Patient-specific affect-abdominal pain interactions in endometriosis: an experience sampling method (ESM) study.

OBJECTIVES: Cross-sectional studies show that endometriosis-related pain is associated with affect. Measuring these symptoms in real-time in a longitudinal perspective yields the ability to analyze the temporal relationship between variables. The aim was to evaluate the association between affect and abdominal pain, using the Experience Sampling Method (ESM) as a real-time, randomly repeated assessment. METHODS: Thirty-four endometriosis patients and 31 healthy subjects completed up to 10 real-time self-assessments concerning abdominal pain and affective symptoms during seven consecutive days. RESULTS: Endometriosis patients experienced more abdominal pain and negative affective symptoms, and scored lower on positive affect compared to healthy controls. A significant association was found between abdominal pain and both positive and negative affect in endometriosis patients. For healthy controls, less strong or non-significant associations were found. When looking at abdominal pain as a predictor for affect and vice versa, we found that only in endometriosis patients, pain was subsequently accompanied by negative affect, and positive affect may alleviate pain in these patients. CONCLUSIONS: This study confirms a concurrent and temporal relationship between affect and abdominal pain in endometriosis patients and supports the use of real-time symptom assessment to interpret potential influencers of abdominal complaints in patients with endometriosis.

Atypical endometrial polyps and the incidence of endometrial cancer: a retrospective cohort study.

OBJECTIVE: The aim of this study was to evaluate the incidence of endometrial carcinoma, proven after hysterectomy, in patients diagnosed with atypical endometrial hyperplasia confined to a polyp. A secondary aim was to establish factors associated with (pre-)malignant alterations in a polyp. DESIGN: A retrospective cohort study. SETTING: Maastricht University Medical Centre (MUMC+) and Máxima Medical Centre in Eindhoven/Veldhoven (Máxima MC). POPULATION: Women who underwent a hysteroscopic polyp resection between 2008 and 2016. METHODS: Patient characteristics and histopathology results of the polyp and, in the case of a hysterectomy, uterus were collected from patients' charts. RESULTS: A total of 1445 complete hysteroscopic polyp resections were included. Of those, 1390 polyps showed benign histopathology results, 39 polyps contained atypical hyperplasia and 16 polyps contained endometrial carcinoma. A hysterectomy was performed in 35 women who were diagnosed with atypical hyperplasia confined to a polyp after hysteroscopic polyp resection. Histopathological assessment showed no additional (pre-)malignant changes of the endometrium in 12 women (30.8%), atypical hyperplasia in 11 women (28.2%) and endometrial carcinoma in 12 women (30.8%). None of the prognostic factors under consideration were significantly associated with (pre-)malignant changes in a polyp. CONCLUSION: The incidence of endometrial carcinoma in the surrounding endometrium after complete resection of a polyp with atypical hyperplasia is 30.8% in this study. This supports the current advice to perform a hysterectomy and bilateral salpingo-oophorectomy. No prognostic factor for (pre-)malignant changes in a polyp was established. TWEETABLE ABSTRACT: The incidence of endometrial carcinoma after complete resection of a polyp with atypical hyperplasia is high.

Diagnostic accuracy of saline contrast sonohysterography in detecting endometrial polyps in women with postmenopausal bleeding: systematic review and meta-analysis.

