Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial.

OBJECTIVE: The aim of this study was to compare chronic postoperative inguinal pain (CPIP) in patients with an inguinal hernia after the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal Technique (TIPP). BACKGROUND: The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding CPIP with low recurrence rates. Two open preperitoneal techniques, TREPP and TIPP, were compared in a randomized clinical trial with the hypothesis of fewer patients with CPIP after TREPP due to complete avoidance of nerve contact. METHODS: Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Before the trial's start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events, and health-related quality of life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months, and 1 year. RESULTS: Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but CPIP at rest at 1 year was comparable: 1.9% after TREPP vs 1.4% after TIPP, P = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, P = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, P = 0.591). CONCLUSION: Both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1-year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation. TRIAL REGISTRATION: ISRCTN18591339.

Effect of Digital Care Platforms on Quality of Care for Oncological Patients and Barriers and Facilitators for Their Implementation: Systematic Review.

BACKGROUND: Oncological health care services are challenged by the increasing number of cancer survivors, long-term follow-up care, and fragmentation of care. Digital care platforms are potential tools to deliver affordable, patient-centered oncological care. Previous reviews evaluated only one feature of a digital care platform or did not evaluate the effect on enhancement of information, self-efficacy, continuity of care, or patient- and health care provider-reported experiences. Additionally, they have not focused on the barriers and facilitators for implementation of a digital care platform in oncological care. OBJECTIVE: The aim of this systematic review was to collect the best available evidence of the effect of a digital care platform on quality of care parameters such as enhancement of available information, self-efficacy, continuity of care, and patient- and health care provider-reported experiences. Additionally, barriers and facilitators for implementation of digital care platforms were analyzed. METHODS: The PubMed (Medline), Embase, CINAHL, and Cochrane Library databases were searched for the period from January 2000 to May 2020 for studies assessing the effect of a digital care platform on the predefined outcome parameters in oncological patients and studies describing barriers and facilitators for implementation. Synthesis of the results was performed qualitatively. Barriers and facilitators were categorized according to the framework of Grol and Wensing. The Mixed Methods Appraisal Tool was used for critical appraisal of the studies. RESULTS: Seventeen studies were included for final analysis, comprising 8 clinical studies on the effectiveness of the digital care platform and 13 studies describing barriers and facilitators. Usage of a digital care platform appeared to enhance the availability of information and self-efficacy. There were no data available on the effect of a digital care platform on the continuity of care. However, based on focus group interviews, digital care platforms could potentially improve continuity of care by optimizing the exchange of patient information across institutes. Patient-reported experiences such as satisfaction with the platform were considerably positive. Most barriers for implementation were identified at the professional level, such as the concern for increased workload and unattended release of medical information to patients. Most facilitators were found at the patient and innovation levels, such as improved patient-doctor communication and patient empowerment. There were few barriers and facilitators mentioned at the economic and political levels. CONCLUSIONS: The use of digital care platforms is associated with better quality of care through enhancement of availability of information and increased self-efficacy for oncological patients. The numerous facilitators identified at the patient level illustrate that patients are positive toward a digital care platform. However, despite these favorable results, robust evidence concerning the effectiveness of digital care platforms, especially from high-quality studies, is still lacking. Future studies should therefore aim to further investigate the effectiveness of digital care platforms, and the barriers and facilitators to their implementation at the economic and political levels.

A short or a long Roux limb in gastric bypass surgery: does it matter?

BACKGROUND: The Roux-en-Y gastric bypass (RYGB) still remains the gold standard in bariatric surgery. However, no consensus exists on the optimal limb lengths to induce maximum weight reduction. The aim of the present study was to assess the effect of a longer alimentary limb (AL) length on weight reduction after RYGB. METHODS: A retrospective analysis of a prospectively collected database of patients who underwent a primary laparoscopic RYGB between January 2001 and March 2011 was performed. Patients received a short AL (SAL; 100 cm) or a long AL (LAL; 150 cm). Primary outcome was weight loss, and secondary outcomes were short- and long-term complication rates. RESULTS: A total of 768 patients received a RYGB during the study period. Of these, 730 consecutive patients were included for long-term analysis and had a mean follow-up (FU) of 37 ± 26 [range 0-120] months; 360 (47 %) patients received a SAL RYGB. Overall %TBWL was 33 ± 9 % after 2 years (FU 74 %) and 28 ± 12 % after 5 years (FU 20 %). No significant differences in %TBWL were found between SAL RYGB and LAL RYGB during the study period. The 30-day mortality rate was 0.13, 9 % overall short-term complication rate and 19 % cumulative long-term complication rate. No differences in complications were found between SAL and LAL RYGB patients. CONCLUSION: Lengthening of the alimentary limb from 100 to 150 cm did not affect post-RYGB weight loss. Overall complication rates were low and comparable in this series of RYGB patients.

Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study.

BACKGROUND: The use of low intra-abdominal pressure (<10 mmHg) reduces postoperative pain scores after laparoscopic surgery. OBJECTIVE: To investigate whether low-pressure pneumoperitoneum with deep neuromuscular blockade improves the quality of recovery after laparoscopic donor nephrectomy (LDN). DESIGN, SETTING AND PARTICIPANTS: In a single-center randomized controlled trial, 64 live kidney donors were randomly assigned to 6 or 12 mmHg insufflation pressure. A deep neuromuscular block was used in both groups. Surgical conditions were rated by the five-point Leiden-surgical rating scale (L-SRS), ranging from 5 (optimal) to 1 (extremely poor) conditions. If the L-SRS was insufficient, the pressure was increased stepwise. MAIN OUTCOME MEASURE: The primary outcome measure was the overall score on the quality of recovery-40 (QOR-40) questionnaire at postoperative day 1. RESULTS: The difference in the QOR-40 scores on day 1 between the low- and standard-pressure group was not significant (p = .06). Also the overall pain scores and analgesic consumption did not differ. Eight procedures (24%), initially started with low pressure, were converted to a standard pressure (≥10 mmHg). A L-SRS score of 5 was significantly more prevalent in the standard pressure as compared to the low-pressure group at 30 min after insufflation (p < .01). CONCLUSIONS: Low-pressure pneumoperitoneum facilitated by deep neuromuscular blockade during LDN does not reduce postoperative pain scores nor improve the quality of recovery in the early postoperative phase. The question whether the use of deep neuromuscular blockade during laparoscopic surgery reduces postoperative pain scores independent of the intra-abdominal pressure should be pursued in future studies. TRIAL REGISTRATION: The trial was registered at clinicaltrial.gov before the start of the trial (NCT02146417).

Nighttime kidney transplantation is associated with less pure technical graft failure.

PURPOSE: To minimize cold ischemia time, transplantations with kidneys from deceased donors are frequently performed during the night. However, sleep deprivation of those who perform the transplantation may have adverse effects on cognitive and psychomotor performance and may cause reduced cognitive flexibility. We hypothesize that renal transplantations performed during the night are associated with an increased incidence of pure technical graft failure. METHODS: A retrospective analysis of data of the Dutch Organ Transplant Registry concerning all transplants from deceased donors between 2000 and 2013 was performed. Nighttime surgery was defined as the start of the procedure between 8 p.m. and 8 a.m. The primary outcome measure was technical graft failure, defined as graft loss within 10 days after surgery without signs of (hyper)acute rejection. RESULTS: Of 4.519 renal transplantations in adult recipients, 1.480 were performed during the night. The incidence of pure technical graft failure was 1.0 % for procedures started during the night versus 2.6 % for daytime surgery (p = .001). In a multivariable model, correcting for relevant donor, recipient and graft factors, daytime surgery was an independent predictor of pure technical graft failure (p < .001). CONCLUSIONS: Limitation of this study is mainly to its retrospective design, and the influence of some relevant variables, such as the experience level of the surgeon, could not be assessed. We conclude that nighttime surgery is associated with less pure technical graft failures. Further research is required to explore factors that may positively influence the performance of the surgical team during the night.

Is the Reluctance for the Implantation of Right Donor Kidneys Justified?

