Single chest drain is not inferior to double chest drain after robotic esophagectomy: a propensity score-matched analysis.

Background: Chest drain management has a significant influence on postoperative recovery after robot-assisted minimally invasive esophagectomy (RAMIE). The use of chest drains increases postoperative pain by irritating intercostal nerves and hinders patients from early postoperative mobilization and recovery. To our knowledge, no study has investigated the use of two vs. one intercostal chest drains after RAMIE. Methods: This retrospective cohort study evaluated patients undergoing elective RAMIE with gastric conduit pull-up and intrathoracic anastomosis. Patients were divided into two groups according to placement of one (11/2020-08/2022) or two (08/2018-11/2020) chest drains. Propensity score matching was performed in a 1:1 ratio, and the incidences of overall and pulmonary complications, drainage-associated re-interventions, radiological diagnostics, analgesic use, and length of hospital stay were compared between single drain and double drain groups. Results: During the study period, 194 patients underwent RAMIE. Twenty-two patients were included after propensity score matching in the single and double chest drain group, respectively. Time until removal of the last chest drain [postoperative day (POD) 6.7 ± 4.4 vs. POD 9.4 ± 2.7, p = 0.004] and intensive care unit stay (4.2 ± 5.1 days vs. 5.3 ± 3.5 days, p = 0.01) were significantly shorter in the single drain group. Overall and pulmonary complications, drainage-associated events, re-interventions, number of diagnostic imaging, analgesic use, and length of hospital stay were comparable between both groups. Conclusion: This study is the first to demonstrate the safety of single intercostal chest drain use and, at least, non-inferiority to double chest drains in terms of perioperative complications after RAMIE.

Ensuring privacy protection in the era of big laparoscopic video data: development and validation of an inside outside discrimination algorithm (IODA).

BACKGROUND: Laparoscopic videos are increasingly being used for surgical artificial intelligence (AI) and big data analysis. The purpose of this study was to ensure data privacy in video recordings of laparoscopic surgery by censoring extraabdominal parts. An inside-outside-discrimination algorithm (IODA) was developed to ensure privacy protection while maximizing the remaining video data. METHODS: IODAs neural network architecture was based on a pretrained AlexNet augmented with a long-short-term-memory. The data set for algorithm training and testing contained a total of 100 laparoscopic surgery videos of 23 different operations with a total video length of 207 h (124 min ± 100 min per video) resulting in 18,507,217 frames (185,965 ± 149,718 frames per video). Each video frame was tagged either as abdominal cavity, trocar, operation site, outside for cleaning, or translucent trocar. For algorithm testing, a stratified fivefold cross-validation was used. RESULTS: The distribution of annotated classes were abdominal cavity 81.39%, trocar 1.39%, outside operation site 16.07%, outside for cleaning 1.08%, and translucent trocar 0.07%. Algorithm training on binary or all five classes showed similar excellent results for classifying outside frames with a mean F1-score of 0.96 ± 0.01 and 0.97 ± 0.01, sensitivity of 0.97 ± 0.02 and 0.0.97 ± 0.01, and a false positive rate of 0.99 ± 0.01 and 0.99 ± 0.01, respectively. CONCLUSION: IODA is able to discriminate between inside and outside with a high certainty. In particular, only a few outside frames are misclassified as inside and therefore at risk for privacy breach. The anonymized videos can be used for multi-centric development of surgical AI, quality management or educational purposes. In contrast to expensive commercial solutions, IODA is made open source and can be improved by the scientific community.

Drainless robot-assisted minimally invasive oesophagectomy-randomized controlled trial (RESPECT).

