Reproductive outcomes after laparoscopic resection of symptomatic niches in uterine cesarean scars: Long-term follow-up on the prospective LAPNICHE study.

INTRODUCTION: After incomplete healing of the uterine cesarean section scar, a niche can be observed; 24% of the women develop large niches with a residual myometrial thickness <3 mm. In these cases a laparoscopic resection is possible. The effect of this new treatment on fertility outcome is not known yet. This paper describes reproductive outcomes 2 years after a laparoscopic niche resection and compares women with or without secondary infertility at baseline. MATERIAL AND METHODS: A prospective cohort study was performed, with consecutive inclusion of women between 2011 and 2019. Women with a niche in the uterine cesarean scar, with a residual myometrial thickness of <3 mm and with a desire to become pregnant, were scheduled to undergo a laparoscopic niche resection because of one or more of the following problems (1) postmenstrual spotting; (2) midcycle intrauterine fluid accumulation diagnosed during the fertility workup or (3) difficulties with a previous embryo transfer and preferring a surgical therapy. The study is registered in the ISRCTN register (ref. no. ISRCTN02271575) on April 23, 2013. RESULTS: There were 133 (62%) women included with a desire to become pregnant, 88 with secondary infertility. In all, 83 had an ongoing pregnancy at the 2-year follow-up. The ongoing pregnancy rate in patients with previous fertility problems was 60.2% compared with 66.7% in patients without infertility (odds ratio [OR] 0.68, 95% confidence interval [CI] 0.32-1.7). The OR for live births was 0.57 (95% CI 0.02-1.2). Overall, 8.3% of the pregnancies resulted in miscarriages by the 2-year follow-up. CONCLUSIONS: The reproductive outcomes in women with and without previous fertility problems undergoing resection of a large niche are very promising and quite comparable in both groups. These results suggest, but do not prove, a beneficial effect of this therapy for these indications. The results support the design of future randomized controlled trials to evaluate the effect of niche resection vs expectant management to assess its additional value in women with or without fertility problems who desire pregnancy.

The link between intrauterine adhesions and impaired reproductive performance: a systematic review of the literature.

BACKGROUND: Intrauterine adhesions (IUAs) are one of the main reproductive system diseases in women worldwide. Fusion between the injured opposing walls leads to partial-to-complete obliteration of the cavity and/or cervical canal. The main clinical manifestations in case of IUAs are menstrual disturbances, cyclic pain and reproductive disorders. The reproductive outcomes of women with IUAs remain limited and inefficient compared to women without IUAs, even after adhesiolysis. An exact understanding of the underlying mechanisms and processes to explain the compromised reproductive performance and outcomes in case of IUAs are lacking. METHODS: A systematic literature review of MEDLINE-PubMed (1966 to January 2022) and EMBASE (1974 to January 2022) was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported underlying causes, related mechanisms and processes to explain the association between IUAs and impaired reproductive performance, pregnancy and obstetric complications. RESULTS: After an extensive review of the literature, 58 articles were identified reporting underlying mechanisms to explain the association between IUAs and impaired fertility. Intrauterine scarring influences the process of fertilization, reproductive performance and ultimately reproductive outcome. IUAs can disturb the cervico-utero-tubal sperm transport and result in an avascular and unresponsive endometrium with decreased receptivity and thickness. Abnormal decidualization and abnormal trophoblastic infiltration leads to placental attachment disorders. Moreover, the risk for premature delivery, intrauterine fetal growth restriction and fetal anomalies is increased in case of IUAs. CONCLUSION: The impact of IUAs on reproductive performance, even after adhesiolysis, is becoming more apparent. The postulated mechanisms to explain the association are related to sperm transport, embryo implantation and placentation. Prevention, by preserving the basal layer of the endometrium is essential. Effective and evidence-based strategies for the prevention of endometrial injury and formation of IUAs, are urgently needed.

Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial.

