Pre-operative Radiotherapy And Deep Inferior Epigastric Artery Perforator (DIEP) flAp study (PRADA): Aesthetic outcome and patient satisfaction at one year.

INTRODUCTION: The optimal combination of radiotherapy and breast reconstruction has not yet been defined. Post-mastectomy radiotherapy (PMRT) has deleterious effects on breast reconstruction, leading to caution amongst surgeons. Pre-operative radiotherapy (PRT) is a growing area of interest, is demonstrated to be safe, and spares autologous flaps from radiotherapy. This study evaluates the aesthetic outcome of PRT and deep inferior epigastric artery perforator (DIEP) flap reconstruction within the Pre-operative Radiotherapy And Deep Inferior Epigastric artery Perforator (DIEP) flAp (PRADA) cohort. METHODS: PRADA was an observational cohort study designed to evaluate the feasibility and safety of PRT for women undergoing neoadjuvant chemotherapy and DIEP reconstruction. Panel evaluation of 3D surface images (3D-SIs) and patient-reported outcome measures (BREAST-Q) for a subset of women in the study were compared with those of a DIEP-PMRT cohort who had undergone DIEP reconstruction and PMRT. RESULTS: Seventeen out of 33 women from the PRADA study participated in this planned substudy. Twenty-eight women formed the DIEP-PMRT cohort (median follow-up 23 months). The median (inter-quartile range [IQR]) 'satisfaction with breasts' score at 12 months for the PRADA cohort was significantly better than the DIEP-PMRT cohort (77 [72-87] versus 64 [54-71], respectively), p=0.01). Median [IQR] panel evaluation (5-point scale) was also significantly better for the PRADA cohort than for the DIEP-PMRT cohort (4.3 [3.9-4.6] versus 3.6 [2.8-4] p=0.003). CONCLUSIONS: Aesthetic outcome for the PRADA cohort was reported to be 'good' or 'excellent' in 93% of cases using a bespoke panel assessment with robust methodology. Patient satisfaction at one year is encouraging and superior to DIEP-PMRT at 23 months. Switching surgery-radiotherapy sequencing leads to similar breast aesthetic outcomes and warrants further large-scale, multi-centre evaluation in a randomised trial

A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

Meeting abstrac

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics

Predictors for anastomotic leak, postoperative complications, and mortality after right colectomy for cancer: Results from an international snapshot audit

Background: A right hemicolectomy is among the most commonly performed operations for colon cancer, but modern high-quality, multination data addressing the morbidity and mortality rates are lacking. Objective: This study reports the morbidity and mortality rates for right-sided colon cancer and identifies predictors for unfavorable short-term outcome after right hemicolectomy. Design: This was a snapshot observational prospective study. Setting: The study was conducted as a multicenter international study. Patients: The 2015 European Society of Coloproctology snapshot study was a prospective multicenter international series that included all patients undergoing elective or emergency right hemicolectomy or ileocecal resection over a 2-month period in early 2015. This is a subanalysis of the colon cancer cohort of patients. Main Outcome Measures: Predictors for anastomotic leak and 30-day postoperative morbidity and mortality were assessed using multivariable mixed-effect logistic regression models after variables selection with the Lasso method. Results: Of the 2515 included patients, an anastomosis was performed in 97.2% (n = 2444), handsewn in 38.5% (n = 940) and stapled in 61.5% (n = 1504) cases. The overall anastomotic leak rate was 7.4% (180/2444), 30-day morbidity was 38.0% (n = 956), and mortality was 2.6% (n = 66). Patients with anastomotic leak had a significantly increased mortality rate (10.6% vs 1.6% no-leak patients; p 65 0.001). At multivariable analysis the following variables were associated with anastomotic leak: longer duration of surgery (OR = 1.007 per min; p = 0.0037), open approach (OR = 1.9; p = 0.0037), and stapled anastomosis (OR = 1.5; p = 0.041). Limitations: This is an observational study, and therefore selection bias could be present. For this reason, a multivariable logistic regression model was performed, trying to correct possible confounding factors. Conclusions: Anastomotic leak after oncologic right hemicolectomy is a frequent complication, and it is associated with increased mortality. The key contributing surgical factors for anastomotic leak were anastomotic technique, surgical approach, and duration of surgery

ESICM LIVES 2016: part two : Milan, Italy. 1-5 October 2016.

Meeting abstrac

Relationship between method of anastomosis and anastomotic failure after right hemicolectomy and ileo-caecal resection: an international snapshot audit

Aim The anastomosis technique used following right-sided colonic resection is widely variable and may affect patient outcome. This study aimed to assess the association between leak and anastomosis technique (stapled vs handsewn). Method This was a prospective, multicentre, international audit including patients undergoing elective or emergency right hemicolectomy or ileo-caecal resection operations over a 2-month period in early 2015. The primary outcome measure was the presence of anastomotic leak within 30 days of surgery, determined using a prespecified definition. Mixed effects logistic regression models were used to assess the association between leak and anastomosis method, adjusting for patient, disease and operative cofactors, with centre included as a random-effect variable. Results This study included 3208 patients, of whom 78.4\% (n = 2515) underwent surgery for malignancy and 11.7\% (n = 375) underwent surgery for Crohn's disease. An anastomosis was performed in 94.8\% (n = 3041) of patients, which was handsewn in 38.9\% (n = 1183) and stapled in 61.1\% (n = 1858). Patients undergoing hand-sewn anastomosis were more likely to be emergency admissions (20.5\% handsewn vs 12.9\% stapled) and to undergo open surgery (54.7\% handsewn vs 36.6\% stapled). The overall anastomotic leak rate was 8.1\% (245/3041), which was similar following handsewn (7.4\%) and stapled (8.5\%) techniques (P = 0.3). After adjustment for cofactors, the odds of a leak were higher for stapled anastomosis (adjusted OR = 1.43; 95\% CI: 1.04-1.95; P = 0.03). Conclusion Despite being used in lower-risk patients, stapled anastomosis was associated with an increased anastomotic leak rate in this observational study. Further research is needed to define patient groups in whom a stapled anastomosis is safe