BACKGROUND: The purpose of this randomized trial is to evaluate the early removal of postoperative drains after robot-assisted minimally invasive oesophagectomy (RAMIE). Evidence is lacking about feasibility, associated pain, recovery, and morbidity. METHODS/DESIGN: This is a randomized controlled multicentric trial involving 72 patients undergoing RAMIE. Patients will be allocated into two groups. The "intervention" group consists of 36 patients. In this group, abdominal and chest drains are removed 3 h after the end of surgery in the absence of contraindications. The control group consists of 36 patients with conventional chest drain management. These drains are removed during the further postoperative course according to a standard algorithm. The primary objective is to investigate whether postoperative pain measured by NRS on the second postoperative day can be significantly reduced in the intervention group. Secondary endpoints are the intensity of pain during the first week, analgesic use, number of postoperative chest X-ray and CT scans, interventions, postoperative mobilization (steps per day as measured with an activity tracker), postoperative morbidity and mortality. DISCUSSION: Until now, there have been no trials investigating different intraoperative chest drain strategies in patients undergoing RAMIE for oesophageal cancer with regard to perioperative complications until discharge. Minimally invasive approaches combined with enhanced recovery after surgery (ERAS) protocols lower morbidity but still include the insertion of chest drains. Reduction and early removal have been proposed after pulmonary surgery but not after RAMIE. The study concept is based on our own experience and the promising current results of the RAMIE procedure. Therefore, the presented randomized controlled trial will provide statistical evidence of the effectiveness and feasibility of the "drainless" RAMIE. TRIAL REGISTRATION: ClinicalTrials.gov NCT05553795. Registered on 23 September 2022.

Analysis of predictors for postoperative complications after pancreatectomy--what is new after establishing the definition of postpancreatectomy acute pancreatitis (PPAP)?

PURPOSE: We aimed to analyze the predictive value of hyperamylasemia after pancreatectomy for morbidity and for the decision to perform rescue completion pancreatectomy (CP) in a retrospective cohort study. METHODS: Data were extracted from a retrospective clinical database. Postoperative hyperamylasemia (POH) and postoperative hyperlipasemia (POHL) were defined by values greater than those accepted as the upper limit at our institution on postoperative day 1 (POD1). The endpoints of the study were the association of POH with postoperative morbidity and the possible predictors for postpancreatectomy acute pancreatitis (PPAP) and severe complications such as the necessity for rescue CP. RESULTS: We analyzed 437 patients who underwent pancreaticoduodenectomy over a period of 7 years. Among them, 219 (52.3%) patients had POH and 200 (47.7%) had normal postoperative amylase (non-POH) levels. A soft pancreatic texture (odds ratio [OR] 3.86) and POH on POD1 (OR 8.2) were independent predictors of postoperative pancreatic fistula (POPF), and POH on POD1 (OR 6.38) was an independent predictor of rescue CP. The clinically relevant POPF (49.5% vs. 11.4%, p < 0.001), intraabdominal abscess (38.3% vs. 15.3%, p < 0.001), postoperative hemorrhage (22.8% vs. 5.1%, p < 0.001), major complications (Clavien-Dindo classification > 2) (52.5% vs. 25.6%, p < 0.001), and CP (13% vs. 1.8%, p < 0.001) occurred significantly more often in the POH group than in the non-POH group. CONCLUSION: Although POH on POD1 occurs frequently, in addition to other risk factors, it has a predictive value for the development of postoperative morbidity associated with PPAP and CP.

How we do it-the use of peritoneal patches for reconstruction of vena cava inferior and portal vein in hepatopancreatobiliary surgery.

PURPOSE: Extended resections in hepatopancreatobiliary (HPB) surgery frequently require vascular resection to obtain tumor clearance. The use of alloplastic grafts may increase postoperative morbidity due to septic or thrombotic complications. The use of suitable autologous venous interponates (internal jugular vein, great saphenous vein) is frequently associated with additional incisions. The aim of this study was to report on our experience with venous reconstruction using the introperative easily available parietal peritoneum, focusing on key technical aspects. METHODS: All patients who underwent HPB resections with venous reconstruction using peritoneal patches at our department between January 2017 and November 2021 were included in this retrospective analysis with median follow-up of 2 months (IQR: 1-8 months). We focused on technical aspects of the procedure and evaluated vascular patency and perioperative morbidity. RESULTS: Parietal peritoneum patches (PPPs) were applied for reconstruction of the inferior vena cava (IVC) (13 patients) and portal vein (PV) (4 patients) during major hepatic (n = 14) or pancreatic (n = 2) resections. There were no cases of postoperative bleeding due to anastomotic leakage. Following PV reconstruction, two patients showed postoperative vascular stenosis after severe pancreatitis with postoperative pancreatic fistula and bile leakage, respectively. In patients with reconstruction of the IVC, no relevant perioperative vascular complications occurred. CONCLUSIONS: The use of a peritoneal patch for reconstruction of the IVC in HPB surgery is a feasible, effective, and low-cost alternative to alloplastic, xenogenous, or venous grafts. The graft can be easily harvested and tailored to the required size. More evidence is still needed to confirm the safety of this procedure for the portal vein regarding long-term results.