STUDY QUESTION: Are the long-term reproductive outcomes following recurrent dilatation and curettage (D&C) for miscarriage in women with identified and treated intrauterine adhesions (IUAs) comparable to women without IUAs. SUMMARY ANSWER: Reproductive outcomes in women with identified and treated IUAs following recurrent D&C for miscarriage are impaired compared to women without IUAs; fewer ongoing pregnancies and live births are achieved with a prolonged time to a live birth. WHAT IS KNOWN ALREADY: The Prevention of Adhesions Post Abortion (PAPA) study showed that application of auto-crosslinked hyaluronic acid (ACP) gel, an absorbable barrier in women undergoing recurrent D&C for miscarriage resulted in a lower rate of IUAs, 13% versus 31% (relative risk 0.43, 95% CI 0.22 to 0.83), lower mean adhesion score and significant less moderate to severe IUAs. It is unclear what the impact is of IUAs on long-term reproductive performance. STUDY DESIGN, SIZE, DURATION: This was a follow-up of the PAPA study, a multicenter randomized controlled trial evaluating the application of ACP gel in women undergoing recurrent D&C for miscarriage. All included women received a diagnostic hysteroscopy 8-12 weeks after randomization to evaluate the uterine cavity and for adhesiolysis if IUAs were present. Here, we present the reproductive outcomes in women with identified and treated IUAs versus women without IUAs, 46 months after randomization. PARTICIPANTS/MATERIALS, SETTING, METHODS: Between December 2011 and July 2015, 152 women with a first-trimester miscarriage with at least one previous D&C, were randomized for D&C alone or D&C with immediate intrauterine application of ACP gel. Participants were approached at least 30 months after randomization to evaluate reproductive performance, obstetric and neonatal outcomes and cycle characteristics. Additionally, the medical files of all participants were reviewed. Main outcome was ongoing pregnancy. Outcomes of subsequent pregnancies, time to conception and time to live birth were also recorded. MAIN RESULTS AND THE ROLE OF CHANCE: In women pursuing a pregnancy, 14/24 (58%) ongoing pregnancies were recorded in women with identified and treated IUAs versus 80/89 (90%) ongoing pregnancies in women without IUAs odds ratio (OR) 0.18 (95% CI 0.06 to 0.50, P-value <0.001). Documented live birth was also lower in women with IUAs; 13/24 (54%) with versus 75/89 (84%) without IUAs, OR 0.22 (95% CI: 0.08 to-0.59, P-value 0.004). The median time to conception was 7 months in women with identified and treated IUAs versus 5 months in women without IUAs (hazard ratio (HR) 0.84 (95% CI 0.54 to 1.33)) and time to conception leading to a live birth 15 months versus 5.0 months (HR 0.54 (95% CI: 0.30 to 0.97)). In women with identified and treated IUAs, premature deliveries were recorded in 3/16 (19%) versus 4/88 (5%) in women without IUAs, P-value 0.01. Complications were recorded in respectively 12/16 (75%) versus 26/88 (30%), P-value 0.001. No differences were recorded in mean birth weight between the groups. LIMITATIONS, REASONS FOR CAUTION: In the original PAPA study, randomization was applied for ACP gel application. Comparing women with and without IUAs is not in line with the randomization and therefore confounding of the results cannot be excluded. IUAs, if visible during routine hysteroscopy after randomization were removed as part of the study protocol; the influence of IUAs on reproductive outcome may therefore be underestimated. Women undergoing a recurrent D&C for miscarriage were included, a specific group likely to generate clinically significant adhesions. The findings should therefore not be generalized to all women undergoing D&C for miscarriage. WIDER IMPLICATIONS OF THE FINDINGS: As IUAs have an impact on reproductive performance, even after hysteroscopic adhesiolysis, primary prevention is essential. Expectative and medical management should therefore be considered as serious alternatives for D&C in women with a miscarriage. In case D&C is necessary, application of ACP gel should be considered. STUDY FUNDING/COMPETING INTEREST(S): The original PAPA study (NTR 3120) was an investigator initiated study that was funded by the Foundation for scientific investigation in Obstetrics and Gynaecology of the Saint Lucas Andreas Hospital (currently renamed OLVG Oost), SWOGA. The syringes containing ACP gel were received from Anika Therapeutics, the manufacturer of Hyalobarrier® Gel Endo. The current follow-up study was also an investigator-initiated study without funding. The funder and sponsor had no role in the design of this follow-up study, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the report or any aspect pertinent to the study. ABH, RAL, JAFH and JWRT have no conflict to declare. HAMB reports being a member of safety board research Womed. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NTR 3120.

Role of 3-Dimensional Sonography in the Assessment of Submucous Fibroids: A Pilot Study.

OBJECTIVES: To investigate the accuracy and reliability of 3-dimensional (3D) transvaginal sonography in classifying submucous fibroids using the International Federation of Gynecology and Obstetrics PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) classification and protrusion (percent) compared to 2-dimensional (2D) transvaginal sonography, 2D saline infusion sonography, and 3D saline infusion sonography, using hysteroscopy as a reference test. METHODS: A prospective cohort pilot study was performed among 14 consecutive patients undergoing hysteroscopic surgery, preceded by routine sonography (2D transvaginal sonography, 2D saline infusion sonography, 3D transvaginal sonography, and 3D saline infusion sonography). RESULTS: The intraclass correlation coefficient (ICC) for 2D transvaginal sonography versus hysteroscopy was 0.69 (95% confidence interval [CI], 0.06, 0.90) compared to 0.94 (95% CI, 0.83, 0.98) for 2D saline infusion sonography. The ICCs for 3D transvaginal sonography versus hysteroscopy were 0.69 (95% CI, 0.03, 0.90 [investigator A]) and 0.55 (95% CI, -0.48, 0.86 [investigator B]). The ICCs for 3D saline infusion sonography versus hysteroscopy were 0.94 (95% CI, 0.81, 0.98 [investigator A]) and 0.87 (95% CI, 0.60, 0.96 [investigator B]). Interobserver agreement of 3D transvaginal sonography was 0.81 (95% CI, 0.43, 0.94) compared to 0.86 (95% CI, 0.56, 0.96) for 3D saline infusion sonography. CONCLUSIONS: In these preliminary data, 3D transvaginal sonography was not as accurate as 2D or 3D saline infusion sonography and was not more accurate than 2D transvaginal sonography. There was moderate interobserver agreement for 3D transvaginal sonography. There might be room for improvement, as 3D transvaginal sonography is more accurate when endometrial thickness increases. Further study is warranted to evaluate in which patients saline infusion sonography eventually can be obviated.

Changes in the Uterine Scar during the First Year after a Caesarean Section: A Prospective Longitudinal Study.

AIM: To study changes in a ceasarean section (CS) scar during the first year after a CS using gel installation sonography (GIS). METHODS: Proof-of-concept study, prospective cohort study. Twenty women who delivered by their first CS were evaluated by both transvaginal sonography and GIS 2 months and 1 year after CS. A niche was defined as an anechogenic space at the uterine caesarean scar with a depth >2 mm. The primary outcome was any change in the thickness of the residual myometrium (RMT) as evaluated by GIS. RESULTS: Mean RMT changed in time from 11.9 mm at 2 months to 6.5 mm at 12 months after the CS (p < 0.001). Niche prevalence did not change. The adjacent myometrium (AM) reduced from 15 to 12.4 mm (p = 0.04). The ratio between RMT and AM with GIS decreased from 0.80 at 2 months to 0.54 at 12 months (p = 0.002). CONCLUSION: RMT thickness, the adjacent myometium and the ratio between the RMT and AM reduces from 2 to 12 months after a CS. The prevalence did not change. This needs to be taken into account when deciding on the timing of niche measurement and the interpretation of the RMT.

