Raoul J. Burchette

Outcome After Anterior Vaginal Prolapse Repair : A Randomized Controlled Trial

OBJECTIVES: To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh–reinforced anterior vaginal prolapse repair with anterior colporrhaphy. METHODS: Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. RESULTS: Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group. CONCLUSION: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00535301 LEVEL OF EVIDENCE: I

Sodium Bicarbonate vs Sodium Chloride for the Prevention of Contrast Medium–Induced Nephropathy in Patients Undergoing Coronary Angiography: A Randomized Trial

CONTEXT Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality. OBJECTIVE To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography. DESIGN, SETTING, AND PATIENTS Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years. INTERVENTIONS Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure). MAIN OUTCOME MEASURE The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure. RESULTS Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all). CONCLUSION The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00312117.

Incidence of atypical nontraumatic diaphyseal fractures of the femur

Bisphosphonates reduce the rate of osteoporotic fractures in clinical trials and community practice. “Atypical” nontraumatic fractures of the diaphyseal (subtrochanteric or shaft) part of the femur have been observed in patients taking bisphosphonates. We calculated the incidence of these fractures within a defined population and examined the incidence rates according to duration of bisphosphonate use. We identified all femur fractures from January 1, 2007 until December 31, 2011 in 1,835,116 patients older than 45 years who were enrolled in the Healthy Bones Program at Kaiser Southern California, an integrated health care provider. Potential atypical fractures were identified by diagnostic or procedure codes and adjudicated by examination of radiographs. Bisphosphonate exposure was derived from internal pharmacy records. The results showed that 142 patients had atypical fractures; of these, 128 had bisphosphonate exposure. There was no significant correlation between duration of use (5.5 ± 3.4 years) and age (69.3 ± 8.6 years) or bone density (T‐score −2.1 ± 1.0). There were 188,814 patients who had used bisphosphonates. The age‐adjusted incidence rates for an atypical fracture were 1.78/100,000/year (95% confidence interval [CI], 1.5–2.0) with exposure from 0.1 to 1.9 years, and increased to 113.1/100,000/year (95% CI, 69.3–156.8) with exposure from 8 to 9.9 years. We conclude that the incidence of atypical fractures of the femur increases with longer duration of bisphosphonate use. The rate is much lower than the expected rate of devastating hip fractures in elderly osteoporotic patients. Patients at risk for osteoporotic fractures should not be discouraged from initiating bisphosphonates, because clinical trials have documented that these medicines can substantially reduce the incidence of typical hip fractures. The increased risk of atypical fractures should be taken into consideration when continuing bisphosphonates beyond 5 years.

A Prospective Randomized Study of Anterior Cruciate Ligament Reconstruction: A Comparison of Patellar Tendon and Quadruple-Strand Semitendinosus/Gracilis Tendons Fixed with Bioabsorbable Interference Screws

Background Debate exists regarding the optimal graft for anterior cruciate ligament reconstruction. Few studies have compared the differences in outcome after reconstruction using similar fixation methods. Hypothesis Similar outcomes will be seen after anterior cruciate ligament reconstruction with bone-patellar tendon-bone or quadruple-strand semitendinosus/gracilis tendons fixed with bioabsorbable interference screws. Study Design Randomized controlled trial; Level of evidence, 1. Methods Ninety-nine patients were prospectively randomized to bone-patellar tendon-bone (46 patients) or quadruple-strand semitendinosus/gracilis (53 patients) reconstruction groups. The bone-patellar tendon-bone group had slightly lower preinjury Tegner scores (6.7 vs 7.1, P = .03); otherwise, the groups were similar. All surgeries were performed by a single surgeon using an endoscopic technique with bioabsorbable interference screw fixation. Patients were evaluated at 3, 6, 12, and 24 months. Results Forty-six bone-patellar tendon-bone and 50 quadruple-strand semitendinosus/gracilis patients were available at 24 months (97%). No differences in International Knee Documentation Committee grade, Lysholm score, Tegner activity level, range of motion, single-legged hop test, KT-1000 arthrometer manual maximum difference, Short Form-36, or patient knee rating were found. The bone-patellar tendon-bone group had better flexion strength in the operated leg than in the nonoperated leg (102% vs 90%, P = .0001), fewer patients complaining of difficulty jumping (3% vs 17%, P = .03), and a greater number of patients returning to preinjury Tegner level (51% vs 26%, P = .01). The quadruple-strand semitendinosus/gracilis group had better extension strength in the operated leg than in the nonoperated leg (92% vs 85%, P = .04), fewer patients with sensory deficits (14% vs 83%, P = .0001), and fewer patients with difficulty kneeling (6% vs 20%, P = .04). Both groups showed significant improvement in KT-1000 arthrometer manual maximum difference, Lysholm score, Tegner activity level, International Knee Documentation Committee grade, and patient knee rating score. Conclusions Good outcomes were seen in both the bone-patellar tendon-bone and quadruple-strand semitendinosus/gracilis groups. Subtle differences were noted between the groups, which may help guide optimal graft choice.

