Determining whether sonography is reliable when monitoring benign-aspect ovarian tumours and if it enables the following of the natural progression of these lesions is the principal objective of the IOTA study, the 5th phase of which involves the participation of a team from the Department of Gynaecology at the University of Navarra Hospital, one of just two centres in Spain to take part in the international research.
“The IOTA research is designed to analyse the role of sonography in the identification of ovarian lesions of a benign nature, such as simple cysts, dermoid cysts, endometriomas or mucinous cysts; and malignant ones, such as cancer of the ovary. This international study began its first phase in 2000. In its first four phases the results have proved the technique to be excellent and to reliably differentiate benign lesions from malignant ones”, explained doctor Juan Alcázar, specialist at the Department of Gynaecology at the University Hospital and lead researcher in this medical study.
In this fifth part of the research the goal is focused on “determining the natural progress of benign lesions of the ovary in the long term”, explained the specialist. “In short, it involved responding to a fundamental question: to know what happens when it is decided not to operate on a patient who has been diagnosed with an apparently non-malignant ovarian lesion”, he explained.
Premenopausal patients are candidates for the study
The research currently under way is aimed at women with a diagnosed ovarian tumour (lesion) of a benign appearance, according to diagnostic sonography which shows asymptomatic results (without apparent symptoms), “i.e. the lesion was diagnosed by chance”, the expert pointed out. These are the sine qua non requisites for a patient to be included in the research. Initially, the study is aimed solely at women less than 45 or 50 (pre-menopausal).
Amongst this female population ovarian cancer has a very low incidence, unlike what occurs amongst postmenopausal women, where it is more prevalent. This is why, amongst this group of older women, surgical operations for these tumours are more common, explained the gynaecologist.
Nevertheless, many young women today opt for surgery when perhaps there is a valid alternative, avoiding the risks arising from surgery and possible loss of, at least, an ovary.
The University Hospital’s previous research
The invitation for the University of Navarra Hospital to participate in this IOTA international research arose from the previous experience at the Navarre hospital with similar lines of research, pointed out the expert. In concrete, doctora Begoña Olartecoechea, specialist at the Department of Gynaecology at the University Hospital, analysed – within the remit of her thesis – the progress of benign ovarian lesions identified in 165 patients with monitoring, in some cases up to 15 years. This is the trend study of these kinds of ovarian disorders undertaken over the longest period of time to date.
Although the goal of this current research is to get phase 5 of IOTA under way – the aim of the research at the University Hospital likewise – the difference lies in that the sampling to be analysed on the international and multicentre level involves thousands of patients, “and thus its statistical value will be unquestionable”, highlighted the specialist.
Conclusions of the sonographic study by the University Hospital
Amongst the main conclusions of the research undertaken by doctor Olartecoechea is “that the rate of complications due to detected benign ovarian lesions (torsion, break or haemorrhage) is very small – under 1% of cases”. At the University Hospital, the control of patients is effected by means of an annual sonography. With this diagnostic test, specialists at the Department of Gynaecology observed that, of the 165 women examined, only in one case was there ovarian torsion and in two the lesion progressed over time to a cancer. Of these two, one became malignant after 10 years of monitoring and the other after 4 years. For both the tumour prognosis is good, “given that they were diagnosed very early”, emphasised doctor Alcázar. “This conclusion confirms, moreover, that the type of ovary cancer arising from benign lesions is a slow process”.
Another of the relevant aspects of the research by doctor Olartecoechea is the analysis of risks arising from surgery, taking into account that the University Hospital research focuses on the group of postmenopausal women, and so of reproductive age. “The risks concomitant with surgical operation are particularly related to reproduction. In those cases where the tumour is large and thus has induced a total deterioration in the ovary, the procedure is clear, and the surgeon has to extirpate it. However, if the tumour is small and there is some healthy ovary, extirpation is more questionable, taking into consideration the risks involved with surgery”, stated the specialist. In this regard, he pointed to a number of studies showing that “despite removing only the ovarian cyst and conserving the ovarian parenchyma, the follicular count or ovarian reserve (the capacity to produce ovules) diminishes significantly”.
In this sense, Doctor Alcázar states that, with the non-surgery option, it can be argued that the cyst could also interfere in reproduction. “The difference is that with surgery this definitely happens, while if you leave the cyst and control and observe its progress, a negative affect on reproduction is not definite”. In concrete, this is another of the aspects to be dealt with by this fifth phase of the international IOTA research.