Long-Term Assessment of a Prospective Cohort of Patients Undergoing Laparoscopic Sacrocolpopexy.

OBJECTIVE: To report long-term outcomes after laparoscopic sacrocolpopexy. METHODS: We conducted a prospective descriptive cohort study on 331 consecutive patients who underwent laparoscopic sacrocolpopexy for symptomatic prolapse (Pelvic Organ Prolapse Quantification [POP-Q] system stage 2 or greater) at one center, with minimum 1.5 years of follow-up by April 30, 2014. Primary outcome measures were Patient Global Impression of Change score and failure at the apex (C≥-1 cm; POP-Q stage 2 or greater). Secondary outcomes were anatomical failure in other compartments, duration of follow-up, occurrence and time point of complications, reinterventions, and functional outcomes by response to a standardized 24-question interview on prolapse and bladder, bowel, and sexual function. Assessment was by an experienced clinician not involved in patient management. RESULTS: The follow-up rate was 84.6% (280/331); 185 of 331 (55.9%) patients were both physically examined and interviewed, and 95 of 331 (25.7%) were interviewed only. The median age at interview was 72 years (interquartile range 13 years), with a follow-up period of 85.5 months (interquartile range 46 months). Approximately 83% (231/280) reported improvement; 5.7% (16/280) were unchanged, 5.7% (16/280) felt slightly worse, and 6.8% (17/280) reported clear deterioration. Anatomical failure at point-C was 8.6% (16/185); anterior (22.2%, 41/185) and posterior (28.6%, 53/185) prolapse were more common than apical prolapse. Of those with level-I anatomical cure, 10.1% (17/185) felt worse; half of them (9/17) because of prolapse in another compartment. The others had urinary problems (41.2%, 7/17), obstructive defecation (11.8%, 2/17), or dyspareunia (11.8%, 2/17). Conversely, the majority of patients with recurrence at the vault (62.5%, 10/16) self-reported to be improved. The reoperation rate was 17.8% (48/270), including 19 (7.0%) for graft-related complications and nine (3.3%) for prolapse. CONCLUSION: More than four out of five patients (82.5%) felt improved 86 months after laparoscopic sacrocolpopexy. Of those not improved, two thirds had recurrent prolapse; however, typically mid-vaginal. The other third reported urinary or bowel problems or dyspareunia. Reintervention for prolapse was 3.3%. The most common reasons for reoperation were graft-related complications (7.0%) and urinary incontinence (6.7%).

Analysis of the learning process for laparoscopic sacrocolpopexy: identification of challenging steps.

INTRODUCTION AND HYPOTHESIS: We earlier demonstrated that the operation time of laparoscopic sacrocolpopexy (LSCP) by an experienced surgeon drops significantly after 30 cases to reach a steady state after 90. We now aimed to define the learning curve and to identify the most challenging steps for a trainee learning LSCP. METHODS: Prospective consecutive series of 60 patients undergoing LSCP performed by a trainee experienced in operative laparoscopy but not LSCP. Prior to the first case, the trainee primed his endoscopic suturing skills on an endotrainer for 15 h. His operation time and performance score were analysed using moving average analysis (MOA). The former and the occurrence of complications or short-term failures were compared with those of a concurrent control group consisting of patients operated on by a surgeon experienced in LSCP (teacher). The procedure was empirically divided into five consecutive steps (dissection of the promontory, the paracolic gutter and vagina, suturing of the mesh to the vault, stapling to the promontory, and peritonealisation). RESULTS: The MOA of the operation time demonstrated a learning curve for all steps, except for the dissection of and fixation to the promontory. The most time-consuming step is the dissection of the vault, for which it took the trainee 31 procedures to achieve an operation time comparable to that of the teacher. Also, the quality of the dissection improved over time. Suturing of the implant to the vault and peritonealisation took only 10 and 6 procedures respectively. There was no difference in the occurrence of major complications and in one case the trainee asked for assistance. CONCLUSION: Quality of LSCP improves with experience. Operation time falls as well, and the most time-consuming step is the dissection of the paracolic and perivaginal spaces. Prior training in laparoscopic suturing coincided with a short learning process for the phases requiring suturing.

