Preoperative anaemia in distal pancreatectomy: a propensity-score matched analysis.

BACKGROUND: Preoperative anaemia is a prevalent morbidity predictor that adversely affects short- and long-term outcomes of patients undergoing surgery. This analysis aimed to investigate preoperative anaemia and its detrimental effects on patients after distal pancreatectomy. MATERIAL AND METHODS: The present study was a propensity-score match analysis of 286 consecutive patients undergoing distal pancreatectomy. Patients were screened for preoperative anaemia and classified according to WHO recommendations. The primary outcome measure was overall morbidity. The secondary endpoints were in-hospital mortality and rehospitalization. RESULTS: The preoperative anaemia rate before matching was 34.3% (98 patients), and after matching a total of 127 patients (non-anaemic 42 vs. anaemic 85) were included. Anaemic patients had significantly more postoperative major complications (54.1% vs. 23.8%; p < 0.01), a higher comprehensive complication index (26.2 vs. 4.3; p < 0.01), and higher in-hospital mortality rate (14.1% vs. 2.4%; p = 0.04). Multivariate regression analysis confirmed these findings and identified preoperative anaemia as a strong independent risk factor for postoperative major morbidity (OR 4.047; 95% CI: 1.587-10.320; p < 0.01). CONCLUSION: The current propensity-score matched analysis strongly considered preoperative anaemia as a risk factor for major complications following distal pancreatectomy. Therefore, an intense preoperative anaemia workup should be increasingly prioritised.

Textbook outcome after pancreatoduodenectomy and distal pancreatectomy with postoperative hyperamylasemia-a propensity score matching analysis.

PURPOSE: Postoperative serum hyperamylasemia (POH) is a part of the new, increasingly highlighted, definition for postpancreatectomy pancreatitis (PPAP). This study aimed to analyze whether the biochemical changes of PPAP are differently associated with postoperative complications after distal pancreatectomy (DP) compared with pancreatoduodenectomy (PD). The textbook outcome (TO) was used as a summary measure to capture real-world data. METHODS: The data were retrospectively extracted from a prospective clinical database. Patients with POH, defined as levels above our institution's upper limit of normal on postoperative day 1, after DP and the corresponding propensity score-matched cohort after PD were evaluated on postoperative complications by using logistic regression analyses. RESULTS: We analyzed 723 patients who underwent PD and DP over a period of 9 years. After propensity score matching, 384 patients (192 patients in each group) remained. POH was observed in 78 (41.1%) and 74 (39.4%) after PD and DP correspondingly. There was a significant increase of postoperative complications in the PD group: Clavien-Dindo classification system ≥3 (P < .01 vs P = .71), clinically relevant postoperative pancreatic fistula (P < .001 vs P = .2), postpancreatectomy hemorrhage (P < .001 vs P = .11), and length of hospital stay (P < .001 vs P = .69) if POH occurred compared with in the DP group. TO was significantly unlikely in cases with POH after PD compared with DP (P > .001 vs P = .41). Furthermore, POH was found to be an independent predictor for missing TO after PD (odds ratio [OR], 0.29; 95% CI, 0.14-0.60; P < .001), whereas this was not observed in patients after DP (OR, 0.53; 95% CI, 0.21-1.33; P = .18). CONCLUSION: As a part of the definition for PPAP, POH is a predictive indicator associated with postoperative complications after PD but not after DP.

The development of tissue handling skills is sufficient and comparable after training in virtual reality or on a surgical robotic system: a prospective randomized trial.

