A Comparative Analysis of the Pipelle Device and Conventional Dilatation and Curettage as Investigative Tools for Abnormal Uterine Bleeding: Assessing Sample Adequacy and Patient Perspectives: A Prospective Observational Cohort Study.

This study was designed as a prospective observational comparative investigation conducted within the Department of Obstetrics and Gynecology in collaboration with the Department of Pathology and Lab Medicine at a tertiary center in Eastern India. The research was initiated following the acquisition of ethical clearance from the Institutional Ethical Committee (T/IM-F/O and G/21/106). The primary objective of this study was to assess the adequacy of samples for microscopic evaluation and compare the efficacy of outpatient endometrial sampling utilizing a Pipelle device with D and C performed under anesthesia. The secondary objectives included comparing postprocedure pain and discomfort between the two groups and evaluating patient satisfaction. Women over 40 years old with AUB were included in the study if they met one of the following criteria: (1) no pelvic pathology as determined by ultrasound; (2) ultrasound findings suggestive of fibroids, adenomyosis, endometriosis, or malignancy; or (3) an endometrial thickness >12 mm in perimenopausal women. Women were excluded from the study if they met any of the following conditions: (1) AUB due to coagulopathy, medications, or endocrine disorders; (2) Pregnancy; (3) Postmenopausal status; (4) Cervical stenosis; (5) Bleeding due to cervical or vaginal pathology; (6) Genital tract infections or pelvic inflammatory disease; or (7) Women who refused to participate. This study included 300 women diagnosed with AUB who presented to the gynecology outpatient department from January 2022 to June 2023. Participants who met the established inclusion criteria underwent endometrial sampling as a component of standard clinical practice. Upon obtaining informed consent, the participants in this study were randomly assigned to two distinct groups: Group A ( n = 150) and Group B ( n = 150). In Group A, outpatient endometrial aspiration was conducted utilizing a Pipelle aspirator. Conversely, Group B underwent D and C procedures, which were performed under anesthesia in accordance with established hospital protocols. Endometrial samples were preserved in formalin containers before their dispatch for histopathological evaluation. A certified histopathologist thoroughly assessed sample adequacy through a light microscopic examination of the submitted biopsy specimens. Postprocedure pain levels and patient satisfaction were systematically evaluated within 4 h following the intervention. Postprocedure pain was scored using a visual analog pain scale where 0 depicts no pain, and 10 indicates the worst pain experienced. Patient satisfaction was assessed using Patient Satisfaction Questionnaire-III, which includes a series of questions, and responses are graded from strongly agree with a score of 1 to strongly disagree with a score of 5. All findings were rigorously documented on a predesigned patient data sheet encompassing comprehensive details, including age, parity, mode of delivery, presenting complaints, associated comorbidities, examination findings, and ultrasound reports. These reports provided essential information regarding endometrial thickness, sample adequacy, histopathological patterns, postprocedure pain scores, and patient satisfaction metrics [ Figure 1 ]. Work plan for methodology (STROBE flow diagram). AUB: Abnormal uterine bleeding, PID: Pelvic inflammatory disease An analysis of endometrial samples obtained through dilation, curettage, and the Pipelle method was conducted utilizing Fisher’s exact test and the Chi-square test, as appropriate. The accuracy of the analyses was calculated and presented as a percentage, accompanied by a 95% confidence interval. Statistical procedures were performed using Social Sciences (SPSS) software, IBM, Chicago, USA, ver 25.0, and a P < 0.05 was deemed statistically significant.