BACKGROUND: The lengths of right renal veins are shorter when compared to their left counterparts. Since the implantation of kidneys with short renal veins is considered more challenging, many surgeons prefer left kidneys for transplantation. Therefore, our hypothesis is that the implantation of right kidneys from living and deceased donors is associated with more technical graft failures as compared to left kidneys. METHODS: Two consecutive cohorts of adult renal allograft recipients of living (n = 4.372) and deceased (n = 5.346) donor kidneys between January 1, 2000 and January 1, 2013 were analyzed. Data were obtained from the prospectively maintained electronic database of the Dutch Organ Transplant Registry. Technical graft failure was defined as failure of the renal allograft within 10 days after renal transplantation without signs of acute rejection. RESULTS: In the living donor kidney transplantation cohort, the implantation of right donor kidneys was associated with a higher incidence of technical graft failure (multivariate analysis p = 0.03). For recipients of deceased donor kidneys, the implantation of right kidneys was not significantly associated with technique-related graft failure (multivariate analysis p = 0.16). CONCLUSIONS: Our data show that the implantation of right kidneys from living donors is associated with a higher incidence of technique-related graft failure as compared to left kidneys.

The ileo neo rectal anastomosis: long-term results of surgical innovation in patients after ulcerative colitis and familial adenomatous polyposis.

PURPOSE: Restorative proctocolectomy with ileo neo rectal anastomosis (INRA) combines cure of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) with restoration of intestinal continuity. Evaluation of long-term results was needed to determine if there is a place for INRA in the armamentarium of a surgeon besides the ileal pouch anal anastomosis (IPAA). METHODS: All patients with INRA were included in the analysis. Patient demographics and clinical and follow-up data (morbidity, dietary problems, defecation frequency, fecal continence, anal and neorectal physiology, and neorectal mucosa assessment) were registered prospectively. RESULTS: Seventy-nine patients were enrolled, and in 58 patients (50 UC, 8 FAP), INRA was successful. In 21 patients, intraoperative conversion to IPAA was needed. In 49 patients with INRA, a functional reservoir was achieved. No pelvic sepsis or bladder or sexual dysfunction occurred. Thirteen patients experienced episodes of reservoir inflammation. Median bowel movements of six (5, 8) with a nocturnal defecation frequency of one were recorded with fecal continence or minor incontinence. Anal manometry and neorectal physiology showed a decrease in resting pressure and an increase in squeeze pressure and maximum tolerated volume. The median follow-up was 8.1 years (6.7, 10.1). CONCLUSIONS: This is an example of a surgical innovation with a theoretical potential to be superior to the current technique. This potential was not confirmed in short- and long-term evaluations. Hence, IPAA is currently the best available alternative to a conventional ileostomy.

Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis.

AIM: So far, not many clinical examples that follow the IDEAL (Idea, Development, Evaluation, Assessment, and Long-term study) recommendations for evaluating and reporting surgical innovation and adoption are available. METHODS: In this article, all IDEAL stages will be described for a recent surgical innovation, the ileo neorectal anastomosis (INRA), a procedure restoring intestinal continuity after colectomy. RESULTS: INRA showed that the technique of small-bowel transposition with a vascular pedicle is feasible, with good long-term results. From the patient's point of view, no distinct advantage for INRA was found, with morbidity and functional results being in range with the gold standard ileal pouch anal anastomosis. CONCLUSION: The adoption of the IDEAL recommendations-that is, by performing evidence-based surgical studies-will improve surgical science, with the consequence that progress in surgical care continues and interventions become safer and more efficient and allow a better quality of life in surgical patients.

Computed Tomography-Based Radiomics Using Tumor and Vessel Features to Assess Resectability in Cancer of the Pancreatic Head.

The preoperative prediction of resectability pancreatic ductal adenocarcinoma (PDAC) is challenging. This retrospective single-center study examined tumor and vessel radiomics to predict the resectability of PDAC in chemo-naïve patients. The tumor and adjacent arteries and veins were segmented in the portal-venous phase of contrast-enhanced CT scans, and radiomic features were extracted. Features were selected via stability and collinearity testing, and least absolute shrinkage and selection operator application (LASSO). Three models, using tumor features, vessel features, and a combination of both, were trained with the training set (N = 86) to predict resectability. The results were validated with the test set (N = 15) and compared to the multidisciplinary team's (MDT) performance. The vessel-features-only model performed best, with an AUC of 0.92 and sensitivity and specificity of 97% and 73%, respectively. Test set validation showed a sensitivity and specificity of 100% and 88%, respectively. The combined model was as good as the vessel model (AUC = 0.91), whereas the tumor model showed poor performance (AUC = 0.76). The MDT's prediction reached a sensitivity and specificity of 97% and 84% for the training set and 88% and 100% for the test set, respectively. Our clinician-independent vessel-based radiomics model can aid in predicting resectability and shows performance comparable to that of the MDT. With these encouraging results, improved, automated, and generalizable models can be developed that reduce workload and can be applied in non-expert hospitals.

