Performance Assessment for Total Laparoscopic Hysterectomy in the Operating Room: Validity Evidence of a Procedure-specific Rating Scale.

STUDY OBJECTIVE: The technical conduct of total laparoscopic hysterectomy (LH) is critical to surgical outcomes. This study explored the validity evidence of an objective scale specific to the assessment of technical skills (H-OSATS) for 7 tasks of an LH with salpingo-oophorectomy procedure performed in the operating room. DESIGN: Observational cohort study. SETTING: Two academic hospitals in Marseille and Montpellier, France. PATIENTS: Three groups of operators (novice, intermediate, and experienced surgeons) were video recorded during their live performances of LH on a simple case. For each group, a dozen unedited videos were obtained for the following tasks: division of the round ligament, division of the infundibulopelvic ligament, creation of the bladder flap, opening of the posterior peritoneum, division of the uterine vessels, colpotomy, and closure of the vault. INTERVENTIONS: Two qualified raters blindly assessed each video using the H-OSATS rating scale. Inter-rater reliability and test-retest reliability were calculated as measures of internal structure. In a separate round of evaluations, the raters provided a global competent/noncompetent decision for each performance. As a measure of consequential validity, a pass/fail score was set for each task using the contrasting group method. MEASUREMENTS AND MAIN RESULTS: Three tasks (creation of the bladder flap, colpotomy, and closure of the vault) displayed sound validity evidence: a meaningful total score difference among the 3 groups of experience as well as between the intermediate and experienced surgeons, reliability outcomes of >0.7, and a pass/fail score with a theoretical false-positive rate of <10%. CONCLUSION: The validity evidence of the H-OSATS rating scale differed for separate evaluations of the 7 tasks. Three tasks (i.e., creation of the bladder flap, colpotomy, and closure of the vault) revealed sound validity evidence, including at the level of the attending surgeon, whereas other tasks were more consistent with low-stakes formative evaluation standards.

Development of an evidence-based training program for laparoscopic hysterectomy on a virtual reality simulator.

BACKGROUND: Substantial evidence in the scientific literature supports the use of simulation for surgical education. However, curricula lack for complex laparoscopic procedures in gynecology. The objective was to evaluate the validity of a program that reproduces key specific components of a laparoscopic hysterectomy (LH) procedure until colpotomy on a virtual reality (VR) simulator and to develop an evidence-based and stepwise training curriculum. METHODS: This prospective cohort study was conducted in a Marseille teaching hospital. Forty participants were enrolled and were divided into experienced (senior surgeons who had performed more than 100 LH; n = 8), intermediate (surgical trainees who had performed 2-10 LH; n = 8) and inexperienced (n = 24) groups. Baselines were assessed on a validated basic task. Participants were tested for the LH procedure on a high-fidelity VR simulator. Validity evidence was proposed as the ability to differentiate between the three levels of experience. Inexperienced subjects performed ten repetitions for learning curve analysis. Proficiency measures were based on experienced surgeons' performances. Outcome measures were simulator-derived metrics and Objective Structured Assessment of Technical Skills (OSATS) scores. RESULTS: Quantitative analysis found significant inter-group differences between experienced intermediate and inexperienced groups for time (1369, 2385 and 3370 s; p < 0.001), number of movements (2033, 3195 and 4056; p = 0.001), path length (3390, 4526 and 5749 cm; p = 0.002), idle time (357, 654 and 747 s; p = 0.001), respect for tissue (24, 40 and 84; p = 0.01) and number of bladder injuries (0.13, 0 and 4.27; p < 0.001). Learning curves plateaued at the 2nd to 6th repetition. Further qualitative analysis found significant inter-group OSATS score differences at first repetition (22, 15 and 8, respectively; p < 0.001) and second repetition (25.5, 19.5 and 14; p < 0.001). CONCLUSIONS: The VR program for LH accrued validity evidence and allowed the development of a training curriculum using a structured scientific methodology.