Abnormal uterine bleeding (AUB) is defined as bleeding from the uterine corpus that deviates from established norms for menstrual characteristics. These characteristics include: (1) Frequency: 24–38 days between menstrual cycles. (2) Duration: 8 days or fewer for each cycle. (3) Variation in cycle length: a maximal difference of 7–9 days between the shortest and longest cycle. (4) Flow volume: an average level the patient assesses.[ 1 ] It is notable that a significant proportion of women estimated to be between 10% and 30%, of reproductive age present to gynecology outpatient departments with complaints related to AUB.[ 2 ] The primary objective of evaluating AUB is to exclude intrauterine pathologies, with particular emphasis on endometrial hyperplasia and carcinoma. As the risk of endometrial malignancy significantly increases for women over the age of 40, all individuals in this age bracket who present with AUB must undergo endometrial sampling for histopathological assessment before determining any definitive management strategy. The accuracy of histopathological diagnoses directly correlates with the volume of endometrial tissue obtained, underscoring the necessity of a screening tool capable of acquiring a sufficient tissue sample for thorough evaluation.[ 3 ] Endometrial sampling can be performed utilizing a variety of techniques, including Dilatation and Curettage (D and C) with metal curettes, such as the Novak and Kevorkian, as well as endometrial aspiration employing flexible instruments, including the Pipelle aspirator and Karman cannula. D and C provide significant access to the endometrial cavity; however, it is accompanied by several limitations. These limitations include the requirement for cervical dilation and anesthesia, as well as potential risks such as uterine perforation, hemorrhage, infection, and patient discomfort. In contrast, endometrial aspiration biopsy utilizing flexible cannulas, including the 4 mm Karman and 3 mm Pipelle aspirators, has been thoroughly evaluated as a safer alternative to D and C. This method aims to mitigate the associated risks while maintaining effective diagnostic capabilities.[ 3 ] In a Pipelle aspiration biopsy, a 20 mL syringe is securely attached to the aspirator. Suction is maintained for 2 min once the device is introduced into the endometrial cavity. Subsequently, the aspirator is rotated gently in all directions to facilitate the collection of endometrial tissue for histopathological examination.[ 4 ] The Pipelle aspirator presents several limitations, notably the potential for obtaining insufficient tissue samples for histological analysis, difficulties accessing the uterine cavity, and a suboptimal negative predictive value.[ 4 ] Numerous studies have compared the efficacy of Pipelle endometrial biopsy and D and C, yielding comparable results.[ 5 6 7 ] Despite the availability of Pipelle aspiration for endometrial biopsy, numerous medical centers continue to prefer D and C performed under anesthesia. This preference is often attributed to concerns regarding the potential inadequacy of tissue collection with Pipelle aspiration and the superior access to the endometrial cavity provided by D and C. According to the guidelines established by the Federation of Obstetric and Gynecological Societies of India (FOGSI), it is recommended that all women aged 40 years and above who are deemed to be at low risk for the development of endometrial carcinoma undergo endometrial sampling. The American College of Obstetricians and Gynecologists and the National Institute for Health and Care Excellence (NICE) also advocate for endometrial sampling in women aged 45 years and older. Moreover, the NICE guidelines suggest that hysteroscopy should be employed while cautioning against the use of blind procedures in cases of AUB.[ 8 9 ] Furthermore, FOGSI endorses endometrial aspiration as the preferred technique for obtaining samples for histopathological analysis, in preference to D and C, particularly in the Indian context.[ 10 ] It is essential to acknowledge that office hysteroscopy, as suggested by NICE guidelines, is not feasible in low-resource settings like those in developing countries like India. Due to the lack of consensus regarding the method of endometrial sampling, a study was conducted in a tertiary center to compare the adequacy of endometrial samples and the ability of the Pipelle aspirator to detect malignancies obtained through the Pipelle aspirator versus D and C. In addition, the pain scores and overall acceptability of both procedures were compared among the study participants.

The mean age of patients in Group A was 45.34 years, whereas in Group B, it was 46.27 years. Most women in both groups were multiparous, with 95% in Group A and 99% in Group B, indicating no statistically significant difference. The predominant complaint among these women was heavy menstrual bleeding, with or without dysmenorrhea, which was reported in 269 out of 300 cases (90%) and was comparable across both groups. Additional symptoms included intermenstrual bleeding and irregular menstrual cycles. In this analysis, it was found that 48.67% of women exhibited no uterine pathology, whereas 49.67% were identified with either adenomyosis, fibroids, or a combination of both conditions. The ultrasound findings pertaining to uterine pathology and endometrial thickness demonstrated comparable results across both groups. Despite the similar distribution of diabetes within both cohorts, there was a statistically significant difference in the prevalence of hypertensive disorders. The subsequent table offers a detailed comparison of the baseline characteristics for both groups [ Table 1 ]. Comparison of baseline characteristics between Groups A and B *Fisher’s exact test, ‡ Independent t -test, § Mann–Whitney test, † Chi-square test. BMI: Body mass index, USG: Ultrasonography, HMB: Heavy menstrual bleeding, ET: Endometrial thickness The mean endometrial thickness in Group A was measured at 7.8 mm, whereas in Group B, it was recorded at 7.9 mm. These measurements indicate that the endometrial thickness in both groups was comparable [ Figure 2 ]. Comparison of endometrial thickness (mm) between Groups A and B (nonparametric variable, Box–whisker plot). ET: Endometrial thickness The study revealed that the samples obtained through Pipelle aspiration were adequate in 94.56% of cases. In comparison, D and C conducted under anesthesia yielded sufficient samples in 95.33% of participants. The analysis indicated no statistically significant difference in the adequacy of samples obtained through either technique [ Table 2 ]. Comparison of outcome between Groups A and B *Fisher’s exact test, ‡ Independent t -test, § Mann–Whitney test, † Chi-square test. TB: Tuberculosis, HMB: Heavy menstrual bleeding, HPE: Histopathological examination Endometrial adenocarcinoma and endometrial hyperplasia with atypia could be identified after histopathological examination of samples obtained with Pipelle. The procedure done under anesthesia did not show any additional advantage in detecting tuberculosis or malignant or premalignant conditions [ Table 2 ]. In the postoperative period, the pain scores reported by women in the Pipelle aspiration group were predominantly mild, with 59% experiencing very mild pain, 33% reporting discomfort, and 7% describing tolerable pain, all of which were of a minor degree, notably, 1% of cases reported no pain at all. In contrast, women who underwent endometrial biopsy under anesthesia (Group B) reported significantly less pain, with 71% experiencing no pain, 11% reporting discomforting pain, and 18% describing very mild pain, highlighting the analgesic benefits of anesthesia during the procedure [ Figure 3 ]. The average patient satisfaction score was significantly higher in Group B (55.33 ± 6.98) compared to Group A (53.36 ± 7.26), which can be attributed to the lower pain levels experienced by patients in Group B, where endometrial sampling was performed under anesthesia [ Figure 4 ]. Comparison of postoperative pain score between Groups A and B (nonparametric variable, Box–whisker plot) Comparison of patient satisfaction between Groups A and B

