Clinical and Patient-Reported Outcomes after Absorbable Strap Fixation for Ventral Hernia Repair.

INTRODUCTION: Various mesh fixation methods are employed by surgeons during ventral hernia repair. These may include tacks, straps, sutures, glue, or a combination of methods. One of these choices is an absorbable fixation device, Securestrap® (Ethicon Inc., Somerville, New Jersey), consisting of an absorbable copolymer barbed U-shaped strap with a spring-loaded deployment system. MATERIALS AND METHODS: The International Hernia Mesh Registry is a prospective multi-center registry, designed to collect longitudinal data on hernia repair methods, products, and outcomes. Patients complete the Carolinas Comfort Scale™ (CCS) (The Charlotte-Mecklenburg Hospital Authority, Charlotte, North Carolina) pre-operatively, and at one month, six months, and 12 months post-operatively. Symptomatic patients defined as responding >1 to any CCS™ question. Statistical comparison of symptom frequency was made with the McNemar test and Kaplan Meier methods to determine the recurrence rate up to 365 days. RESULTS: Patients were enrolled at 16 centers. Data was available on 100 of the 203 patients at six months and on 119 patients at 12 months. Demographics: mean age of 52.7 (13.2 standard deviation[ SD]); mean body mass index (BMI) of 33.2 (7.5 SD) kg/m2; 64.3% having a BMI over 30kg/m2; male patients 47.4%; 16.7% for recurrent hernias. Mesh fixation with straps alone in 48.3% of cases or straps and sutures in 51.7% of cases. Percentage of patients with symptomatic pain decreased slightly from baseline to one month (70.0 vs. 60.6, p=0.0782) and significantly from one month to six months (60.6% symptomatic vs. 23.2%; p=0.0004). From six months to twelve months, the change in percentage of symptomatic patients was not significant (23.2% vs. 28.7%; p=0.8084). Similar results were observed with symptomatic CCS™ movement limitations. Overall recurrence rate at 12 months was 4.72% (2.39%-9.22%). CONCLUSION: Mesh fixation with straps with or without additional sutures is associated with significant improvements in patient-reported pain and movement limitation from baseline to six months post-operative.

Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding.

STUDY OBJECTIVES: To estimate the incidence of amenorrhea at 36 months after treatment using a third-generation thermal uterine balloon therapy (UBT) system and to compare it with the first-generation UBT system. The secondary objective was to estimate the effect of post-procedure curettage on patient outcomes at 36 months after endometrial ablation. DESIGN: Multicenter controlled study (Canadian Task Force classification I). SETTING: Thirteen hospitals: 12 in the United States and 1 in Mexico. PATIENTS: Two-hundred fifty premenopausal women aged at least 30 years with heavy menstrual bleeding not responsive to previous medical therapy for at least 3 months. INTERVENTION: After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive post-procedure curettage (PPC) or no PPC. MEASUREMENTS AND MAIN RESULTS: Amenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24- and 36-month follow-up by patient response of amenorrhea on a 5-point scale (amenorrhea, spotting, and light, normal, or excessive bleeding). In the intention-to-treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third-generation UBT system, and 13.0% with the first-generation UBT system. Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group. CONCLUSION: At extended 36-month follow-up, results were similar to the previously reported results at 1 year using prospectively defined matched-pair analysis, and demonstrated superiority in treating amenorrhea using the third-generation UBT system vs the first-generation UBT system.

Clinical evaluation of a third-generation thermal uterine balloon therapy system for menorrhagia coupled with curettage.

STUDY OBJECTIVES: To estimate the incidence of amenorrhea 12 months after treatment with a third-generation thermal uterine balloon therapy (UBT) system. Secondary objectives were to compare the incidence of amenorrhea observed with this third-generation system with that of a first-generation system, to estimate the effect of postprocedure curettage on patient outcome, and to evaluate the workings of this new system. DESIGN: Multicenter, controlled study (Canadian Task Force classification I). SETTING: Thirteen hospitals: 12 in the United States and 1 in Mexico. PATIENTS: Two hundred fifty premenopausal women aged 30 years or older with menorrhagia not responsive to previous medical therapy for at least 3 months. INTERVENTION: After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive postprocedure curettage or no further treatment. MEASUREMENTS AND MAIN RESULTS: The rate of amenorrhea 12 months after treatment with the third-generation thermal UBT system was similar in patients receiving postprocedure curettage (33.3%) and those receiving no further treatment (37.1%; p=.53). In addition, postprocedure curettage did not have any significant effect on any other patient outcome, for example, pain. Patients who were matched to historic control patients treated with the original first-generation system demonstrated a significantly greater success rate (amenorrhea) at 12 months (32.6%) compared with those treated with the first-generation system (13.7%). The third-generation thermal UBT instrument functioned as designed, with no unanticipated adverse device effects. CONCLUSION: The third-generation thermal UBT system shows greater efficacy in producing amenorrhea than the original first-generation system, with no significant safety issues. Postprocedural curettage did not alter amennorhea rates.