CLINICAL ARTICLE Effectiveness and safety of loop electrosurgical excision procedure for cervical neoplasia in rural India Rengaswamy Sankaranarayanan a, ⁎, Vijay Keshkar b , Ashok Kothari b , Shubhada Kane c , Jean-Marie Fayette a , Surendra Shastri c a Screening Group, International Agency for Research on Cancer, Lyon, France b Nargis Dutt Memorial Cancer Hospital, Tata Memorial Centre Rural Cancer Extension Project, Barshi, Solapur District, Maharashtra, India c Tata Memorial Centre, Parel, Mumbai, India abstract article info Article history: Received 14 August 2008 Received in revised form 5 September 2008 Accepted 8 September 2008 Keywords: Cervical cancer Cervical intraepithelial neoplasia Cure Loop electrosurgical excision procedure Safety See-and-treat Objective: To evaluate the effectiveness and safety of loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in rural India. Method: Women with CIN colposcopic features unsuitable for cryotherapy were treated with LEEP using a “see-and-treat” approach. Women with unsatisfactory colposcopy had diagnostic LEEP. Cure was defined as no clinical or histologic evidence of CIN at 1-year follow-up. Factors influencing cure rates were evaluated by χ 2 tests. Results: Of the 1141 women who underwent LEEP (569 see-and-treat; 572 unsatisfactory colposcopy), 634 had histologically proven CIN. Of those, 489 reported for follow-up and 459 (93.9%) had no evidence of disease. Cure rates were 98.1% for women with CIN 1, 93.6% for CIN 2, and 85.0% for CIN 3. Patients with CIN 2–3 had significantly lower cure rates. Conclusion: Cure rates for LEEP provided by newly trained doctors in rural India were similar to those reported in the gynecological literature. © 2008 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. 1. Introduction Loop electrosurgical excision procedure (LEEP), or large loop excision of the transformation zone (LLETZ), is the most widely used surgical treatment modality for cervical intraepithelial neoplasia (CIN) and has virtually replaced cold knife conization. Among CIN excision treatment modalities, LEEP is certainly the easiest to learn and the equipment required is less expensive than for laser. LEEP provides an excised tissue specimen for histology. Evidence from published studies from high-income countries [1–8] indicates that LEEP is associated with cure rates exceeding 90% [8]. However, it is not clear whether similar cure rates could be achieved for LEEP in lower-income countries. LEEP is increasingly used in a “see-and- treat” approach to diagnose and treat CIN thereby avoiding multiple visits and reducing noncompliance [9]. There has been very limited evaluation of the see-and-treat approach in lower-income countries [7]. We adapted the see-and-treat principles to achieve maximum compliance of women who screened positive for treatment of CIN in a randomized controlled screening trial in western India, which was designed to evaluate the impact of a single round of screening with conventional cytology, visual inspection with acetic acid (VIA), or human papillomavirus (HPV) testing (using the HC2 test) on cervical cancer incidence and mortality. The screening trial, a collaborative research project of Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi, India, Tata Memorial Centre (TMC), Mumbai, India, and the International Agency for Research on Cancer (IARC), Lyon, France, was reviewed and approved by the institutional ethical committees and the design and methodology have been published elsewhere [10,11]. The present study describes the results of the effectiveness and safety of LEEP in the treatment of CIN in the context of the population-based study described above. 2. Materials and methods Women who appeared healthy, were aged between 30 and 59 years, and with an intact uterus and no past history of cervical neoplasia were considered eligible to participate. Female health workers explained the study, risk factors, prevention, early detection, and treatment of cervical cancer to eligible women and obtained informed consent from all participants. Patients with positive test results on VIA, cytology or HPV testing were referred to the NDMCH for colposcopy and further management. Colposcopy and LEEP had never been widely practiced at the NDMCH—or anywhere else in Maharashtra State—before this screen- ing trial study due to the lack of a cervical screening program and colposcopy services in the state. Hence, 5 doctors at NDMCH were trained in colposcopy and LEEP before initiation of this study using the International Journal of Gynecology and Obstetrics 104 (2009) 95–99 ⁎ Corresponding author. Screening Group, International Agency for Research on Cancer,150 cours Albert Thomas, 69372, Lyon cedex 08, France. Tel.: +33 472 73 85 99; fax: +33 472 73 85 18. E-mail address: sankar@iarc.fr (R. Sankaranarayanan). 0020-7292/$ – see front matter © 2008 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijgo.2008.09.009 Contents lists available at ScienceDirect International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo