopic procedure, and were given to the research nurse. The THL was performed using the transvaginal hydrolaparoscopy system (Circon, Lisses, France).

All procedures were performed by well-experienced laparoscopic surgeons, and each one of them had performed at least 10 THL procedures prior to the study. All procedures were performed in the late proliferative phase of the menstrual cycle under general anaesthesia. The patients were placed in the dorso-lithotomy position. Following disinfection, a Foley catheter number 8 was introduced into the bladder and another catheter was introduced into the uterus. The posterior lip of the cervix was grasped by a tenaculum in order to expose the posterior fornix. The insertion of the Veress needle was facilitated by a stab incision in the posterior fornix, 1.5 cm below the cervix. A 3 mm blunt trocar was introduced into the posterior fornix. A 2.7 mm diameter semi-rigid endoscope was used, with an optical angle of 30°. Normal saline solution (250 ml) was instilled into the pouch of Douglas under gravity. Illumination was provided by a high-intensity cold-light source (250 W) via a fibre-optic lead. The images were viewed on a high-resolution colour monitor. Examination started at the posterior wall of the uterus, and by rotation and deeper insertion of the endoscope, the tubes and the ovaries were evaluated. Evaluation by THL was defined as complete when the pouch of Douglas, the posterior wall of the uterus, the utero-sacral ligaments (USL), the tubes and the fimbriae, the ovaries from all sides and fossae were all visible. After examination of the whole pelvic cavity, tubal patency was evaluated using dye injection through the uterine catheter. At the end of the examination the instruments were removed and the posterior fornix was sutured using 3/0 absorbable suture. All procedures were followed by hysteroscopy to evaluate the uterine cavity.

Immediately after the THL procedure, standard laparoscopy was performed. A Veress needle was inserted through the umbilicus and the abdomen insufflated with CO2. After induction of pneumoperitoneum and insertion of the video-laparoscope, one or two suprapubic punctures were made for the ancillary instruments. No intracervical instruments were used for mobilization of the uterus. The abdominal and the pelvic cavities with their structures were evaluated.

Main outcome measures were the success rate of accessing the pouch of Douglas, the rate of complications, and the accuracy of THL in comparison with standard laparoscopy. In order to evaluate the accuracy of the THL, findings in term of tubal pathology, endometriosis and adhesions were analysed.

The THL was defined as normal when there were no abnormal findings following complete evaluation of the whole pelvis, or abnormal when any pathology was seen following complete or incomplete evaluation.

Statistical analysis was performed using Student's t-test, and P < 0.05 was considered to be statistically significant.


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
A total of 60 women was enrolled into our study. Among them, there were 54 women with anteverted uteri. Unsuccessful access into the pouch of Douglas occurred in six patients. Among these six failures, five cases of retroperitoneal insertion of the Veress needle were noted. In one case, rectal perforation occurred in a woman with a retroverted uterus and pelvic endometriosis. She was treated expectantly.

The access failure rates were found to be related to the position of the uterus. There were three access failures among the six women with a retroverted uterus (50%) in comparison with three failures among the 54 women with an anteverted uterus (5.6%) (P < 0.005). These six women were excluded, since THL was not performed. Therefore, the study population included 54 women. The frequency of successful access to the pouch of Douglas and the complication rates were 90.0 and 1.9% respectively.

The ability to evaluate the pelvis and its structures by THL versus standard laparoscopy is presented in Table IGo. There were no difficulties in inspecting the cul-de-sac, the posterior wall of the uterus, or the USL using THL. However, the tubes with all their parts, the ovaries and all its sides, and fossae were evaluated in 87.0, 89.8 and 66.7% of the patients respectively (Table IGo). Pelvic adhesions were noted in 15 out of the 18 patients with incomplete evaluation.


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Table I. Successful evaluation of the pelvis and its structures by transvaginal hydrolaparoscopy (THL) versus standard laparoscopy
 
Tubal findings by THL and standard laparoscopy are presented in Table IIGo. There were 14 cases of tubal abnormalities diagnosed by laparoscopy, 13 of which (92.9%) were diagnosed correctly by THL. All cases of proximal tubal obstructions (n = 3), tubal phimosis (n = 5) and five out of six cases of hydrosalpinx were diagnosed correctly by THL. In the case of hydrosalpinx missed by THL, severe pelvic adhesions were noted which prevented complete evaluation.


