Recommendations from the ERAS® Society for standards for the development of enhanced recovery after surgery guidelines.

BACKGROUND: ERAS® Society guidelines are holistic, multidisciplinary tools designed to improve outcomes after surgery. The enhanced recovery after surgery (ERAS) approach was initially developed for colorectal surgery and has been implemented successfully across a large number of settings, resulting in improved patient outcomes. As the ERAS approach is increasingly being adopted worldwide and new guidelines are being generated for new populations, there is a need to define an ERAS® Society guideline and the methodology that should be followed in its development. METHODS: The ERAS® Society recommended approach for developing new guidelines is based on the creation of multidisciplinary guideline development groups responsible for defining topics, planning the literature search, and assessing the quality of the evidence. RESULTS: Clear definitions for the elements of an ERAS guideline involve multimodal and multidisciplinary approaches impacting on multiple patient outcomes. Recommended methodology for guideline development follows a rigorous approach with systematic identification and evaluation of evidence, and consensus-based development of recommendations. Guidelines should then be evaluated and reviewed regularly to ensure that the best and most up-to-date evidence is used consistently to support surgical patients. CONCLUSION: There is a need for a standardized, evidence-informed approach to both the development of new ERAS® Society guidelines, and the adaptation and revision of existing guidelines.

ANTECEDENTES: Las guías de la sociedad ERAS® (Enhanced Recovery After Surgery) son herramientas holísticas y multidisciplinares diseñadas para mejorar los resultados después de la cirugía. Los programas ERAS (guías de recuperación intensificada) se desarrollaron inicialmente para la cirugía colorrectal y se han implementado con éxito en muchos otros ámbitos, lo que resulta en mejores resultados para los pacientes. A medida que los programas ERAS se adoptan cada vez más en todo el mundo y se generan nuevas guías para nuevas poblaciones, es necesario definir una guía clínica de la sociedad ERAS® y la metodología a seguir para su desarrollo. MÉTODOS: La sociedad ERAS® recomienda que el enfoque para desarrollar las nuevas guías se base en el establecimiento de grupos multidisciplinares responsables de la definición de los temas, planteamiento de la revisión de la literatura y valoración de la calidad de la evidencia. RESULTADOS: Las definiciones precisas de los elementos de una guía ERAS implican enfoques multimodales y multidisciplinares que tengan en cuenta los múltiples resultados que afectan a los pacientes. La metodología recomendada para el desarrollo de guías debe seguir un enfoque riguroso con identificación sistemática y evaluación de evidencia, y el desarrollo de recomendaciones basadas en el consenso. Posteriormente, las guías deben evaluarse y revisarse regularmente para garantizar que la evidencia mejor y más actualizada se aplique al manejo de los pacientes quirúrgicos. CONCLUSIÓN: Es necesario un enfoque estandarizado, basado en la evidencia, tanto para el desarrollo de nuevas guías de la sociedad ERAS® como para la adaptación y revisión de las guías ya existentes.

Sustainability of the relationship between preoperative symptoms and postoperative improvement in quality of life after inguinal hernia repair.

PURPOSE: Chronic pain and discomfort are common before and after inguinal hernia repair (IHR) and pain is clearly linked to reduced quality of life (QoL). The long-term effect of IHR on QoL in relation to preoperative symptoms is incompletely described. METHODS: 309 men (18-75 years) undergoing IHR under local anesthesia and day care surgery were included. Pre- and postoperative symptoms, pain and QoL (SF-36) were measured before and up to 3 years after surgery. RESULTS: Before surgery, 197 patients (64%) reported pain (VAS 0.9-5.4) from their inguinal hernia. 102 patients (33%) had other inguinal symptoms, and 26% were asymptomatic. Patients with preoperative groin pain (P) scored their physical QoL (PCS) lower compared with controls (C) (median (IQR) 43.5 (34.7-50.3) vs. 53.9 (47.8-56.9, p < 0.001)), whereas patients with no pain (N) did not (53.0 (47.9-55.9), p = 0.57). Mental QoL was not affected before or after surgery. At 1, 2 and 3 years after surgery, 14, 12 and 7% of patients, respectively, reported groin pain. In P, PCS increased from 43.5 before surgery to 55.3 (p < 0.001) at 36 months, but was unchanged in N (53.0 vs 55.9, p = ns). CONCLUSIONS: The incidence of inguinal pain decreases over time after inguinal hernia repair. Both preoperative reduction and long-term improvement in physical QoL are strongly associated with the presence of preoperative groin pain. This supports, from a QoL perspective, that patients with preoperative pain are those who benefit the most from IHR, also from a long-term perspective.

Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS®) Society Recommendations: 2018.

BACKGROUND: This is the fourth updated Enhanced Recovery After Surgery (ERAS®) Society guideline presenting a consensus for optimal perioperative care in colorectal surgery and providing graded recommendations for each ERAS item within the ERAS® protocol. METHODS: A wide database search on English literature publications was performed. Studies on each item within the protocol were selected with particular attention paid to meta-analyses, randomised controlled trials and large prospective cohorts and examined, reviewed and graded according to Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. RESULTS: All recommendations on ERAS® protocol items are based on best available evidence; good-quality trials; meta-analyses of good-quality trials; or large cohort studies. The level of evidence for the use of each item is presented accordingly. CONCLUSIONS: The evidence base and recommendation for items within the multimodal perioperative care pathway are presented by the ERAS® Society in this comprehensive consensus review.

Robotic vs laparoscopic rectal tumour surgery: a cohort study.

AIM: The aim of this study was to compare robotic and laparoscopic rectal surgery in terms of perioperative data, short-term outcome and compliance to the Enhanced Recovery After Surgery (ERAS) protocol. METHOD: In this cohort study, 224 patients scheduled for rectal resection for cancer or adenoma between January 2011 and January 2017 were evaluated. In the first time period (12 January 2011 to 23 April 2014), 47 (46%) of 102 patients had laparoscopic surgery. In the second time period (24 April 2014 to 30 January 2017), 72 (59%) of 122 patients had robotic surgery. Perioperative data and short-term outcome were collected from the ERAS database and patient charts. Data obtained from laparoscopic and robotic surgery in the two time periods studied were compared. Primary outcome was hospital length of stay (LOS) and secondary outcomes were compliance to the ERAS protocol, difference in postoperative complications and conversion to open surgery. RESULTS: Compliance to the ERAS protocol was 81.1% in the robotic group and 83.4% in the laparoscopic group (P = 0.890). Robotic surgery was associated with shorter median LOS (3 days vs 7 days, P < 0.001), lower conversion rate (11.1% vs 34.0%, P = 0.002), lower rate of postoperative complications (25% vs 49%, P < 0.01) and longer duration of surgery (5.8 h vs 4.5 h, P < 0.001). The differences remained after multivariate analysis. CONCLUSION: Robotic surgery was associated with shorter LOS, lower conversion rates and fewer postoperative complications compared with laparoscopic surgery. Robotic surgery may add benefits to the ERAS protocol.

Rates of and methods used at reoperation for recurrence after primary inguinal hernia repair with Prolene Hernia System and Lichtenstein.

INTRODUCTION: Since the introduction of tension-free mesh repair of inguinal hernia ad modum Lichtenstein (L), recurrence rates have been reduced to 1-2%. The bi-layer mesh Prolene Hernia System (PHS) is an alternative mesh with a theoretical potential to further reduce recurrence rates. However, a reoperation due to recurrence after PHS might be technically difficult since both the anterior and posterior space has been utilized. METHODS: Data on all males 18-75 years undergoing primary inguinal hernia repair (IHR) with PHS or L between January 1999 and October 2010 was collected from the Swedish Hernia Register (SHR). Moreover, data was collected for all operations due to recurrence after primary IHR with PHS or L between January 1st 1999 and December 31st 2014. RESULTS: A total of 1229 primary IHR with PHS and 78,230 with L was identified. Rates of reoperation for recurrence after PHS was significantly lower compared to L (1.5 vs. 2.7 %), [OR 0.38 (0.20-0.74)]. A medial recurrence was most common in both groups. At reoperation, an open anterior mesh repair was used in 74 % after PHS and a posterior mesh repair was performed in 58 % after L. Re-operating time was shorter, although not statistically significant in the PHS group (47 vs. 58 min, p = 0.29). Complication rates after surgery due to recurrence did not differ between groups. CONCLUSION: The findings from this dataset suggest that recurrence rates after primary IHR with PHS might be lower and that reoperation due to recurrence after PHS is not more complicated than after L.

