Implementation of an Innovative Technology Called the OR Black Box: A Feasibility Study.

Introduction. The operating room (OR) Black Box is an innovative technology that captures and compiles extensive real-time data from the OR, allowing identification and analysis of factors that influence intraoperative procedures and performances - ultimately improving patient safety. Implementation of this kind of technology is still an emerging research area and prone to face challenges. Methods. Observational study running from May 2017 to May 2021 conducted at Copenhagen University Hospital - Rigshospitalet, Denmark, involving 152 OR staff and 306 patients. Feasibility of the OR Black Box was assessed in accordance with Bowen's framework with 8 focus areas. Results. The OR Black Box had a high level of acceptability among stakeholders with 100% participation from management, 93% from OR staff, and 98% from patients. The implementation process improved over time, and an average of 80% of the surgeries conducted were captured. The practical aspects such as numerous formal and informal meetings, ethical and legal approval, recruitment of patients were acceptable, albeit time-consuming. The OR Black Box was adopted without any changes in scheduled surgery program, but capturing hours were adjusted to match the surgery program and relocation of OR staff declining to provide consent was possible. Conclusions. Implementation of the OR Black Box was feasible yet challenging. Management, nearly all staff, and patients embraced the initiative; however, ongoing evaluation, information meetings, and commitment from stakeholders are required and crucial to sustain momentum, continue implementation and expansion. Ideas from this study can be useful in the implementation of similar initiatives.

Pelvic organ prolapse surgery after native tissue vault suspension at hysterectomy-A prospective cohort study.

OBJECTIVE: The effect of prophylactic vaginal vault suspension during hysterectomy in prevention of subsequent development of pelvic organ prolapse (POP) is unknown. We aimed to investigate incidences and risk of POP surgery in women who had undergone hysterectomy on benign indication with and without prophylactic suspension. STUDY DESIGN: We linked the national clinical Danish Hysterectomy and Hysteroscopy Database (DHHD) to administrative registries to assess data on all total hysterectomies (1 May 2012 to 31 December 2014), suspension methods, age, POP surgery, births, obstetric complications, prescriptions, socioeconomic- and vital status. Women undergoing total hysterectomy on non-prolapse and benign indication with no prior POP surgery were included and followed from hysterectomy to POP surgery, death/emigration or end of study period (maximum 2 years). Descriptive statistics, cumulative incidence curves and multivariable Cox proportional hazard models were fitted to assess the associated risk of POP in relation to prophylactic suspension. RESULTS: We included 7625 patients undergoing total hysterectomy; of these, 6538 (85.7%) were registered with prophylactic suspension during hysterectomy and 1087 (14.3%) women were specifically registered with no suspension in the DHHD. At baseline, women undergoing hysterectomy with suspension were on average 47.1 years of age (standard error SE 0.1) compared to 48.4 years (SE 0.3) in women with no suspension (p-value <0.0001). Moreover, women with suspension differed from their counterparts with no suspension with respect to geographical site of hysterectomy, hysterectomy method, parity and income. The cumulative risk of POP surgery after two years follow-up was 0.9% and 0.5% in the suspension group and the no suspension group, respectively. In the adjusted analysis, we found no association of prophylactic suspension and risk of POP surgery, hazard ratio (HR) = 2.1 (95% confidence interval (CI) 0.8-5.3, p-value 0.13). CONCLUSION: Of all women undergoing hysterectomy for benign indication, 0.84% (N = 64) were surgically treated for POP. At two-year follow-up, there was no association between prophylactic vaginal vault suspension at time of hysterectomy and subsequent POP surgery.

Type I Versus Type II Endometrial Cancer: Differential Impact of Comorbidity.