Arthroscopic Release and Latissimus Dorsi Transfer for Shoulder Internal Rotation Contractures and Glenohumeral Deformity Secondary to Brachial Plexus Birth Palsy

BACKGROUND Internal rotation contractures due to external rotation weakness secondary to brachial plexus birth palsy frequently lead to glenohumeral deformity and impaired shoulder function. Our surgical approach to treat these contractures relies on arthroscopic release for young children (less than three years old) and combines arthroscopic release with latissimus dorsi transfer for older children. We report the results for the first thirty-three children followed for a minimum of two years after such treatment. METHODS Nineteen children with a mean age of 1.5 years (all younger than three years of age) underwent arthroscopic contracture release as the only primary procedure, and fourteen children with a mean age of 6.7 were also treated with a latissimus dorsi transfer. Passive external rotation with the arm at the side and passive and active elevation were measured for all patients preoperatively. Passive and active external rotation, internal rotation, and elevation were measured for all patients postoperatively. Magnetic resonance imaging was performed preoperatively and postoperatively to evaluate the status of the glenohumeral joint. RESULTS Preoperative passive external rotation averaged -2 degrees for the children who underwent arthroscopic contracture release only and -24 degrees for those who also were treated with a latissimus dorsi transfer. Arthroscopic release achieved a marked increase in passive external rotation and a centered position of the glenohumeral joint at the time of surgery in all but the oldest child in the series, who had severe deformity. The contracture recurred in four of the younger children who had an isolated release, and this was treated with a repeat arthroscopic release and a secondary latissimus dorsi transfer. None of the children who had a primary latissimus dorsi transfer had recurrence of the contracture. At the time of follow-up, the mean passive external rotation was increased by 67 degrees (p < 0.005) in the fifteen children with a successful arthroscopic release, 81 degrees (p < 0.005) in those treated with a primary latissimus dorsi transfer, and 78 degrees in the four patients who were treated with a late latissimus dorsi transfer because the isolated arthroscopic release failed. The mean active elevation increased 12 degrees , 3 degrees , and 10 degrees , respectively, in the three groups. Internal rotation was not measured consistently preoperatively, but when it had been it was found to have decreased substantially postoperatively. Magnetic resonance imaging performed prior to the surgery showed a pseudoglenoid deformity in eighteen of the children. At two years, magnetic resonance images were available for fifteen of those children, and twelve of the images showed marked remodeling of the deformity. CONCLUSIONS In children who are younger than three years of age, arthroscopic release effectively restores nearly normal passive external rotation and a centered glenohumeral joint at the time of surgery. In most of these children, external rotation strength is sufficient to maintain this range of motion and to improve glenoid development when preoperative deformity was present. The addition of a latissimus dorsi transfer in older children predictably results in similar improvements. Gains in active elevation are minimal. All children have a loss of internal rotation, which is moderate in most of them but is severe in some.

A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: A randomized trial

Objective.—To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew.

Knee replacement: epidemiology, outcomes, and trends in Southern California 17,080 replacements from 1995 through 2004