The effect of fibrin glue on the early healing phase of intestinal anastomoses in the rat.

PURPOSE: Protecting the anastomotic integrity using suture or staple line reinforcement remains an important goal for ongoing research. The present comprehensive study aims to establish the effects of fibrin glue on the early phase of anastomotic healing in the rat intestine. METHODS: One hundred and eight young adult male Wistar rats underwent resection and anastomosis of both the ileum and colon. In half, fibrin glue was applied around the anastomoses. Parameters for repair included wound strength, both bursting pressure and breaking strength at days 1, 3, and 5 after operation; hydroxyproline content; and histology, the latter also after 7 days. RESULTS: A transient colonic ileus was observed in the experimental group. Anastomotic breaking strength was always similar in both the control and fibrin glue groups. Anastomotic bursting pressures remained low at days 1 and 3, without any differences between the groups. In both groups, the bursting pressure increased sharply (p < 0.001) between days 3 and 5. At day 5, the bursting pressure in the fibrin glue group remained below than that in the controls, although only significantly (p = 0.0138) so in the ileum. At day 5, but not at day 7, the wounds in the fibrin glue group contained less collagen. Other aspects of microscopic wound architecture appeared to be the same. CONCLUSIONS: There is no justification for using fibrin glue on patent anastomoses constructed under low-risk conditions. Its potential benefit under conditions where chances for anastomotic leakage are enhanced needs further investigation.

Update of complications and functional outcome of the ileo-pouch anal anastomosis: overview of evidence and meta-analysis of 96 observational studies.

OBJECTIVE: The objective of this study is to provide a comprehensive update of the outcome of the ileo-pouch anal anastomosis (IPAA). DATA SOURCES: An extensive search in PubMed, EMBASE, and The Cochrane Library was conducted. STUDY SELECTION AND DATA EXTRACTION: All studies published after 2000 reporting on complications or functional outcome after a primary open IPAA procedure for UC or FAP were selected. Study characteristics, functional outcome, and complications were extracted. DATA SYNTHESIS: A review with similar methodology conducted 10 years earlier was used to evaluate developments in outcome over time. Pooled estimates were compared using a random-effects logistic meta-analyzing technique. Analyses focusing on the effect of time of study conductance, centralization, and variation in surgical techniques were performed. RESULTS: Fifty-three studies including 14,966 patients were included. Pooled rates of pouch failure and pelvic sepsis were 4.3% (95% CI, 3.5-6.3) and 7.5% (95% CI 6.1-9.1), respectively. Compared to studies published before 2000, a reduction of 2.5% was observed in the pouch failure rate (p = 0.0038). Analysis on the effect of the time of study conductance confirmed a decline in pouch failure. Functional outcome remained stable over time, with a 24-h defecation frequency of 5.9 (95% CI, 5.0-6.9). Technical surgery aspects did not have an important effect on outcome. CONCLUSION: This review provides up to date outcome estimates of the IPAA procedure that can be useful as reference values for practice and research. It is also shows a reduction in pouch failure over time.

Paracetamol does not compromise early wound repair in the intestine or abdominal wall in the rat.