OBJECTIVE: Two distinct types of endometrial carcinoma (EC) with different etiology, tumor characteristics, and prognosis are recognized. We investigated if the prognostic impact of comorbidity varies between these 2 types of EC. Furthermore, we studied if the recently developed ovarian cancer comorbidity index (OCCI) is useful for prediction of survival in EC. MATERIALS AND METHODS: This nationwide register-based cohort study was based on data from 6487 EC patients diagnosed in Denmark between 2005 and 2015. Patients were assigned a comorbidity index score according to the Charlson comorbidity index (CCI) and the OCCI. Kaplan-Meier survival statistics and adjusted multivariate Cox regression analyses were used to investigate the differential association between comorbidity and overall survival in types I and II EC. RESULTS: The distribution of comorbidities varied between the 2 EC types. A consistent association between increasing levels of comorbidity and poorer survival was observed for both types. Cox regression analyses revealed a significant interaction between cancer stage and comorbidity indicating that the impact of comorbidity varied with stage. In contrast, the interaction between comorbidity and EC type was not significant. Both the CCI and the OCCI were useful measurements of comorbidity, but the CCI was the strongest predictor in this patient population. CONCLUSIONS: Comorbidity is an important prognostic factor in type I as well as in type II EC although the overall prognosis differs significantly between the 2 types of EC. The prognostic impact of comorbidity varies with stage but not with type of EC.

The distress thermometer in survivors of gynaecological cancer: accuracy in screening and association with the need for person-centred support.

PURPOSE: Unrecognised psychological distress among cancer survivors may be identified using short screening tools. We validated the accuracy of the distress thermometer (DT) to detect psychological distress on the Hospital Anxiety and Depression Scale (HADS) among early stage gynaecological cancer survivors and whether the women's DT and HADS scores were associated with the need of an individualised supportive intervention. METHODS: One hundred sixty-five gynaecological cancer survivors answered DT and HADS before randomisation in a trial testing a nurse-led, person-centred intervention using supportive conversations. The number of conversations was decided in the woman-nurse dyad based on the woman's perceived need. Nurses were unaware of the women's DT and HADS scores. We validated DT's accuracy for screening using HADS as gold standard and receiver operating characteristic curves. Associations between DT and HADS scores and the number of conversations received were investigated. RESULTS: For screening of distress (HADS ≥ 15), a DT score ≥ 2, had a sensitivity of 93% (95% CI 82-98%), a specificity of 40% (32-49%), and positive and negative predictive values of 36% (28-45%), and 94% (84-98%), respectively; area under curve was 0.73 (0.64-0.81). Higher DT and HADS scores were associated with more interventional conversations. CONCLUSIONS: In gynaecological cancer survivors, DT may perform fairly well as a first stage screening tool for distress, but a second stage is likely needed due to a high number of false positives. DT and HADS scores may predict the number of supportive conversations needed in an individualised intervention in gynaecological cancer survivors.

Ovarian Cancer and Comorbidity: Is Poor Survival Explained by Choice of Primary Treatment or System Delay?

OBJECTIVES: Comorbidity influences survival in ovarian cancer, but the causal relations between prognosis and comorbidity are not well characterized. The aim of this study was to investigate the associations between comorbidity, system delay, the choice of primary treatment, and survival in Danish ovarian cancer patients. METHODS: This population-based study was conducted on data from 5317 ovarian cancer patients registered in the Danish Gynecological Cancer Database. Comorbidity was classified according to the Charlson Comorbidity Index and the Ovarian Cancer Comorbidity Index. Pearson χ test and multivariate logistic regression analyses were used to investigate the association between comorbidity and primary outcome measures: primary treatment ("primary debulking surgery" vs "no primary surgery") and system delay (more vs less than required by the National Cancer Patient Pathways [NCPPs]). Cox regression analyses, including hypothesized mediators stepwise, were used to investigate if the impact of comorbidity on overall survival is mediated by the choice of treatment or system delay. RESULTS: A total of 3945 patients (74.2%) underwent primary debulking surgery, whereas 1160 (21.8%) received neoadjuvant chemotherapy. When adjusting for confounders, comorbidity was not significantly associated to the choice of treatment. Surgically treated patients with moderate/severe comorbidity were more often experiencing system delay longer than required by the NCPP. No association between comorbidity and system delay was observed for patients treated with neoadjuvant chemotherapy. Survival analyses demonstrated that system delay longer than NCPP requirement positively impacts survival (hazard ratio, 0.90 [95% confidence interval, 0.82-0.98]), whereas primary treatment modality has no significant impact on survival. CONCLUSIONS: Patients with moderate/severe comorbidity experience often a longer system delay than patients with no or mild comorbidity. Age, stage, and comorbidity are factors influencing the choice of treatment, with stage being the most important factor and comorbidity of lesser importance. The impact of comorbidity on survival does not seem to be mediated by the choice of treatment or system delay.