OBJECTIVE: In women with postmenopausal bleeding, endometrial polyps are a frequent finding and the risk of a focal (pre)malignancy in a polyp is up to 6%. Because of this reported risk, the detection of polyps in these women, preferably by a minimally invasive method, is important. The aim of this systematic review was to assess the accuracy of saline contrast sonohysterography (SCSH) for diagnosis of endometrial polyps in women with postmenopausal bleeding. METHODS: In August 2018, an electronic search was performed of MEDLINE, EMBASE and Web of Science databases to identify all diagnostic studies in which SCSH was used to detect endometrial polyps in postmenopausal women. Studies were included if SCSH was performed to detect endometrial polyps in women with postmenopausal bleeding and if detection of a polyp on hysteroscopy or diagnosis on histopathology was used as a reference standard. Two reviewers assessed methodological quality using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. Two separate analyses were performed for each reference standard. Pooled sensitivity and specificity were calculated using the hierarchical summary receiver-operating characteristics (HSROC) model and HSROC curves were plotted. RESULTS: After selection and quality assessment, five studies were included. Using 'polyps diagnosed with histopathology' as the reference standard, the pooled sensitivity of SCSH was 86.5% (95% CI, 63.6-100%) and the pooled specificity was 91.1% (95% CI, 63.2-100%). Using 'polyps seen on hysteroscopy' as the reference standard, the pooled sensitivity of SCSH was 85.1% (95% CI, 66.9-100%) and the pooled specificity was 84.5% (95% CI, 68.1-100%). Excluding the one study that included women in whom the SCSH examination was reported to be suboptimal, the pooled sensitivity increased to 90.7% (95% CI, 72.8-100%) using hysteroscopy as the reference standard. The sensitivity of hysteroscopy to detect polyps, as reported in two studies, was 81-98%. CONCLUSIONS: Provided that the SCSH examination is of optimal quality, it can be considered as a method to stratify women with postmenopausal bleeding for further diagnostic workup and treatment with hysteroscopy. In women without suspicion of a polypoid lesion on SCSH, and with a benign endometrial sample, expectant management should be considered. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Precisión del diagnóstico de la sonohisterografía con contraste salino en la detección de pólipos endometriales en mujeres con hemorragia postmenopáusica: revisión sistemática y metaanálisis OBJETIVO: En las mujeres con hemorragia postmenopáusica, los pólipos endometriales son frecuentes y el riesgo de una (pre)malignidad focal en un pólipo es de hasta el 6%. Debido a este riesgo reportado, es importante la detección de pólipos en estas mujeres, preferiblemente por un método mínimamente invasivo. El objetivo de esta revisión sistemática fue evaluar la precisión de la sonohisterografía con contraste salino (SCSH, por sus siglas en inglés) para el diagnóstico de pólipos endometriales en mujeres con hemorragia postmenopáusica. MÉTODOS: En agosto de 2018 se realizó una búsqueda electrónica en las bases de datos MEDLINE, EMBASE y Web of Science para identificar todos los estudios diagnósticos en los que se utilizó la SCSH para detectar pólipos endometriales en mujeres postmenopáusicas. Los estudios se incluyeron cuando la SCSH se realizó para detectar pólipos endometriales en mujeres con hemorragia postmenopáusica o cuando la detección de un pólipo en la histeroscopia o el diagnóstico sobre la histopatología se utilizó como estándar de referencia. Dos revisores evaluaron la calidad metodológica mediante la evaluación de calidad de la herramienta de estudios de precisión diagnóstica (QUADAS-2). Se realizaron dos análisis separados para cada estándar de referencia. La sensibilidad y especificidad combinadas se calcularon utilizando el modelo jerárquico de resumen de las características operativas del receptor (HSROC, por sus siglas en inglés) y se trazaron las curvas HSROC. RESULTADOS: Después de la selección y la evaluación de calidad, se incluyeron cinco estudios. Utilizando los 'pólipos diagnosticados con histopatología' como estándar de referencia, la sensibilidad combinada de la SCSH fue del 86,5% (IC 95%, 63,6-100%) y la especificidad combinada fue del 91,1% (IC 95%, 63,2-100%). Utilizando como estándar de referencia los 'pólipos observados en la histeroscopia', la sensibilidad combinada de la SCSH fue del 85,1% (IC 95%: 66,9-100%) y la especificidad combinada fue del 84,5% (IC 95%: 68,1-100%). Excluyendo el único estudio que incluyó mujeres en las que se reportó que el examen por SCSH no fue adecuado, la sensibilidad combinada aumentó al 90,7% (IC 95%: 72,8-100%), usando la histeroscopia como estándar de referencia. La sensibilidad de la histeroscopia para detectar pólipos, tal y como se informó en dos estudios, fue del 81-98%. CONCLUSIONES: Siempre que el examen por SCSH sea de calidad óptima, puede considerarse como un método para estratificar a las mujeres con hemorragia postmenopáusica para su posterior diagnóstico y tratamiento con histeroscopia. En mujeres sin sospecha de una lesión polipoide mediante SCSH y con una muestra endometrial benigna, se debe considerar el tratamiento expectante. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Randomised controlled trial to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment manoeuvre.