BACKGROUND: Virtual reality is a frequently chosen method for learning the basics of robotic surgery. However, it is unclear whether tissue handling is adequately trained in VR training compared to training on a real robotic system. METHODS: In this randomized controlled trial, participants were split into two groups for "Fundamentals of Robotic Surgery (FRS)" training on either a DaVinci VR simulator (VR group) or a DaVinci robotic system (Robot group). All participants completed four tasks on the DaVinci robotic system before training (Baseline test), after proficiency in three FRS tasks (Midterm test), and after proficiency in all FRS tasks (Final test). Primary endpoints were forces applied across tests. RESULTS: This trial included 87 robotic novices, of which 43 and 44 participants received FRS training in VR group and Robot group, respectively. The Baseline test showed no significant differences in force application between the groups indicating a sufficient randomization. In the Midterm and Final test, the force application was not different between groups. Both groups displayed sufficient learning curves with significant improvement of force application. However, the Robot group needed significantly less repetitions in the three FRS tasks Ring tower (Robot: 2.48 vs. VR: 5.45; p < 0.001), Knot Tying (Robot: 5.34 vs. VR: 8.13; p = 0.006), and Vessel Energy Dissection (Robot: 2 vs. VR: 2.38; p = 0.001) until reaching proficiency. CONCLUSION: Robotic tissue handling skills improve significantly and comparably after both VR training and training on a real robotic system, but training on a VR simulator might be less efficient.

Satisfaction of surgeons with the current state of training in minimally invasive surgery: a survey among German surgeons.

BACKGROUND: Minimally invasive surgery (MIS) requires intense education and training with structured supervision and feedback. However, a standardized training structure is lacking in Germany. This nationwide survey aimed to assess the current state of minimally invasive surgery (MIS) training and factors impacting surgeons' satisfaction. METHODS: Between July and October 2021, an online survey was conducted among general, abdominal, and thoracic surgeons in Germany. The survey collected data on department size, individual operative experience, availability of MIS training equipment and curricula, and individual satisfaction with training. A linear regression analysis was conducted to investigate factors influencing the surgeons' satisfaction with the MIS training. RESULTS: A total of 1008 surgeons participated in the survey, including residents (26.1%), fellows (14.6%), attendings (43.8%), and heads of departments (15.2%). Of the respondents, 57.4% reported having access to MIS training equipment, 29.8% and 26% had a curriculum for skills lab MIS training and intraoperative MIS training, respectively. In multivariate linear regression analysis, strongest predictors for surgeons' satisfaction with skills lab MIS training and intraoperative training were the availability of respective training curricula (skills lab: ß 12.572; p < 0.001 & intraoperative: ß 16.541; p < 0.001), and equipment (ß 5.246; p = 0.012 & ß 4.295; p = 0.037), and experience as a first surgeon in laparoscopy (ß 12.572; p < 0.001 & ß 3.748; p = 0.007). Additionally, trainees and teachers differed in their satisfaction factors. CONCLUSION: Germany lacks standardized training curricula and sufficient access to MIS training equipment. Trainees and teachers have distinct factors influencing their satisfaction with MIS training. Standardized curricula, equipment accessibility, and surgical experience are crucial for improving surgeons' satisfaction with training.

COMPASS: deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer.

BACKGROUND: Colorectal cancer stands as a prevalent cause of cancer-related mortality, necessitating effective treatment strategies. Acute colonic obstruction occurs in approximately 20% of patients and represents a surgical emergency with substantial morbidity and mortality. The optimal approach for managing left-sided colon cancer with acute colonic obstruction remains debatable, with no consensus on whether emergency resection or bridge-to-surgery, involving initial decompressing stoma and subsequent elective resection after recovery, should be employed. Current studies show a decrease in morbidity and short-term mortality for the bridge-to-surgery approach, yet it remains unclear if the long-term oncological outcome is equivalent to emergency resection. METHODS: This prospective, randomized, multicenter trial aims to investigate the management of obstructive left-sided colon cancer in a comprehensive manner. The study will be conducted across 26 university hospitals and 40 academic hospitals in Germany. A total of 468 patients will be enrolled, providing a cohort of 420 evaluable patients, with an equal distribution of 210 patients in each treatment arm. Patients with left-sided colon cancer, defined as cancer between the left splenic flexure and > 12 cm ab ano and obstruction confirmed by X-ray or CT scan, are eligible. Randomization will be performed in a 1:1 ratio, assigning patients either to the oncological emergency resection group or the bridge-to-surgery group, wherein patients will undergo diverting stoma and subsequent elective oncological resection after recovery. The primary endpoint of this trial will be 120-day mortality, allowing for consideration of the time interval between diverting stoma and resection. DISCUSSION: The findings derived from this trial possess the potential to reshape the current clinical approach of emergency resection for obstructive left-sided colon cancer by favoring the bridge-to-surgery practice, provided that a reduction in morbidity can be achieved without compromising the oncological long-term outcome. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) under the identifier DRKS00031827. Registered on May 15, 2023. PROTOCOL: 28.04.2023, protocol version 2.0F.