Development and evaluation of an endoscopic surgery course for medical students.

INTRODUCTION: Surgical training has changed with the introduction of endoscopic surgery. However, a gap in undergraduate medical training has become evident regarding theoretical principles of and basic skills training in endoscopic surgery. The objective of this study was to develop and evaluate a course in endoscopic surgery for medical students. METHODS: Kern's six-step approach in curriculum development was used. A course including interactive, faculty-led didactic sessions (14 hours, distributed over three days) and simulation-based basic skills training in endoscopic surgery (nine hours, distributed over four sessions) was developed. Knowledge was tested using a 35-item test before and after the course, and finally the course was evaluated electronically. The project group in cooperation with the faculty -developed the goals and objectives, the test and the evaluation questionnaire. RESULTS: The test-scores significantly improved after the course, p < 0.0001, with a mean difference of 12.95 (95% confidence interval: 11.47-14.44). A total of 74% (14/19) responded that the course increased their interest in a career in a surgical specialty and 58% (11/19) were considering specialising in a surgical specialty. CONCLUSIONS: A course in endoscopic surgery was developed based on Kern's six-step approach. The course was positively perceived by the students in terms of contents as well as structure and relevance. FUNDING: University of Copenhagen, Aase og Ejner Danielsen Fonden, The Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet. TRIAL REGISTRATION: not relevant.

A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery.

BACKGROUND: The value of tranexamic acid (TA) treatment as bleeding prophylaxis in major uterine surgery is unclear. OBJECTIVES: To evaluate the antihemorrhagic effect of prophylactic TA treatment in major benign uterine surgery. SEARCH STRATEGY: PubMed, Embase, Cochrane Library, and Web of Science were searched from 1980 to 2015 without language restriction using search terms related to major uterine surgery combined with TA. SELECTION CRITERIA: Randomized controlled trials comparing prophylactic TA with placebo or no intervention in women undergoing elective major benign uterine surgery. DATA COLLECTION AND ANALYSIS: Basic information and outcomes were collected and meta-analyses performed. MAIN RESULTS: Sixteen trials were included, with five trials considered to have an overall low risk of bias. In cesarean delivery, TA significantly reduced intraoperative bleeding (mean -136 mL, 95% confidence interval [CI] -189 to -83), blood loss of more than 1000 mL (relative risk 0.38, 95% CI 0.18-0.81), and blood transfusion (relative risk 0.32, 95% CI 0.17-0.59). In abdominal myomectomy, TA also significantly reduced intraoperative bleeding (mean -251 mL, 95% CI -391 to -110). CONCLUSIONS: Prophylactic TA treatment significantly reduced operative bleeding in women undergoing elective cesarean delivery or abdominal myomectomy. Additional randomized trials with low risk of bias are needed.

Vaginal vault suspension during hysterectomy for benign indications: a prospective register study of agreement on terminology and surgical procedure.