The use of 3D power Doppler ultrasound in the quantification of blood vessels in uterine fibroids: feasibility and reproducibility.

BACKGROUND: To evaluate the interobserver agreement and discriminating value of three-dimensional power Doppler ultrasound (3D PDUS) in patients with fibroids. METHODS: An observational prospective cohort study in 19 patients with fibroids. 3D PDUS was performed by one examiner and evaluated by three independent examiners in order to evaluate various vascular parameters: vascular index (VI), flow index, and vascular flow index of the fibroid, the vascular capsule and of its highest vascular area, using both manual and automatic contour modes. The intraclass correlation coefficient and discriminating values were calculated. The correlation between VI and volume was studied using Kendall's Tau test. RESULTS: In the manual contour mode, the VIs of the fibroid and of the vascular capsule had the highest interobserver agreements (intraclass correlation coefficients of 0.89 and 0.87, respectively). Both parameters seem to have good discriminating values, given the large range of these parameters between different fibroids, independent of their volume. The vascularity of the fibroid and capsule was related. VI was not related to the volume of the fibroid. CONCLUSIONS: VI assessed using 3D PDUS is a reproducible parameter in the assessment of fibroid vascularization with discriminating abilities. Additional studies are needed to further evaluate its validity and clinical relevance.

Functional characteristics of vaginal fibroblastic cells from premenopausal women with pelvic organ prolapse.

Pelvic organ prolapse (POP) remains a great therapeutic challenge with no optimal treatment available. Tissue maintenance and remodelling are performed by fibroblasts, therefore altered cellular functionality may influence tissue quality. In this study, we evaluated functional characteristics of fibroblastic cells from tissues involved in POP. To rule out normal ageing tissue degeneration, biopsies from 18 premenopausal women were collected from the precervical region (non-POP site) after hysterectomy of 8 healthy and 10 POP cystocele cases (POP-Q stage ≥ II). Extra tissues from the prolapsed sites were taken in the POP cases to distinguish between intrinsic and acquired cellular defects. Twenty-eight primary fibroblastic cultures were studied in vitro. A contractility assay was used to test fibroblast-mediated collagen contraction. Cellular mechanoresponses on collagen-coated or uncoated substrates were evaluated by measuring matrix remodelling factors at protein or gene expression levels. No differences were found between fibroblasts from the controls and the non-POP site of the case group. Fibroblastic cells from the prolapsed site showed delayed fibroblast-mediated collagen contraction and lower production of matrix metalloproteinase-2 (MMP-2) on collagen-coated plates. On uncoated surfaces the gene MMP-2 and its tissue inhibitor of metalloproteinases-2 were up-regulated in POP site fibroblastic cells. In conclusion, fibroblastic cells derived from prolapsed tissues of patients with cystocele, display altered in vitro functional characteristics depending on the surface substrate and compared with non-prolapsed site. This implies an acquired rather than an intrinsic defect for most patients with cystocele, and should be taken into account when trying to improve treatments for POP.

Causes and prevention of laparoscopic ureter injuries: an analysis of 31 cases during laparoscopic hysterectomy in the Netherlands.

