A study to compare the efficacy, inadequacy and patient knowledge of pipelle and dilatation and curettage (D&C) for patients with abnormal uterine bleeding

DOI - 10.21276/obgyn.2021.7.2.19 ISSN Print – 2454-2334; ISSN Online – 2454-2342 RESEARCH ARTICLE A study to compare the efficacy, inadequacy and patient knowledge of pipelle and dilatation and curettage (D&C) for patients with abnormal uterine bleeding Meeta Gupta, Poonam Yadav, Narita Jamwal, Vanita Gupta Corresponding author: Dr. Vanita Gupta, Address: F-311, Sainik Colony, Jammu-180011, India; Email : Distributed under Attribution-Non Commercial – Share Alike 4.0 International (CC BY-NC-SA 4.0) ABSTRACT Objective: We aimed to assess the patient knowledge/choice for subsequent procedure, sampling adequacy, and diagnostic accuracy of Pipelle endometrial sampling and conventional D&C in patients with abnormal uterine bleeding (AUB). Methods: This study included total 443 women >40 years of age, with AUB requiring endometrial evaluation. Pipelle biopsy was done without cervical dilation followed by D&C. The histopathology of both the procedures was compared, considering histopathology of the D&C sample as gold standard. Outcomes were compared among the two procedures. Results: Overall accuracy of the Pipelle device was 399(90.67%). Pipelle device was inadequate in 29(6.55%) cases. Pipelle was 100% sensitive and 100% specific for diagnosis of atrophy, endometritis and endometrial carcinoma each. Pipelle was 100% sensitive for diagnosis of proliferative endometrium and secretory endometrium each and 96.48% and 97.92% specific respectively with excellent AUC of 0.98 and 0.99 respectively. Patients’ knowledge/choice for subsequent procedure and procedure associated pain was significantly less for the Pipelle biopsy as compared to D and C. Conclusion: Pipelle is a good, relatively painless, cheap OPD procedure for endometrial aspiration but with the disadvantage of sample inadequacy due to which its routine use remains an enigma for the patient and the doctor. Keywords: Abnormal uterine bleeding, pipelle, D&C, endometrial sampling. Menstrual disturbances or nonmenstrual bleeding in women of peri and postmenopausal age group require medical evaluation and if needed endometrial sampling to rule out an objective cause like hyperplasia and carcinoma. Screening of such women becomes important to avoid unnecessary surgeries and sorting the women for medical therapy. With the increasing morbidity and mortality of endometrial carcinoma similar to cervical carcinoma around the world, there would be social and economic benefit from a screening tool as used in the screening of cervical carcinoma (pap smear), that could be used for early detection, leading to th th earlier treatment of endometrial carcinoma. For the long time, the gold standard for the assessment of women with abnormal uterine bleeding (AUB) is dilatation and curettage (D & C) under general anesthesia. However, it has been superseded by other techniques due to its certain disadvantages. 1,2 The other main screening devices for endometrial carcinoma are aspiration devices (the Vabra aspirator), Pipelle, Tao Brush, and SAP-1 brush sampler.1 All the devices stated here for evaluation of endometrial changes are associated with limitations or disadvantages for clinical use. th Received: 10 May 2020, Peer review completed: 27 June 2020, Accepted: 29 June 2020. Gupta M, Yadav P, Jamwal N, Gupta V. A study to compare the efficacy, inadequacy and patient knowledge of pipelle and dilatation and curettage (D&C) for patients with abnormal uterine bleeding. The New Indian Journal of OBGYN. 2021; 7(2): 206-11. The New Indian Journal of OBGYN. 2021 (January-June);7(2) In a developing country as ours, a cheaper screening option for endometrial lesions in women with AUB is the need of the hour. Though D and C is the gold standard, its disadvantages warrant the validation of another routine screening device for endometrial sampling with good pathological accuracy and adequate sampling. Among the various devices, Pipelle seems to be a better option for a country as ours due to being cheap and comparable sample adequacy and accuracy. Thus we aim to evaluate the patient knowledge/choice for subsequent procedure, sampling adequacy and diagnostic accuracy of Pipelle endometrial sampling and conventional D&C in patients with abnormal uterine bleeding. Materials and methods A prospective comparative analytical study was conducted over a period of 3 years from April 2016 to March 2019, which included all women >40 years of age, presenting with AUB undergoing endometrial evaluation. Pregnant women, women with pelvic inflammatory disease or known malignancy and menopausal women with endometrial thickness < 4mm on transvaginal sonography were excluded from the study. The study was approved from the institutional ethical committee (ASCOMS/IEC /RP&T/2018/316). Informed consent was obtained from the patient before the procedure after explaining regarding the procedure and associated complications. Sample size for the study was calculated based on the study of Ilavarasi C et al.,2 who observed that sensitivity and specificity of pipelle biopsy for endometrial hyperplasia was 64.2% and 88.8% and for endometrial carcinoma was 75% and 100% respectively. Taking these values as reference, the minimum required sample size with desired precision of 7.5%, 90% power of study and 5% level of significance is 409 patients. To reduce margin of error, total sample size taken is 443. Detailed clinical history of the patient including age, parity, socio-economic status, any hormone therapy was taken. Per speculum examination, pap smear and per vaginal examination was done in detail of all the patients. Transvaginal sonography (TVS) was done to evaluate the endometrial thickness before any intervention was planned. Thyroid and prolactin status was also evaluated. Pipelle biopsy was taken as an OPD procedure without cervical dilation under full aseptic precautions after informed consent. The same patients were also subjected to conventional D & C with or without anaesthesia according to patient’s pain threshold. The histopathology of both the 207 procedures were sent and the reports were compared. Histopathology of the D&C sample was considered to be the gold standard. Post-procedure, the patients were asked 1. if they had prior knowledge about the procedure 2. If they would voluntarily opt for the procedure for the next time (patient acceptability) 3. To rate the procedural pain on the VAS scale The outcome measures comprised of histopathology report of the endometrium, complications of the procedure, patient acceptability and the pain associated with the procedure. All the outcomes were compared among the two procedures. For the data analysis, categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± SD. Diagnostic test was used to calculate sensitivity, specificity, NPV and PPV. The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) (...truncated)