Does practice make perfect? Laparoscopic training mainly improves motion efficiency: a prospective trial.

Training improves skills in minimally invasive surgery. This study aimed to investigate the learning curves of complex motion parameters for both hands during a standardized training course using a novel measurement tool. An additional focus was placed on the parameters representing surgical safety and precision. Fifty-six laparoscopic novices participated in a training course on the basic skills of minimally invasive surgery based on a modified Fundamentals of Laparoscopic Surgery (FLS) curriculum. Before, twice during, and once after the practical lessons, all participants had to perform four laparoscopic tasks (peg transfer, precision cut, balloon resection, and laparoscopic suture and knot), which were recorded and analyzed using an instrument motion analysis system. Participants significantly improved the time per task for all four tasks (all p < 0.001). The individual instrument path length decreased significantly for the dominant and non-dominant hands in all four tasks. Similarly, both hands became significantly faster in all tasks, with the exception of the non-dominant hand in the precision cut task. In terms of relative idle time, only in the peg transfer task did both hands improve significantly, while in the precision cut task, only the dominant hand performed better. In contrast, the motion volume of both hands combined was reduced in only one task (precision cut, p = 0.01), whereas no significant improvement in the relative time of instruments being out of view was observed. FLS-based skills training increases motion efficiency primarily by increasing speed and reducing idle time and path length. Parameters relevant for surgical safety and precision (motion volume and relative time of instruments being out of view) are minimally affected by short-term training. Consequently, surgical training should also focus on safety and precision-related parameters, and assessment of these parameters should be incorporated into basic skill training accordingly.

The Effect of the Frequently Used Cinacalcet for pHPT during the COVID-19 Pandemic on Perioperative Decrease in Parathyroid Hormone.

Background: Cinacalcet is a calcimimetic drug that has increasingly been used as a bridging therapy for primary hyperparathyroidism (pHPT), especially during the COVID-19 pandemic. The aim of our study was to investigate if preoperative cinacalcet therapy affects intraoperative parathyroid hormone (IOPTH) monitoring during parathyroidectomy, which is an important indicator for the success of surgery. Methods: In this single-center retrospective analysis, we studied the outcomes of 72 patients who underwent surgery for pHPT. We evaluated two groups: those with cinacalcet therapy before operation­the cinacalcet group (CG)­and those without medical therapy preoperatively (non-CG). In order to perform a between-group comparison of time trends, we fit a linear mixed-effects model with PTH as the response variable and predictors PTH levels preoperatively, group (cinacalcet yes/no), time, the group-by-time interaction, and a random intercept (per subject). Results: Our cohort included 51 (71%) women and 21 (29%) men, who were operated upon for pHPT in the period from January 2018 until August 2021. All patients were diagnosed with pHPT and 54% of the cohort were symptomatic for hypercalcemia. Moreover, 30% of the patients were treated with cinacalcet as a bridging therapy preoperatively, and this increased during the COVID-19 pandemic, as 64% of this group were treated in the last two years. Calcium values were significantly different before (p < 0.001) and after (p = 0.0089) surgery, but calcium level change did not differ significantly between the CG and non-CG. Parathyroid hormone (PTH) levels dropped significantly in both groups during 10 min IOPTH monitoring (p < 0.001), but there was no significant difference between the two groups (p = 0.212). Conclusions: In the examined patient cohort, the use of cinacalcet did not affect the value of IOPTH monitoring during surgery for pHPT.