BACKGROUND: Ureter injuries are the most dreaded complication in gynecological surgery. Some risk factors for the occurrence of urinary tract injuries are known, but clear guidelines to prevent ureter injuries during laparoscopic hysterectomy (LH) are lacking. The aim of this study was to analyze all known ureter injuries that occurred during LH for a benign indication in the Netherlands, in order to identify patient- and surgeon-related risk factors. METHODS: Ninety-five LH-performing gynecologists were asked to recall all cases of known ureter injuries during LH in their hospital. After identification of ureter injuries, a structured interview was performed with a questionnaire that focused on the identification of predisposing factors which could account for the cause of the injury. RESULTS: Forty-one injuries were detected in 37 patients (4 bilateral ureter injuries) in a 20-year period. The questionnaire could be completed for 31 cases. Predisposing factors were retrospectively assessed and classified into categories: patient-related (i.e., deep infiltrating endometriosis, intraligamentary fibroids) (n = 18), surgeon-related (insufficient experience and/or technique) (n = 16), or both (insufficient experience and difficult case) (n = 8). According to earlier-mentioned recommendations in a Delphi study among experts, in 48.4 % of these ureter injury cases, more than one of the recommended techniques or predisposing conditions were not applied or available. Only one ureter injury was diagnosed during the LH; the mean time to diagnose the injury was 29 days. CONCLUSIONS: Incomplete learning curve, insufficient applied technique such as coagulation of the uterine artery without the use of a uterine manipulator, and/or from the contralateral side and/or without previously performed ureterolysis in case of distorted anatomy may be considered as the main predisposing factors.

Fibroblasts from women with pelvic organ prolapse show differential mechanoresponses depending on surface substrates.

INTRODUCTION AND HYPOTHESIS: Little is known about dynamic cell-matrix interactions in the context of pathophysiology and treatments for pelvic organ prolapse (POP). This study sought to identify differences between fibroblasts from women with varying degrees of prolapse in reaction to mechanical stimuli and matrix substrates in vitro. METHODS: Fibroblasts from the vaginal wall of three patients with POP Quantification (POP-Q) system stages 0, II, and IV were stretched on artificial polymer substrates either coated or not coated with collagen I. Changes in morphology and anabolic/catabolic compounds that affect matrix remodelling were evaluated at protein- and gene-expression levels. Statistical analysis was performed using one-way analysis of variance (ANOVA), followed by Tukey-Kramer's post hoc test. RESULTS: POP fibroblasts show delayed cell alignment and lower responses to extracellular matrix remodelling factors at both enzymatic- and gene-expression levels compared with healthy fibroblasts. CONCLUSION: POP fibroblasts, when compared with healthy cells, show differential mechanoresponses on two artificial polymer substrates. This should be taken into account when designing or improving implants for treating POP.

Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review.

BACKGROUND: Adequate hemostatic techniques are essential for optimal intra- and postoperative results. A number of different hemostatic techniques and devices have been developed over the past few years, but which device should be preferred during laparoscopic and open abdominal procedures? METHODS: We conducted a systematic search for randomized controlled trials (RCTs) that compared the effectiveness and costs of vessel-sealing devices with those of other electrothermal or ultrasonic devices in abdominal surgical procedures. RESULTS: Seven RCTs that included 554 patients met the inclusion criteria. Various procedures that used a vessel-sealing device (LigaSure™) (n = 264) were compared to ultrasonic devices (n = 139) and mono- (n = 20) or bipolar devices (n = 130). LigaSure was favored in two studies with respect to less blood loss, shorter operating time, and lower costs. However, no differences were observed in the other studies. Considering the relatively low number of complications, all hemostatic devices used may be considered relatively safe. None of the studies reported on quality of life or cost effectiveness. CONCLUSIONS: Vessel-sealing devices may be considered safe and their use may reduce costs due to reduced blood loss and shorter operating time in some abdominal surgical procedures compared to mono- or bipolar electrothermal devices. Wider-ranging RCTs of sufficient quality that assess (cost) effectiveness are required to make firm conclusions.

Perioperative outcomes using LigaSure™ compared to conventional bipolar instruments in laparoscopic salpingo-oophorectomy: a randomized controlled trial.