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Table II. Tubal findings by transvaginal hydrolaparoscopy (THL) versus standard laparoscopy
 
The accuracy of THL in diagnosis of endometriosis by location of the lesions is presented in Table IIIGo. Endometriosis was diagnosed by the diagnostic laparoscopy in 11 women (20.4%). All of them were classified as stage I or II endometriosis according to the revised AFS classification (American Fertility Society, 1985Go). The most common sites were the USL, and ovarian surface or fossa. Using THL, six patients (54.5%) were diagnosed correctly. In four out of five patients with missed endometriosis by THL, pelvic adhesions were noted and a completed evaluation could not be performed. In these cases, endometriotic lesions were located at the ovarian surface, fossa and endometriomata <3 cm in two cases. These two endometriomata were pre-operatively diagnosed by ultrasound as luteal cysts. The fifth patient had a complete pelvic examination but an endometriotic lesion located at the ovarian surface was missed. There was no case of false positive diagnosis of endometriosis by THL. In three women endometriotic lesions located in the vesico-uterine fold were diagnosed by laparoscopy. All of them had other lesions that were diagnosed correctly by THL.


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Table III. Evaluation of the endometriosis by transvaginal hydrolaparoscopy (THL) versus standard laparoscopy. Most patients had endometriosis lesions in more than one location
 
The evaluation of the adhesions by THL versus standard laparoscopy is presented in Table IVGo. Pelvic adhesions were noted in 15 patients (27.8%) by laparoscopy. Five of these patients (23.8%) were misdiagnosed by the THL. Adhesions located in the pouch of Douglas (n = 8) were diagnosed in all cases by THL. In cases with adhesions located in the pouch of Douglas, a complete evaluation was not possible and therefore not all of the additional adhesions were seen.


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Table IV. Evaluation of the adhesions by transvaginal by hydrolaparoscopy (THL) versus standard laparoscopy. Most patients had adhesions in more than one location
 
In all of the five misdiagnosed cases, fine adhesions with peri-ovarian location or located at the ovarian fossa were diagnosed by laparoscopy. In four out of these five cases, a completed evaluation was not performed. Therefore, taking into account only complete THL evaluation, there was one false negative case.

In two out of seven cases peri-colonic adhesions were diagnosed correctly by THL. However, the additional adhesions were located out of the pelvis. There was no case of false positive diagnosis of adhesions using THL. In addition, there were two cases of uterine leiomyoma, both located in the posterior wall of the uterus, and both were identified by THL.

In our study population, 24 patients (44.5%) had a normal evaluation of the pelvis according to the standard laparoscopy. Abnormal evaluation by THL was noted in 24 out of the 30 women who had pelvic abnormality according to the laparoscopic findings. Therefore, normal THL evaluation was inaccurately noted in six women. However, in only two out of these six patients was a complete evaluation performed. In all cases of normal THL, normal laparoscopy was noted, hence there was no case of false positive evaluation by THL.

Overall, the THL examination was closely related to the diagnostic laparoscopy result in 49 out of 54 cases (90.7%). Since false negative can be calculated only in cases of complete evaluation by THL, the sensitivity, specificity, positive and negative predictive values were 92.3, 100, 100 and 92.3% respectively.

The mean duration of the THL was 15 min (range 10–20). There were no postoperative complications in our study population.


    Discussion
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Our study shows that THL is a feasible, reproducible and safe procedure. Therefore, it is consistent with earlier results (Gordts et al., 1998aGo; Watrelot et al., 1999Go). The success rate of accessing the cul-de-sac and performing THL was 90.2%. In their first report, three failures were described out of 28 cases (Gordts et al., 1998aGo). Failures mostly occurred at the beginning of our experience. These results can be compared to a failure rate of 3.1% recorded previously (Watrelot et al., 1999Go). We did not exclude from the study women with retroverted uterus, as others have done. We found significantly more access to the cul-de-sac failures in cases of retroverted uterus and it should be considered as a relative contra-indication. However, since we had only one complication it was impossible to draw any conclusion concerning the complications associated with retroverted uterus. We did not have any complication associated with the laparoscopic evaluation. However, the risks of this procedure are very well established (Chapron et al., 1997Go).

Complete evaluation of all the pelvic organs was not possible in all cases. We noted that without manipulation of the adnexa, it is difficult in some cases to investigate the ovarian surface from all sides, and in particular the ovarian fossae. This was noted especially in cases of pelvic adhesions, which can explain some of the misdiagnoses of endometriosis lesions.

Previous reports investigating the role of THL did not evaluate the pathologies by their number and location, and did not compare their findings with laparoscopy (Gordts et al., 1998aGo,bGo; Watrelot et al., 1999Go). Therefore, the accuracy of this method was not fully assessed and the conclusions were based on a small number of patients for comparison (seven patients: Gordts et al., 1998b; 10 patients: Campo et al., 1999).

The results of our study indicate that THL is a valuable technique for the diagnosis of tubal pathology. The comparison of the two methods was highly accurate for Fallopian tube pathologies. Previous studies on THL reported similar results (Gordts et al., 1998; Watrelot et al., 1999Go) and demonstrated that even salpingoscopy can be performed successfully using THL. However, the non-blinded approach and the small sample study limited the data in these studies.