Does speed equal quality? Time pressure impairs minimally invasive surgical skills in a prospective crossover trial.

BACKGROUND: Time pressure can cause stress, subsequently influencing surgeons during minimally invasive procedures. This trial aimed to investigate the effect of time pressure on surgical quality, as assessed by force application and errors during minimally invasive surgical tasks. METHODS: Sixty-three participants (43 surgical novices trained to proficiency and 20 surgeons) performed four laparoscopic tasks (PEG transfer, precise Cutting, balloon resection, surgical knot) both with and without time pressure. The primary endpoint was the mean and maximal force exertion during each task. Secondary endpoints were the occurrence of predefined errors and the self-assessed stress level. RESULTS: Time pressure led to a significant shortening of the task time in all four tasks. However, significantly more errors were noticed under time pressure in one task (suture precision P < 0.001). Moreover, time pressure led to a significant increase in mean force in all tasks (PEG: P < 0.001; precision cutting: P = 0.001; surgical knot: P < 0.001; balloon: P = 0.004). In three tasks the maximal force application (PEG: P < 0.001; precision cutting: P < 0.001; surgical knot: P = 0.006) increased significantly. Performing the tasks under time pressure significantly increased the stress level. Cohort analysis revealed that time pressure impaired the performance of both, surgical novices and surgeons but novices were more strongly affected compared to surgeons. CONCLUSION: Time pressure during minimally invasive surgery may improve procedural time but impair the quality of surgical performance in terms of the incidence of errors and force exertion. Experience may only partially compensate for the negative influence of time pressure.

[Highlights of pancreatic surgery: extended indications in pancreatic neuroendocrine tumors]. / Highlights der Pankreaschirurgie: erweiterte Indikationen bei neuroendokrinen Tumoren des Pankreas.

Advanced pancreatic neuroendocrine tumors (paNET) are mostly characterized by infiltration of vascular structures and/or neighboring organs. The indications for resection in these cases should be measured based on the possibility of an R0 resection. Although the data situation for this rare entity is limited, small case series have shown a significant survival advantage in patients who underwent a radical resection in locally advanced stages of paNET. Both vascular reconstruction and multivisceral resection, when performed at experienced centers, should be considered as curative treatment options. The very special biological behavior of the paNET and the often young patient age justify a much more aggressive approach compared to the pancreatic ductal adenocarcinoma.

Short-term preoperative drainage is associated with improved postoperative outcomes compared to that of long-term biliary drainage in pancreatic surgery.