INTRODUCTION AND HYPOTHESIS: Several suspension methods are used to try to prevent pelvic organ prolapse (POP) after hysterectomy. We aimed to evaluate agreement on terminology and surgical procedure of these methods. METHODS: We randomly chose 532 medical records of women with a history of hysterectomy from the Danish Hysterectomy and Hysteroscopy Database (DHHD). Additionally, we video-recorded 36 randomly chosen hysterectomies. The hysterectomies were registered in the DHHD. The material was categorized according to predefined suspension methods. Agreement compared suspension codes in DHHD (gynecologists' registrations) with medical records (gynecologists' descriptions) and with videos (reviewers' categorizations) respectively. Whether the vaginal vault was suspended (pooled suspension) or not (no suspension method + not described) was analyzed, in addition to each suspension method. RESULTS: Regarding medical records, agreement on terminology was good among patients undergoing pooled suspension in cases of hysterectomy via the abdominal and vaginal route (agreement 78.7, 92.3%). Regarding videos, agreement on surgical procedure was good among pooled suspension patients in cases of hysterectomy via the abdominal, laparoscopic, and vaginal routes (agreement 88.9, 97.8, 100%). Agreement on individual suspension methods differed regarding both medical records (agreement 0-90.1%) and videos (agreement 0-100%). CONCLUSIONS: Agreement on terminology and surgical procedure regarding suspension method was good in respect of pooled suspension. However, disagreement was observed when individual suspension methods and operative details were scrutinized. Better consensus of terminology and surgical procedure is warranted to enable further research aimed at preventing POP among women undergoing hysterectomy.

Evaluation of Procedural Simulation as a Training and Assessment Tool in General Surgery-Simulating a Laparoscopic Appendectomy.

BACKGROUND: Laparoscopic appendectomy is a commonly performed surgical procedure, but few training models have been described for it. We examined a virtual reality module for practising a laparoscopic appendectomy. METHODS: A prospective cohort study with the following 3 groups of surgeons (n = 45): novices (0 procedures), intermediates (10-50 procedures), and experienced (>100 procedures). After being introduced to the simulator and 1 familiarization attempt on the procedural module, the participants practiced the module 20 times. Movements, task time, and procedure-specific parameters were compared over time. RESULTS: The time and movement parameters were significantly different during the first attempt, and more experienced surgeons used fewer movements and less time than novices (p < 0.01), although only 2 parameters were significantly different between novices and intermediates. All 3 groups improved significantly over 20 attempts (p < 0.0001). The intraclass correlation coefficient varied between 0.55 and 0.68 and did not differ significantly between the 3 groups (p > 0.05). When comparing novices with experienced surgeons, novices had a higher risk of burn damage to cecum (odds ratio [OR] = 3.0 [95% CI: 1.3; 7.0] p = 0.03), pressure damage to appendix (OR = 3.1 [95% CI: 2.0; 4.9] p < 0.0001), and grasping of the appendix (OR = 2.9 [95% CI: 1.8; 4.7] p < 0.0001). The risk of causing a perforation was not significantly different among the different experience levels (OR = 1.9 [95% CI: 0.9; 3.8] p = 0.14). Only 3 out of 5 error parameters differed significantly when comparing novices and experienced surgeons. Similarly, when comparing intermediates and novices, it was only 2 of the parameters that differed. DISCUSSION: The simulator module for practising laparoscopic appendectomy may be useful as a training tool, but further development is required before it can be used for assessment purposes. Procedural simulation may demonstrate more variation for movement parameters, and future research should focus on developing better procedure-specific parameters.

Simulation-based camera navigation training in laparoscopy-a randomized trial.