Single-Port Laparoscopy vs Conventional Laparoscopy in Benign Adnexal Diseases: A Systematic Review and Meta-Analysis.

Single-port laparoscopy (SPL) was developed approximately 30 years ago in minimally invasive surgery. Literature comparing SPL with conventional laparoscopy (CL) for adnexal surgery (i.e., cystectomy and adnexectomy) is inconsistent. The objective of this systematic review and meta-analysis was to evaluate the advantage of SPL over CL for adnexal surgery. PubMed, Embase, and MEDLINE were searched for publications in English and in French published between 1975 and November 2015 using the following key words: (((single port) or (single site) or (one port) or (single-port access laparoscopy) or (single-site laparoscopy) or (laparoscopic single-site surgery)) and ((adnexal disease) or (ovarian cystectomy) or (ovariectomy) or (adnexectomy))) not (pregnancy). The primary outcome was postoperative pain assessed at 24 hours postsurgery. The secondary outcomes were postoperative pain at 6 and 48 hours postsurgery, analgesic consumption, operative time, blood loss, laparotomy conversion rate, mean hospital stay, and cosmetic results at 1 month. Sixteen relevant articles were identified by electronic search. The pooled analysis of randomized trials showed no significant difference between SPL and CL in terms of postoperative pain at 6 and 24 hours, blood loss, mean length of hospital stay, cosmetic results, and laparotomy conversion rate; however, operative time was longer for SPL (p = .03). The pooled analysis including all the selected studies showed no significant difference for all of these outcomes. This review and meta-analysis found no significant difference between SPL and CL for adnexal surgery, except for operative time. Further large-scale randomized trials should be conducted to investigate the potential advantages of SPL over CL before this laparoscopic approach can be recommended.

Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center.

BACKGROUND: Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS). METHODS: This observational study evaluated the implementation of ERP in gynaecologic oncological surgery in a minimally invasive techniques (MIT) expert center with more than 85% of procedures done with MIT. We compared a prospective cohort of 100 patients involved in ERP between December 2015 and June 2016 to a 100 patients control group, without ERP, previously managed in the same center between April 2015 and November 2015. All the included patients were referred for hysterectomy and/or pelvic or para-aortic lymphadenectomy for gynaecological cancer. The primary objective was to achieve a significant decrease of median LOS in the ERP group. Secondary objectives were decreases in proportion of patients achieving target LOS (2 days), morbidity and readmissions. RESULTS: Except a disparity in oncological indications with a higher proportion of endometrial cancer in the group with ERP vs. the group without ERP (42% vs. 22%; p = 0.003), there were no differences in patient's characteristics and surgical procedures. ERP were associated with decreases of median LOS (2.5 [0 to 11] days vs. 3 [1 to 14] days; p = 0.002) and proportion of discharged patient at target LOS (45% vs. 24%; p = 0.002). Morbidities occurred in 25% and 26% in the groups with and without ERP and readmission rates were respectively of 6% and 8%, without any significant difference. CONCLUSION: ERP in gynaecologic oncological surgery is associated with a decrease of LOS without increases of morbidity or readmission rates, even in a center with a high proportion of MIT. Although it is already widely accepted that MIT improves early recovery, our study shows that the addition of ERP's clinical pathways improve surgical outcomes and patient care management.

Exclusive intraoperative radiotherapy for invasive breast cancer in elderly patients (>70 years): proportion of eligible patients and local recurrence-free survival.