PURPOSE: The treatment of choice for patients presenting with obstructive cholestasis due to periampullary carcinoma is oncologic resection without preoperative biliary drainage (PBD). However, resection without PBD becomes virtually impossible in patients with obstructive cholangitis or severely impaired liver cell function. The appropriate duration of drainage by PBD has not yet been defined for these patients. METHODS: A retrospective analysis was conducted on 170 patients scheduled for pancreatic resection following biliary drainage between January 2012 and June 2018 at the University Hospital Dresden in Germany. All patients were deemed eligible for inclusion, regardless of the underlying disease entity. The primary endpoint analysis was defined as the overall morbidity (according to the Clavien-Dindo classification). Secondary endpoints were the in-hospital mortality and malignancy adjusted overall and recurrence-free survival rates. RESULTS: A total of 170 patients were included, of which 45 (26.5%) and 125 (73.5%) were assigned to the short-term (< 4 weeks) and long-term (≥ 4 weeks) preoperative drainage groups, respectively. Surgical complications (Clavien-Dindo classification > 2) occurred in 80 (47.1%) patients, with significantly fewer complications observed in the short-term drainage group (31.1% vs. 52%; p = 0.02). We found that long-term preoperative drainage (unadjusted OR, 3.386; 95% CI, 1.507-7.606; p < 0.01) and periampullary carcinoma (unadjusted OR, 5.519; 95% CI, 1.722-17.685; p-value < 0.01) were independent risk factors for postoperative morbidity, based on the results of a multivariate regression model. The adjusted overall and recurrence-free survival did not differ between the groups (p = 0.12). CONCLUSION: PBD in patients scheduled for pancreatic surgery is associated with substantial perioperative morbidity. Our results indicate that patients who have undergone PBD should be operated on within 4 weeks after drainage.

[Preoperative diagnostics and typing of abdominal soft tissue sarcomas]. / Präoperative Diagnostik und Typisierung abdomineller Weichteilsarkome.

BACKGROUND: Abdominal sarcomas are a heterogeneous group of rare soft tissue tumors and can be localized intraperitoneally or retroperitoneally. A pretherapeutic differentiated subtyping is essential for planning an individual, multimodal treatment concept in an interdisciplinary team of experts. OBJECTIVE: The central aspects of histology acquisition, imaging diagnostics and (molecular) pathological subtyping of abdominal soft tissue sarcomas are described in detail. MATERIAL AND METHODS: Imaging and pathological diagnostics are depicted based on the German S3 guidelines on adult soft tissue sarcomas, a current literature search and personal experiences at the Sarcoma Center at the National Center for Tumor Diseases in Dresden (NCT/UCC). RESULTS: Preoperative imaging and (molecular) pathological subtyping of abdominal soft tissue sarcomas place high demands on surgeons, radiologists and pathologists. Genome analyses of sarcomas have the potential to identify points of attack for individualized treatment options. The limitations of resectability can only be assessed by experienced sarcoma surgeons at specialized centers. CONCLUSION: The treatment of abdominal soft tissue sarcomas at an experienced center is associated with a better prognosis. Even at the first suspicion of an abdominal sarcoma, a referral to an experienced center should be made in order to guarantee optimal expertise in diagnostics and treatment.

Perioperative Blood Management of Preoperative Anemia Determines Long-Term Outcome in Patients with Pancreatic Surgery.

BACKGROUND/PURPOSE: Anemia affects the postoperative course of patients undergoing a major surgical procedure. However, it remains unclear whether anemia has a different impact on the long-term outcome of patients with malignant or benign pancreatic disease. METHODS: A retrospective analysis of patients undergoing pancreatic surgery for pancreatic malignancies or chronic pancreatitis was conducted between January 2012 and June 2018 at the University Hospital Dresden, Germany. The occurrence of preoperative anemia and the administration of pre-, intra-, and postoperative blood transfusions were correlated with postoperative complications and survival data by uni- and multivariate analysis. RESULTS: A total of 682 patients were included with 482 (70.7%) undergoing surgical procedures for pancreatic malignancies. Univariate regression analysis confirmed preoperative anemia as a risk factor for postoperative complications > grade 2 according to the Clavien-Dindo classification. Multivariate regression analyses indicated postoperative blood transfusion as an independent risk factor for postoperative complications in patients with a benign (OR 20.5; p value < 0.001) and a malignant pancreatic lesion (OR 4.7; p value < 0.01). Univariate and multivariate analysis revealed preoperative anemia and pre-, intra-, and postoperative blood transfusions as independent prognostic factors for shorter overall survival in benign and malignant patients (p value < 0.001-0.01). CONCLUSION: Preoperative anemia is a prevalent, independent, and adjustable factor in pancreatic surgery, which poses a significant risk for postoperative complications irrespective of the entity of the underlying disease. It should therefore be understood as an adjustable factor rather than an indicator of underlying disease severity.