In comparison with these encouraging efficacy results of THL in evaluating the tubal pathology, we correctly diagnosed 54.6 and 66.7% of patients with endometriosis and with adhesions respectively. This was due to the fact that there were hidden places during the examination, particularly in cases of pelvic adhesions. However, as a screening tool, THL should identify the patients with pelvic abnormalities that require further treatment intervention such as laparoscopy. The overall accuracy of THL in diagnosis of pelvic abnormality, in comparison with standard laparoscopy was 88.9% with no false positive results.

THL has limitations when compared with laparoscopy. First, the view is limited to the posterior part of the true pelvis. Second, most gynaecologists are more familiar with the panoramic view of the pelvis and its organs as seen at laparoscopy. Third, without manipulating the adnexa not all the pathologies are seen, as was demonstrated in this study. Furthermore, the range of interventions that can be performed is limited in comparison to laparoscopy. The current practice in most centres is to treat pathologies such as endometriotic lesions, or adhesions, surgically, whenever seen during laparoscopy. This cannot yet be performed by THL. However, using this method will allow a more critical selection of patients likely to benefit from laparoscopy.

In our prospective blind study, which did not exclude women with prior pelvic or abdominal surgery, only 44.5% of the patients had normal pelvic findings. THL may be an alternative method to investigate the pelvis even in these cases.

The main advantage of THL is the ability to perform the procedure on an outpatient basis with local anaesthesia, as was reported previously (Gordts et al., 1998). When local anaesthesia is used, the procedure is associated with minimal discomfort and is well accepted and tolerated by the patients. Another important advantage of the THL by local anaesthesia is that the patient can follow the procedure on the video screen, and this allows it to be explained to her and her partner (Brosens et al., 1999Go).

The different levels of experience of the physicians that performed the THL could have affected our results and could have been an additional reason for incomplete THL evaluation. The fact that those who performed the laparoscopy were blinded to the THL findings could not prevent this potential bias from affecting the results.

In conclusion, our pilot study suggests that THL is a feasible and accurate method and may be considered as an alternative procedure for evaluating infertile women. Retroverted uteri should be considered as a relative contra-indication for this procedure. In cases of abnormal findings or incomplete evaluation by THL, laparoscopy is indicated as a second step of evaluation.


    Notes
 
3 To whom correspondence should be addressed at: Service de Gynécologie, Hôpital Hôtel-Dieu de Paris, 2 rue d'arcole,75004 Paris, France. E-mail: emile.darai{at}htd.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]

Brosens, I., Campo, R. and Gordts, S. (1999) Office hydrolaparoscopy for the diagnosis of endometriosis and tubal infertility. Curr. Opin. Obstet. Gynecol., 11, 371–377.[ISI][Medline]

Campo, R., Gordts, S., Rombauts, L. and Brosens, I. (1999) Diagnostic accuracy of the transvaginal hydrolaparoscopy in infertility. Fertil. Steril., 71, 1157–1160.[ISI][Medline]

Chapron, C., Pierre, F. and Lacroix, S. (1997) Major vascular injuries during gynecologic laparoscopy. J. Am. Coll. Surg., 185, 461–465.[ISI][Medline]

Forman, R.G., Robinson, J.N., Metha, Z. and Barlow, D.H. (1993) Patient history as a simple predictor of pelvic pathology in subfertile women. Hum. Reprod., 8, 53–55.[Abstract]

Gordts, S., Campo, R., Rombauts, L. and Brosens, I. (1998a) Transvaginal hydrolaparoscopy as an outpatient procedure for infertility investigation. Hum. Reprod., 13, 99–103.[Abstract]

Gordts, S., Campo, R., Rombauts, L. and Brosens, I. (1998b) Transvaginal salpingoscopy: an office procedure for infertility investigation. Fertil. Steril., 70, 523–526.[ISI][Medline]

Jansen, F.J., Kapiteyn, K., Trimbos-Kemper, T. et al. (1997) Complications of laparoscopy: a prospective multicentre observational study. Br. J. Obstet. Gynaecol., 104, 595–560.[ISI][Medline]

Querleu, D., Chevalier, L., Chapron, C. and Bruhat, M.A. (1993) Complications of gynecological laparoscopic surgery. A French multicentre collaborative study. Gynecol. Endosc., 2, 3–6.

Watrelot, A., Dreyfus, J.M. and Andine, J.P. (1999) Evaluation of the performance of fertiloscopy in 160 consecutive infertile patients with no obvious pathology. Hum. Reprod., 14, 707–711.[Abstract/Free Full Text]

Submitted on February 4, 2000; accepted on July 18, 2000.