BACKGROUND: Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. MATERIALS AND METHODS: A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group). Participants were surgical novices without prior laparoscopic experience. The primary outcome was assessment of camera navigation skills during a laparoscopic cholecystectomy. The secondary outcome was technical skills after training, using a previously developed model for testing camera navigational skills. The exploratory outcome measured participants' motivation toward the task as an operating assistant. RESULTS: Thirty-six participants were randomized. No significant difference was found in the primary outcome between the three groups (p = 0.279). The secondary outcome showed no significant difference between the interventions groups, total time 167 s (95% CI, 118-217) and 194 s (95% CI, 152-236) for the camera group and the procedure group, respectively (p = 0.369). Both interventions groups were significantly faster than the control group, 307 s (95% CI, 202-412), p = 0.018 and p = 0.045, respectively. On the exploratory outcome, the control group for two dimensions, interest/enjoyment (p = 0.030) and perceived choice (p = 0.033), had a higher score. CONCLUSIONS: Simulation-based training improves the technical skills required for camera navigation, regardless of practicing camera navigation or the procedure itself. Transfer to the clinical setting could, however, not be demonstrated. The control group demonstrated higher interest/enjoyment and perceived choice than the camera group.

Incidence of pelvic organ prolapse repair subsequent to hysterectomy: a comparison between radical hysterectomy and total abdominal hysterectomy.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the incidence of subsequent pelvic organ prolapse (POP) repair in women following radical hysterectomy versus total abdominal hysterectomy. METHODS: From the Danish National Patient Registry, we collected data on all radical hysterectomies, all total abdominal hysterectomies, and all POP operations performed in Denmark from 1 January 1977 to 31 December 2009. We excluded patients with prior POP repair, POP diagnosis, or concomitant POP repair at hysterectomy. We analyzed the incidence of POP surgery using Kaplan-Meier curves and hazard ratio (HR). RESULTS: In all, 5279 women underwent radical hysterectomy, and 63 of these underwent subsequent POP surgery. In the same period, 149,920 women underwent total abdominal hysterectomy, and 6107 of these had POP surgery subsequent to the hysterectomy. The cumulative incidence of POP surgery was significantly lower for radical hysterectomy than for abdominal hysterectomy-3.4 % and 9.5 %, respectively, at the end of the study period, yielding a crude HR of 0.36 and an adjusted HR of 0.40 in favor of the radical hysterectomy. The distribution of POP operations in the defined compartments was the same for the two types of hysterectomy. CONCLUSIONS: This study found a significantly lower incidence of subsequent POP operations among women who undergo radical hysterectomy than total abdominal hysterectomy.

A new clinically applicable age-specific comorbidity index for preoperative risk assessment of ovarian cancer patients.

OBJECTIVE: To develop and validate a new feasible comorbidity index based on self-reported information suited for preoperative risk assessment of ovarian cancer patients. METHODS: The study was based on patient self-reported data from ovarian cancer patients registered in the Danish Gynecological Cancer Database between January 1, 2005 and December 31, 2012. The study population was divided into a development cohort (n=2020) and a validation cohort (n=1975). Age-stratified multivariate Cox regression analyses were conducted to identify comorbidities significantly impacting five-year overall survival in the development cohort, and regression coefficients were used to construct a new weighted comorbidity index. The index was applied to the validation cohort, and its predictive ability in regard to overall and cancer-specific five-year-survival was investigated. Finally, the performance of the new index was compared to that of the Charlson Comorbidity Index. RESULTS: Regression coefficients of age and five comorbidities (atherosclerotic cardiac disease, chronic obstructive pulmonary disease, diabetes, dementia and hypertension) were included in the new comorbidity index. The validation study found the new index to be significantly associated to both overall survival (HR 1.44, p=0.013) and cancer-specific survival (HR 1.51, p=0.017) in multivariate analyses adjusted for other prognostic factors. The index was a significantly better predictor than the Charlson Comorbidity Index. CONCLUSION: This new age-specific comorbidity index based on self-reported information is a significant predictor of overall and cancer-specific survival in ovarian cancer. It can be used to quickly identify those ovarian cancer patients requiring special attention in terms of preoperative optimization and postoperative care.

A person-centered intervention targeting the psychosocial needs of gynecological cancer survivors: a randomized clinical trial.