[The suffering surgeon-How do German surgeons protect themselves? : Survey of the German Society of General and Visceral Surgery on the extent of occupational safety measures and health burden among German surgeons]. / Der leidende Chirurg ­ Wie schützen Chirurgen sich selbst? : DGAV-Umfrage zur Verbreitung von Arbeitssicherheitsmaßnahmen und Gesundheitsbelastung bei deutschen Chirurgen.

BACKGROUND: There are few data on how surgeons implement occupational safety measures to protect their own health and how they assess their subjective health burden. OBJECTIVE: In times of a shortage of surgeons it makes sense to examine these relationships in order to evaluate future-oriented adjustments to increase the attractiveness of the profession of "surgeon". MATERIAL AND METHODS: An online questionnaire was sent to the registered members of the German Society for General and Visceral Surgery (DGAV) in October 2016. The members were asked about the application of occupational safety measures, individual living conditions, working conditions and the subjective health burden depending on the level of training and type of hospital (basic, standard, maximum care). RESULTS: The response rate was 21% (1065/5011). Occupational safety measures were not strictly implemented: routine use of dosimeters, thyroid radiation protection, smoke extraction and protective goggles only took place in 40% (427/1065), 39% (411/1065), 10% (104/1065) and 5% (55/1065), respectively. The majority of surgeons (51%, 548/1065) rated their lifestyle as unhealthy. The majority of them are senior physicians, 46% (250/548) consider their job to be a health hazard. The proportion of chief physicians and assistant physicians is only 21% (115/548) and 18% (98/548). CONCLUSION: Guidelines for standardizing the perioperative protection of German surgeons are desirable. Health-promoting behavior could have a positive effect on the occupational safety of surgeons and ultimately also on patient safety. This can contribute to increasing the attractiveness of the profession "surgeon" in the long term.

[Process management in surgery]. / Prozessmanagement in der Chirurgie.

Process management is defined as the concept of identifying processes in a company or healthcare organization, analyzing them and improving productivity and efficiency. In hospitals, process management focuses on patient safety, an increase in economic resources and employee satisfaction. The integration of process management into clinical pathways helps to accelerate workflows and to improve the quality of patient service. The different types of process management encompass the radical concept of process renewal (revolutionary renewal) as well as the concept of evolutionary optimization. Process management in surgery is applied to preoperative, perioperative and postoperative procedures. The development and implementation of evidence-based treatment pathways can help to standardize and structure treatment processes in a surgical department. In this context, the operating room (OR) plays a particularly central role as the most important part of the healthcare provision of perioperative services. Process management is indispensable for the utilization of an optimal OR capacity taking a maximum patient safety and the desired optimal satisfaction of employees into account. The benefits of process management in the OR area are illustrated in an exemplary case study, demonstrating how innovative process management results in an increase of the operation capacity with a simultaneous reduction in costs.

Edoxaban for treatment of venous thromboembolism in patient groups with different types of cancer: Results from the Hokusai VTE Cancer study.

BACKGROUND: The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups. METHODS: We evaluated the occurrence of the primary outcome in large cancer groups. The primary outcome was the composite of recurrent VTE or major bleeding over 12 months. RESULTS: In patients with gastrointestinal cancer, the primary outcome occurred in 19.4% patients given edoxaban and in 15.0% given dalteparin (risk difference [RD], 4.4%; 95%-CI, -4.1% to 12.8%). The corresponding rates for edoxaban and dalteparin were 10.4% and 10.7% for lung cancer (RD, -0.3%; 95%-CI, -10.0% to 9.5%), 13.6% and 12.5% for urogenital cancer (RD, 1.1; 95%-CI, -10.1-12.4), 3.1% and 11.7% for breast cancer (RD, -8.6; 95%-CI, -19.3-2.2), 8.9% and 10.9% for hematological malignancies (RD, -2.0; 95%-CI, -13.1-9.1), and 10.4% and 17.4% for gynecological cancer (RD, -7.0; 95%-CI, -19.8-5.7). In the subgroup of gastrointestinal cancer, edoxaban was associated with a 3.5% lower absolute risk of recurrent VTE and a 7.9% higher risk of major bleeding. CONCLUSION: Edoxaban has a similar risk-benefit ratio to dalteparin in most cancer groups. In those with gastrointestinal cancer, the lower risk of recurrent VTE and the advantages of oral therapy need to be balanced against the increased risk of major bleeding.