Pipelle aspiration can provide adequate samples for histopathological examination, making it comparable to endometrial biopsy under anesthesia for low-risk women with AUB. It is a practical option in resource-limited settings. However, the choice of procedure should consider the patient’s perspective. Patient satisfaction and postoperative pain are crucial as healthcare moves toward patient-centered care, especially in high-resource areas. When possible, endometrial biopsy under anesthesia should be offered to women with AUB. There are no conflicts of interest.

In this study, baseline characteristics were matched to minimize selection bias. The study population was limited to perimenopausal women to reduce confounding factors. Postmenopausal women were excluded from the study due to their higher risk of cervical stenosis, which increases the likelihood of procedural failure. A study by Tanko et al . found that success rates were significantly lower in women over the age of 55 and postmenopausal women when using an outpatient Pipelle aspirator.[ 11 ] The study included multiparous and nulliparous women, with 96.67% of the participants being multiparous. A higher incidence of hypertension was noted in the cohort undergoing endometrial sampling under anesthesia. This distinction may introduce a selection bias among women with hypertension, given the heightened risk of endometrial malignancies associated with this population. Numerous studies have demonstrated that samples obtained using the Pipelle aspirator yield satisfactory results. The adequacy rates for endometrial samples collected for histopathological examination in premenopausal women have been reported to range between 89.74% and 98%.[ 12 13 14 15 16 17 18 19 20 21 ] A sample retrieval success rate of 76% was observed in general medical practice, whereas studies conducted in secondary care reported success rates ranging from 83% to 96%.[ 22 23 ] Our research demonstrated that adequate samples were obtained in 94.56% of cases where endometrial sampling was performed using the Pipelle method. In comparison, D and C conducted under anesthesia achieved an adequacy rate of 95.33% for histopathological examination. Histopathological examination of samples obtained through Pipelle aspiration and endometrial biopsy under anesthesia revealed no significant statistical differences. A comparable study conducted by Iqbal and Rizvi similarly found no statistical discrepancies in the histopathological findings between samples acquired through Pipelle and those obtained through D and C.[ 24 ] The results indicated that most patients exhibited secretory endometrium (61.76%), followed by proliferative endometrium at approximately 22.06%. Only 12% of the women presented with abnormal endometrium, of which 4% demonstrated atypical endometrium or endometrial carcinoma. The Pipelle aspirator successfully identified conditions such as tuberculosis, atypical endometrium, and adenocarcinoma of the endometrium. The observed prevalence of secretory endometrium is likely attributable to the procedure conducted during the menstrual cycle’s secretory phase. Most research efforts have predominantly centered on the comparison of postoperative pain scores in awake patients who have undergone endometrial sampling through either D and C or endometrial aspiration. A considerable number of these studies indicate that patients typically report minimal discomfort when utilizing the Pipelle method.[ 25 ] Our analysis specifically investigated postoperative pain levels in women who underwent endometrial sampling using both the Pipelle method and D and C procedures performed under anesthesia, as D and C are not routinely conducted on awake patients. The findings revealed that patients who underwent endometrial sampling with the Pipelle reported higher postoperative pain scores in comparison to those who received an endometrial biopsy under anesthesia. In light of the findings from this study, outpatient endometrial sampling employing the Pipelle aspirator emerges as a viable option in low-resource settings. Nonetheless, it is essential to consider postoperative pain and patient satisfaction when determining the appropriate procedure in high-resource environments. Existing research comparing endometrial sampling conducted in outpatient settings to that performed under anesthesia is limited, particularly in evaluating patient perspectives and satisfaction. Histopathological examination of hysterectomy specimens is regarded as the gold standard for assessing endometrial pathology. Nevertheless, because the majority of patients in this study did not undergo hysterectomy and received medical management for their symptoms, it was not possible to evaluate the sensitivity and specificity of the procedure. Furthermore, the study exclusively focused on premenopausal patients, as the probability of failure resulting from cervical stenosis is heightened in outpatient procedures. A long-term follow-up of the patients who underwent the procedure was not conducted. A cost-effectiveness analysis was also not performed, given that the hospital provides complimentary services for outpatients and inpatients.