Selective Decontamination of the Digestive Tract in Pancreatic Head Resections-A Propensity Score-Matched Analysis.

(1) Background: The postoperative morbidity rate after pancreatic head resection remains high, partly due to infectious complications. The primary aim of this study was to analyze the influence of selective decontamination of the digestive tract (SDD) on the postoperative infection rate after pancreatic surgery. (2) Methods: From January 2019, the standard of care for patients undergoing pancreatic head resections at the Department for Visceral, Thoracic, and Vascular Surgery, University Hospital Dresden was the preoperative oral administration of SDD. The influence of SDD was evaluated for patients operated on between January 2019 and June 2020 in comparison to a propensity score-matched cohort, extracted from an existing database including all pancreatic resections from 2012 to 2018. The primary endpoint of the study was the shift of the bacterial load on the intraoperative bile swab test. The secondary endpoint was the association of SDD with postoperative complications. (3) Results: In total, 200 patients either with SDD (n = 100; 50%) or without SDD (non-SDD, n = 100; 50%) were analyzed. In the patient group without a preoperative biliary stent, 44% (n = 11) of the non-SDD group displayed positive bacterial results, whereas that was the case for only 21.7% (n = 10) in the SDD group (p = 0.05). Particularly, Enterobacter species (spp.) were reduced from 41.2% (n = 14) (non-SDD group) to 23.5% (n = 12) (SDD group) (p = 0.08), and Citrobacter spp. were reduced by 13.7% (p = 0.09) from the non-SDD to the SDD cohort. In patients with a preoperative biliary stent, the Gram-negative Enterobacter spp. were significantly reduced from 52.2% (n = 12) in the non-SDD group to 26.8% (n = 11) in the SDD group (p = 0.04). Similarly, Citrobacter spp. decreased by 20.6% from 30.4% (n = 7) to 9.8% (n = 4) in the non-SDD compared to the SDD group (p = 0.04). In general, deep fluid collection and abscesses occurred more frequently in the non-SDD group (36%; n = 36 vs. 27%; n = 27; p = 0.17). (4) Conclusions: Adoption of SDD before pancreatic head surgery may reduce the bacterial load in bile fluid. SDD administration does not significantly affect the postoperative infectious complication rate after pancreatic head resections.

Vascular surgery in liver resection.

Vascular surgery in liver resection is a standard part of liver transplantation, but is also used in oncological liver surgery. Malignant liver tumors with vascular involvement have a poor prognosis without resection. Surgery is currently the only treatment to provide long-term survival in advanced hepatic malignancy. Even though extended liver resections are increasingly performed, vascular involvement with need of vascular reconstruction is still considered a contraindication for surgery in many institutions. However, vascular resection and reconstruction in liver surgery-despite being complex procedures-are safely performed in specialized centers. The improvements of the postoperative results with reduced postoperative morbidity and mortality are a result of rising surgical and anesthesiological experience and advancements in multimodal treatment concepts with preconditioning measures regarding liver function and systemic treatment options. This review focuses on vascular surgery in oncological liver resections. Even though many surgical techniques were developed and are also used during liver transplantation, this special procedure is not particularly covered within this review article. We provide a summary of vascular reconstruction techniques in oncological liver surgery according to the literature and present also our own experience. We aim to outline the current advances and standards in extended surgical procedures for liver tumors with vascular involvement established in specialized centers, since curative resection improves long-term survival and shifts palliative concepts to curative therapy.

[Indications for Surgical Therapy in Chronic Pancreatitis]. / Operationsindikationen bei der chronischen Pankreatitis.