Pain and bleeding pattern related to levonorgestrel intrauterine system (LNG-IUS) insertion.

OBJECTIVE: To investigate whether the pattern or pain or bleeding during levonorgestrel intrauterine system (LNG-IUS) insertion and in the first 6 weeks thereafter is altered by LNG-IUS malposition. STUDY DESIGN: Prospective cohort of 413 women undergoing LNG-IUS insertion or replacement. A first questionnaire on pain perception was completed by the women immediately after insertion. In a second questionnaire the women were asked to record pain in the 3 days following insertion and both pain and bleeding from 4 to 6 weeks after insertion. Six weeks after insertion a 2D- and 3D-ultrasound examination was performed to evaluate the position of the LNG-IUS and of the uterus. RESULTS: Parity was inversely related to pain at insertion, in the first 3 days and at 4-6 weeks. LNG-IUS insertion was less painful in the postpartum period. Women who had had a LNG-IUS as prior contraceptive method reported a higher percentage of amenorrhea at 4-6 weeks. The position of the LNG-IUS or of the uterus did not influence the pain scores or the bleeding pattern. The fact that the LNG-IUS arms appeared embedded in the uterine wall on coronal 3D-volume reconstruction did not influence pain or the bleeding pattern. CONCLUSIONS: Because neither pain nor bleeding is a reliable predictor of LNG-IUS position, we suggest an ultrasound examination to confirm correct LNG-IUS placement in all patients at about 6 weeks after insertion.

Subjective assessment by ultrasound is superior to the risk of malignancy index (RMI) or the risk of ovarian malignancy algorithm (ROMA) in discriminating benign from malignant adnexal masses.

PURPOSE: The combination of two tumour markers, CA125 and HE4, in the risk of ovarian malignancy assay (ROMA) has been shown to be successful in classifying patients into those who have a high or low risk of epithelial ovarian cancer. In the present study, the diagnostic accuracy of ROMA was assessed and compared to the diagnostic accuracy of the two most widely used ultrasound methods, namely the risk of malignancy index (RMI) and subjective assessment by ultrasound. METHODS: From August, 2005 to March, 2009, 432 women with a pelvic mass who were scheduled to have surgery were enrolled in a single-centre prospective cohort study. A preoperative ultrasound was performed and preoperative CA125 and HE4 serum levels were measured. Once the final surgical pathology reports were obtained, the diagnostic accuracy and performance indices of ROMA, RMI and subjective assessment were calculated. RESULTS: Of the 432 eligible patients, 374 could be analysed. Subjective assessment had the highest area under the receiver operator characteristic curve (AUC) (0.968, 95%CI:0.945-0.984), followed by the RMI (0.931, 95%CI:0.901-0.955). The subjective assessment and RMI both had significantly higher AUCs than the ROMA (0.893, 95%CI:0.857-0.922; P<0.0001 and P=0.0030, respectively). The pre- and postmenopausal populations generated similar results. CONCLUSION: Although new tumour markers models are promising, they do not contribute significantly to the diagnosis of ovarian cancer. Ultrasound, especially subjective assessment by ultrasound, remains superior in discriminating malignant from benign ovarian masses.

Detection of endometrial pathology using saline infusion sonography versus gel instillation sonography: a prospective cohort study.

