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Background: Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse.Methods: We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included.Discussion: The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse.Trial Registration: Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of an informative 360-degree virtual reality (VR) video on preoperative anxiety before visiting a one-stop clinic for abnormal uterine bleeding.Study Design: A randomized controlled trial was performed in a teaching hospital in the Netherlands. A total of 83 women scheduled for a first consultation at the one-stop clinic between April 2017 and September 2017 were included in the analysis. All women received a standard information leaflet about the clinic. 40 women were randomized to receive a 360-degree VR-video of the clinic in addition. The primary outcome was change in the Visual Analogue Scale for Anxiety (VAS-A), measured at baseline (before randomization) and in the waiting room (before visit, after randomization). Anxiety assessed with the State-Trait Anxiety Inventory (STAI-S) was a secondary outcome. Other secondary outcomes included anxiety during the visit and the opinion of the women about the provided information.Results: Only 27 out of the 40 women actually watched the VR-video. Women in the VR-group who actually watched the video reported lower levels of anxiety at baseline compared to women in the VR-group who did not watch the video. In the intention-to-treat analysis, there was no difference in change in anxiety between the VR-group and the control group (mean difference VAS-A = 0.07, 95% CI -0.96 to 1.10; mean difference STAI-S = 1.97, 95% CI -1.82 to 5.77). In the per-protocol analysis, women in the VR-group reported lower anxiety scores in the waiting room. However, the change in anxiety scores between baseline and waiting room was comparable in both groups. 31% of the women who watched the VR-video reported that the video resulted in a reduction of anxiety, 69% reported that the video is of added value and 65% would use a VR-video again in future.Conclusions: Adding the informative 360-degree VR-video to conventional information did not result in a reduction of anxiety prior to visiting the one-stop clinic. However, the majority of women who watched the video felt that it was of added value. Remarkable was that women who reported higher anxiety at baseline seemed less willing to watch the video. [ABSTRACT FROM AUTHOR]

Objectives: Women's preferences for treatment of heavy menstrual bleeding (HMB) are important in clinical decision-making. Our aim was to investigate whether women with HMB have a preference for treatment characteristics of the levonorgestrel intrauterine system (LNG-IUS) or endometrial ablation and to assess the relative importance of these characteristics.Study Design: A discrete choice experiment was performed in general practices and gynaecology outpatient clinics in the Netherlands. Women with HMB were asked to choose between hypothetical profiles containing characteristics of LNG-IUS or endometrial ablation. Characteristics included procedure performed by gynaecologist or general practitioner; reversibility of the procedure; probability of dysmenorrhea; probability of irregular bleeding; additional use of contraception; need to repeat the procedure after five years; and treatment containing hormones. Data were analysed using panel mixed logit models. The main outcome measures were the relative importance of the characteristics and willingness to make trade-offs.Results: 165 women completed the questionnaire; 36 (22%) patients were recruited from general practices and 129 (78%) patients were recruited from gynaecology outpatient clinics. The characteristic found most important was whether a treatment contains hormones. Women preferred a treatment without hormones, a treatment with the least side effects, and no need for a repeat procedure or additional contraception. Women completing the questionnaire at the gynaecology outpatient clinic differed from women in primary care in their preference for a definitive treatment to be performed by a gynaecologist.Conclusions: Whether or not a treatment contains hormones was the most important characteristic influencing patient treatment choice for HMB. Participants preferred characteristics that were mostly related to endometrial ablation, but were willing to trade-off between characteristics. [ABSTRACT FROM AUTHOR]

Background: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery.Methods: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699.Findings: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups.Interpretation: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures.Funding: ZonMw. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of curettage versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Study Design: We conducted a multicenter cohort study alongside a randomized clinical trial (RCT) between June 2012 until July 2014. 27 Dutch hospitals participated. Women with an incomplete evacuation after misoprostol treatment for first trimester miscarriage who declined to participate in the RCT, received treatment of their preference; curettage (n=65) or expectant management (n=132). A successful outcome was defined as an empty uterus on sonography at six weeks or uneventful clinical follow-up. We furthermore assessed complication rate and (re)intervention rate RESULTS: Of the 197 women who declined to participate in the RCT, 65 preferred curettage and 132 expectant management. A successful outcome was observed in 62/65 women (95%) in the surgical group versus 112/132 women (85%) in the expectant group (RR 1.1, 95% CI 1.03-1.2), with complication rates of 6.2% versus 2.3%, respectively (RR 2.7, 95% CI 0.6-12).Conclusion: In women with an incomplete evacuation of the uterus after misoprostol treatment, expectant management is an effective and safe option. This finding could restrain the use of curettage in women that have used misoprostol in the treatment of first trimester miscarriage. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of bipolar radiofrequency (Novasure®) ablation and balloon endometrial ablation (Thermablate®).Study Design: We performed a multi-center double blind, randomized controlled trial in three hospitals in The Netherlands. Women with heavy menstrual bleeding were randomly allocated to bipolar or balloon endometrial ablation, performed in the office, using a paracervical block. The primary outcome was amenorrhea. Secondary outcome measures were pain, satisfaction, quality of life and reintervention.Results: 104 women were randomized into the bipolar (52) and balloon (52) groups. After 12 months amenorrhea rates were 56% (29/52) in the bipolar group and 23% (12/52) in the balloon group (relative risk (RR) 0.6, 95% confidence interval (CI) 0.4-0.8). The mean visual analog pain score of the total procedure was 7.1 in the bipolar group and 7.4 in the balloon group (P<.577). 87% (45/52) of the patients in the bipolar group were satisfied with the result of the treatment versus 69% (36/52) in the balloon group (RR 0.44, 95% CI 0.2-0.97). The reintervention rates were 5/52 (10%) in the bipolar group and 6/52 (12%) in the balloon group (RR 1.02, 95% CI 0.9-1.2). Quality of life (Shaw score) improved over time (P<.001) and was significantly higher in the bipolar group at 12 months follow-up (P=.025).Conclusion: In the treatment of heavy menstrual bleeding, bipolar radiofrequency endometrial ablation is superior to balloon endometrial ablation as an office procedure in amenorrhea rate, patient satisfaction and quality of life. [ABSTRACT FROM AUTHOR]

Objective: To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs).Design: Multicenter; women and assessors blinded prospective randomized trial.Setting: University and university-affiliated teaching hospitals.Patient(s): A total of 152 women with a miscarriage of <14 weeks with at least one previous D&C for miscarriage or termination of pregnancy.Intervention(s): Women were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A follow-up diagnostic hysteroscopy was scheduled 8-12 weeks after the D&C procedure.Main Outcome Measure(s): The primary outcome was the number of women with IUAs and the secondary outcome was the severity of IUAs.Result(s): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The IUAs were observed in 10 (13.0%) and 22 women (30.6%), respectively (relative risk, 0.43; 95% confidence interval 0.22-0.83). Mean adhesion score and the amount of moderate-to-severe IUAs were significantly lower in the intervention group according to the American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions.Conclusion(s): Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes.Clinical Trial Registration Number: NTR 3120. [ABSTRACT FROM AUTHOR]