Chronic pancreatitis is a recurrent disease with repeating exacerbations of inflammation of the pancreatic gland - associated with belt-like back pain. Without treatment, recurrent chronic pancreatitis leads to development of opioid-dependent pain. The chronic pancreatitis leads to recurrent hospital stays for the affected patient and socioeconomic challenges. In progress it can lead to local complications of chronic pancreatitis, such as formation of pseudocysts, biliary duct obstruction, duodenal obstruction or portal hypertension. The aim of this article is a detailed description of the indication for surgical therapy in chronic pancreatitis. The underlying analysis was a systematic literature research and evaluation, the formulation of key questions according to the PICO system and the evaluation of indications and key statements and questions, as implemented in a three level Delphi process among the members of the pancreas research group and the indications for the surgery group of the German Society of General and Visceral Surgery (DGAV). Surgical resection of the inflammatory pancreatic head pseudotumour, after initial conservative therapy, is a highly efficient therapy for the control of pain and the avoidance of complications in chronic pancreatitis. For this purpose, well evaluated surgical strategies are available. Delay in surgical therapy can lead to chronic pain, kachexia and malnutrition and increase complications of surgical therapy.

[Indications for Surgery in Pancreatic Ductal Adenocarcinoma - Consensus Recommendations by the German Society for General and Visceral Surgery]. / Von der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie konsentierte Operationsindikationen beim duktalen Pankreasadenokarzinom.

BACKGROUND: Surgery for pancreatic cancer in Germany is increasing due to the climbing incidence of this cancer in the population. This review presents a summary of modern evidence-based indications for surgery in patients with pancreatic ductal adenocarcinoma (PDAC). METHODS: The German Society for General and Visceral Surgery (DGAV) authorised a task force to define evidence based indications for surgery in patients with PDAC. A systematic literature search in Medline and Cochrane Library databases (1989 - 2019) was performed. Recommendations were summarised on the basis of the most relevant and recent guidelines and clinical studies and then voted by members of the Working Group on Hepato-Biliary and Pancreatic Diseases (CALGP) in a Delphi procedure. RESULTS: Indications for surgery in patients with PDAC should be set by experienced pancreatic surgeons within a tumour board. Decisions should consider the guidelines as well as the individual patient characteristics. Large vessel infiltration, metastatic disease and severe comorbidities are the most common contraindications for surgery. Borderline-resectable, primary resectable oligometastatic and secondary resectable PDAC should be preferably managed at high-volume centres as a part of clinical studies. Centralisation of pancreatic surgery reduces mortality and improves survival. Palliative bypass surgery as well as staging laparoscopy are still indicated in a large proportion of patients with PDAC. CONCLUSION: Irrespective of the recent development of multimodal therapeutic concepts, surgical resection remains the sole chance of long-term cure for patients with PDAC. Due to the significant proportion of patients in advanced stages of the disease, palliative surgery still plays an important role in the complex management of this cancer.

[Indications for Surgical and Interventional Therapy of Acute Pancreatitis]. / Indikationen zur chirurgischen und interventionellen Behandlung der akuten Pankreatitis.

