OBJECTIVE: To evaluate the use of tenaculum on pain perception of patients and on ease of endometrial sampling procedure with a pipelle. METHODS: A randomized controlled trial was conducted in 118 patients for assessing pain perception and the ease of the procedure. Patients were randomly assigned to group 1 (without tenaculum) and group 2 (with tenaculum). Visual analog scale (VAS) was used to assess patients' pain at four different times during the process. VAS-3 reflected the pain during the procedure. Likert scale was employed by the surgeon to measure the ease of the procedure. Main outcome was VAS and the secondary outcomes were Likert scale and success rate in obtaining adequate samples of endometrial tissue for histopathological diagnosis. RESULTS: Endometrial sampling procedure could not be performed only on three patients who belonged to group 1. The VAS-3 scores were higher in group 2 than group 1 (p = 0.001). Nullipar patients had higher VAS-3 scores than multipars (p = 0.012). VAS-3 did not vary in pre-peri-postmenopausal women (p = 0.901). Likert scale was lower in postmenopausal women than peri- or pre-menopausal patients (p = 0.020, 0.017, respectively). Use of tenaculum was found by logistic regression analysis to be an independent risk factor for patients' pain perception (p = 0.0001, RR 31.8, 95 % CI 8.3-122.4). Inadequate endometrial sampling was reported in 12 patients who were all postmenopausal. CONCLUSION: Endometrial sampling procedure without tenaculum is feasible and yields less pain perception than with tenaculum.
RCT Entities:
OBJECTIVE: To evaluate the use of tenaculum on pain perception of patients and on ease of endometrial sampling procedure with a pipelle. METHODS: A randomized controlled trial was conducted in 118 patients for assessing pain perception and the ease of the procedure. Patients were randomly assigned to group 1 (without tenaculum) and group 2 (with tenaculum). Visual analog scale (VAS) was used to assess patients' pain at four different times during the process. VAS-3 reflected the pain during the procedure. Likert scale was employed by the surgeon to measure the ease of the procedure. Main outcome was VAS and the secondary outcomes were Likert scale and success rate in obtaining adequate samples of endometrial tissue for histopathological diagnosis. RESULTS: Endometrial sampling procedure could not be performed only on three patients who belonged to group 1. The VAS-3 scores were higher in group 2 than group 1 (p = 0.001). Nullipar patients had higher VAS-3 scores than multipars (p = 0.012). VAS-3 did not vary in pre-peri-postmenopausal women (p = 0.901). Likert scale was lower in postmenopausal women than peri- or pre-menopausal patients (p = 0.020, 0.017, respectively). Use of tenaculum was found by logistic regression analysis to be an independent risk factor for patients' pain perception (p = 0.0001, RR 31.8, 95 % CI 8.3-122.4). Inadequate endometrial sampling was reported in 12 patients who were all postmenopausal. CONCLUSION: Endometrial sampling procedure without tenaculum is feasible and yields less pain perception than with tenaculum.
Authors: Bich Ngoc Bui; Sarah F Lensen; Ahmed Gibreel; Wellington P Martins; Helen Torrance; Frank J Broekmans Journal: Cochrane Database Syst Rev Date: 2021-03-18