Fast track — ArticlesEffect of quality of gynaecological ultrasonography on management of patients with suspected ovarian cancer: a randomised controlled trial
Introduction
A clinical diagnosis of an adnexal tumour is often made in patients who complain of abdominal swelling and pelvic pain. These tumours can also be noted incidentally during bimanual pelvic examination or on ultrasonography, when an examination is done for early pregnancy complications or other gynaecological symptoms.1, 2, 3, 4
The differential diagnosis of adnexal masses includes ovarian cancer and patients are often offered additional investigations, such as tumour-marker tests, to clarify the nature of the tumour.5 However, the nature of adnexal tumours often remains uncertain despite several tests and, as a result, many patients undergo major surgery because of the fear of missing an ovarian cancer.6
Ultrasonography is a sensitive method for the detection of adnexal abnormalities and is routinely used for the assessment of patients with various gynaecological complaints. The ability of ultrasonography to establish the nature of an adnexal tumour is variable and depends mainly on the experience and skill of the operator.7, 8 Studies have shown that, when carried out by experts (known as level III ultrasonography), gynaecological ultrasonography can distinguish between benign and malignant adnexal tumours with an accuracy of 164 of 173 (95%) tumours.7 The accuracy of routine ultrasonography (known as level II ultrasonography), which is usually done by less experienced operators, is likely to be lower.8 The best survival for patients with ovarian cancer is achieved when treatment is organised and carried out by gynaecological oncologists who work in cancer centres.9 However, patients with asymptomatic benign tumours can be managed expectantly3, 10, 11 or by minimally invasive surgery if symptomatic.12, 13 These procedures can be safely undertaken by general gynaecologists in local hospitals.
In the UK, most patients with suspected or confirmed adnexal masses are referred to rapid-access gynaecological oncology clinics for detailed investigations and treatment. Most gynaecological ultrasonography examinations, both in local hospitals and tertiary cancer centres, are done by sonographers who are usually trained to do level II14 ultrasonography. Before this study, patients who attended our regional gynaecological cancer centre (Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK) with an adnexal mass and had non-diagnostic level II ultrasonography, were subsequently referred for level III scans14 at our unit. Although level III scans were not incorporated in the protocol of the regional gynaecological cancer centre, a retrospective audit showed an improved accuracy of level III scanning for the diagnosis of ovarian cancers compared with level II scans.
The aim of this study was to assess whether the improved accuracy of level III ultrasonography has a measurable effect on the management of patients with adnexal masses compared with routine level II ultrasonography.
Section snippets
Methods
We did a prospective randomised controlled study, which took place at Guy's and St Thomas' NHS Foundation Trust and at King's College Hospital NHS Foundation Trust (London, UK). The study was approved by the ethics committee and the research and development committee at both hospitals.
Results
The study was done between May 31, 2004, and February 15, 2007. 165 patients met the inclusion criteria, but ten patients declined participation and five were excluded because they needed urgent surgical treatment (figure). The remaining 150 patients were randomised into the study, with 77 randomly assigned to level III ultrasonography and 73 randomly assigned to level II ultrasonography. The demographic data of the patients in both groups of the study are presented in table 1. The two groups
Discussion
This study shows that the quality of gynaecological ultrasonography has a significant effect on the choices made by gynaecological oncologists in the management of patients with suspected ovarian cancer. The number of major surgical staging procedures for presumed ovarian cancer was significantly lower after level III (expert) ultrasonography compared with after a routine scan (level II) done by a non-specialist. This finding is likely to be the consequence of the greatly increased proportion
References (24)
- et al.
The value of ultrasound visualization of the ovaries during the routine 11-14 weeks nuchal translucency scan
Eur J Obstet Gynecol Reprod Biol
(2007) - et al.
The management of a persistent adnexal mass in pregnancy
Am J Obstet Gynecol
(1995) - et al.
Elective vs conservative management of ovarian tumors in pregnancy
Int J Gynecol Obstet
(2004) - et al.
Treatment of nonendometriotic benign adnexal cysts: a randomized comparison of laparoscopy and laparotomy
Obstet Gynecol
(1995) Use of morphology to characterize and manage common adnexal masses
Best Pract Res Clin Obstet Gynaecol
(2004)- et al.
Evaluation of a clinical test. II: Assessment of validity
BJOG
(2001) - et al.
Growth and malignancy of ovarian tumors in pregnancy
Aust N Z J Obstet Gynecol
(1971) - et al.
Cysts in pregnancy discovered by sonography
J Clin Ultrasound
(1986) - et al.
Transvaginal sonographic ovarian findings in a random sample of women 25-40 years old
Ultrasound Obstet Gynecol
(1999) - et al.
A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer
Br J Obstet Gynecol
(1990)