SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

STUDY QUESTIONS:The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (-30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY:Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN SIZE DURATION:This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS SETTING METHODS:Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTERESTS:This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER:Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE:2 January 2019. DATE OF FIRST PATIENT’S ENROLMENT:First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.E. van Barneveld, V.B.Veth, J.M. Sampat, A.M.F. Schreurs, M. vanWely, J.E. Bosmans ... et al

The randomised uterine septum transsection trial (TRUST): Design and protocol

Background: A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus. Methods/design: A multi-centre randomised contr

Functional constipation in children: a systematic review on prognosis and predictive factors

Background and Aim: Knowledge regarding prognosis and factors influencing the clinical course of functional constipation in children is important to enable general practitioners and paediatricians to give accurate patient information, to compare treatment strategies, and identify children with high risk for unfavourable outcome. The objective of the study was to investigate and summarize the quantity and quality of evidence on prognosis of childhood constipation with and without treatment and its predictive factors. Methods: An extensive literature search in MEDLINE and Embase was performed to identify prospective follow-up studies evaluating the prognosis or prognostic determinants of functional constipation. Methodological quality was assessed using a standardised list. Results on prognosis of constipation were statistically pooled, and the influence of prognostic factors was summarised in a best evidence synthesis. Results: The search strategy resulted in a total of 2882 abstracts. Only 14 publications met our inclusion criteria, of which 21% scored high methodological quality. Included studies showed large heterogeneity in study populations and outcome measures. Without regard to these differences, 49.3% + 11.8% of all of the children studied for 6 to 12 months were found to recover and taken off laxatives. The percentage of children who were free from complaints, regardless of laxative use, after 6 to 12 months was 60.6% +/- 19.2%. There is substantial evidence that defecation frequency and a positive family history are not associated with recovery from constipation. Conclusions: The few studies published on prognosis of childhood functional constipation and predictive factors showed large heterogeneity and poor methodological quality. Overall, 60.6% of children are found to be free from symptoms after 6 to 12 months. Recovery rate showed no relation with defecation frequency or positive family history. Based on the present literature, we are unable to identify a group of children with high risk for poor prognosis

Absence of menstruation in female athletes: why they do not seek help

Background It is known that amenorrhea is highly prevalent among female athletes. However, a large percentage of them do not seek help if this complaint occurs. We performed this study to gain more insight into the reasons why female athletes do not seek help when experiencing amenorrhea and how care for these women could be improved. Method Qualitative focus group research. Female athletes were approached to take part in a focus group. They were asked about the main reasons for not reporting amenorrhea and how care for amenorrhea, in their opinion, would ideally be organised. The women were asked to make a list of their top five reasons for both subjects and discuss this among their peers. Results According to the participants, the five main reasons for not reporting the amenorrhea were: (1) normalizing of the subject, (2) the absence of menstruation is not perceived as a problem by the athletes themselves, (3) experienced shame and taboo, (4) prioritisation of sports performance, and (5) denial. Factors to improve care around menstrual cycle problems in female athletes were: (1) informing athletes, coaches, trainers and mentors, (2) informing doctors, (3) conducting more research on long-term consequences, (4) breaking the taboo on menstrual problems, and (5) having a multidisciplinary collaboration between different specialisms. Conclusion By informing athletes, coaches, trainers, and mentors about menstrual cycle problems in athletes, more awareness among those groups can be created. According to the athletes, more research is needed on the long-term consequences of amenorrhea in sports, to enable them to make a better assessment of their possible future health risks. Women experience a taboo on discussing menstrual problems; role models discussing the problem may help in decreasing the taboo. A multidisciplinary collaboration of health care providers may improve care around female athletes with menstrual problems