OBJECTIVE: To evaluate the effect of two manoeuvres at the end of gynaecological laparoscopy on postoperative pain. DESIGN: Randomised controlled trial. SETTING: One teaching and one university hospital in the Netherlands. SAMPLE: Women aged between 18 and 65 years, with American Society of Anaesthesiologists (ASA) classification I-II, scheduled for an elective laparoscopic procedure for a benign gynaecological indication. METHODS: Women were randomly allocated to two groups. In the intervention group, carbon dioxide was removed from the abdomen by a combination treatment of intraperitoneal warm saline and performing a pulmonary recruitment manoeuvre. In the control group, carbon dioxide was removed with gentle abdominal pressure. MAIN OUTCOME MEASURES: Frequency and intensity of post-laparoscopic shoulder pain and pain in the upper abdomen at 8, 24, and 48 hours after surgery. RESULTS: A total of 200 women participated, with 100 in each group. No difference was observed in the occurrence of post-laparoscopic shoulder pain during the first 48 hours after surgery between the intervention group (46%) and the control group (55%). The incidence of abdominal pain was not significantly different between the two groups. The mean visual analogue scale (VAS) scores of participants who reported shoulder pain were not statistically different between the groups. The mean VAS score for abdominal pain at 8 hours after surgery was significantly lower in the intervention group compared with the control group (3.2 versus 4.2, P = 0.02). No difference in pain medication between the groups was observed, nor was there any difference in nausea or vomiting. CONCLUSIONS: Combined intervention of intraperitoneal saline and the pulmonary recruitment manoeuvre does not lower post-laparoscopic shoulder pain. FUNDING: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. TWEETABLE ABSTRACT: PRM with intraperitoneal saline does not influence the incidence and intensity of post-laparoscopic shoulder pain.

POstLAparoscopic Reduction of pain By combining intraperitoneal normal salinE And the pulmonary Recruitment maneuver (POLAR BEAR trial). RCT to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment maneuver.

BACKGROUND: Shoulder pain and pain in the upper abdomen are common complaints after laparoscopy, sometimes surpassing the pain at incision sites. The incidence of shoulder pain ranges from 35 to 80%. Post-laparoscopic pain is caused by retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm, causing referred pain in the shoulder and in the upper abdomen. A promising strategy to reduce this post-laparoscopic pain is the pulmonary recruitment maneuver, which indirectly increases intraperitoneal pressure and thereby facilitates removal of residual carbon dioxide. An alternative strategy is the infusion of intraperitoneal normal saline. With normal saline infusion, carbon dioxide rises and escapes through the port sites. In addition, normal saline offers a physiologic buffer system to dissolve excess carbon dioxide. METHODS/DESIGN: This multicenter randomized controlled trial is conducted in two teaching hospitals in the Netherlands. Women between 18 and 65 years of age, with an ASA classification of I-II who are scheduled to undergo an elective laparoscopic procedure with benign gynecologic indication can participate. Following informed consent, participants are randomly allocated into two groups at the end of the surgical procedure. In the intervention group, the upper abdomen is filled with normal saline infusion with the patient in the Trendelenburg position. Then the anesthesiologist performs a standardized pulmonary recruitment maneuver with a pressure of 40 cm H2O. The trocar sleeve valves will be left open, so carbon dioxide can escape the abdominal cavity. With the patient in a neutral position the instruments are removed from the abdomen. In the control group, carbon dioxide is removed from the abdominal cavity at the end of surgery, with gentle abdominal pressure and passive exsufflation through the port sites, with open sleeve valves. The primary outcomes are the incidence and intensity of post-laparoscopic pain in the shoulder, upper abdomen and at the operation sites, at 8, 24 and 48 h after surgery. Secondary outcomes are postoperative use of analgesics, nausea, vomiting and pulmonary complications. DISCUSSION: This study may reduce post-laparoscopic pain in women undergoing laparoscopy. TRIAL REGISTRATION: Dutch trial register, number NTR4812 .

Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling. DESIGN: Multicentre, randomised controlled trial. SETTING: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands. POPULATION: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling. METHODS: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management. MAIN OUTCOMES: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered. RESULTS: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer. CONCLUSION: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling. TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

A Structured Assessment to Decrease the Amount of Inconclusive Endometrial Biopsies in Women with Postmenopausal Bleeding.

OBJECTIVE: To determine whether structured assessment of outpatient endometrial biopsies decreases the number of inconclusive samples. DESIGN: Retrospective cohort study. SETTING: Single hospital pathology laboratory. POPULATION: Endometrial biopsy samples of 66 women with postmenopausal bleeding, collected during the usual diagnostic work-up and assessed as insufficient for a reliable histological diagnosis. METHODS: Endometrial biopsy samples were requested from the pathology laboratories. The retrieved samples were systematically reassessed by a single pathologist specialized in gynecology. MAIN OUTCOME MEASURE: Disagreement between initial assessment and conclusion after structured reassessment. RESULTS: We retrieved 36 of 66 endometrial biopsy samples from six different pathology laboratories. Structured reassessment of the retrieved samples by a single pathologist specialized in gynecology did not change the conclusion in 35 of the 36 samples. The remaining sample contained a large amount of endometrial tissue and the diagnosis at reassessment was endometrial hyperplasia without atypia. All other samples contained insufficient material for a reliable diagnosis. CONCLUSION: A structured reassessment of endometrial biopsies samples, which were classified as inconclusive due to insufficient material, did not change the conclusion. Although it might be helpful for pathologists to have diagnostic criteria for adequacy and/or inadequacy of an endometrial biopsy sample, the gain in efficiency is likely to be small.