Background and purpose There are limited popula-tion-based data on utilization, outcomes, and trends in total knee arthroplasty (TKA). The purpose of this study was to examine TKA utilization and short-term outcomes in a pre-paid health maintenance organization (HMO), and to determine whether rates and revision burden changed over time. We also studied whether this population is representative of the general population in California and in the United States. Methods Using hospital utilization and membership databases from 1995 through 2004, we calculated incidence rates (IRs) of primary and revision TKA for every 10,000 health plan members. The demographics of the HMO population were compared to published census data from California and the United States. Results The age and sex distributions of the study population were similar to those of the general population in California and the United States. 15,943 primary TKAs and 1,137 revision TKAs were performed during the 10-year period. Patients below the age of 65 accounted for one-third of all primary replacements and one-third of all revision replacements. IRs of primary TKAs increased from 6.3 per 10,000 in 1995 to 11.0 per 10,000 in 2004, at a rate of 5% per year (p<0.001). IRs of revision TKAs increased from 0.41 per 10,000 in 1995 to 0.74 per 10,000 in 2004 (p=0.4). Revision burden remained stable over the 10-year observation period. Surgical complications were higher in revision TKA than in primary TKA (10% vs. 7.7%; p=0.007). 90day complication rates for primary and revision TKA including death were 0.3% and 0.6% (p=0.1) and for pulmonary embolism 0.5% and 0.4% (p=0.6). 90day re-admission rates for primary and revision TKA including infection were 0.5% and 4.2% (p<0.001), for myocardial infarction 0.1% each, and for pneumonia 0.2% and 0.4% (p=0.08). Interpretation The incidence of primary and revision TKA increased between 1995 and 2005. The rates of postoperative complications were low. Comparisons of the study population and the underlying general populations of interest indicate that this population can be used to predict the incidences and outcomes of TKA in the general population of California and of the United States as a whole.

Inappropriate gold standard bias in cervical cancer screening studies

As acetic acid‐aided visual inspection (VIA) and colposcopic‐directed biopsy miss small ≥cervical intraepithelial neoplasia (CIN) 2, inflation of sensitivity of VIA may occur when colposcopic‐directed biopsy is the gold standard for ≥CIN 2. To determine whether such inflation occurs, we reviewed 375 women with ≥CIN 2 from the Shanxi Province Cervical Cancer Screening Study II. These women had positive self or physician‐collected tests for high‐risk human papillomavirus or abnormal cervical cytology and had VIA followed by colposcopy with directed biopsy and endocervical curettage (ECC). If a cervical quadrant had no lesion, a random biopsy at the squamocolumnar junction within that quadrant was obtained. Sensitivity of colposcopic‐directed biopsy was higher for ≥CIN 2 involving 3–4 cervical quadrants (81.3%) than for ≥CIN 2 involving 0–2 quadrants (49.0%, p < 0.001). Sensitivities of VIA, cytology of ≥ASC‐US, ≥LSIL, and ≥HSIL were higher for ≥CIN 2 involving 3–4 quadrants than for ≥CIN 2 involving 0–2 quadrants. When a colposcopic‐directed biopsy gold standard was compared with that of a 5‐biopsy standard (which included ≥CIN 2 from colposcopic‐directed biopsy, random biopsy, or ECC), the sensitivity for ≥CIN 2 of VIA was inflated by 20.0% (65.9% vs. 45.9%, p < 0.001). Sensitivities of other screening tests were not affected. Similar inflation of sensitivity of VIA was found with an endpoint of ≥CIN 3 (70.4% vs. 52.0%, p = 0.0013). Inflation of sensitivity of VIA depended upon agreement between colposcopic‐directed biopsy and the screening tests as measured by kappa. Studies of VIA that used colposcopic‐directed biopsy as the gold standard require reevaluation.

Somatic Symptoms in Headache Patients: The Influence of Headache Diagnosis, Frequency, and Comorbidity

Background.—Mood disorders of anxiety and depression are well known to be comorbid with primary headache disorders. Less is known of the comorbidity of other somatic symptoms with headache.

Effective use of laparoscopy for long-term peritoneal dialysis access

BACKGROUND Laparoscopy is an underused modality for peritoneal dialysis access procedures. The strengths of laparoscopy are that it can both prevent and resolve the common mechanical problems that adversely effect dialysis catheter outcomes. METHOD Laparoscopically enabled catheter implantation and rescue procedures included rectus sheath catheter tunneling, omentopexy, adhesiolysis, resection of epiploic appendices, colopexy, salpingectomy, and appendectomy. Using these techniques, the outcomes of 428 laparoscopically implanted catheters were studied. RESULTS During a mean follow-up of 21.6 months, mechanical obstruction complicated 3.7% of implantation procedures. The incidence of pericatheter leak was 2.6%. There were no occurrences of pericatheter hernia or subcutaneous cuff extrusion. Laparoscopic salvage procedures limited losses from mechanical catheter problems to .9%. Cumulative revision-free and assisted catheter survival probabilities for loss from mechanical complications at 5 years were .96 and .99, respectively. COMMENTS Because it is enabled by techniques not available to other catheter-placement methods, laparoscopy produces superior outcomes.