OBJECTIVE: To compare saline infusion sonography (SIS) with gel instillation sonography (GIS) in terms of feasibility and diagnostic accuracy. DESIGN: Prospective cohort study. SETTING: Leuven University bleeding clinic. PATIENT(S): A total of 804 patients: two consecutive cohorts of 402 women undergoing SIS or GIS. INTERVENTION(S): Vaginal ultrasound (n=804) followed by SIS (n=402) or GIS (n=402); office hysteroscopy in 685 patients, and endometrium sampling in 487 patients; surgery in 274 women: operative hysteroscopy (n=230) or hysterectomy (n=44). MAIN OUTCOME MEASURE(S): Patients' characteristics, technical failure rates, and final diagnosis. Pathology was defined as endometrial hyperplasia, polyp, cancer, or intracavitary myomas. RESULT(S): The technical failure rate (difference between proportions and confidence interval) was 5.0% for SIS versus 1.8% for GIS, respectively (3.21; [0.69-5.95]). Failure due to inadequate distension was 1.5% versus 0.3% for SIS and GIS, respectively (1.25; [-0.16-2.99]). Pathology was diagnosed in 180 patients (49%) of the SIS group versus 147 patients of the GIS group (40.2%) (8.88; [1.69-15.95]). The sensitivity was 77.8% and 85.0%, respectively (NS). The negative predictive value was 79.1% for SIS and 88.6% for GIS (9.54; [2.17-16.89]). CONCLUSION(S): Gel instillation sonography is a feasible, accurate alternative for SIS in the evaluation of women with abnormal bleeding, and has fewer technical failures.

Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group.

OBJECTIVES: To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result. DESIGN: Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive. SETTING: 19 ultrasound centres in eight countries. PARTICIPANTS: 1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant. MAIN OUTCOME MEASURES: Diagnostic sensitivity and specificity. RESULTS: Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of CA-125 measurements, the sensitivities were 89% (83% to 93%) for subjective assessment, 50% (42% to 58%) for the risk of malignancy index, 89% (83% to 93%) for logistic regression model 1, and 82% (75% to 87%) for logistic regression model 2; the corresponding specificities were 78% (72% to 83%), 84% (78% to 88%), 44% (38% to 51%), and 48% (42% to 55%). Use of the simple rules as a triage test and subjective assessment for those masses for which the simple rules yielded an inconclusive result gave a sensitivity of 91% (88% to 93%) and a specificity of 93% (91% to 94%), compared with a sensitivity of 90% (88% to 93%) and a specificity of 93% (91% to 94%) when subjective assessment was used in all masses. CONCLUSIONS: The use of the simple rules has the potential to improve the management of women with adnexal masses. In adnexal masses for which the rules yielded an inconclusive result, subjective assessment of ultrasonic findings by an experienced ultrasound examiner was the most accurate diagnostic test; the risk of malignancy index and the two regression models were not useful.

Sacrocolpopexy using xenogenic acellular collagen in patients at increased risk for graft-related complications.

AIMS: We studied the long-term anatomical and functional outcome following sacrocolpopexy for apical vaginal prolapse using xenogenic grafts in a population at increased risk for graft-related complications (GRCs). METHODS: Twenty-two consecutive patients with symptomatic apical prolapse were scheduled for laparoscopic sacrocolpopexy (LSC) with porcine grafts because they were presumed to be at risk for GRC, because of pre-existing vaginal ulcerations (n = 4), concomitant vaginal prolapse repair (n = 15), total hysterectomy (n = 1), or intra-operative abdominal contamination due to accidental laceration of the vagina, bowel perforation (n = 1) or the presence of infection (n = 1). Either small intestinal submucosa (n = 8) or dermal collagen (n = 14) was used. Outcome measures were GRCs, anatomical cure (

Chronic fatigue syndrome: a hormonal origin? A rare case of dysmenorrhea membranacea.

BACKGROUND: Membranous dysmenorrhea is a rare entity involving expulsion of fragments of endometrium retaining the shape of the uterus. The condition is often linked to high progesterone levels. An association with a chronic fatigue syndrome was never described. CASE: A 44-year-old woman with a chronic fatigue syndrome (CFS), presented with membranous dysmenorrhea after taking an oral contraceptive pill containing ethinylestradiol 0.02 mg and desogestrel 0.15 mg for 3 months in a continuous regimen as treatment for dysfunctional bleeding. Oral contraception was discontinued and she resumed normal menstruations. Remarkably, she mentioned complete disappearance of the CFS since expulsion of the tissue and started working again. CONCLUSION: The occurrence of membranous dysmenorrhea with a dissolving chronic fatigue syndrome is very rare and was never described before. This case suggests a hormonal dysfunction as a possible cause of chronic fatigue syndrome. A review of the literature on membranous dysmenorrhea is presented.