Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.

BACKGROUND: Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. OBJECTIVE: We aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy. STUDY DESIGN: This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. RESULTS: Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery. CONCLUSION: The 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.

Development of a surgical competency assessment tool for sentinel lymph node dissection by minimally invasive surgery for endometrial cancer.

INTRODUCTION: Sentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance. METHODS: A Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability. RESULTS: Seventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88). CONCLUSION: Specific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care.

International radical trachelectomy assessment: IRTA study.

BACKGROUND: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. PRIMARY OBJECTIVE: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. STUDY HYPOTHESIS: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. STUDY DESIGN: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. INCLUSION CRITERIA: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both). EXCLUSION CRITERIA: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach. PRIMARY ENDPOINT: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. SAMPLE SIZE: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.

A randomized trial comparing vaginal and laparoscopic hysterectomy vs robot-assisted hysterectomy.

STUDY OBJECTIVE: To investigate the hospital cost and short-term clinical outcome of traditional minimally invasive hysterectomy vs robot-assisted hysterectomy in women primarily not considered candidates for vaginal surgery. DESIGN: Randomized controlled trial (Canadian Task Force classification I). SETTING: University Hospital in Sweden. PATIENTS: One hundred twenty-two women with uterine size ≤ 16 gestational weeks scheduled to undergo minimally invasive hysterectomy because of benign disease. INTERVENTIONS: Robot-assisted hysterectomy or traditional vaginal or laparoscopic minimally invasive hysterectomy. MEASUREMENTS AND MAIN RESULTS: All women underwent surgery as randomized. There were no demographic differences between the 2 groups. Vaginal hysterectomy was possible in 41% in the traditional minimally invasive group, at a mean hospital cost of $4579 compared with $7059 for traditional laparoscopic hysterectomy. This was reflected in a mean hospital cost of $993 more per robotic-assisted hysterectomy than for traditional minimally invasive hysterectomy when the robot was a preexisting investment. This hospital cost increased by $1607 when including investments and cost of maintenance. A per-protocol subanalysis comparing laparoscopy and robotics demonstrated similar hospital cost when the robot was a preexisting investment ($7059 vs $7016). Robotic-assisted hysterectomy was associated with less blood loss and fewer postoperative complications. CONCLUSION: A similar hospital cost can be attained for laparoscopy and robotics when the robot is a preexisting investment. From the perspective of hospital costs, robotic-assisted hysterectomy is not advantageous for treating benign conditions when a vaginal approach is feasible in a high proportion of patients.

Costs of production loss and primary health care interventions for return-to-work of sick-listed workers in Sweden.

PURPOSE: The aim of this study was to investigate, from the perspective of society, the costs of sick leave and rehabilitation of recently sick-listed workers with musculoskeletal disorders (MSD) or mental disorders (MD). METHODS: In a prospective cohort study, 812 sick-listed workers with MSD (518) or MD (294) were included. Data on consumption of health care and production loss were collected over six months from an administrative casebook system of the health care provider. Production loss was estimated based on the number of sick-leave days. Societal costs were based on the human capital approach. RESULTS: The mean costs of production loss per person were EUR 5978 (MSD) and EUR 6381 (MD). Health care interventions accounted for 9.3% (MSD) and 8.2% (MD) of the costs of production loss. Corresponding figures for rehabilitation activities were 3.7% (MSD) and 3.1% (MD). Health care interventions were received by about 95% in both diagnostic groups. For nearly half of the cohort, no rehabilitation intervention at all was provided. CONCLUSIONS: Costs associated with sick leave were dominated by production loss. Resources invested in rehabilitation were small. By increasing investment in early rehabilitation, costs to society and the individual might be reduced. IMPLICATIONS FOR REHABILITATION: Resources invested in rehabilitation for sick-listed with musculoskeletal and mental disorders in Sweden are very small in comparison with the costs of production loss. For policy makers, there may be much to gain through investments into improved rehabilitation processes for return to work. Health care professionals need to develop rehabilitative activities aiming for return to work, rather than symptoms treatment only.

Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study.

BACKGROUND: This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome. The frequency and degree of dysphagia, the effects on quality of life (QoL), and health economy were also examined. METHODS: Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [laparoscopic myotomy (LM) n = 25] or repetitive pneumatic dilatation [pneumatic dilatation (PD) n = 28]. The median observation period was 81.5 months (range 12-131). RESULTS: At the minimal follow-up of 5 years, ten patients (36%) in the dilatation group and two patients (8%) in the myotomy group, including two patients lost to follow-up (one in each arm), were classified as failures (p = 0.016). The cumulative incidence of treatment failures was analyzed by survival statistics. Taking the entire follow-up period into account, a significant difference was observed in favor of the LM strategy (p = 0.02). Although both treatments resulted in significant improvements in dysphagia scores, LM was significantly favored over PD after 1 and 3 years, but not after 5 years. Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years, but the difference was not fully statistically significant at 5 years. Direct medical costs during the entire follow-up period were in median $13,421 for LM as compared to $5,558 for PD (p = 0.001). CONCLUSIONS: This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia, albeit that this surgical strategy is burdened by high initial direct medical costs. www.ClinicalTrials.gov NCT 02086669.

The prognostic value of radiologic parameters for long-term outcome assessment after an isolated unilateral calcaneus fracture.