Absence of menstruation in female athletes: why they do not seek help

Background It is known that amenorrhea is highly prevalent among female athletes. However, a large percentage of them do not seek help if this complaint occurs. We performed this study to gain more insight into the reasons why female athletes do not seek help when experiencing amenorrhea and how care for these women could be improved. Method Qualitative focus group research. Female athletes were approached to take part in a focus group. They were asked about the main reasons for not reporting amenorrhea and how care for amenorrhea, in their opinion, would ideally be organised. The women were asked to make a list of their top five reasons for both subjects and discuss this among their peers. Results According to the participants, the five main reasons for not reporting the amenorrhea were: (1) normalizing of the subject, (2) the absence of menstruation is not perceived as a problem by the athletes themselves, (3) experienced shame and taboo, (4) prioritisation of sports performance, and (5) denial. Factors to improve care around menstrual cycle problems in female athletes were: (1) informing athletes, coaches, trainers and mentors, (2) informing doctors, (3) conducting more research on long-term consequences, (4) breaking the taboo on menstrual problems, and (5) having a multidisciplinary collaboration between different specialisms. Conclusion By informing athletes, coaches, trainers, and mentors about menstrual cycle problems in athletes, more awareness among those groups can be created. According to the athletes, more research is needed on the long-term consequences of amenorrhea in sports, to enable them to make a better assessment of their possible future health risks. Women experience a taboo on discussing menstrual problems; role models discussing the problem may help in decreasing the taboo. A multidisciplinary collaboration of health care providers may improve care around female athletes with menstrual problems

Immediate catheter removal after laparoscopic hysterectomy: A retrospective analysis

Objectives: All patients undergoing a laparoscopic hysterectomy receive an indwelling catheter during surgery. The optimum timing of removal of the catheter is uncertain. A possible advantage of leaving the catheter in up to 12 h after surgery is to reduce the risk of urinary retention. Possible disadvantages are patient discomfort and increased risk of urinary tract infection. Timing of removal of the catheter after laparoscopic hysterectomy has not been studied. Previous studies have assessed timing of catheter removal after abdominal hysterectomy. In these studies immediate removal seems safe and feasible after an uncomplicated hysterectomy. In 2015 immediate catheter removal after an uncomplicated hysterectomy was introduced in our clinic. We performed a retrospective analysis of all patients who underwent a laparoscopic hysterectomy. The primary objective of this study was to evaluate the rate of urinary retentions and the secondary objective was to investigate the rate of urinary tract infections when the indwelling catheter was removed immediate after surgery.Study design: We included all women who underwent a laparoscopic hysterectomy from April 2015 until December 2017. Informed consent was obtained from all patients. Medical records were analysed to identify baseline characteristics, surgical details and complications. General practitioners of the included patients were contacted to check for post-operative urinary tract infection up to 6 weeks after surgery.Results: 325 patients underwent an uncomplicated hysterectomy between April 2015 and December 2017. After informed consent we ultimately included 242 cases in our analysis. The mean age of our study population was 50 years. In 194 (802 %) patients the catheter was removed immediately after surgery. Main reason for delayed removal of the catheter was resection of deep endometriosis (n = 21). The incidence of urinary retention was 4,6 % (95 % CI 2,3-8,3 %) in the immediate removal group. In these 9 cases, 5 (2,6 %) where solved after single catheterisation. The remaining 4 patients (2,0 %) had an indwelling catheter for 24 h after which the urinary retention resolved. The incidence of urinary tract infection was 9,3 % (95 % CI 5,8-14,0- %), when the catheter was removed immediately after surgery. The incidence of urinary retention and UTI were respectively 2,1% (95 % CI 0,1-9,8%) and 208 % (95 % CI 11,1-34,0 %) in the cases with delayed catheter removal (N = 48).Conclusion: Immediate removal of the urine catheter after uncomplicated hysterectomy is safe and results in low levels of urinary retention. (C) 2020 Published by Elsevier B.V

Algemene ergonomische concepten

De laatste jaren hebben zich veel ontwikkelingen voorgedaan op het gebied van endoscopische chirurgie. Steeds meer operaties, nu al 40.000 tot 50.000 per jaar in Nederland, worden op deze wijze uitgevoerd. Naast voordeel voor de patiënt, brengt de endoscopische chirurgie echter ook nieuwe mentale en fysieke belastingen voor het OK-team met zich mee op het gebied van ergonomie, training en efficiëntie. In dit hoofdstuk gaan we in op de ergonomische aspecten van endoscopische chirurgie