BACKGROUND: To estimate the proportion of elderly patients (>70 years) with breast cancer eligible for an Exclusive IntraOperative RadioTherapy (E-IORT) and to evaluate their local recurrence-free survival rate. METHODS: This retrospective study examining two cohorts focuses on patients over 70 years old: a multi-centric cohort of 1411 elderly patients and a mono-centric cohort of 592 elderly patients. All patients underwent conservative surgery followed by external radiotherapy for T0-T3 N0-N1 invasive breast cancer, between 1980 and 2008. RESULTS: Within each cohort two groups were identified according to the inclusion criteria of the RIOP trial (R group) and TARGIT E study (T group). Each group was divided into two sub-groups, patients eligible (E) or non-eligible (nE) for IORT. The population of patients that were eligible in the TARGIT E study but not in the RIOP trial were also studied in both cohorts. The proportion of patients eligible for IORT was calculated, according to the eligibility criteria of each study. A comparison of the 5-year local or locoregional recurrence-free survival rate between eligible vs non-eligible patients was made. In both cohorts, the proportion of patients eligible according to the RIOP trial's eligibility criteria was 35.4 and 19.3%, and according to the TARGIT E study criteria was 60.9 and 45.3%. The 5-year locoregional recurrence-free survival rate was not significantly different between RE and RnE groups, TE and TnE groups. In both cohorts RE and (TE-RE) groups were not significantly different. CONCLUSIONS: Our results encourage further necessary studies to define and to extend the eligibility criteria for per operative exclusive radiotherapy.

Cervical Dysplasia and Treatments Barrier in Jail: A Study in Marseille's Detention Center-Les Baumettes, France.

Introduction: The main objective was to estimate the prevalence of cervical dysplasia among incarcerated women. The secondary objective was to identify obstacles to the possible management of a cervical dysplasia in detention by assessing their knowledge of screening for cervical cancer (CC), the existence of vaccination, and the management of precancerous lesions. Materials and Methods: The first part of the study was descriptive and retrospective, studying pap-smear results in women's correctional facility at the Baumettes prison center (PC) in Marseille, France. The second part of the study was qualitative and prospective and took place at the Baumettes PC. Voluntary and French-speaking inmates aged 25-65 years answered an short-form 12 quality-of-life questionnaire and a more targeted questionnaire on CC screening and cervical dysplasia treatments. Results: In total, 201 pap-smear tests were assessed, 135 were normal (66.8%) and 33 unsatisfactory (16.3%). There were 33 abnormal pap-smear tests (16%). The patients were 38.9 years (±9.5 years), had 4.05 pregnancies (±2.7), and 2.29 children (±1.85). Seventy-five percent were smokers. Psychiatric disorders were found in 52.2% inmates. In the second part of the study, among the 35 inmates questioned, the SF-12 questionnaire's analysis shows that the physical health component score was on average 43.6 and the mental health component score (MCS) was 36.5. Analysis demonstrated that the uncertainty of the exact day of hospitalization is an obstacle to treatment for 15 patients presenting significantly a lower MCS score (p = 0.047). Conclusion: Prevalence of pathological pap-smear tests is higher within a prison population, screening is accepted and the inmates are receptive to information about CC prevention, delivered during individual interviews. Mental health's management and care system's reorganization in detention are essentials factors for care acceptance.

The integrator complex recognizes a new double mark on the RNA polymerase II carboxyl-terminal domain.

The carboxyl-terminal domain (CTD) of the largest subunit of RNA polymerase II (pol II) comprises multiple tandem repeats of the heptapeptide Tyr(1)-Ser(2)-Pro(3)-Thr(4)-Ser(5)-Pro(6)-Ser(7). This unusual structure serves as a platform for the binding of factors required for expression of pol II-transcribed genes, including the small nuclear RNA (snRNA) gene-specific Integrator complex. The pol II CTD specifically mediates recruitment of Integrator to the promoter of snRNA genes to activate transcription and direct 3' end processing of the transcripts. Phosphorylation of the CTD and a serine in position 7 are necessary for Integrator recruitment. Here, we have further investigated the requirement of the serines in the CTD heptapeptide and their phosphorylation for Integrator binding. We show that both Ser(2) and Ser(7) of the CTD are required and that phosphorylation of these residues is necessary and sufficient for efficient binding. Using synthetic phosphopeptides, we have determined the pattern of the minimal Ser(2)/Ser(7) double phosphorylation mark required for Integrator to interact with the CTD. This novel double phosphorylation mark is a new addition to the functional repertoire of the CTD code and may be a specific signal for snRNA gene expression.

Prognosis impact of posttreatment pelvic MRI in patients treated for stage IB2-IIB cervical cancer with chemoradiation therapy.

OBJECTIVES: To evaluate the performances of systematic posttreatment pelvic magnetic resonance imaging (PPMRI) in predicting prognosis of patients treated with chemoradiation therapy (CRT) for locally advanced cervical cancer (LACC). MATERIALS AND METHODS: Multi-institutional data from 216 patients presenting FIGO IB2-IIB cervical cancer for which PPMRI was performed following CRT were retrospectively reviewed. Incomplete response was defined as the identification of persistent lesion on PPMRI. Primary endpoints were patients' 5-year recurrence free (RFS) and overall (OS) survivals. Secondary endpoint was the identification of residual histologic disease on hysterectomy specimens when completion surgery was performed. RESULTS: PPMRI identified an incomplete response in 102 (47.2%) cases. A 70% or more reduction in tumor size on PPMRI was identified as the best predictive cut-off for recurrence (37.7% sensitivity and 78.7% specificity) and death (50% sensitivity and 77.9% specificity) with significant impact on those risks (HRa: 0.42; 95%CI: 0.23-0.77 and HRa: 0.18; 95%CI: 0.06-0.50, respectively). Completion hysterectomy was performed in 117 (54.4%) cases, with histologic residual disease in 55 (47.4%). PPMRI demonstrated 74.5% sensitivity and 50.8% specificity in predicting residual disease. Although survival of patients with complete response at PPMRI was not impacted by completion hysterectomy, it significantly increased 5-year RFS and OS of those with incomplete response: 38.7% vs. 65.3% (p < 0.001) and 63% vs. 82.9% (p = 0.038), respectively. CONCLUSION: A 70% or more reduction of in tumor size on PPMRI following CRT in patients with LACC is predictive of RFS and OS. PPMRI could help triaging patients who could benefit from completion hysterectomy.

Prognostic value of posttreatment FEDG-PET imaging following combined chemoradiation therapy in locally advanced cervical cancer.

OBJECTIVES: To evaluate the performances of posttreatment FEDG-PET to predict the prognosis of patients treated with concurrent chemoradiotherapy (CT/RT) for locally advanced cervical cancer. MATERIALS AND METHODS: The medical records of 131 patients treated in 9 French academic institutions for IB2-IIB cervical cancer and for which a posttherapy FEDG-PET was performed were reviewed. All patients received CT/RT, possibly completed with vaginal brachytherapy (VBT) and completion surgery. Posttreatment FEDG-PET was performed within 3 months after completion of CT/RT or VBT. Incomplete metabolic response (IMR) was defined as the persistence of FEDG uptake. RESULTS: An IMR was identified in 44 (33.6 %) cases. IMR was associated with higher risk of recurrence (aHR = 2.8; 95 %CI: 1.3-5.7; p = 0.006) and death (aHR = 4.5 ;95 %CI: 1.4-13.8; p = 0.009). Completion surgery was performed in 61 (46.9 %) patients with histologic cervical residual disease identified in 31 (50.8 %). FEDG-PET sensitivity and specificity in predicting cervical residual disease following CT/RT was 48.4 % (95 %CI: 30.8-66) and 80 % (95 %CI: 65.7-94.3), respectively. CONCLUSIONS: In patients treated with CT/RT for locally advanced cervical cancer, despite limited performances to predict cervical residual disease, posttreatment FEDG-PET is predictive of patients' prognosis and long-term outcome.

Robotic breast and reconstructive surgery: 100 procedures in 2-years for 80 patients.

OBJECTIVE: To analyze results of the first 100 robotic breast surgeries: feasibility, morbidity, indications and standardization of patient positioning and operative technique. BACKGROUND: Robotic breast surgery is an emergent procedure. METHODS: A prospective cohort of patients undergoing robotic latissimus dorsi-flap reconstruction (RLDFR) and or robotic mastectomy, over a period of 24 months was analyzed. We analyzed patient's characteristics, previous treatment for breast cancer, primitive breast cancer or local recurrence, immediate or delayed breast reconstruction and type of reconstruction. Surgical techniques and duration of surgery were reported according to three successive periods. RESULTS: 46.2% of patients (37/80) had previous breast radiotherapy and 26.2% (21/80) had received neo-adjuvant chemotherapy. Surgical procedure and patient position are described. Surgical incision used for RLDFR was: 37 axillar (50.7%), 20 (27.4%) areolar, 7 (9.6%) central breast, 10 (13.7%) previous incision. Number of surgical procedures was >2 for 35 patients. In logistic regression, factors significantly associated with duration of surgery ≥305mn were: P2 with decreased operative duration (OR: 0.077, p = 0.002) and P3 (OR: 0.015, p < 0.0001) versus P1; and number of surgical procedures: 4 surgical procedures (OR: 15.60, p = 0.048) versus 1. Median hospital stay was 4 days. Total complication rate was 57.5% (46 patients) with 6 grade 2, 9 grade 3 and 1 grade 4 complication. For RLDFR we reported 1 grade 3 (1.3%) and 29 grade 1 (39.7%) complications consisting in dorsal seromas. CONCLUSION: RLDFR is a safe and reproducible procedure that allows breast reconstruction through a single incision, without dorsal scar. A decrease in surgery duration was observed with technique standardization and throughout the learning curve.

Tubular and mucinous breast cancer: results of a cohort of 917 patients.

OBJECTIVES:: To analyze axillary lymph node involvement (ALNI) rate and survival for mucinous (MC) and tubular (TC) breast carcinomas considered being of very good prognosis and for which an axillary surgical exploration could be questioned. METHODS:: Our multicentric cohort consisted of 21,135 patients with clinically node-negative invasive breast cancer, without neoadjuvant therapy, between 1999 and 2013 in 10 French centers. ALNI rate and survival were analyzed according to patient and tumor characteristics. RESULTS:: Our cohort consisted of 672 TC and 245 MC. Patients were older and tumor size greater for MC and pathologic factors were more pejorative. The rate of mastectomies and adjuvant chemotherapy was higher in the MC group. Axillary lymph node status was determined by SLNB alone in 71.2% of patients. ALNI rates were 17.9% and 18% for TC and MC, respectively. ALNI rate was lesser for MC (OR 0.503, p = 0.024) and greater in case of lympho-vascular invasion (OR 5.0, p < 0.0001) and for tumors >10 mm (OR 2.17, p = 0.042). Median follow-up was 58 months. The 5- and 7-year overall survival rates were 97.1% and 95% for TC, respectively; 92.3% and 91.2% for MC ( p = 0.043); 5- and 7-year disease-free survival rates were 97.9% and 97.2% versus 95.2 and 93.6% ( p = 0.041). Lympho-vascular invasion was the only predictive factor for overall survival (hazard ratio [HR] = 2.70)' grade 2 (HR = 10) and HR-negative (HR = 4.9) were the two predictive factors for disease-free survival. CONCLUSION:: This study confirms the need for an axillary exploration for these tumors even for a tumor size <10 mm and a favorable prognosis.

Development of an objective assessment tool for total laparoscopic hysterectomy: A Delphi method among experts and evaluation on a virtual reality simulator.

INTRODUCTION: Total Laparoscopic hysterectomy (LH) requires an advanced level of operative skills and training. The aim of this study was to develop an objective scale specific for the assessment of technical skills for LH (H-OSATS) and to demonstrate feasibility of use and validity in a virtual reality setting. MATERIAL AND METHODS: The scale was developed using a hierarchical task analysis and a panel of international experts. A Delphi method obtained consensus among experts on relevant steps that should be included into the H-OSATS scale for assessment of operative performances. Feasibility of use and validity of the scale were evaluated by reviewing video recordings of LH performed on a virtual reality laparoscopic simulator. Three groups of operators of different levels of experience were assessed in a Marseille teaching hospital (10 novices, 8 intermediates and 8 experienced surgeons). Correlations with scores obtained using a recognised generic global rating tool (OSATS) were calculated. RESULTS: A total of 76 discrete steps were identified by the hierarchical task analysis. 14 experts completed the two rounds of the Delphi questionnaire. 64 steps reached consensus and were integrated in the scale. During the validation process, median time to rate each video recording was 25 minutes. There was a significant difference between the novice, intermediate and experienced group for total H-OSATS scores (133, 155.9 and 178.25 respectively; p = 0.002). H-OSATS scale demonstrated high inter-rater reliability (intraclass correlation coefficient [ICC] = 0.930; p<0.001) and test retest reliability (ICC = 0.877; p<0.001). High correlations were found between total H-OSATS scores and OSATS scores (rho = 0.928; p<0.001). CONCLUSION: The H-OSATS scale displayed evidence of validity for assessment of technical performances for LH performed on a virtual reality simulator. The implementation of this scale is expected to facilitate deliberate practice. Next steps should focus on evaluating the validity of the scale in the operating room.

The Performance Gap for Residents in Transfer of Intracorporeal Suturing Skills From Box Trainer to Operating Room.

OBJECTIVE: Training on laparoscopic box trainer (BT) improves suturing skills in the operating room (OR). Optimal laboratory training should provide trainees with an adequate level of skills that can be transferred to the OR with no decline in performances. This study aimed to compare OR intracorporeal suturing performances of residents who trained with a fundamentals of laparoscopic surgery (FLS) BT vs. those of experienced laparoscopists. DESIGN: This was a prospective observational study. Residents received training with an FLS BT over a period of 4 months. Their performances with the BT and in the OR were then compared with those of experienced senior surgeons. OR assessment took place during a laparoscopic myomectomy. Performance evaluation was based on time taken and 2 validated qualitative assessment tools (GOALS and the Moorthy checklist). SETTINGS: One academic tertiary care center, La Conception Hospital, Assistance Publique -Hopitaux de Marseille, Marseille, France, was involved. PARTICIPANTS: Twelve gynecology residents and 6 experienced laparoscopic surgeons. RESULTS: Following the FLS training period, performances of residents with the BT were equivalent to those of the experienced surgeons. When tested in the OR, the trained residents performed more slowly than experienced surgeons (279.75 vs. 159.75s; p = 0.001), and they obtained lower qualitative outcomes in terms of GOALS (13 vs. 16.75; p = 0.002) and checklist (18.25 vs. 21; p = 0.049). Transfer from the BT to the OR revealed an increase in time taken that was significantly higher for the trained residents' group than for the experienced group (137s vs. 49s; p < 0.001). CONCLUSION: A performance gap emerged between trained residents and experienced surgeons when transferring from the BT to the OR. Finding an intermediate training platform between the BT and independently suturing in the OR is hence warranted.

Outcome and Follow-up of Patients with Endometrial Carcinoma Diagnosed on Operative Hysteroscopic Resection Specimens.

AIM: To study outcomes of patients diagnosed with endometrial carcinoma (EC) after histological analysis of endometrial resections retrieved during operative hysteroscopy performed for a presumed benign lesion. PATIENTS AND METHODS: A retrospective study was conducted using medical records of patients who underwent operative hysteroscopy for a presumed benign lesion with a final diagnosis of EC between January 1994 and April 2014 in two tertiary academic centers. RESULTS: A total of 29 patients were selected. International federation of gynecology and obstetrics (FIGO) classification was distributed as follows: 16 stages IA, 7 stages IB, 4 stages II and 2 stages III. Peritoneal cytology was positive in one case (stage IIIA). Median follow-up was 4.2 years (range=0.3-20.51). Two deaths were observed and were attributed to endometrial cancer. CONCLUSION: Operative hysteroscopy does not appear to influence stage of EC nor cause retrograde seeding of EC for 27/29 (93%) patients. For 2 patients, the impact of operative hysteroscopy remains uncertain.