Does probability guided hysteroscopy reduce costs in women investigated for postmenopausal bleeding?

OBJECTIVE: To evaluate whether a model to predict a failed endometrial biopsy in women with postmenopausal bleeding (PMB) and a thickened endometrium can reduce costs without compromising diagnostic accuracy. DESIGN, SETTING, AND POPULATION: Model based cost-minimization analysis. METHODS: A decision analytic model was designed to compare two diagnostic strategies for women with PMB: (I) attempting office endometrial biopsy and performing outpatient hysteroscopy after failed biopsy and (II) predicted probability of a failed endometrial biopsy based on patient characteristics to guide the decision for endometrial biopsy or immediate hysteroscopy. Robustness of assumptions regarding costs was evaluated in sensitivity analyses. MAIN OUTCOME MEASURES: Costs for the different strategies. RESULTS: At different cut-offs for the predicted probability of failure of an endometrial biopsy, strategy I was generally less expensive than strategy II. The costs for strategy I were always € 460; the costs for strategy II varied between € 457 and € 475. At a 65% cut-off, a possible saving of € 3 per woman could be achieved. CONCLUSIONS: Individualizing the decision to perform an endometrial biopsy or immediate hysteroscopy in women presenting with postmenopausal bleeding based on patient characteristics does not increase the efficiency of the diagnostic work-up.

Diagnostic evaluation of the endometrium in postmenopausal bleeding: an evidence-based approach.

Postmenopausal bleeding (PMB) is a common complaint in general gynecological practice. Women with PMB have around a 10% chance of having endometrial carcinoma and therefore PMB always needs further evaluation. This article summarizes the reviews on the subject and provides an overview of the use of diagnostic tools in patients with PMB. Four types of diagnostic test are described: sonographic measurement of endometrial thickness, endometrial sampling, hysteroscopy and saline infusion sonography. All four have been independently shown to be accurate in excluding endometrial cancer. However, neither in systematic reviews nor in international guidelines is consensus found regarding the sequence in which these methods should be employed in women with PMB. For measurement of endometrial thickness in symptomatic women, a cut-off value of 3mm is recommended, but the cost-effectiveness of this strategy has yet to be shown. Research should now focus on the incorporation of individual patient characteristics and pre-test probabilities for cancer in algorithms for the investigation of PMB, and the most cost-effective sequenced combination of the four types of test.

Effectiveness of routine reporting to identify minor and serious adverse outcomes in surgical patients.

OBJECTIVE: To assess the effectiveness of routine reporting to identify surgical adverse outcomes in comparison with retrospective medical record review. DESIGN: Independent assessment of two methods applied to one sample. Surgeons and surgical residents routinely reported all adverse outcomes for patients in their care during admission. A trained research assistant, blinded to the surgeons' reporting data, retrospectively reviewed the medical records of selected patients and registered all adverse outcomes identified from paper or electronic patient records. SETTING: Dutch university hospital. STUDY SAMPLE: A 5% sample of patients (N = 150) discharged in 2002 was taken; oversampling of patients undergoing reoperations, sick patients (ASA >or=3), and those undergoing technically complex surgery was done to increase the yield of adverse outcomes. MAIN OUTCOME MEASURES: The number of adverse outcomes identified by each method was compared with the total number identified by either method. This was done both for all adverse outcomes and for serious adverse outcomes. RESULTS: Routine reporting identified fewer adverse outcomes than medical record review (62.5% v 78.2%). Complete agreement was achieved in only 40.7% of adverse outcomes. Routine reporting identified slightly more serious adverse outcomes (84.8% v 79.5% of the total), but this difference was not statistically significant. Extrapolating these results to the total number of admissions in 2002, routine reporting underestimated the annual adverse outcome incidence by 1.8% (increasing from 14.5% to 16.3%) and the incidence of serious adverse outcomes by 0.3% (increasing from 6.9% to 7.2%). CONCLUSIONS: Neither method identified all adverse outcomes. Routine reporting underestimated the incidence of minor events but was as accurate as record review in identifying serious adverse outcomes.