PURPOSE: We investigated the effect of a person-centered intervention consisting of two to four nurse-led conversations using guided self-determination tailored to gynecologic cancer (GSD-GYN-C) on gynecological cancer survivors' quality of life (QOL), impact of cancer, distress, anxiety, depression, self-esteem, and self-reported ability to monitor and respond to symptoms of recurrence. METHODS: We randomly assigned 165 gynecological cancer survivors to usual care (UC) plus GSD-GYN-C or UC alone. Self-reported QOL-cancer survivor (QOL-CS) total score and subscale scores on physical, psychological, social, and spiritual well-being were assessed before randomization and at 3 and 9 months after randomization using t tests. Bonferroni and Pipper corrections were applied for multiple testing adjustments. RESULTS: At 9 months, the GSD-GYN-C plus UC group scored significantly higher on the QOL-CS total scale (P = 0.02) and on the QOL-CS physical well-being subscale (P = 0.01), compared to women receiving UC alone. After adjusting for baseline scores, only the difference in the physical well-being subscale was statistically significant. No other measured outcomes differed between the intervention and control groups after baseline adjustment. CONCLUSION: We observed higher physical well-being 9 months after randomization in the GSD-GYN-C group, as compared to women receiving usual care. IMPLICATIONS FOR CANCER SURVIVORS: The results suggest that the person-centered intervention GSD-GYN-C may improve physical well-being in gynecological cancer survivors. However, further testing is needed.

Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial.

BACKGROUND: Hysterectomy is one of the most frequently performed major gynecological surgical procedures. Even when the indication for the procedure is benign, relatively high complication rates have been reported. Perioperative bleeding seems to represent the most common cause of complications and in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an antifibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge about the drug's effect in relation to benign hysterectomy is still missing. OBJECTIVE: To investigate the antihemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy. STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at 4 gynecological departments in Denmark from April 2013 to October 2014. A total of 332 women undergoing benign abdominal, laparoscopic, or vaginal hysterectomy were included in the trial, randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-square test and Student t test statistical analyses were applied. RESULTS: The primary outcome of intraoperative total blood loss was reduced in the group treated with tranexamic acid compared to the placebo group when estimated both subjectively by the surgeon and objectively by weight (98.4 mL vs 134.8 mL, P = .006 and 100.0 mL vs 166.0 mL, P = .004). The incidence of blood loss ≥500 mL was also significantly reduced (6 vs 21, P = .003), as well as the use of open-label tranexamic acid (7 vs 18, P = .024). Furthermore, the risk of reoperations owing to postoperative hemorrhage was significantly reduced in the tranexamic acid group compared to the placebo group (2 vs 9, P = .034). This corresponds to an absolute risk reduction of 4.2% and number needed to treat of 24. No incidence of thromboembolic events or death was observed in any of the groups. CONCLUSION: The results support the hypothesis that prophylactic treatment with tranexamic acid reduces the overall total blood loss, the incidence of substantial blood loss, and the need for reoperations owing to postoperative hemorrhage in relation to benign hysterectomy. No incidences of serious adverse events occurred. Thus, tranexamic acid should be considered as a prophylactic treatment prior to elective benign hysterectomy.

Age at hysterectomy as a predictor for subsequent pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate the association between patient age at the time of hysterectomy and subsequent pelvic organ prolapse (POP) surgery. METHODS: We gathered data on all benign hysterectomies and POP surgeries performed in Denmark on Danish women from 1977 to 2009 from the Danish National Patient Registry. The cohort consisted of 154,882 hysterectomized women, who were followed up for up to 32 years. Survival analysis for each age group at hysterectomy was performed using Kaplan-Meier product limit methods. RESULTS: For all hysterectomized women, we found that low age at hysterectomy yielded a lower risk of subsequent POP surgery than did hysterectomy at an older age. This difference diminished after stratification by indication; all non-POP hysterectomies had a low cumulative incidence at 8-11 % at the end of the follow-up period. For all women hysterectomized, the predominant compartment for POP surgery was the posterior. Women hysterectomized when aged over 66 years had a higher proportion of POP surgery in the apical compartment than in the other age groups (p = 0.000). CONCLUSION: Our findings indicate that age at hysterectomy only marginally influences the risk of subsequent POP surgery for women hysterectomized for indications other than POP. If POP is the indication for hysterectomy, the risk of undergoing subsequent POP surgery increases substantially.

