FDA-Approved Sodium Tetradecyl Sulfate (STS) versus Compounded STS for Venous Sclerotherapy

BACKGROUND: In the area of endovenous chemical ablation (sclerotherapy), there has been much debate regarding sclerosant quality and efficacy. Only sodium tetradecyl sulfate (STS) has garnered Food and Drug Administration (FDA) approval in the United States. OBJECTIVE: The primary objective of this study was to compare clinical performance measures of compounded STS from 27% industrial-strength stock (compounded STS) versus FDA-approved Sotradecol (Bioniche Pharma USA, Inc., Belleville, Ontario, Canada). MATERIALS AND METHODS: Phase I of this study focused on the chemical composition of the drugs, whereas Phase II studied the ablative abilities of the two drugs at comparable concentrations of 3%. RESULTS: We documented the presence of various impurities in compounded STS. No impurities in AngioDynamics STS were found. Our studies suggest that compounded STS may have significant variation in concentration. The AngioDynamics STS concentration was found to be manufactured within a tight tolerance. Segments of incomplete ablation were more frequent in the compounded STS group when compared to the AngioDynamics STS group. This reached statistical significance (p=.02). Primary closure using the Kaplan-Meier statistic demonstrated a trend in the favor of AngioDynamics STS when compared to compounded STS. CONCLUSION: When product quality, efficacy, and liability are carefully considered, we conclude that it would behoove physicians to use pharmaceutical-grade, FDA-approved sclerosant when treating their patients.     

Does the false-negative rate for 1 or 2 negative sentinel nodes after neo-adjuvant chemotherapy translate into a high local recurrence rate?

Prospective trials demonstrate that sentinel node (SN) biopsy after neo-adjuvant chemotherapy (NACT) has a significant false-negative rate (FNR) when only 1 or 2 SNs are removed. It is unknown whether this increased FNR correlates with an elevated risk of recurrence. Tumor Registry data at an NCI-Designated Comprehensive Cancer Center were reviewed from 2004 to 2018 for patients having a negative SN biopsy after NACT. Among 190 patients with histologically negative nodes after NACT having 1 (n = 42), 2 (n = 46), and ≥3 (n = 102) SNs, axillary recurrences occurred in 7.14%, 0%, and 1.96% (p = 0.09), breast recurrences occurred in 2.38%, 6.52%, and 0.98% (p = 0.12), and distance recurrences occurred in 16.67%, 8.70%, and 7.84% (p = 0.27), respectively. Time to first recurrence did not differ by SN count (p = 0.41). After adjustment for age, race, clinical stage, and receptor status, there were no differences in the rates of axillary (p = 0.26), breast (p = 0.44), or distance recurrence (p = 0.24) by numbers of SNs harvested. Median follow-up was 46.8 months. Despite higher post-NACT FNRs reported in randomized trials for patients having <3 sentinel nodes, recurrence rates were not significantly different for 1 versus 2 versus ≥3 SNs. This suggests that patients having 1 or 2 post-NACT SNs identified may not necessitate axillary dissection.     

The Superiority of the Left Subcostal Incision Compared to Mid-line Incisions in Surgery for Morbid Obesity

We describe a 13-year experience using a left subcostal incision in performing gastroplasties and Roux-en-Y gastric bypasses (RYGBP) in morbidly obese patients. We have also used it successfully in the general population in several other types of surgical procedures, including Nissen fundoplications in adults and infants, gastrectomies, truncal vagotomies, pyloroplasties, jejunoileal bypass reversals, and elective splenectomies. Over 200 cholecystectomies have been carried out through this incision as additional procedures with relative ease, not requiring any further extension of the incision. There were no hernias in a group of 1067 primary gastroplasty and RYGBP patients, and the wound infection rate has been quite low, apparently because of the incision's distance from the potentially contaminated umbillicus. We feel that the use of this incision further simplifies and therefore adds a safety factor not seen with the standard vertical incision in this group of surgical patients.     

Quality of Life Assessment,of Ileogastrostomy

Twenty of 26 (77%) consecutive patients undergoing ileogastrostomy, performed by the same surgeon (IGMC) between February 1989 and May 1992, responded to a mailed quality of life survey. Average present weight was reported as 50.9 kg less than a mean preoperative weight of 139.7 kg. Mean time of follow-up was 24.75 months. When comparing perceptions before and after surgery, several quality of life improvements were noted in the areas of vocation, relationships, emotional well-being and physical well-being. Post-surgery, jobs were rated more satisfying, eating habits improved, self-image and self-confidence increased and body disparagement declined. Satisfaction with sexual relations increased, as did frequency. In general, relations with partners, co-workers and friends seemed to improve. Exercise also increased significantly. In contrast, foul flatus, bloating, and bowel movements regularly hampered activities or caused embarassment when in public. Despite these physical side-effects, we observed that a large majority of persons undergoing ileogastrostomy noted significant improvements in quality of life.     

Radical “Fleur-de-Lis” Abdominoplasty after Bariatric Surgery

The massive weight loss produced by bariatric surgical procedures on the morbidly obese can result in gross redundancy of abdominal and trunk skin. Standard abdominoplasty procedures may be insufficient to correct this debilitating deformity. A radical version of the “Fleur-de-Lis” abdominoplasty has been carried out on 45 such patients, with good cosmetic and functional results and low morbidity.