GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases.

BACKGROUND: The French PRODIGE 7 trial, published on January 2021, has raised doubts about the specific survival benefit provided by HIPEC with oxaliplatin 460 mg/m2 (30 minutes) for the treatment of peritoneal metastases from colorectal cancer. However, several methodological flaws have been identified in PRODIGE 7, specially the HIPEC protocol or the choice of overall survival as the main endpoint, so its results have not been assumed as definitive, emphasizing the need for further research on HIPEC. It seems that the HIPEC protocol with high-dose mytomicin-C (35 mg/m2) is the preferred regime to evaluate in future clinical studies. METHODS: GECOP-MMC is a prospective, open-label, randomized, multicenter phase IV clinical trial that aims to evaluate the effectiveness of HIPEC with high-dose mytomicin-C in preventing the development of peritoneal recurrence in patients with limited peritoneal metastasis from colon cancer (not rectal), after complete surgical cytoreduction. This study will be performed in 31 Spanish HIPEC centres, starting in March 2022. Additional international recruiting centres are under consideration. Two hundred sixteen patients with PCI ≤ 20, in which complete cytoreduction (CCS 0) has been obtained, will be randomized intraoperatively to arm 1 (with HIPEC) or arm 2 (without HIPEC). We will stratified randomization by surgical PCI (1-10; 11-15; 16-20). Patients in both arms will be treated with personalized systemic chemotherapy. Primary endpoint is peritoneal recurrence-free survival at 3 years. An ancillary study will evaluate the correlation between surgical and pathological PCI, comparing their respective prognostic values. DISCUSSION: HIPEC with high-dose mytomicin-C, in patients with limited (PCI ≤ 20) and completely resected (CCS 0) peritoneal metastases, is assumed to reduce the expected risk of peritoneal recurrence from 50 to 30% at 3 years. TRIAL REGISTRATION: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).

Hair loss in females after sleeve gastrectomy: predictive value of serum zinc and iron levels.

A common complication after bariatric surgery is hair loss, which is related to rapid weight reduction, but zinc, iron, and other micronutrient deficiencies can also be involved. Little is studied after laparoscopic sleeve gastrectomy (LSG). A prospective observational study was performed of 42 morbidly obese females undergoing LSG. Incidence of hair loss was monitored. Micronutrients were investigated preoperatively and three, six, and 12 months after surgery. Sixteen patients (41%) reported hair loss in the postoperative course. A significant association was observed between hair loss and zinc levels (P = 0.021) but mean zinc levels were within the normal range in patients reporting hair loss. Only three patients (7.7%) presented low zinc levels, all of them reporting hair loss. There was also a significant association between iron levels and alopecia (P = 0.017), but mean values of the patients with hair loss were within normal range. Only four patients (10.2%) presented low iron levels, all of them presenting hair loss. A variable consisting of the addition of zinc + iron showed a significant association with hair loss (P = 0.013). A cutoff point was established in 115 (odds ratio, 4; P = 0.006). All the patients but two reporting hair loss presented addition levels under 115. This variable showed sensibility 88 per cent, specificity 84 per cent, positive predictive value 79 per cent, and negative predictive value 91 per cent to predict hair loss. Hair loss is a frequent condition after sleeve gastrectomy. In most cases, iron and zinc levels are within the normal range. The variable addition (zinc + iron) is a good predictor of hair loss. Patients with addition levels below 115 are fourfold more susceptible to present hair loss. In these cases, zinc supplements achieve the stop of hair loss in most cases.

Mid-term effects of sleeve gastrectomy on calcium metabolism parameters, vitamin D and parathormone (PTH) in morbid obese women.

BACKGROUND: Despite routine supplementation of vitamins and minerals after bariatric surgery, an important number of patients suffer from deficiencies. Little is still known about the novel restrictive procedure, sleeve gastrectomy. METHODS: A retrospective study of 30 morbidly obese patients undergoing a laparoscopic sleeve gastrectomy, between May 2008 and September 2010, was performed. Baseline albumin, ferritin, iron, zinc, calcium, vitamin D, parathormone (PTH), vitamin B12, and folic acid were obtained before operation and postoperative determinations 1, 3, 6, 9, 12, 18, and 24 months after surgery. RESULTS: Before surgery, 96.7% of the patients presented vitamin D deficiency, 20% had elevated PTH, 3.3% hypoalbuminemia, and 3.3% folic acid deficiency. One year after surgery, only one patient (3.3%) presented vitamin D deficiency and had elevated PTH. The rest of parameters were within normal range. The second year after surgery, the results remain similar. A significant difference was obtained when comparing preoperative vitamin D values and postoperative determinations 12 months after surgery (increase of 51.9 ng/dl, 95% confidence interval (CI) (41.8-61.3); p < 0.001). A significant difference was determined when comparing preoperative PTH values and postoperative determinations 3 months after surgery (decrease of 16.6 pg/ml, 95% CI (2.6-30.6); p = 0.03). A significant inverse correlation was observed between weight loss and vitamin D increase at the third month after surgery (Pearson correlation coefficient -0.948; p = 0.033). CONCLUSIONS: Postoperative values of vitamin D show a progressive increase, while PTH ones present a significant reduction, without any impact on serum calcium levels. We have demonstrated an inverse correlation between weight loss and vitamin D increase at the third month after surgery.