Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial.

BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.

Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) feasibility trial protocol: a multicentre, feasibility cohort study with embedded randomised control trial to compare sacral neuromodulation and transanal irrigation to optimised conservative management in the management of major low anterior resection syndrome following rectal cancer treatment.

INTRODUCTION: Rectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to bowel function known as low anterior resection syndrome (LARS). There are currently no clear guidelines on the management of LARS with only limited evidence for different treatment modalities. METHODS AND ANALYSIS: Patients who have undergone an anterior resection for rectal cancer in the last 10 years will be approached for the study. The feasibility trial will take place in four centres with a 9-month recruitment window and 12 months follow-up period. The primary objective is to assess the feasibility of recruitment to the POLARiS trial which will be achieved through assessment of recruitment, retainment and follow-up rates as well as the prevalence of major LARS.Feasibility outcomes will be analysed descriptively through the estimation of proportions with confidence intervals. Longitudinal patient reported outcome measures will be analysed according to scoring manuals and presented descriptively with reporting graphically over time. ETHICS AND DISSEMINATION: Ethical approval has been granted by Wales REC1; Reference 22/WA/0025. The feasibility study is in the process of set up. The results of the feasibility trial will feed into the design of an expanded, international trial. TRIAL REGISTRATION NUMBER: CT05319054.

Dynamic Article: Permanent Sacral Nerve Stimulation Under Local Anesthesia: Feasibility, Best Practice, and Patient Satisfaction.

BACKGROUND: The increasing incidence of fecal incontinence and the use of sacral neuromodulation have an increasing impact on health care providers and health care costs. OBJECTIVE: The purpose of this study was to investigate the technical and clinical success rates, complications, and patient satisfaction of the implantation of permanent sacral nerve stimulation under local anesthesia. DESIGN: A cohort analysis of consecutive patients with sacral nerve stimulation for fecal incontinence over a period of 1 year was performed. SETTINGS: This study was conducted at a specialized pelvic floor unit in a tertiary care center. PATIENTS: Sixty-one patients were available for the assessment after 1-year follow-up. MAIN OUTCOME MEASURES: Technical success, procedural time, and complications were noted. Clinical outcome (including Fecal Incontinence Severity Index, Fecal Incontinence Quality of Life scale, and Gastrointestinal Quality of Life Index were collected prospectively before and after treatment. RESULTS: All procedures were successfully completed under local anesthesia, with a median total procedural time of 50 minutes (range, 26-72 minutes). All patients were discharged on the day of their procedure. Postoperative complications occurred in 3 patients (4.9%). At 3 months follow-up, the median Fecal Incontinence Severity Index score was reduced from 37 to 27 (p = 0.001). Both the Fecal Incontinence Quality of Life scale and the Gastrointestinal Quality of Life Index had improved from 63 to 82 (p < 0.001) and 72 to 90 (p = 0.012). At a mean follow-up of 13 months, both the Fecal Incontinence Quality of Life scale and the Gastrointestinal Quality of Life Index improved further to 90 (p < 0.001) and 94 (p < 0.001). All patients would recommend the procedure under local anesthesia to other patients. No patients experienced leg pain during follow-up. LIMITATIONS: This study involved a relatively small group of patients, and patient satisfaction was only recorded for the last 22 patients. No exact cost calculations were made. CONCLUSIONS: Permanent sacral nerve stimulation implantation under local anesthesia has high technical and clinical success rates. It is safe, well tolerated by patients, and has obvious logistical and financial benefits.

Sacral neuromodulation for faecal incontinence: is the outcome compromised in patients with high-grade internal rectal prolapse?

BACKGROUND: High-grade internal rectal prolapse appears to be one of the contributing factors in the multifactorial origin of faecal incontinence. Whether it affects the outcome of sacral neuromodulation is unknown. We compared the functional results of sacral neuromodulation for faecal incontinence in patients with and without a high-grade internal rectal prolapse. METHOD: One hundred six consecutive patients suffering from faecal incontinence, who were eligible for sacral neuromodulation between 2009 and 2012, were identified from a prospective database. All patients underwent preoperative defaecating proctography, anorectal manometry and ultrasound. Symptoms were assessed preoperatively and at 12 months after operation using a standardized questionnaire incorporating the Faecal Incontinence Severity Index (FISI range = 0-61) and the Gastrointestinal Quality of Life Index (GIQLI). Success was defined as a decrease in the FISI score of 50 % or more. RESULTS: High-grade internal rectal prolapse (HIRP) was found in 36 patients (34%). The patient characteristics were similar in both groups. Temporary test stimulation was successful in 60 patients without HIRP (86%) and in 25 patients with HIRP (69 %) (p = 0.03). A permanent pulse generator was then implanted on these patients. After 1-year follow-up, the median FISI was reduced in patients without HIRP from 37 to 23 (p < 0.01). No significant change in FISI score was observed in patients with a HIRP (FISI, 38 to 34; p = 0.16). Quality of life (GIQLI) was only improved in patients without HIRP. A successful outcome per protocol was achieved in 31 patients without HIRP (52%) versus 4 patients with HIRP (16%) (p < 0.01). CONCLUSION: The presence of a high-grade internal rectal prolapse has a detrimental effect on sacral neuromodulation for faecal incontinence.