BACKGROUND: 15 to 20% of patients with acute pancreatitis develop necrosis of the pancreatic parenchyma or extrapancreatic tissue. The disease is associated with a mortality rate of up to 20%. The mainstays of treatment consist of intensive medical care and surgical and interventional therapy. METHODS: A systematic literature search focused on indications for surgical and interventional therapy of necrotising pancreatitis. 85 articles were analysed for this review. By using the Delphi method, the results were presented to the quality committee for pancreas diseases of the German Society for General and Visceral Surgery and to expert pancreatologists in an interactive conference using plenary voting during the visceral medicine congress 2019 in Wiesbaden. For the finalised recommendations, an agreement of 84% of participants was achieved. RESULTS: Documented or clinical suspicion of infected, necrotising pancreatitis are indications for surgical and interventional therapy (recommendation grade: strong; evidence grade; low). Sterile necrosis is a less common indication for intervention due to late complications or persistent severe pancreatitis. Invasive interventions should be delayed when possible until four weeks after onset of pancreatitis. Optimal treatment strategy consists of a "step-up approach" (evidence grade: high; recommendation grade: strong). The first step is catheter drainage, followed, if necessary, by minimally invasive surgical or interventional necrosectomy. If minimally invasive techniques do not result in clinical improvement, open necrosectomy is necessary. 35 to 50% of patients are successfully treated with drainage alone. Indications for emergency intervention are bowel perforation, bowel ischemia and bleeding. Surgical decompression of abdominal compartment syndrome is indicated if the patient is refractory to medical treatment and percutaneous drainage. Abscesses and symptomatic pseudocysts are indications for interventional drainage. Early cholecystectomy during index admission is recommended for patients with mild biliary pancreatitis. Cholecystectomy should be delayed after severe, biliary pancreatitis. CONCLUSION: The recommendations for surgical an interventional therapy of necrotising pancreatitis address the basis of current indications in literature. They should serve in daily practice as a reference standard for decision making in multidisciplinary teams.

[Indications for the Surgical Management of Pancreatic Cystic Lesions]. / Operationsindikationen bei zystischen Tumoren des Pankreas.

A steady improvement in modern imaging as well as increasing age in society have led to an increasing number of cystic pancreatic tumours being detected. Pancreatic cysts are a clinically challenging entity because they span a broad biological spectrum and their differentiation is often difficult, especially in small tumours. Therefore, they require a differentiated indication for indication of surgery. To determine recommendations for the surgical indication in cystic tumours of the pancreas, a quality committee for pancreatic diseases of the German Society for General and Visceral Surgery performed a systematic literature search and created this review. Based on the current evidence, signs of malignancy and high-risk criteria (icterus due to cystic pancreatic duct obstruction in the bile duct, enhancing mural nodules ≥ 5 mm or solid components in the cyst or pancreatic duct ≥ 10 mm), as well as symptoms, are a surgical indication, independently of the cyst entity (except pseudocysts). If the entity of the pancreatic cyst is detectable by diagnostic imaging, all main duct IPMN and IPMN of the mixed type, all MCN > 4 cm and all SPN should be resected. SCN and branch-duct IPMN without worrisome features do not constitute an indication for surgery. The indication of operation in branch-duct IPMN with relative risk criteria and MCN < 4 cm is the subject of current discussions and should be individualised. By defining indication recommendations, the present work aims to improve the indication quality in cystic pancreatic tumours. However, the surgical indication should always be individualised, taking into account age, comorbidities and the patient's wishes.

Prognosis in patients with synchronous colorectal cancer metastases after complete resection of the primary tumor and the metastases.

BACKGROUND: Synchronous metastases are considered a negative prognostic factor in patients with metastatic colorectal cancer (CRC). We investigated the outcomes of stage IV CRC patients undergoing complete gross resection (R0/1) of both the primary tumor and the metastases under the guidance of a multidisciplinary team (MDT). METHODS: All CRC patients with synchronous metastases were retrieved from a prospective database. Patients treated from 2006 to 2017 who underwent complete resection were analyzed. Various factors, including multiple metastatic sites and complex procedures, were investigated. Univariate and multivariate overall survival (OS) calculations were performed. RESULTS: Of 330 consecutive patients with synchronous metastases, 101 (30.6%) achieved an R0/1 status including 12 (11.9%) patients with multiple metastatic sites. Complex procedures were necessary in 45 (44.6%) patients. Five-year OS was 53.0% for the R0/1 patient group. Multivariate analysis could not detect factors associated with prognosis. CONCLUSIONS: With modern treatment, the prognosis of patients with synchronous CRC metastases can be improved. Decisions made by a MDT offered one-third of patients a potentially curative approach to their stage IV disease. Despite the treatment of a high rate of patients with complex metastases necessitating complex procedures, we achieved a favorable 5-year OS rate.