BACKGROUND: Paracetamol is a cornerstone for perioperative pain relief. Its mechanism of action may include a local anti-inflammatory effect with inhibition of cyclooxygenase isoenzymes. The scarce literature available on its effects on wound healing consists of preclinical studies into the effect of paracetamol on healing of the musculoskeletal system. Although the drug is used abundantly for pain relief after surgery of the gastrointestinal tract, there are no published data on the influence of paracetamol on anastomotic and abdominal healing. This also holds for the crucial, early inflammatory phase of repair. The recovery of wound strength could therefore conceivably be affected by paracetamol. METHODS: In 78 male Wistar rats, we constructed an anastomosis in colon and ileum. The rats received either low- or high-dose (50 or 200 mg/kg/d, divided over 2 doses) paracetamol or vehicle (controls) until they were killed on day 3 or 7 after surgery (n = 13 each). In anastomoses, the main outcome variables were 2 independent measures for wound strength, bursting pressure, and breaking strength, the latter being the primary outcome variable. In addition, collagen levels were measured and histology was performed. In fascia, breaking strength was analyzed. RESULTS: No significant differences were found between control and paracetamol-treated groups at any time point for any of the variables. Wound strength increased significantly from day 3 to day 7 in all groups. In the colon anastomosis, the breaking strength increased from 130 ± 9 g (mean ± SEM) at day 3 to 232 ± 17 g at day 7 in the control group, from 144 ± 10 to 224 ± 9 g in the low-dose group, and from 130 ± 12 to 263 ± 28 g in the high-dose group. The lower limit for the 95% confidence interval was -11 for the difference between control and low-dose groups at day 3 and -25 for the difference between control and high-dose groups. No differences in collagen levels were found between the high-dose and control groups. Histology did not indicate the presence of gross differences between groups. CONCLUSIONS: Perioperative use of paracetamol in a rat model of intestinal surgery does not significantly impede wound repair in the early postoperative period.

Carprofen for perioperative analgesia causes early anastomotic leakage in the rat ileum.

BACKGROUND: There is increasing evidence that perioperative use of NSAIDs may compromise the integrity of intestinal anastomoses. This study aims to characterize the negative effects of carprofen on early anastomotic healing in the rat ileum. RESULTS: In 159 male Wistar rats an anastomosis was constructed in the ileum. In experiment 1 eighty-four rats were divided over control and experimental groups, which received daily buprenorphine or carprofen, respectively, as an analgesic and were killed on day 1, 2 or 3 after surgery. In experiment 2 three groups of 15 rats received carprofen either immediately after surgery or with a delay of 1 or 2 days. Animals were killed after 3 days of carprofen administration. In experiment 3 three groups of 10 rats received different doses (full, half or quarter) of carprofen from surgery. In significant contrast to buprenorphine, which never did so, carprofen induced frequent signs of anastomotic leakage, which were already present at day 1. If first administration was delayed for 48 hours, the leakage rate was significantly reduced (from 80 to 20%; p = 0.0028). Throughout the study, the anastomotic bursting pressure was lowest in animals who displayed signs of anastomotic leakage. Loss of anastomotic integrity did not coincide with reduced levels of hydroxyproline or increased activity of matrix metalloproteinases. CONCLUSIONS: Carprofen interferes with wound healing in the rat ileum at a very early stage. Although the mechanisms responsible remain to be fully elucidated, one should be aware of the potential of NSAIDs to interfere with the early phase of wound repair.

Misdiagnosis of OTA type B (Weber B) ankle fractures leading to nonunion.

Little is known about the specific etiology of nonunion of stable Orthopaedic Trauma Association (OTA) type B fractures. In the present retrospective cohort study, we investigated all patients with a nonunion in a level 1 trauma center during an 8.5-year period. Patient history, clinical findings, radiographic features, and therapeutic aspects were critically evaluated to be able to predict the nonunion. In the predefined period, 388 patients were treated for a stable OTA type B fracture. Eight patients (2.1%) developed a nonunion. Retrospectively, the radiographic features in 6 of the 8 patients and clinical findings in 1 of the 8 patients could predict the nonunion. We conclude that in almost every nonunion occurring after a "stable" OTA type B fracture in the present study were, in fact, originally unstable fractures.

Use of an acrylic mold for mortise view improvement in ankle fractures: a feasibility study.