The indication for hysterectomy as a risk factor for subsequent pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate whether the indication for hysterectomy was itself a risk factor for subsequent pelvic organ prolapse (POP) in Danish women who underwent hysterectomy from 1977 to 2009. METHODS: Data from 154,882 women who underwent hysterectomy for benign conditions during the period 1977 - 2009 were extracted from the Danish National Patient Register. Patients were followed up from hysterectomy to POP surgery, death/emigration, or end of study period. Hazard ratios (HR) for the first POP surgery in each woman were calculated using the Cox proportional hazards model. Survival analysis for each indication for hysterectomy was performed using the Kaplan-Meier product limit method. RESULTS: Fibroids/polyps as the indication was used as the reference when calculating HRs. After adjustment for calendar period, patient age, and hysterectomy route, the HR for POP was 6.57 (95% confidence interval 5.91 - 7.30). The HR for abnormal uterine bleeding (AUB), pain, endometriosis, and "other indications" was significantly higher than the reference. POP surgery was performed predominantly in the posterior compartment for all indications except benign ovarian tumors. CONCLUSIONS: POP as the indication for hysterectomy was associated with the highest cumulative incidence of subsequent POP surgery 32 years after hysterectomy. But the indications AUB, pain, endometriosis, and "other indications" were associated with a higher risk of subsequent POP surgery after hysterectomy than the indication fibroids/polyps. The predominant compartment for POP surgery was the posterior compartment for almost all indications. The indication for hysterectomy and the compartment in which POP surgery was performed subsequent to hysterectomy were associated.

The psychosocial needs of gynaecological cancer survivors: A framework for the development of a complex intervention.

PURPOSE: To develop and pilot test an intervention targeting the women's psychosocial needs during the follow-up period after surgical treatment for gynaecological cancer. METHODS: The project consisted of four phases. Phase 1 involved development of an intervention on the basis of meetings with key healthcare professionals, a literature review and six semi-structured interviews with women who attended the existing follow-up program. The Guided Self-Determination (GSD) method developed in diabetes care was identified as an appropriate framework for the intervention. GSD consists of reflection sheets for patients and advanced professional communication skills. The GSD method was adapted to women in a follow-up program after gynaecologic cancer treatment (GSD-GYN-C). Phase 2 involved primary pilot testing of the intervention and the findings were used to modify the intervention in phase 3. This modification involved the development of additional reflection sheets and a fidelity assessment tool. A systematic training program was arranged for the GSD-GYN-C-nurses. Phase 4 involved secondary pilot testing where nurses and women confirmed the applicability of GSD-GYN-C and final adjustments were made. Selected measurements were tested for sensitivity during pilot testing. Data from phase 2 and 4 were also used to select the primary outcome and calculate power for a future randomized clinical trial (RCT). RESULTS: Pilot testing supported our hypothesis that GSD-GYN-C may be transferable and useful to survivors of gynaecological cancer. CONCLUSION: GSD-GYN-C was developed and validated and is now ready for evaluation in an RCT.

Effect of instructor feedback on skills retention after laparoscopic simulator training: follow-up of a randomized trial.