The impact of perioperative fluid therapy on short-term outcomes and 5-year survival among patients undergoing colorectal cancer surgery - A prospective cohort study within an ERAS protocol.

BACKGROUND: Restricted perioperative fluid therapy is one of several interventions in the enhanced recovery after surgery (ERAS) protocol, designed to reduce morbidity and hospital stay after surgery. The impact of this single intervention on short and long term outcome after colorectal surgery is unknown. PATIENTS AND METHODS: This cohort study includes all consecutive patients operated with abdominal resection of colorectal cancer 2002-2007 at Ersta Hospital, Stockholm, Sweden. All patients were treated within an ERAS protocol and registered in the ERAS-database. Compliance to interventions in the ERAS protocol was analysed. The impact of a restrictive perioperative fluid therapy (≤3000 ml on the day of surgery) protocol on short-term outcomes as well as 5-year survival was assessed with multivariable analysis adjusted for confounding factors. RESULTS: Nine hundred and eleven patients were included. Patients receiving ≤3000 ml of intravenous fluids on the day of surgery had a lower risk of complications OR 0.44 (95% C I 0.28-0.71), symptoms delaying discharge OR 0.47(95% C I 0.32-0.70) and shorter length of stay compared with patients receiving >3000 ml. In cox regression analysis, the risk of cancer specific death was reduced with 55% HR 0.45(95% C I 0.25-0.81) for patients receiving ≤ 3000 ml compared with patients receiving >3000 ml. CONCLUSION: A restrictive compared with a non-restrictive perioperative fluid therapy on the day of surgery may be associated with lower short-term complication rates, faster recovery, shorter length of stay and improved 5-year survival.

The effect of diverting stoma on long-term morbidity and risk for permanent stoma after low anterior resection for rectal cancer.

BACKGROUND: Anastomotic leakage (AL) is a severe complication after low anterior resection (LAR) in rectal cancer surgery. A diverting loop ileostomy has been reported to reduce early clinical AL and thereby decrease short-term morbidity. Less is known if long-term morbidity is affected by a loop ileostomy constructed at LAR. METHODS: At Ersta Hospital, Sweden, 287 consecutive patients were operated on with LAR, 2002-2011. Follow-up time was 3 years after LAR. Due to a shift in routines, 15% were diverted at LAR, 2002-2006 and 91%, 2007-2011. Data on long-term morbidity and permanent stoma in patients with or without a diversion at primary surgery were compared. RESULTS: During LAR, 139 patients were diverted (S+), 148 were not (S-). Total rate of AL, both early and late, was 26% in S+ and 30% in S-, p 0.25. Late AL (>30 days after LAR) was found in 6% and 15% were readmitted in the late postoperative period with no difference between the groups. Total length of hospital stay (30 days-3 years after LAR) was longer among S+ compared to S-, mean 7 vs. 4 days (p < 0.001). One out of six ended up with a permanent stoma (17% S+, 14% S-, p 0.47). Clinical AL was an independent risk factor and the most common cause for a permanent stoma in both groups. CONCLUSION: A diverting loop ileostomy at LAR did not reduce long-term morbidity but was associated with a longer total length of hospital stay during a 3-year follow up.

UltraPro Hernia System, Prolene Hernia System and Lichtenstein for primary inguinal hernia repair: 3-year outcomes of a prospective randomized controlled trial.

PURPOSE: Chronic pain and discomfort are common after inguinal hernia repair (IHR). In this study, results from a 3-year follow-up from a randomized controlled study comparing three different mesh repairs for postoperative pain, discomfort, Quality of Life (QoL) and patient satisfaction are reported. METHODS: Between November 1, 2006 and January 31, 2009, 309 men, who underwent day surgery for primary unilateral inguinal hernia under local anesthesia, were randomized to three different mesh repairs; UltraPro Hernia System (U), Prolene Hernia System (P) and Lichtenstein procedure (L). RESULTS: Preoperatively, there were no differences between groups regarding demographics, symptoms, inguinal pain or QoL (SF-36 and a hernia-specific questionnaire). Operating time, postoperative pain, complications and time to full recovery were similar. At 36 months, 21 patients indicated pain [L, n = 6, P, n = 6 and U, n = 9; VAS (median (IQR)): L 0.4 (0.2-1.7), P 0.2 (0.1-2.3) and U 1.6 (0.7-4.6), p = ns]. Physical QoL was reduced in all groups before surgery and was similarly increased to normal levels after 3 months without further changes throughout the study. Although 92 % of participants were satisfied, sixteen percent reported any discomfort from the groin (ns between groups). Five recurrences were reported (L, n = 2, P, n = 1 and U, n = 2, p = ns). CONCLUSIONS: After 3 years of follow-up, all three procedures provided equally good results regarding, pain, discomfort and QoL and could therefore be recommended for primary IHR in LA.

Laparoscopic and open right-sided colonic resection in daily routine practice. A prospective multicentre study within an Enhanced Recovery After Surgery (ERAS) protocol.

AIM: The study compared the outcome of laparoscopic and open surgery in daily practice when performed in a strict Enhanced Recovery After Surgery (ERAS) environment. METHOD: Two-hundred and ninety-two consecutive patients who received elective surgery, in three Swedish ERAS centres, for cancer or adenoma in the right colon in the period 1 January 2011 to 31 December 2012, were prospectively registered in a Web-based ERAS database. Peri-operative data were collected from the database and patient charts. The primary end-points included postoperative recovery and morbidity. The secondary objective was to identify preoperative variables that influenced the selection of patients for laparoscopic or open surgery. RESULTS: One-hundred and twenty-three (42%) patients were selected for laparoscopic surgery. The overall preoperative ERAS-compliance rate was 87% and no significant difference was seen between the surgical techniques. In multivariate analysis, patients treated with laparoscopy had significantly earlier pain control (2.4 ± 3.2 days vs 4.2 ± 5.9 days; P = 0.016) and a shorter length of hospital stay (LOS) (4 days vs 6 days; P = 0.002) compared with open surgery. There was no significant difference in the complication rate [18.7% vs 21.3%; OR = 1.0 (95% CI: 0.5-2.0)], the number of lymph nodes removed or the rate of R0 resection between laparoscopic and open surgery. Tumours selected for laparoscopy were generally smaller, had a lower T-stage and were predominantly situated in the caecum and the ascending colon compared with those of patients selected for open surgery. CONCLUSION: The use of laparoscopy in routine right-sided colectomy in an ERAS environment, with data on outcome corrected for selection bias, may result in faster recovery compared with open surgery.

External validation of models predicting the individual risk of metachronous peritoneal carcinomatosis from colon and rectal cancer.

AIM: To externally validate previously published predictive models of the risk of developing metachronous peritoneal carcinomatosis (PC) after resection of nonmetastatic colon or rectal cancer and to update the predictive model for colon cancer by adding new prognostic predictors. METHOD: Data from all patients with Stage I-III colorectal cancer identified from a population-based database in Stockholm between 2008 and 2010 were used. We assessed the concordance between the predicted and observed probabilities of PC and utilized proportional-hazard regression to update the predictive model for colon cancer. RESULTS: When applied to the new validation dataset (n = 2011), the colon and rectal cancer risk-score models predicted metachronous PC with a concordance index of 79% and 67%, respectively. After adding the subclasses of pT3 and pT4 stage and mucinous tumour to the colon cancer model, the concordance index increased to 82%. CONCLUSION: In validation of external and recent cohorts, the predictive accuracy was strong in colon cancer and moderate in rectal cancer patients. The model can be used to identify high-risk patients for planned second-look laparoscopy/laparotomy for possible subsequent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

The effect of diverting stoma on postoperative morbidity after low anterior resection for rectal cancer in patients treated within an ERAS program.

BACKGROUND: Anastomotic leakage (AL) is a serious complication after low anterior resection (LAR) with total mesorectal excision (TME) for rectal cancer. Whether the Enhanced Recovery After Surgery (ERAS)-protocol influences the risk of short-term morbidity in relation to the use of a diverting stoma is unclear. METHODS: Between 2002 and 2011, 287 consecutive patients underwent LAR with TME for rectal cancer at Ersta Hospital, Sweden. All patients were treated according to the ERAS program and thereby included. Between 2002 and 2006 15% had a diverting stoma compared to 91 %, 2007 to 2011. RESULTS: One hundred and thirty-nine patients were operated with a diverting stoma at primary surgery (S+), 148 patients were not (S-). The groups were comparable regarding pre- and peroperative data and patients' characteristics. Postoperative morbidity within 30 days after surgery (S+ 53% vs. S- 43%) and hospital stay (S+ 11 days vs. S- 9 days) did not differ. AL occurred in 22% of all patients. In a multivariate analysis, no significant difference in AL was found in relation to the use of a diverting stoma (S+ vs. S-, OR 0.64, 95% CI 0.34-1.19). Eleven patients (8%) in the S+ group underwent relaparotomy versus 22 (15%) in the S- group (p = 0.065). Total overall compliance to the ERAS program was 65%. Patients in S- had faster postoperative recovery. CONCLUSION: A diverting stoma did not affect postoperative morbidity in this large cohort of patients undergoing LAR within an ERAS program. However, the routine use of a diverting stoma could be expected to delay postoperative recovery.

Individualized prediction of risk of metachronous peritoneal carcinomatosis from colorectal cancer.

AIM: The purpose of the study was to develop a tool for predicting the individual risk of metachronous peritoneal carcinomatosis after surgery for non-metastatic colorectal cancer. METHOD: Independent predictors for metachronous colorectal carcinomatosis have previously been identified using a population-based database. Predictive models for colon and rectal cancer were developed from these data. The predictive models were based on multivariable Cox proportional hazard regression and were internally validated with bootstrapping. Performance was assessed by the concordance index and calibration plots. RESULTS: In all, 8044 patients who underwent abdominal resection of colorectal cancer Stage I-III were included. The colon and rectal cancer risk score models predicted metachronous peritoneal carcinomatosis with a concordance index of 80% and 78%, respectively. Factors in the models included age, pathological pT stage, pN stage, number of examined lymph nodes (0-11, 12+), type of surgery (emergency/elective), completeness of cancer resection (R0/R1/R2), adjuvant chemotherapy (yes/no), preoperative radiotherapy and tumour location. CONCLUSION: The proposed predictive models showed high internal validity and enabled individualized prediction of peritoneal recurrence of colorectal cancer. The models may help in the planning of treatment and follow-up of patients. However, external validation is warranted to assess generalizability of the predicted absolute risks.

Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations.

BACKGROUND: This review aims to present a consensus for optimal perioperative care in colonic surgery and to provide graded recommendations for items for an evidenced-based enhanced perioperative protocol. METHODS: Studies were selected with particular attention paid to meta-analyses, randomised controlled trials and large prospective cohorts. For each item of the perioperative treatment pathway, available English-language literature was examined, reviewed and graded. A consensus recommendation was reached after critical appraisal of the literature by the group. RESULTS: For most of the protocol items, recommendations are based on good-quality trials or meta-analyses of good-quality trials (quality of evidence and recommendations according to the GRADE system). CONCLUSIONS: Based on the evidence available for each item of the multimodal perioperative-care pathway, the Enhanced Recovery After Surgery (ERAS) Society, International Association for Surgical Metabolism and Nutrition (IASMEN) and European Society for Clinical Nutrition and Metabolism (ESPEN) present a comprehensive evidence-based consensus review of perioperative care for colonic surgery.

Haemoglobin A1c as a predictor of postoperative hyperglycaemia and complications after major colorectal surgery.

BACKGROUND: Hyperglycaemia following major surgery increases morbidity, but may be improved by use of enhanced-recovery protocols. It is not known whether preoperative haemoglobin (Hb) A1c could predict hyperglycaemia and/or adverse outcome after colorectal surgery. METHODS: Some 120 patients without known diabetes underwent major colorectal surgery within an enhanced-recovery protocol. HbA1c was measured at admission and 4 weeks after surgery. All patients received an oral diet beginning 4 h after operation. Plasma glucose was monitored five times daily. Patients were stratified according to preoperative levels of HbA1c (within normal range of 4.5-6.0 per cent, or higher). RESULTS: Thirty-one patients (25.8 per cent) had a preoperative HbA1c level over 6.0 per cent. These had higher mean(s.d.) postoperative glucose (9.3(1.5) versus 8.0(1.5) mmol/l; P < 0.001) and C-reactive protein (137(65) versus 101(52) mg/l; P = 0.008) levels than patients with a normal HbA1c level. Postoperative complications were more common in patients with a high HbA1c level (odds ratio 2.9 (95 per cent confidence interval 1.1 to 7.9)). CONCLUSION: Postoperative hyperglycaemia is common among patients with no history of diabetes, even within an enhanced-recovery protocol. Preoperative measurement of HbA1c may identify patients at higher risk of poor glycaemic control and postoperative complications.

Pre-operative carbohydrate loading may be used in type 2 diabetes patients.

BACKGROUND: Post-operative insulin resistance and hyperglycaemia are associated with an impaired outcome after surgery. Pre-operative oral carbohydrate loading (CHO) reduces post-operative insulin resistance with a reduced risk of hyperglycaemia during post-operative nutrition. Insulin-resistant diabetic patients have not been given CHO because the effects on pre-operative glycaemia and gastric emptying are unknown. METHODS: Twenty-five patients (45-73 years) with type 2 diabetes [glycated haemoglobin (HbA1c) 6.2 +/- 0.2%, mean +/- SEM] and 10 healthy control subjects (45-72 years) were studied. A carbohydrate-rich drink (400 ml, 12.5%) was given with paracetamol 1.5 g for determination of gastric emptying. RESULTS: Peak glucose was higher in diabetic patients than in healthy subjects (13.4 +/- 0.5 vs. 7.6 +/- 0.5 mM; P<0.01) and occurred later after intake (60 vs. 30 min; P<0.01). Glucose concentrations were back to baseline at 180 vs. 120 min in diabetic patients and healthy subjects, respectively (P<0.01). At 120 min, 10.9 +/- 0.7% and 13.3 +/- 1.2% of paracetamol remained in the stomach in diabetic patients and healthy, subjects respectively. Gastric half-emptying time (T50) occurred at 49.8 +/- 2.2 min in diabetics and at 58.6 +/- 3.7 min in healthy subjects (P<0.05). Neither peak glucose, glucose at 180 min, gastric T50, nor retention at 120 min differed between insulin (HbA1c 6.8 +/- 0.7%)- and non-insulin-treated (HbA1c 5.6 +/- 0.4%) patients. CONCLUSIONS: Type 2 diabetic patients showed no signs of delayed gastric emptying, suggesting that a carbohydrate-rich drink may be safely administrated 180 min before anaesthesia without risk of hyperglycaemia or aspiration pre-operatively.