We investigated an acrylic mold for use in obtaining ankle radiographs in 31 consecutive patients with ankle fracture. The radiologic examination consisted of routine lateral and mortise views, with the same views procured with the use of the acrylic mold to position the ankle. Radiographic evidence of ankle displacement was ascertained using both sets of radiographs, and 3 radiographic spaces (lateral talofibular, central talotibial, and medial talotibial) were considered identifiable on the mortise view. The routine radiographs identified 58 joint spaces (62.37%) and the use of the acrylic mold showed 74 (79.57%; p < .0001). On the basis of the medial clear space, surgical repair was indicated in 6 patients (19.36%) using the routine radiographs and in 8 (25.81%) using the radiographs procured with the acrylic mold (p = .317). On the basis of fibular dislocation alone, surgical repair was indicated in 12 patients (38.71%) using the routine radiographs and in 15 (48.39%) using the radiographs procured with the acrylic mold (p = .083). On the basis of medial clear space and fibular dislocation, surgery was indicated in 12 patients (38.71%) using the routine radiographs and in 16 (51.61%) using the radiographs procured with the acrylic mold (p = .046). The sensitivity and specificity of the radiographs obtained with the acrylic mold was 75% and 100%, respectively. We concluded that the use of the acrylic mold improved the radiographic diagnostic accuracy compared with routine radiographs for the treatment of ankle fractures.

A prospective cohort study to investigate cost-minimisation, of Traditional open, open fAst track recovery and laParoscopic fASt track multimodal management, for surgical patients with colon carcinomas (TAPAS study).

BACKGROUND: The present developments in colon surgery are characterized by two innovations: the introduction of the laparoscopic operation technique and fast recovery programs such as the Enhanced Recovery After Surgery (ERAS) recovery program. The Tapas-study was conceived to determine which of the three treatment programs: open conventional surgery, open 'ERAS' surgery or laparoscopic 'ERAS' surgery for patients with colon carcinomas is most cost minimizing? METHOD/DESIGN: The Tapas-study is a three-arm multicenter prospective cohort study. All patients with colon carcinoma, eligible for surgical treatment within the study period in four general teaching hospitals and one university hospital will be included. This design produces three cohorts: Conventional open surgery is the control exposure (cohort 1). Open surgery with ERAS recovery (cohort 2) and laparoscopic surgery with ERAS recovery (cohort 3) are the alternative exposures. Three separate time periods are used in order to prevent attrition bias. Primary outcome parameters are the two main cost factors: direct medical costs (real cost price calculation) and the indirect non medical costs (friction method). Secondary outcome parameters are mortality, complications, surgical-oncological resection margins, hospital stay, readmission rates, time back to work/recovery, health status and quality of life. Based on an estimated difference in direct medical costs (highest cost factor) of 38% between open and laparoscopic surgery (alfa = 0.01, beta = 0.05), a group size of 3 x 40 = 120 patients is calculated. DISCUSSION: The Tapas-study is three-arm multicenter cohort study that will provide a cost evaluation of three treatment programs for patients with colon carcinoma, which may serve as a guideline for choice of treatment and investment strategies in hospitals. TRIAL REGISTRATION: ISRCTN44649165.

A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.

BACKGROUND: Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS: Multicenter randomized controlled trial including 120 women with a serum ferritin <20 µg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS: At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION: In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The study was registered at clinicaltrials.gov under number NCT02271997.

Long-term nutritional status in patients following Roux-en-Y gastric bypass surgery.

BACKGROUND & AIMS: Roux-en-Y gastric bypass (RYGB) is an effective treatment for obesity. However, it also leads to multiple nutritional deficiencies. Much is known about the short term prevalence, but hardly any long term data is available on deficiencies. The aim of this study was to assess the long term outcome of nutritional status after RYGB. METHODS: We performed a retrospective analysis of prospectively collected data obtained from 51 morbidly obese patients who underwent a primary laparoscopic RYGB. Primary outcomes were iron, vitamin B12 and vitamin D deficiencies. Secondary outcomes were deficiencies of other vitamins and minerals and compliance of the patients to multivitamin use. RESULTS: The mean follow-up was 81 ± 27 months. A total of 35%, 16% and 55% of the patients had deficiencies for iron, vitamin B12 and vitamin D respectively. Sixty-nine percent of patients used a (nonspecific) multivitamin supplement on a daily basis. Patients with multivitamin usage had a lower rate of iron deficiency (26% vs. 56%, p = 0.034), vitamin B12 (11% vs. 25%, p = 0.46) and vitamin D (46% vs. 75%, p = 0.07), compared to non-compliant patients. CONCLUSIONS: Nutritional deficiencies are common after a RYGB operation. Therefore, strict follow-up by a bariatric surgeon, endocrinologist or general practitioner is required, both short and long term.