BACKGROUND: Instructor feedback reduces the number of repetitions and time to reach proficiency during laparoscopic simulator training. The objective of this study was to examine the effect of instructor feedback on long-term skill retention. METHODS: A 6-month follow-up of a randomized trial. Participants were surgical novices (medical students). All participants (n = 99) initially practiced a laparoscopic salpingectomy on the LapSim virtual reality simulator to proficiency. The intervention group could request instructor feedback, whereas the control group could not. After 6 months, the participants (n = 65) practiced on the simulator until they reached proficiency again. The primary outcomes were the total time and the number of repetitions. RESULTS: Initially, the intervention group used significantly fewer repetitions (29 vs 65, p < 0.0005) and less total training time (162 vs 342 min, p < 0.0005) than the control group to reach the proficiency level. At follow-up, both the groups used an equal number of repetitions (21 vs 20, p = 0.72) and time (83 vs 73 min, p = 0.37) to reach the same proficiency level. CONCLUSIONS: Instructor feedback during proficiency-based laparoscopic simulator training does not affect the long-term retention of skills.

Incidence and lifetime risk of pelvic organ prolapse surgery in Denmark from 1977 to 2009.

INTRODUCTION AND HYPOTHESIS: The purpose of the study was to describe the incidence of pelvic organ prolapse (POP) surgeries in Denmark during the last 30 years, age distribution over time, and the lifetime risk of undergoing POP surgery. METHODS: We carried out a population-based registry study. The setting was the Danish National Patient Registry. The sample consisted of Danish women of all ages undergoing prolapse surgery during the period 1977-2009. Data were retrieved from the Danish National Patient Registry. Prolapse surgery included surgery for any type of genital prolapse including hysterectomy due to prolapse. The main outcome measures were incidence of POP, age distribution over time, and lifetime risk of undergoing POP surgery. RESULTS: Surgical interventions for POP decreased by 47 % from 1977 (288 procedures/100,000 women) to 1999 (153 procedures/100,000 women). Subsequently, they increased to 75 % of the original incidence rate; in 2008, the incidence of total POP procedures was 201 out of 100,000 women and the incidence of women undergoing POP surgery was 139 out of 100,000 women. During the study period, the age-specific incidence of POP surgeries increased for women over the age of 65-69 years and decreased for women below that age. In 2008, the lifetime risk for an 80-year-old woman of undergoing at least one POP surgery was 18.7 %. CONCLUSIONS: The incidence of POP surgery varied up to 50 % during the study period. The age distribution changed so that more elderly and less young women had surgery in 2008 compared with 1978. Finally, we found that the lifetime risk of undergoing POP surgery for an 80-year-old was 26.9 % in 1978, 20.5 % in 1988, 17.2 % in 1998, and 18.7 % in 2008.

Pelvic organ prolapse (POP) surgery among Danish women hysterectomized for benign conditions: age at hysterectomy, age at subsequent POP operation, and risk of POP after hysterectomy.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to describe the incidence of pelvic organ prolapse (POP) surgery after hysterectomy from 1977 to 2009, the time interval from hysterectomy to POP surgery, and age characteristics of women undergoing POP surgery after hysterectomy and to estimate the risk of undergoing POP surgery after hysterectomy. METHODS: The study was a population-based registry study. Patient data from 154,882 women hysterectomized for benign conditions in the period from 1977 to 2009 were extracted from the Danish National Patient Registry. Patients were followed up from hysterectomy to POP surgery, death/emigration, or end of study period. An estimate of the hazard of undergoing POP surgery following hysterectomy was calculated. Survival analysis was performed using the Kaplan-Meier product limit method. RESULTS: The frequency of POP surgery on hysterectomized women was high the first 2 years of the follow-up period with almost 800 women operated yearly. More than one third (n = 2,872) of all women operated for POP were operated less than 5 years after the hysterectomy with a median of 8.6 years. The cumulated incidence of POP surgery after hysterectomy with follow-up of up to 32 years was 12 %; 50 % (n = 5,451) of all POP surgeries were in the posterior compartment. The mean age of women undergoing a first POP surgery after hysterectomy was 60 years. CONCLUSIONS: POP after hysterectomy occurs as a long-term complication of hysterectomy; 12 % of hysterectomized women were operated for POP. They were operated at younger age than non-hysterectomized women and half the POP operations were performed in the posterior compartment.