To what extent is the low anterior resection syndrome (LARS) associated with quality of life as measured using the EORTC C30 and CR38 quality of life questionnaires?

PURPOSE: Treatment of rectal cancer often results in disturbed anorectal function, which can be quantified by the Low Anterior Resection Syndrome (LARS) score. This study investigates the association of impaired anorectal function as measured with the LARS score with quality of life (QoL) as measured with the EORTC-QLQ-C30 and CR38 questionnaires. METHODS: All stoma-free patients who had undergone sphincter-preserving surgery for rectal cancer from 2000 to 2014 in our institution were retrieved from a prospective database. They were contacted by mail and asked to return the questionnaires. QoL was evaluated in relation to LARS and further patient- and treatment factors using univariate and multivariate analysis. RESULTS: Of the eligible patients (n = 331), 261 (78.8%) responded with a complete LARS score. Mean score for global QoL according to the EORTC-QLQ-C30 questionnaire was 63 ± 21 for all patients. If major LARS was present, mean score decreased to 56 ± 19 in contrast to 67 ± 20 in patients with no/minor LARS (p < 0.001). In regression analysis, major LARS was furthermore associated with reduced physical, role, emotional, cognitive and social functioning as well as impaired body image, more micturition problems and poorer future perspective. It was not related to sexual function. The variance explained by major LARS in the differences of QoL was approximately 10%. CONCLUSION: The presence of major LARS after rectal resection for cancer is negatively associated with global health as well as many other aspects of QoL. Preserving anorectal function and treatment of LARS are potential measures to improve QoL in this patient group.

No Need for Routine Drainage After Pancreatic Head Resection: The Dual-Center, Randomized, Controlled PANDRA Trial (ISRCTN04937707).

OBJECTIVE: This dual-center, randomized, controlled, noninferiority trial aimed to prove that omission of drains does not increase reintervention rates after pancreatic surgery. BACKGROUND: There is considerable uncertainty regarding intra-abdominal drainage after pancreatoduodenectomy. METHODS: Patients undergoing pancreatic head resection with pancreaticojejunal anastomosis were randomized to intra-abdominal drainage versus no drainage. Primary endpoint was overall reintervention rate (relaparotomy or radiologic intervention). Secondary endpoints were clinically relevant pancreatic fistula (grade B/C), mortality, morbidity, and hospital stay. The planned sample size was 188 patients per group. RESULTS: A total of 438 patients were randomized. Forty-three patients (9.8%) were excluded because no pancreatic anastomosis was performed, and 395 patients (202 drain, 193 no-drain) were analyzed. Reintervention rates were not inferior in the no-drain group (drain 21.3%, no-drain 16.6%; P = 0.0004). Overall in-hospital mortality (3.0%) was the same in both groups (drain 3.0%, no-drain 3.1%; P = 0.936). Overall surgical morbidity (41.8%) was comparable (P = 0.741). Clinically relevant pancreatic fistula (grade B/C: drain 11.9%, no-drain 5.7%; P = 0.030) and fistula-associated complications (drain 26.4%; no drain 13.0%; P = 0.0008) were significantly reduced in the no-drain group. Operation time (P = 0.093), postoperative hemorrhage (P = 0.174), intra-abdominal abscess formation (P = 0.199), biliary leakage (P = 0.382), delayed gastric emptying (P = 0.062), burst abdomen (P = 0.480), wound infection (P = 0.758), and hospital stay (P = 0.487) did not show significant differences. CONCLUSIONS: Omission of drains was not inferior to intra-abdominal drainage in terms of postoperative reintervention and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. There is no need for routine prophylactic drainage after pancreatic resection with pancreaticojejunal anastomosis.