BACKGROUND: The aim of this study was to compare the effects of LigaSure™ versus conventional bipolar techniques on operating time and blood loss during laparoscopic salpingo-oophorectomy in a randomized controlled trial. METHODS: In three teaching hospitals, 100 women undergoing a laparoscopic salpingo-oophorectomy were randomized for LigaSure or conventional bipolar instruments. Primary outcome was operating time (from initial skin incision to removal of the specimen). Secondary outcome measures were total operating time (from initial skin incision to skin closure), time to dissect the ovarian and infundibulopelvic ligaments, intraoperative blood loss, and subjective judgment of the instrument used. RESULTS: There were no differences in operating time and total operating time using LigaSure versus conventional bipolar instruments: 41.0 vs. 39.2 min (p = 0.78; 95 % CI = -10.9 to 14.5) and 54.6 vs. 58.6 min (p = 0.46; 95 % CI = -14.8 to 6.8), respectively. The mean blood loss using LigaSure versus conventional bipolar instruments was 38 vs. 33 mL (p = 0.73; 95 % CI = -22.7 to 32.2). Various subjective efficacy and instrument handling parameters of the two instruments varied among participating centers. CONCLUSION: There were no significant differences in operating time and blood loss with the use of LigaSure compared to conventional bipolar instruments during laparoscopic salpingo-oophorectomy, even after correction for potential confounders.

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

BACKGROUND: Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. METHODS/DESIGN: We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. DISCUSSION: The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2087.

eHealth program to empower patients in returning to normal activities and work after gynecological surgery: intervention mapping as a useful method for development.

BACKGROUND: Full recovery after gynecological surgery takes much longer than expected regardless of surgical technique or the level of invasiveness. After discharge, detailed convalescence recommendations are not provided to patients typically, and postoperative care is fragmented, poorly coordinated, and given only on demand. For patients, this contributes to irrational beliefs and avoidance of resumption of activities and can result in a prolonged sick leave. OBJECTIVE: To develop an eHealth intervention that empowers gynecological patients during the perioperative period to obtain timely return to work (RTW) and prevent work disability. METHODS: The intervention mapping (IM) protocol was used to develop the eHealth intervention. A literature search about behavioral and environmental conditions of prolonged sick leave and delayed RTW in patients was performed. Patients' needs, attitudes, and beliefs regarding postoperative recovery and resumption of work were identified through focus group discussions. Additionally, a literature search was performed to obtain determinants, methods, and strategies for the development of a suitable interactive eHealth intervention to empower patients to return to normal activities after gynecological surgery, including work. Finally, the eHealth intervention was evaluated by focus group participants, medical doctors, and eHealth specialists through questionnaires. RESULTS: Twenty-one patients participated in the focus group discussions. Sufficient, uniform, and tailored information regarding surgical procedures, complications, and resumption of activities and work were considered most essential. Knowing who to contact in case of mental or physical complaints, and counseling and tools for work reintegration were also considered important. Finally, opportunities to exchange experiences with other patients were a major issue. Considering the determinants of the Attitude-Social influence-self-Efficacy (ASE) model, various strategies based on a combination of theory and evidence were used, resulting in an eHealth intervention with different interactive functionalities including tailored convalescence recommendations and a video to communicate the most common pitfalls during the perioperative period to patients and employers. Fifteen patients in the focus groups, 11 physicians, and 3 eHealth specialists suggested points for improvement to optimize the usability of the eHealth intervention and judged it an approachable, appropriate, and attractive eHealth intervention to empower gynecological patients. CONCLUSIONS: The IM protocol was a useful method to develop an eHealth intervention based on both theory and evidence. All patients and stakeholders judged the eHealth intervention to be a promising tool to empower gynecological patients during the perioperative period and to help them to return to normal activities and work.

Electronic Continuous Pain Measurement vs Verbal Rating Scale in gynaecology: A prospective cohort study.

