The impact of pre‐operative intravenous iron on quality of life after colorectal cancer surgery: outcomes from the intravenous iron in colorectal cancer‐associated anaemia (IVICA) trial

Anaemia is associated with a reduction in quality of life, and is common in patients with colorectal cancer . Werecently reported thefindings of the intravenous iron in colorectal cancer-associated anaemia (IVICA) trialcomparing haemoglobin levels and transfusion requirements following intravenous or oral iron replacement inanaemic colorectal cancer patients undergoing elective surgery. In this follow-up study, we compared theefficacy of intravenous and oral iron at improving quality of life in this patient group. We conducted amulticentre, open-label randomised controlled trial. Anaemic colorectal cancer patients were randomlyallocated at least two weeks pre-operatively, to receive either oral (ferrous sulphate) or intravenous (ferriccarboxymaltose) iron. We assessed haemoglobin and quality of life scores at recruitment, immediately beforesurgery and at outpatient review approximately three months postoperatively, using the Short Form 36,EuroQoL 5-dimension 5-level and Functional Assessment of Cancer Therapy–Anaemia questionnaires. Werecruited 116 anaemic patients across seven UK centres (oral iron n=61 (53%), and intravenous iron n=55(47%)). Eleven quality of life components increased by a clinically significant margin in the intravenous irongroup between recruitment and surgery compared with one component for oral iron. Median (IQR [range])visual analogue scores were significantly higher with intravenous iron at a three month outpatient review (oraliron 70, (60–85 [20–95]); intravenous iron 90 (80–90 [50–100]), p=0.001). The Functional Assessment ofCancer Therapy–Anaemia score comprises of subscales related to cancer, fatigue and non-fatigue itemsrelevant to anaemia. Median outpatient scores were higher, and hence favourable, for intravenous iron on theFunctional Assessment of Cancer Therapy–Anaemia subscale (oral iron 66 (55–72 [23–80]); intravenous iron 71(66–77 [46–80]); p=0.002), Functional Assessment of Cancer Therapy–Anaemia trial outcome index (oral iron108 (90–123 [35–135]); intravenous iron 121 (113–124 [81–135]); p=0.003) and Functional Assessment ofCancer Therapy–Anaemia total score (oral iron 151 (132–170 [69–183]); intravenous iron 168 (160–174 [125–186]); p=0.005). Thesefindings indicate that intravenous iron is more efficacious at improving quality of lifescores than oral iron in anaemic colorectal cancer patients

Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial

Background: Closure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site. Methods: In this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964. Findings: Between Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43–0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26–0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60–1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54–1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events. Interpretation: Reinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias. Funding: National Institute for Health Research Research for Patient Benefit and Allergan