OBJECTIVE: The current retrospective case-control study examines the prognostic value of radiologic parameters for long-term clinical outcome assessment after a calcaneus fracture. METHODS: In the authors' trauma department 262 adult patients with an isolated calcaneus fracture were treated from 1995 to 2005. Using conventional x-ray and computed tomography imaging. the calcaneal fractures were classified according to Sanders system. In addition, Boehler's and Gissane's angles were measured before and after therapy and the Larsen stage of subtalar arthrosis was determined. After a mean follow-up interval of 9.5 years, 44 patients were available for clinical and radiological assessment. RESULTS: At the time of trauma the average age of the study group was 52 (range, 29-79) years. Thirty-seven patients were treated operatively and seven conservatively. Patients with a negative Boehler's angle, upon admission, exhibited significantly worse results using four of the five clinical scoring systems than patients with a preserved or slight reduced Boehler's angle. Operative treatment in patients whose Boehler's angle was elevated to normal range or beyond exhibited %worse better results than patients with an over-correction of Boehler's angle. In 11 cases, two primary and nine secondary subtalar arthrodeses were performed. The degree of subtalar arthrosis as per Larsen was increased 2.54 ± 1.14 in the course of hospital admission, arthrodesis and/or follow up examination. The results show no significant difference between operative and conservative treatment. CONCLUSIONS: Boehler's angle at time of admission appears to be a valuable prognosticator for functional long-term results after calcaneus fracture. An operative over-correction of a reduced Boehler's angle should be avoided.

Hospital costs for robot-assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy.

OBJECTIVE: To compare robot-assisted laparoscopy and laparotomy for radical hysterectomy and pelvic lymphadenectomy in terms of hospital costs. METHODS: Consecutive women undergoing radical hysterectomy and pelvic lymphadenectomy as a sole procedure between January 2001 and February 2012 were included. We compared OR times, hospital stay, procedure specific costs, blood transfusions and cost for readmissions and re-interventions until three months after surgery for 231 women operated who received either an open (n=51) or a robot-assisted laparoscopic radical hysterectomy (n=180). The hospital internal charges and purchase costs were used for estimation. The specific robotic cost was based on an investment depreciation time of seven years, with 400 operations performed annually, costs for maintenance, robotic instruments, robot-specific assistant's instruments and robot draping. RESULTS: The estimated mean costs for an open radical hysterectomy was $12,986, for the first 30 robotic radical hysterectomies was $18,382, and for the last 30 was $12,759, with a break even in cost after 90 robotic procedures. The specific robot costs ($3469) was, for the last robot cohort, compensated mainly by an average of 22 min shorter OR time and 4.9 days shorter hospital stay. CONCLUSION: Given 400 robot operations annually, and only after a substantial implementation period, it is feasible to perform robot-assisted radical hysterectomy at an equal hospital cost compared with open surgery.

ADHD from a socio-economic perspective.

AIM: Attention deficit hyperactivity disorder (ADHD) and related disorders affect children's ability to function in school and other environments. Awareness has increased in recent years that the same problems often persist in adulthood. Based on previous studies, we aimed to outline and discuss a descriptive model for calculation of the societal costs associated with ADHD and related disorders. METHODS: Following a literature review including childhood and adult studies, long-term outcomes of ADHD and associated societal costs were outlined in a simple model. RESULTS: The literature concerning long-term consequences of ADHD and related disorders is scarce. There is some evidence regarding educational level, psychosocial problems, substance abuse, psychiatric problems and risky behaviour. The problems are likely to affect employment status, healthcare consumption, traffic and other accidents and criminality. A proposed model structure includes persisting problems in adulthood, possible undesirable outcomes (and their probabilities) and (lifetime) costs associated with these outcomes. CONCLUSIONS: Existing literature supports the conclusion that ADHD and related disorders are associated with a considerable societal burden. To estimate that burden with any accuracy, more detailed long-term data are needed.

Balancing societal costs and users' quality of life--priority setting of interventions for the hard-of-hearing.

In this paper, the need for priority setting in rehabilitation, especially in audiology, and various approaches to providing information for priority setting are discussed. A set of outcome measures is proposed, and their applicability to vertical and horizontal prioritization are considered. Two types of measures are proposed: individual problems assessment, and utility analysis. Results from a European multicentre study and a Swedish study illustrate the performance of the measures in the areas of mobility, hearing, and speech communication. For rehabilitation in the hard-of-hearing, the two types of measures provide different kinds of information, illustrated by the results of simultaneous use of the instruments.

Cost-analyzes based on a prospective, randomized study comparing laparoscopic colposuspension with a tension-free vaginal tape procedure.

BACKGROUND: The aim of this study was to compare laparoscopic colposuspension with tension-free vaginal tape (TVT) in terms of costs to the county. METHODS: In a prospective, randomized study, we approached 270 consecutive women presenting for evaluation of stress urinary incontinence symptoms at one university hospital. Preoperatively, and at 1-year follow-up, the women underwent urodynamic evaluation, an ultra-short pad-test and completed a lower urinary tract symptoms questionnaire. We randomized 79 consenting, eligible women to either procedure; a 1-year follow-up examination was performed on 68/71 (96%) women that were available. The procedures were performed as described previously. Main outcome measures were all relevant costs for goods and services associated with the procedures. RESULTS: The baseline characteristics of the two groups were similar. The TVT procedure was performed significantly faster than the laparoscopic colposuspension, i.e. 44.9 +/- 14.2 min compared with 60.5 +/- 13.4 min (p < 0.0001). Even so, procedural costs were significantly lower for laparoscopic colposuspension than for TVT (euro 1273.4 compared with euro 1342.8 p < 0.001). At the 1-year follow-up visit, three women operated on with TVT and one operated on with laparoscopic colposuspension required re-operation for continuous stress urinary incontinence. One women operated on with TVT had her sling cut for bladder-emptying problems. Total costs, including re-operations were euro 1462.6 for a TVT procedure andeuro; 1314.5 for a laparoscopic colposuspension. CONCLUSION: In our hands, the laparoscopic colposuspension was less expensive to the county than the TVT procedure.