P. Guha

Use of the Limbs and Things Hysterectomy Model to Describe the Process for Establishing Validity

STUDY OBJECTIVEnTo demonstrate the process for establishing or refuting validity for the Limbs and Things hysterectomy model.nnnDESIGNnProspective study using Kanes framework for establishing validity (Canadian Task Force classification: II-2).nnnSETTINGnTotal laparoscopic hysterectomy (TLH) assessments completed in the operating room (OR) and simulation at 3 academic medical centers.nnnPARTICIPANTSnObstetrics and gynecology residents (nu2009=u200926 postgraduate years 3-4), a gynecologic oncology fellow (postgraduate year 5), and a gynecology oncology attending.nnnINTERVENTIONSnParticipants were rated with the myTIPreport feedback application by nonblinded faculty in the OR after TLH. In-person, simulation-based assessments were provided by 2 faculty members blinded to experience level using myTIPreport and Global Operative Assessment of Laparoscopic Skills (GOALS). Videos of simulated TLHs were rated by 2 minimally invasive gynecology fellows.nnnMEASUREMENTS AND MAIN RESULTSnOR scores for TLH steps were significantly higher than simulation assessments (pu2009<u2009.001) with competent marked more frequently in the OR. Number of roboticu2009+u2009conventional TLHs performed as primary surgeon was not significantly correlated with OR myTIPreport rating (Spearman ru2009=u2009.30, pu2009=u2009.14) but was significantly correlated with myTIPreport and GOALS in-person simulation ratings (Spearman ru2009=u2009.39-.58, pu2009=u2009.001-.04). Agreement between in-person simulation rater 1 and 2 myTIPreport assessments was 71.4% (weighted κ, .68; 95% confidence interval, .45-.90), and intraclass correlation for the GOALS overall assessment was .71 (95% confidence interval, .46-.85), indicating substantial agreement. Blinded video reviews showed similar agreement (73.1%) between raters but less correlation with experience (Spearman ru2009=u2009.32-.42, pu2009=u2009.11-.03) than in-person reviews. Using area under the receiver operating characteristic curve, mean score for the individual components of GOALS that best differentiated myTIPreport noncompetent and competent levels of performance was 4.3. Feedback acceptability and model realism were rated highly.nnnCONCLUSIONnThe scoring and generalization validity inferences for Limbs and Things and myTIPreport are supported when global assessments of performance are evaluated but not for individual components of the assessment instruments.

Robotic Placement of the FENIX Continence Restoration System in a Patient with Previous Radiation to the Pelvis: A Case Report

Fecal incontinence (FI) is a disabling problem affecting women. Conservative treatment includes dietary modification, antimotility agents, and pelvic floor physical therapy. If conservative medical management is unsuccessful, surgical intervention may be required. Surgical options include rectal sphincteroplasty, bulking agent injection, radiofrequency anal sphincter remodeling, and sacral nerve stimulation therapy. Recently, a new therapy for FI, the FENIX Continence Restoration System (Torax Medical, Inc., Shoreview, MN), has become available. The FENIX device is placed through a perineal incision; however, pelvic radiation and previous anal carcinoma are both contraindications. We report the case of a 62-year-old woman with FI after anal carcinoma. Treatment included surgery, chemotherapy, and pelvic radiation. Initially, she was treated with conservative therapy and sacral nerve stimulation, which were only partially effective. A physical examination showed perineal skin changes consistent with previous radiation, which increased the patients risk of infection and a nonhealing wound. Therefore, a robotic approach was used to place the FENIX device and improve the patients quality of life. Our case sets a precedent for expanding the treatment options of FI in patients with previous pelvic radiation and using a robotic approach for the placement of the FENIX device.