Rajiv Gala

Implementation, construct validity, and benefit of a proficiency-based knot-tying and suturing curriculum

OBJECTIVES The aim of this proficiency-based, open knot-tying and suturing study was to evaluate the feasibility of implementing this curriculum within a residency program, and to assess construct validity and educational benefit. METHODS PGY1 residents (n = 37) were enrolled in an Institutional Review Board (IRB)-approved prospective study that was conducted over a 12-week period. Trainees viewed a video tutorial during orientation and as needed; they self-practiced to proficiency for 12 standardized knot-tying, practiced suturing tasks; performed 1 repetition of each task at baseline and posttesting; and completed questionnaires. RESULTS Curriculum implementation required 376 person-hours, and material costs were

Systematic Review of Robotic Surgery in Gynecology: Robotic Techniques Compared With Laparoscopy and Laparotomy

776. All trainees achieved proficiency within allotted 12 weeks. Overall, trainees completed 141 +/- 80 repetitions over 12.7 +/- 5.3 hours in addition to performing 13.4 +/- 12.4 operations. Baseline trainee and expert performance were significantly different for all 12 tasks and composite score (732 +/- 294 vs 1488 +/- 26, p < 0.001), which supported construct validity. Baseline trainees demonstrated significant improvement at posttesting according to composite scores (732 +/- 294 vs 1503 +/- 131, p < 0.001), which validates skill acquisition. CONCLUSIONS Implementation of this proficiency-based curriculum within the constraints of a residency program is feasible. This curriculum is educationally beneficial and cost effective; our data support construct validity. Evaluation of transferability to the operating room and more widespread adoption of this curriculum are warranted.

Effect of validated skills simulation on operating room performance in obstetrics and gynecology residents: A randomized controlled trial

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.

Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology.

OBJECTIVES: To estimate whether training on previously validated laparoscopic skill stations translates into improved technical performance in the operating room. METHODS: We performed a multicenter, randomized, controlled trial evaluating the performance of a laparoscopic bilateral midsegment salpingectomy. Residents were randomized to either traditional teaching (no simulation) or faculty-directed sessions in a simulation laboratory. A sample size of at least 44 lower-level residents (postgraduate year [PGY] 1 or 2) and 66 upper-level (PGY 3 or 4) were necessary to demonstrate a 50% improvement in performance assuming an &agr; error of 0.05 and &bgr; error of 0.20 for each group independently. The primary outcomes were the final total normalized simulation score and the operating room performance score. Paired t test and Wilcoxon rank-sum tests were used to evaluate the differences within and between cohorts. Our final model involved a multiple linear regression analysis for the main effects of a priori--specified variables. RESULTS: We enrolled 116 residents from eight centers across the United States. There was no statistically significant difference in baseline simulation or operative performances. Although both groups demonstrated improvement with time, the trained group improved significantly higher normalized simulation scores (378 ± 54 compared with 264 ± 86; P<.01) and higher levels of competence on the simulated tasks (96.2% compared with 61.1%; P<.01). The simulation group also had higher objective structured assessment of technical skills scores in the operating room (27.5 compared with 30.0; P=.03). CONCLUSION: We found that proficiency-based simulation offers additional benefit to traditional education for all levels of residents. The use of easily accessible, low-fidelity tasks should be incorporated into formal laparoscopic training. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NTC00555243. LEVEL OF EVIDENCE: I

Construct and face validity of the American College of Surgeons/Association of Program Directors in Surgery laparoscopic troubleshooting team training exercise

Vaginal hysterectomy fulfills the evidence-based requirements as the preferred route of hysterectomy for benign gynecologic disease. Despite proven safety and effectiveness, the vaginal approach for hysterectomy has been and remains underused in surgical practice. Factors associated with underuse of vaginal hysterectomy include challenges during residency training, decreasing case numbers among practicing gynecologists, and lack of awareness of evidence supporting vaginal hysterectomy. Strategies to improve resident training and promote collaboration and referral among practicing physicians and increasing awareness of evidence supporting vaginal hysterectomy can improve the primary use of this hysterectomy approach.

Clinical Practice Guideline for Abnormal Uterine Bleeding: Hysterectomy versus Alternative Therapy

BACKGROUND Our aim was to develop an objective scoring system and evaluate construct and face validity for a laparoscopic troubleshooting team training exercise. METHODS Surgery and gynecology novices (n = 14) and experts (n = 10) participated. Assessments included the following: time-out, scenario decision making (SDM) score (based on essential treatments rendered and completion time), operating room communication assessment (investigator developed), line operations safety audits (teamwork), and National Aeronautics and Space Administration-Task Load Index (workload). RESULTS Significant differences were detected for SDM scores for scenarios 1 (192 vs 278; P = .01) and 3 (129 vs 225; P = .004), operating room communication assessment (67 vs 91; P = .002), and line operations safety audits (58 vs 87; P = .001), but not for time-out (46 vs 51) or scenario 2 SDM score (301 vs 322). Workload was similar for both groups and face validity (8.8 on a 10-point scale) was strongly supported. CONCLUSIONS Objective decision-making scoring for 2 of 3 scenarios and communication and teamwork ratings showed construct validity. Face validity and participant feedback were excellent.

Postoperative management and restrictions for female pelvic surgery: a systematic review

STUDY OBJECTIVE To develop recommendations in selecting treatments for abnormal uterine bleeding (AUB). DESIGN Clinical practice guidelines. SETTING Randomized clinical trials compared bleeding, quality of life, pain, sexual health, satisfaction, the need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options. PATIENTS Women with AUB, predominantly from ovulatory disorders and endometrial causes. INTERVENTIONS On the basis of findings from a systematic review, clinical practice guidelines were developed. Rating the quality of evidence and the strength of recommendations followed the Grades for Recommendation Assessment, Development, and Evaluation system. MEASUREMENTS AND MAIN RESULTS This paper identified few high-quality studies that directly compared uterus-preserving treatments (endometrial ablation, levonorgestrel intrauterine system and systemically administered medications) with hysterectomy. The evidence from these randomized clinical trials demonstrated that there are trade-offs between hysterectomy and uterus-preserving treatments in terms of efficacy and adverse events. CONCLUSION Selecting an appropriate treatment for AUB requires identifying a womans most burdensome symptoms and incorporating her values and preferences when weighing the relative benefits and harms of hysterectomy versus other treatment options.

Vaginal Versus Oral Administration of Misoprostol for Labor Induction Among Obese Women [28K]

Introduction and hypothesisWe sought to systematically review the literature regarding the effect of postoperative restrictions on clinical outcomes after pelvic surgery.MethodsEnglish-language articles were identified by a MEDLINE and Cochrane Central Register of Controlled Trials search from inception to July 2010. We used key words describing various gynecologic surgical procedures and postoperative activities, including mobility, lifting, work, coitus, and exercise. Randomized and nonrandomized studies comparing interventions with outcomes of interest were included.ResultsThe literature search yielded of 3,491 articles; 115 full-text articles were reviewed, and 38 met eligibility criteria and are reported and analyzed here. Our analysis revealed that expedited discharge protocols and early postoperative feeding and catheter removal result in shorter hospital stay without negative health outcomes. However, there are limited data to guide many other aspects of postoperative care, particularly regarding exercise and resumption of sexual activity after surgery.ConclusionsThere is good evidence to support early postoperative feeding and catheter removal after pelvic surgery. There are limited data to guide many other aspects of postoperative care.

SGS Research Handbook-2nd Edition.

INTRODUCTION: Obese women have an increased risk for failed induction of labor. We compare the effectiveness of vaginal versus oral administration of misoprostol for induction. METHODS: A retrospective chart review was performed of women undergoing induction of labor from November 2012 to June 2015. Included were viable, singleton pregnancies at 34 weeks gestation or beyond whose initial agent of cervical ripening was either misoprostol 25 mcg administered vaginally or 50 mcg orally. Obesity was defined as body mass index greater than or equal to 30. Primary outcome was defined as percentage of patients achieving vaginal delivery within 24 hours. Secondary outcomes included mean interval from start of induction to delivery, rate of neonatal intensive care unit admission, and cesarean rate. RESULTS: Of the 390 women who received misoprostol as initial cervical ripening agent, 124 (31.8%) were obese. Among obese women, 25 (20.2%) were treated vaginally compared to 99 (79.8%) treated orally. No differences in baseline characteristics were observed between groups. Sixty percent receiving vaginal misoprostol delivered vaginally within 24 hours compared to 54.6% (P=.79) treated orally. Mean (± standard deviation) interval from start of induction to delivery was shorter in those receiving vaginal (16.3±9.5 hours) versus oral misoprostol (19.5±7.3 hours, P=.02). Other secondary outcomes were similar in each group. CONCLUSION: In labor induction among obese women, vaginal administration of misoprostol may be associated with decreased time to delivery.

Sexual activity and function in women with and without pelvic floor disorders

T he Society of Gynecologic Surgeons (SGS) strives to promote the highest standards for gynecologic surgical care through acquisition of knowledge and improvement of skills. As originally stated in the mission statement nearly 30 years ago, the enhanced understanding of gynecology and gynecologic surgery will happen through basic and clinical research. The Research Committee of SGS serves to enhance the quality of our society’s research endeavors. Appreciating that many gynecologic surgeons had little exposure to quality research methods, the first edition of the SGS Research Handbook was published in 2002. Since then, we have experienced many challenges to the training of gynecologic scientists, and unfortunately, emphasis on designing and conducting well-designed research has shifted to subspecialty training. The Research Committee decided to revisit and update the original SGS Research Handbook with 3 goals in mind: (1) expand the primer to serve as a resource for any young investigator, (2) demystify the process of conducting research, and (3) enhance the physician’s ability to interpret the medical literature. The second edition of the SGS Research Handbook is organized into 3 broad categories: Prestudy Topics, Conducting the Study, and Poststudy Topics. Within each section, we present material to begin the foundation of knowledge while pointing the reader toward additional resources that can help fill in any gaps. We would like to acknowledge the officers and executive committee of SGS for supporting this project, as well as contributors to the first research handbook in 2002. Wewould also like to thank Drs Steve Young, Joseph Schaffer, and Mike Aronson for their helpful feedback on the new edition. The Research Committee hopes that you will take advantage of the information in this primer and use it as a springboard to conducting your next research project. Good luck!