OBJECTIVE: To compare pain measured with a new electronic device - the Continuous Pain Score Meter (CPSM) - and the Verbal Rating Scale (VRS) during gynaecological procedures in an outpatient setting, and to correlate these outcomes with baseline anxiety and patient (in)tolerance to the procedure. STUDY DESIGN: This prospective cohort study was undertaken in two centres: a university hospital and a large teaching hospital in The Netherlands. Patients undergoing an outpatient hysteroscopy, colposcopy or ovum pick-up procedure for in-vitro fertilization in one of the two participating hospitals with availability of the CPSM were included. Pain was measured by both the CPSM and the VRS. Patient tolerance to the procedure was reported. Various outcomes of the CPSM were compared with those of the VRS and related to baseline anxiety scores. RESULTS: Ninety-one of 108 included patients (84 %) used the CPSM correctly during the procedure, and it was possible to analyse the CPSM scores for 87 women (81 %). The CPSM scores were all linearly related to the VRS. The peak pain score on the CPSM (CPSM-PPS) had the strongest correlation with the VRS score for all three procedures. Higher CPSM-PPS was related to patient (in)tolerance to the procedure (p = 0.03-0.002). Anxiety at baseline was not correlated with pain perception, except for VRS during colposcopy (r = 0.39, p = 0.016). CONCLUSION: The majority of patients were able to use the CPSM correctly, resulting in detailed information on pain perception for each individual pain stimulus during three outpatient gynaecological procedures. The CPSM-PPS had the strongest correlation with the VRS score and patient (in)tolerance to the procedure.

Therapeutic options of caesarean scar pregnancy: case series and literature review.

We describe our experience with the treatment of 4 caesarean scar pregnancies and provide an overview of current literature. Four women diagnosed with a caesarean scar pregnancy in our hospital between 1996 and 2007 were treated with local or systemic methotrexate and had a steady decline of the serum beta-hCG level. The uterus was preserved in all women and 3 of them had an uneventful subsequent pregnancy and delivery. We suggest that transcervical needle aspiration of amniotic fluid followed by intra-amniotic injection of methotrexate should be the treatment of choice, followed by surgical treatment only if methotrexate fails.

Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.

OBJECTIVE: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. DESIGN: Follow-up of a prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. INTERVENTION(S): Participants received a questionnaire 30 months after treatment. MAIN OUTCOME MEASURE(S): Ongoing pregnancy and outcome of subsequent pregnancies. RESULT(S): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. CONCLUSION(S): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. DUTCH CLINICAL TRIAL REGISTRY NUMBER: NTR 3120.

Can prolonged sick leave after gynecologic surgery be predicted? An observational study in The Netherlands.

BACKGROUND: Sick leave frequently has been used as an outcome to evaluate minimal invasive surgery compared with conventional open surgery. However, sick leave is determined not only by the surgical approach. Recently, a postoperative recovery-specific quality-of-life questionnaire, the Recovery Index (RI-10), has been developed and validated. This study investigated the relation of the Recovery Index 10, the RI-6 (a subset of 6 questions), and the type of surgery to sick leave. METHODS: The study enrolled 46 patients with a paid job scheduled for elective gynecologic surgery, who filled out the RI-10. After 8 weeks, the patients were approached by telephone to give information on their return to work. RESULTS: Of the 46 patients, 23 (50%) returned to work completely after 8 weeks, 14 (30%) resumed work partly, and 9 (20%) did not resume work at all. In the analysis, the patients who completely returned to work were compared with those who did not return or partially returned. Recovery as expressed in the RI-6 improved with time after surgery. It appeared that the measurement 2 weeks after surgery showed the best discriminative capacity to predict sick leave after 8 weeks, with an area under the curve of 0.88 (confidence interval, 0.74-1.03). The subjective postoperative recovery as expressed by the RI-6 is more closely related to the type of surgery (p = 0.001) sick leave is (p = 0.14). CONCLUSIONS: The subjective recovery scored by the patient on a questionnaire of six questions is a better outcome than sick leave for evaluating surgical approaches. If administered 2 weeks after surgery, it may predict prolonged sick leave.

Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

BACKGROUND: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered. METHODS/DESIGN: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes. TRIAL REGISTRATION: Clinical Trials NCT00814749.