Endometrial polypectomy using tissue removal device or electrosurgical snare::a randomised controlled trial

Background: Hysteroscopic transcervical resection of endometrial polyps is a widely used method and is increasingly performed in office or outpatient care. To ensure patient comfort is key, smaller instruments are preferred while also achieving a complete resection of the pathology.Objectives: To evaluate the effectiveness of the electrosurgical polyp snare (DPS) in comparison with a tissue removal device (TRD).Materials and Methods: This was a randomised controlled non-inferiority trial which included 66 women with symptomatic endometrial polyps who had been referred to the gynaecological outpatient clinic at the Maxima Medical Centre, Veldhoven, the Netherlands. The patients were randomly allocated by using sealed envelopes to treatment with either the DPS (Duckbill (R), Cook) or the TRD (TruclearTM, Medtronic). Clinicians and patients were not blinded to the treatment performed. An independent observer blindly assessed the results.Main outcome measures: The primary outcome was the complete removal of the endometrial polyp. Secondary outcomes were woman acceptability and pain during the procedure, operating time, peri-operative and immediate postoperative complications.Results: 57% of the polyps in the DPS group and 95% in the TRD group were completely removed (risk difference-0.39; 95% CI:-0.60 to-0.15). Average operating time was longer with DPS compared to the TRD (11.7 min. vs. 6.8 min., p = 0.018). The number of insertions of the hysteroscope was higher with the DPS compared to the TRD (3.9 vs. 1.7, p <0.001). One serious adverse event, a uterine perforation, occurred in the DPS group.Conclusion: The TRD was superior to the DPS in completeness of polyp removal. What is new? TRD has a higher rate of complete polyp resection, overall safety and higher patient satisfaction, this instrument should be considered as the preferred option in outpatient and office gynaecology

Intracavitary deposits on Essure® hysteroscopic sterilization devices: A case report

Objective: To study the composition of intracavitary deposits on Essure® hysteroscopic sterilization devices. Design: Case report. Setting: Reproductive Medicine and Gynecology department of a University Hospital. Patient(s): A 39 years old patient presenting with a request for surgical removal of Essure® sterilization devices. Diagnostic hysteroscopy showed a crystal like white deposit attached to one of the devices. Intervention: Diagnostic hysteroscopy and surgical removal of Essure® devices was performed. The deposits were collected and infrared spectroscopy analysis was performed. Main Outcome Measure: Chemical composition of the deposits attached to the device. Result(s): Infrared spectroscopy of the material showed patterns conclusive with calcite (calcium carbonate, CaCO3). Conclusion: Until now, it is not clear if there is a relationship between reported complaints and formation of calcite deposits on Essure®. Capsule: Infrared spectroscopy of deposits on Essure® devices showed a pattern conclusive with calcite. The relationship between reported complaints and the formation of calcite deposits on Essure® remains unclear

The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis

OBJECTIVE: To evaluate the costs and non‐inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG‐IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost‐effectiveness analysis from a societal perspective alongside a multicentre randomised non‐inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. METHODS: Randomisation to a strategy starting with the LNG‐IUS (n = 132) or EA (n = 138). The incremental cost‐effectiveness ratio was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non‐medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)‐score (non‐inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC‐score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG‐IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC‐scores were 64.8 in the LNG‐IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3–96.7). In the LNG‐IUS group, 87% of women had a PBAC‐score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85–1.01). The ICER was €23 (95% CI €5–111) per PBAC‐point. CONCLUSIONS: A strategy starting with the LNG‐IUS was cheaper than starting with EA, but non‐inferiority could not be demonstrated. The LNG‐IUS is reversible and less invasive and can be a cost‐effective treatment option, depending on the success rate women are willing to accept. TWEETABLE ABSTRACT: Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation