Management of patients with high C-reactive protein levels after elective colorectal surgery: Pilot study on a proactive diagnostic and therapeutic approach (GESPACE).

STUDY OBJECTIVE: To evaluate the feasibility and benefit of a diagnostic and therapeutic algorithm for management of patients presenting with a high C-reactive protein (CRP) level after colorectal surgery. PATIENTS AND METHODS: Prospective study including patients with CRP>125mg/L at the 4th postoperative day following elective colorectal surgery. The protocol involved CT-scan of which the results were to orient subsequent management: antibiotics, radiological drainage, endoscopy or surgical redo. Success (primary endpoint) consisted in the proportion of patients with total duration of hospitalization fewer than 15d. Secondary endpoints were: applicability of the protocol in real-life conditions, number of stomas created, duration of hospitalization in an intensive care unit. RESULTS: One hundred and six (106) patients were included: 51 patients (48%) presented with postoperative complications, of which 21 (41%) were severe. No death occurred. Among the included patients, 68% had a hospital stay<15d. Major deviations from the management algorithm occurred in 38% of cases. No patients had an early endoscopy. There was no significant difference with regard to the secondary endpoints according to whether or not the protocol was strictly observed. CONCLUSION: It is necessary to define a protocol for management of patients presenting with high CRP levels after colorectal surgery, the objective being to reduce the impact of complications and to avoid excessive lengthening of hospital stay. The protocol begins with CT-scan, which is to orient subsequent management.

Minimally invasive versus open distal pancreatectomy for resectable pancreatic neuroendocrine tumors: A propensity score matched multicentric comparative French study.

BACKGROUND: Minimally invasive surgery has gained momentum for left pancreatic resections. However, debate remains about whether it has any advantage over open surgery for distal pancreatectomy for pancreatic neuroendocrine tumors. METHODS: This retrospective review examined pancreatectomies performed for resectable pancreatic neuroendocrine tumors at 21 centers in France between January 2014 and December 2018. Short and long-term outcomes were compared before and after propensity score matching based on tumor size, sex, age, body mass index, center, and method of pancreatic transection. RESULTS: During the period study, 274 patients underwent left pancreatic resection for pancreatic neuroendocrine tumors [109 underwent distal splenopancreatectomy, and 165 underwent spleen-preserving distal pancreatectomy [(splenic vessel preservation (n = 97; 58.7%)/splenic vessel resection (n = 68; 41.3%)]. Before propensity score matching, minimally invasive surgery was associated with a lower rate of major morbidity (P = .004), lower rate of postoperative delayed gastric emptying (P = .04), and higher rate of "textbook" outcomes (P = .04). After propensity score matching, there were 2 groups of 54 patients (n = 30 distal splenopancreatectomy; n = 78 spleen-preserving distal pancreatectomy). Minimally invasive surgery was associated with less blood loss (P = .05), decreased rate of major morbidity (6% vs. 24%; P = .02), less delayed gastric emptying (P = .05) despite similar rates of postoperative fistula, hemorrhage, and reoperation (P > .05). The 5-year overall survival (79% vs. 75%; P = .74) and recurrence-free survival (10% vs 17%; P = .39) were similar. CONCLUSION: Minimally invasive surgery for left pancreatic resection can be safely proposed for patients with resectable left pancreatic neuroendocrine tumors. Minimally invasive surgery decreases the rate of major complications while providing comparable long-term oncologic outcomes.

[COSA 80: Oncologic surgery in the elderly patients]. / COSA 80 : chirurgie oncologique du sujet âgé de plus de 80 ans.

INTRODUCTION: Due to longer life expectancy, an increasing number of older people are at risk of developing cancer. Surgical resection of a non-metastatic and resectable digestive tumor remains the main therapeutic weapon. The objective of our study is to assess the possibility of curative oncological surgery in patients over 80years of age, to study its impact in terms of morbidity and mortality, and to look for risk factors for the occurrence of complications. PATIENTS AND METHODS: The study-included patients aged 80 and over operated on for digestive cancer in a curative situation. This was a multicenter prospective cohort study. A total of 230 patients were included in the study. In addition to demographic and medical data, the patients all benefited from an onco-geriatric assessment with the performance of various tests: WHO score, G8 score, IADL score, ADL score, mobility score, nutritional assessment, clock, thymic evaluation (Mini-GDS). Data collection of geriatric scores was repeated 3months postoperatively. RESULTS: Of a total of 230 patients, 51% were male and 49% female. The average age was 84.7years. Tumor localization was mainly colorectal (65.81%). Age had no influence on the mortality rate, with a mean age with no significant difference in the event of an unfavorable outcome or not (84.6 vs. 85years). The results at the different scores were then analyzed in search of a significant difference between preoperative and at 3months. The only significant difference found was in the number of patients with a WHO status of 0 (P=0.021). CONCLUSION: Our study shows that curative oncological surgery is possible in elderly patients without any adverse effect on their quality of life and level of postoperative autonomy. The multidisciplinary geriatric approach to the patient must make it possible to distinguish the patients who will benefit from a curative treatment and those in whom the benefit-risk balance is unfavorable.

Impact of hospital volume in liver surgery on postoperative mortality and morbidity: nationwide study.

BACKGROUND: This nationwide retrospective study was undertaken to evaluate impact of hospital volume and influence of liver transplantation activity on postoperative mortality and failure to rescue after liver surgery. METHODS: This was a retrospective study of patients who underwent liver resection between 2011 and 2019 using a nationwide database. A threshold of surgical activities from which in-hospital mortality declines was calculated. Hospitals were divided into high- and low-volume centres. Main outcomes were in-hospital mortality and failure to rescue. RESULTS: Among 39 286 patients included, the in-hospital mortality rate was 2.8 per cent. The activity volume threshold from which in-hospital mortality declined was 25 hepatectomies. High-volume centres (more than 25 resections per year) had more postoperative complications but a lower rate of in-hospital mortality (2.6 versus 3 per cent; P < 0.001) and failure to rescue (5 versus 6.3 per cent; P < 0.001), in particular related to specific complications (liver failure, biliary complications, vascular complications) (5.5 versus 7.6 per cent; P < 0.001). Liver transplantation activity did not have an impact on these outcomes. CONCLUSION: From more than 25 liver resections per year, rates of in-hospital mortality and failure to rescue declined. Management of specific postoperative complications appeared to be better in high-volume centres.

How to do robotic Ivor Lewis esophagectomy for lower third oesophageal cancer.

Transthoracic subtotal esophagectomy with two-field lymph node (mediastinal and abdominal) and monobloc posterior mediastinectomy is called Ivor Lewis esophagectomy. This intervention requires an abdominal and thoracic time that is carried out here entirely by robotic way. It is performed a reconstruction by gastroplasty with a manual esophago-gastric anastomosis also by robotic way.

Defining Benchmark Outcomes for Distal Pancreatectomy: Results of a French Multicentric Study.

OBJECTIVE: Defining robust and standardized outcome references for distal pancreatectomy (DP) by using Benchmark analysis. BACKGROUND: Outcomes after DP are recorded in medium or small-sized studies without standardized analysis. Therefore, the best results remain uncertain. METHODS: This multicenter study included all patients undergoing DP for resectable benign or malignant tumors in 21 French expert centers in pancreas surgery from 2014 to 2018. A low-risk cohort defined by no significant comorbidities was analyzed to establish 18 outcome benchmarks for DP. These values were tested in high risk, minimally invasive and benign tumor cohorts. RESULTS: A total of 1188 patients were identified and 749 low-risk patients were screened to establish Benchmark cut-offs. Therefore, Benchmark rate for mini-invasive approach was ≥36.8%. Benchmark cut-offs for postoperative mortality, major morbidity grade ≥3a and clinically significant pancreatic fistula rates were 0%, ≤27%, and ≤28%, respectively. The benchmark rate for readmission was ≤16%. For patients with pancreatic adenocarcinoma, cut-offs were ≥75%, ≥69.5%, and ≥66% for free resection margins (R0), 1-year disease-free survival and 3-year overall survival, respectively. The rate of mini-invasive approach in high-risk cohort was lower than the Benchmark cut-off (34.1% vs ≥36.8%). All Benchmark cut-offs were respected for benign tumor group. The proportion of benchmark cases was correlated to outcomes of DP. Centers with a majority of low-risk patients had worse results than those operating complex cases. CONCLUSION: This large-scale study is the first benchmark analysis of DP outcomes and provides robust and standardized data. This may allow for comparisons between surgeons, centers, studies, and surgical techniques.

Early detection of anastomotic leak with C-reactive protein increases the chances of anastomotic salvage.

AIM: Anastomotic leak results in increased morbidity and affects functional and oncological outcomes after colectomy. Measurement of C-reactive protein (CRP) allows early detection of anastomotic leaks. The aim of this study was to evaluate the benefit to the patient of earlier diagnosis and management of anastomotic leaks, namely avoiding takedown of the anastomosis. METHOD: Patients with an anastomotic fistula after elective colorectal surgery from 2010 to 2020 were included. Three periods were defined according to progressive adherence to the CRP protocol in our department. A comparison was made between the periods 'before' (2010-2013) and 'after' (2016-2020) in terms of morbidity, mortality, anastomotic salvage, days spent in hospital within the first postoperative month, timely adjuvant chemotherapy and anastomotic stenosis. RESULTS: Out of 2655 elective colorectal operations, 171 patients presented with an anastomotic leak and 123 patients were included in the study. In univariate analysis, patients in the 'after' group had fewer severe complications (Clavien-Dindo Grade III to IV, 66.7% vs. 56.9; p = 0.017); the difference did not reach significance regarding timely postoperative chemotherapy (p = 0.058) and anastomotic stenosis (p = 0.682). In both, univariate and multivariate analysis, the 'after' period increased the chances of preserving the anastomosis (OR = 2.37 [1.08-5.17]) and increased the number of days out of hospital (p = 0.0002). CONCLUSION: A CRP-based protocol for the screening of anastomotic leaks after colorectal surgery was related to increased anastomotic conservation, a decreased impact and severity of the leak and a shorter length of hospital stay.

C-reactive protein identifies patients at low risk of anastomotic leak after esophagectomy.

PURPOSE: Fast-track protocols are increasingly used after digestive surgery. After esophagectomy, the gravity and the fear of anastomotic leak may be an obstacle to generalization of such protocols. C-reactive protein (CRP) might be a reliable tool to identify patients at low risk of anastomotic leak after esophagectomy, so that they can be safely included in a fast-track program. The aim of our retrospective bicentric study is to evaluate the interest of C-reactive protein measurement for the early diagnosis of anastomotic leak after esophagectomy. METHODS: Patients having undergone Ivor-Lewis procedure between January 2009 and September 2017 were included in this bicentric retrospective study. CRP values were recorded between postoperative day 3 (POD 3) and postoperative day 5 (POD 5). All postoperative complications were recorded, and the primary endpoint was anastomotic leak. RESULTS: We included 585 patients. Among them, 241 (41.2%) developed infectious complications and 69 patients (11.8%) developed anastomotic leak. CRP had the best predictive value on POD 5 (AUC = 0.74; 95% CI: 0.67-0.81). On POD 5, a cut-off value of 130 mg/L yielded a sensitivity of 87%, a specificity of 51%, and a negative predictive value of 96% for the detection of anastomotic leak. CONCLUSIONS: CRP may help in identifying patients at very low risk of anastomotic leak after esophagectomy. Patients with CRP values < 130 mg/L on POD 5 can safely undertake an enhanced recovery protocol.

Management and Outcomes of Pancreatic Cancer in French Real-World Clinical Practice.

Background: Our objective was to describe real-world patterns of care and outcomes in pancreatic cancer. Methods: 912 patients diagnosed with pancreatic cancer from 2014 to 2017 were registered by the population-based cancer registry of Burgundy (France). Progression-free and net survival were estimated. Results: at diagnosis, 52% of tumors were associated with metastases. Among the 20% of patients fulfilling resectability criteria, half of those aged 75−84 years and none of those ≥85 years actually underwent resection. Age was not associated with 3-year observed survival in patients who underwent resection. Overall, 77% of patients aged <75 years, 55% of those aged 75−84 years and 8% of those ≥85 years received chemotherapy. Among patients who were offered chemotherapy, 73% of those aged ≥85 years refused. Chemotherapy toxicity was higher with Gemcitabine_Oxaliplatin/Gemcitabine_Abraxane and FOLFIRINOX than with Gemcitabine alone. Patients resected after induction FOLFIRINOX and those treated with adjuvant Gemcitabine presented the lowest risk of progression. Three-year net survival was 35% in patients with non-metastatic resectable tumors and under 10% for other patients. Conclusions: Only half of patients aged 75−84 years with a resectable tumor actually underwent resection. Two thirds of patients aged ≥85 years refused chemotherapy, thus underlining the need to expand geriatric assessments.

A colonoscopy quality improvement intervention in an endoscopy unit.

Many studies identified colonoscopy quality indicators in order to improve performance and safety. We conducted a colonoscopy improvement study. Our study was designed according to a Plan-Do-Study-Act cycle: first recording of our quality indicators and identification of shortcomings, second identification of improvement targets and implementation of new procedures, third second recording of quality indicators, fourth validation of procedures and identification of new goals. Quality indicators derived from European and French guidelines were recorded before and after our improvement actions. We were mainly interested in the quality indicators of the colonic preparation, the description of the diagnosed lesions and on the examination reports. The data of 134 patients prospectively included in January-February 2017 were compared to 133 patients included in May-June 2019, after implementation of improvement procedures, in the digestive endoscopy unit of the university hospital of Dijon, France. Our intervention, and in particular the implementation of new standardized forms, improved preparation quality: Boston Bowel Preparation Scale scores increased significantly from 7.8 to 8.2. Cecal intubation rate increased by 6%, and more adenomas were diagnosed and removed (+3.3%). Adenoma detection rate increased significantly from 26 to 42%. The completion of withdrawal time measure improved from 6.7 to 100%. Our study led to the rapid implementation of corrective actions and improved quality in our unit and in our personal practice. This quality improvement strategy could be easily implemented in every digestive endoscopy unit.

Surgical treatment of digestive cancer in a well-defined elderly population.

INTRODUCTION: Digestive cancer is of concern because of its frequency and severity with an increasing older median age of onset. The purpose of this study was to describe in a well-defined population presenting with non-metastatic digestive cancer the frequency of surgical resection and outcomes according to age. PATIENTS AND METHODS: We analyzed 7760 patients with a non-metastatic digestive cancer, recorded in the Burgundy population-based digestive cancer registry between 2009 and 2017. There were 3506 non-colorectal cancers and 4254 colorectal cancers with 3292 colon and 962 rectal cancers. The frequency of surgical resection was analyzed according to age (classified into four categories <70, [70-80[, [80-85[, and ≥85), sex, comorbidities and obesity. Postoperative mortality at 30 and 90 days was determined according to age, sex, comorbidity, obesity, location, surgery R0 or not. The 5-year survival study included 2952 patients with colorectal cancer, non-metastatic and who benefited from an R0 resection. RESULTS: Overall, 64% of the patients with M0 digestive cancer underwent a surgical resection, varying from 31% for Non colorectal Digestive cancers to 94% for colon site. The percentage of patients operated on for a resectable disease decreases from 71% before age 70 to 43% from age 85. Age and comorbidities were the main criteria influencing the probability of resection. At 30 days, postoperative mortality was 3%, all localizations and ages combined. At 90 days, this rate was 5%. In patients over 85 years old it gradually increases from 7% at 30 days and to 10% at 90 days. A man under 70 years of age has a net survival of 0.88 at 5 years, and 0.91 for a woman. For a man between 70 and 80 years old, it decreases to 0.81 and to 0.66 from 80 years old. In women, net survival is 0.87 between 70 and 80 years of age at 5 years, then drops to 0.75 from age 80. CONCLUSION: Our study shows a drop in access to surgery at different pivotal ages depending on the tumor location. This sudden drop in the resection rate is not justified by the increase in mortality with age, which is linear. In addition, the expected benefits of surgery are significant, with a net survival, mainly after the 1st year, of the same order as for younger patients. Age by itself should not be the only criterion in the medical decision. The challenge is to detect and treat the comorbidities that worsen the operative risk and the prognosis. There are few data on the management of digestive cancers specifically in the elderly. Our study shows that access to surgery is strongly linked to age and this in a non-linear way, whereas the expected benefits of surgery are significant, of the same order as for younger patients. Age itself should not be the only criterion in the medical decision.

Detecting Hospital Outliers in Post-Pancreatectomy Care Using Funnel Plots from 2009-2018 Based on Nationwide Medico-Administrative Data.

OBJECTIVES: Our objective was to identify hospitals with unusual mortality rates for major pancreatectomies over a period of ten years using 30-day mortality data from the French national database. METHODS: Data for all patients who underwent pancreatectomy were extracted from the national medico-economic database (Programme de Médicalisation des Systèmes d'Information). To identify quality outliers for each hospital, the observed-to-expected 30-day mortality rates were used as a quality indicator. RESULTS: A total of 19 494 patients underwent a major pancreatectomy in France between January 2009 and December 2018. The overall 30-day mortality rate was 4.8% (n = 944). For the 2009-2014 period, the funnel plot showed that 10 of the 176 hospitals lie outside the central 95% region and 7 lie outside the central 99.8% region. For the 2015-2018 period, out of 176 hospitals, 6 lie outside the central 95% region and 2 lie outside the central 99.8% region. The change in standardized mortality ratios between 2009-2014 and 2015-2018 testing for differences from the overall change, they were there 4 hospitals lie outside the central 95% region and 0 lie outside the central 99.8% region. CONCLUSION: Over time, the improvement in hospital quality was weak. This study suggests that there is a pressing need to reorganize the supply of care for pancreatic surgery in France.

Limited Resection Versus Pancreaticoduodenectomy for Duodenal Gastrointestinal Stromal Tumors? Enucleation Interferes in the Debate: A European Multicenter Retrospective Cohort Study.

BACKGROUND: The optimal surgical procedure for duodenal gastrointestinal stromal tumors (D-GISTs) remains poorly defined. Pancreaticoduodenectomy (PD) allows for a wide resection but is associated with a high morbidity rate. OBJECTIVES: The aim of this study was to compare the short- and long-term outcomes of PD versus limited resection (LR) for D-GISTs and to evaluate the role of tumor enucleation (EN). METHODS: In this retrospective European multicenter cohort study, 100 patients who underwent resection for D-GIST between 2001 and 2013 were compared between PD (n = 19) and LR (n = 81). LR included segmental duodenectomy (n = 47), wedge resection (n = 21), or EN (n = 13). The primary objective was to evaluate disease-free survival (DFS) between the groups, while the secondary objectives were to analyze the overall morbidity and mortality, radicality of resection, and 5-year overall survival (OS) and recurrence rates between groups. Furthermore, the short- and long-term outcomes of EN were evaluated. RESULTS: Baseline characteristics were comparable between the PD and LR groups, except for a more frequent D2 tumor location in the PD group (68.3% vs. 29.6%; p = 0.016). Postoperative morbidity was higher after PD (68.4% vs. 23.5%; p < 0.001). OS (p = 0.70) and DFS (p = 0.64) were comparable after adjustment for D2 location and adjuvant therapy rate. EN was performed more in American Society of Anesthesiologists (ASA) stage III/IV patients with tumors < 5 cm and was associated with a 5-year OS rate of 84.6%, without any disease recurrences. CONCLUSIONS: For D-GISTs, LR should be the procedure of choice due to lower morbidity and similar oncological outcomes compared with PD. In selected patients, EN appears to be associated with equivalent short- and long-term outcomes. Based on these results, a surgical treatment algorithm is proposed.

Pancreatoduodenectomy for Neuroendocrine Tumors in Patients with Multiple Endocrine Neoplasia Type 1: An AFCE (Association Francophone de Chirurgie Endocrinienne) and GTE (Groupe d'étude des Tumeurs Endocrines) Study.

AIM: To assess postoperative complications and control of hormone secretions following pancreatoduodenectomy (PD) performed on multiple endocrine neoplasia type 1 (MEN1) patients with duodenopancreatic neuroendocrine tumors (DP-NETs). BACKGROUND: The use of PD to treat MEN1 remains controversial, and evaluating the right place of PD in MEN1 disease makes sense. METHODS: Thirty-one MEN1 patients from the Groupe d'étude des Tumeurs Endocrines MEN1 cohort who underwent PD for DP-NETs between 1971 and 2013 were included. Early and late postoperative complications, secretory control and overall survival were analyzed. RESULTS: Indication for surgery was: Zollinger-Ellison syndrome (n = 18; 58%), nonfunctioning tumor (n = 9; 29%), insulinoma (n = 2; 7%), VIPoma (n = 1; 3%) and glucagonoma (n = 1; 3%). Mean follow-up was 141 months (range 0-433). Pancreatic fistulas occurred in 5 patients (16.1%), distant metastases in 6 (mean onset of 43 months; range 13-110 months), postoperative diabetes mellitus in 7 (22%), and pancreatic exocrine insufficiency in 6 (19%). Five-year overall survival was 93.3% [CI 75.8-98.3] and ten-year overall survival was 89.1% [CI 69.6-96.4]. After a mean follow-up of 151 months (range 0-433), the biochemical cure rate for MEN-1 related gastrinomas was 61%. CONCLUSION: In MEN1 patients, pancreatoduodenectomy can be used to control hormone secretions (gastrin, glucagon, VIP) and to remove large NETs. PD was found to control gastrin secretions in about 60% of cases.

Portal vein embolization with ethylene-vinyl alcohol copolymer for contralateral lobe hypertrophy before liver resection: safety, feasibility and initial experience.

BACKGROUND: To report our preliminary experience with preoperative portal vein embolization (PVE) using liquid ethylene vinyl alcohol (EVOH) copolymer. METHODS: Retrospectively review of patients with primary or secondary liver malignancies scheduled for extensive hepatectomy after the induction of future liver remnant (FLR) hypertrophy by right or left PVE with EVOH as the only embolic agent between 2014 and 2018 at two academic centers. Cross-sectional imaging liver volumetry data obtained before and 3-6 weeks after PVE were used to assess the FLR volume (FLRV) increase, degree of FLR hypertrophy and the FLR kinetic growth rate (KGR). RESULTS: Twenty-six patients (17 males; mean age, 58.7±11 years; range, 32-79 years) were included. The technical and clinical success rate was 100%. PVE produced adequate FLR hypertrophy in all patients. Embolization occurred in all targeted portal branches and in no non-target vessels. The %FLRV increased by 52.9%±32.5% and the degree of FLR hypertrophy was 16.7%±6.8%. The KGR was 4.4%±2.0% per week. Four patients experience minor complications after PVE which resolved with symptomatic treatment. The resection rate was 84.5%. One patient died during surgery for reasons unrelated to PVE. CONCLUSIONS: Preoperative PVE with EVOH copolymer is feasible, safe, and effective in inducing FLR hypertrophy.

Failure to rescue in patients with distal pancreatectomy: a nationwide analysis of 10,632 patients.

BACKGROUND: FTR appears as a major cause of postoperative mortality (POM). Hospital volume has an impact on FTR in pancreatic surgery but no study has investigated this relationship more specifically in DP. METHODS: We analysed patients with DP between 2009 and 2018 through a nationwide database. FTR definition was mortality among patients who experiment major complications. The cutoff between high and low volume centers was 20 pancreatectomies per year. RESULTS: Some 10,632 patients underwent DP, 5048 (47.5%) were operated in 602 (95.4%) low volume centers and 5584 (52.5%) in 29 (4.6%) high volume centers. Overall FTR occurred in 11.2% of patients and was significantly reduced in high volume centers compared to low volume centers (10.2% vs 12.5%, p = 0.047). In multivariate analysis, surgery in a high volume center was a protective factor for POM (OR = 0.570, CI95% [0.505-0.643], p < 0.001) and also for FTR (OR = 0.550, CI95% [0.486-0.630], p < 0.001). CONCLUSION: Hospital volume has a positive impact on FTR in DP. Patients with higher risk of FTR are men, with high modified Charlson comorbidity index, malignant conditions and open procedures.

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial.

BACKGROUND: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery has been associated with encouraging survival results in some patients with colorectal peritoneal metastases who were eligible for complete macroscopic resection. We aimed to assess the specific benefit of adding HIPEC to cytoreductive surgery compared with receiving cytoreductive surgery alone. METHODS: We did a randomised, open-label, phase 3 trial at 17 cancer centres in France. Eligible patients were aged 18-70 years and had histologically proven colorectal cancer with peritoneal metastases, WHO performance status of 0 or 1, a Peritoneal Cancer Index of 25 or less, and were eligible to receive systemic chemotherapy for 6 months (ie, they had adequate organ function and life expectancy of at least 12 weeks). Patients in whom complete macroscopic resection or surgical resection with less than 1 mm residual tumour tissue was completed were randomly assigned (1:1) to cytoreductive surgery with or without oxaliplatin-based HIPEC. Randomisation was done centrally using minimisation, and stratified by centre, completeness of cytoreduction, number of previous systemic chemotherapy lines, and timing of protocol-mandated systemic chemotherapy. Oxaliplatin HIPEC was administered by the closed (360 mg/m2) or open (460 mg/m2) abdomen techniques, and systemic chemotherapy (400 mg/m2 fluorouracil and 20 mg/m2 folinic acid) was delivered intravenously 20 min before HIPEC. All individuals received systemic chemotherapy (of investigators' choosing) with or without targeted therapy before or after surgery, or both. The primary endpoint was overall survival, which was analysed in the intention-to-treat population. Safety was assessed in all patients who received surgery. This trial is registed with ClinicalTrials.gov, NCT00769405, and is now completed. FINDINGS: Between Feb 11, 2008, and Jan 6, 2014, 265 patients were included and randomly assigned, 133 to the cytoreductive surgery plus HIPEC group and 132 to the cytoreductive surgery alone group. After median follow-up of 63·8 months (IQR 53·0-77·1), median overall survival was 41·7 months (95% CI 36·2-53·8) in the cytoreductive surgery plus HIPEC group and 41·2 months (35·1-49·7) in the cytoreductive surgery group (hazard ratio 1·00 [95·37% CI 0·63-1·58]; stratified log-rank p=0·99). At 30 days, two (2%) treatment-related deaths had occurred in each group.. Grade 3 or worse adverse events at 30 days were similar in frequency between groups (56 [42%] of 133 patients in the cytoreductive surgery plus HIPEC group vs 42 [32%] of 132 patients in the cytoreductive surgery group; p=0·083); however, at 60 days, grade 3 or worse adverse events were more common in the cytoreductive surgery plus HIPEC group (34 [26%] of 131 vs 20 [15%] of 130; p=0·035). INTERPRETATION: Considering the absence of an overall survival benefit after adding HIPEC to cytoreductive surgery and more frequent postoperative late complications with this combination, our data suggest that cytoreductive surgery alone should be the cornerstone of therapeutic strategies with curative intent for colorectal peritoneal metastases. FUNDING: Institut National du Cancer, Programme Hospitalier de Recherche Clinique du Cancer, Ligue Contre le Cancer.