Influence of Molecular Status on Recurrence Site in Patients Treated for a Stage III Colon Cancer: a Post Hoc Analysis of the PETACC-8 Trial.

BACKGROUND: Recurrence patterns in stage III colon cancer (CC) patients according to molecular markers remain unclear. The objective of the study was to assess recurrence patterns according to microsatellite instability (MSI), RAS and BRAFV600E status in stage III CC patients. METHODS: All stage III CC patients from the PETACC-8 randomized trial tested for MSI, RAS and BRAFV600E status were included. The site and characteristics of recurrence were analyzed according to molecular status. Survival after recurrence (SAR) was analyzed. RESULTS: A total of 1650 patients were included. Recurrence occurred in 434 patients (26.3%). Microsatellite stable (MSS) patients had a significantly higher recurrence rate (27.2% vs. 18.7%, P = 0.02) with a trend to more pulmonary recurrence (28.8% vs. 12.9%, P = 0.06) when compared to MSI patients. MSI patients experienced more regional lymph nodes compared to MSS (12.9% vs. 4%, P = 0.046). In the MSS population, the recurrence rate was significantly higher in RAS (32.2%) or BRAF (32.3%) patients when compared to double wild-type patients (19.9%) (p < 0.001); no preferential site of recurrence was observed according to RAS and BRAFV600E mutations. Finally, decreased SAR was observed in the case of peritoneal recurrence or more than two recurrence sites. CONCLUSIONS: Microsatellite, RAS and BRAFV600E status influences recurrence rates in stage III CC patients. However, only microsatellite status seems to be associated with specific recurrence patterns. More than two recurrence sites and recurrence in the peritoneum were associated with poorer SAR.

Robot-Assisted Oesophagectomy: Recommendations Towards a Standardised Ivor Lewis Procedure.

A considerable number of reports have been published on the feasibility, techniques, and early postoperative results of robotic-assisted oesophageal surgery. However, these are mostly smaller case series, suggesting that the robot-assisted Ivor Lewis procedure is still in the implementation phase and far from being standardised. Oesophageal surgeons from seven robotic university centres in Germany, experienced in both minimally invasive and robot-assisted minimally invasive surgery, took part in a workshop on robot-assisted surgery. An intensive exchange of opinions and experiences, followed by a step-by-step re-enactment of the operation in a cadaver lab, enabled us to develop a standardised robot-assisted Ivor Lewis surgical workflow, which is presented here. Systematic and objective comparison of experiences and results using a robot-assisted Ivor Lewis procedure has made it possible to develop a standardised surgical workflow that is now clinically applied in our centres. It is hoped that standardisation of this procedure will help to maintain patient safety, prevent medical errors, and facilitate the learning curve, while introducing robotic surgery into a centre.

[Transanal total mesorectal excision-a critical appraisal]. / Transanale totale mesorektale Exzision ­ eine kritische Standortbestimmung.

INTRODUCTION: Total mesorectal excision (TME) is the international standard for rectal cancer surgery. In addition to laparoscopic TME (lapTME), transanal TME (taTME) was developed in recent years to reduce the rate of incomplete TME, conversion to open surgery and postoperative functional impairment. Despite limited evidence, this technique is becoming increasingly more popular and is already routinely used by many hospitals for rectal cancer in varying tumor level locations. The aim of this review was to evaluate the taTME compared to anterior rectal resection with lapTME as the standard of care in rectal cancer surgery based on currently available evidence. METHOD: The databases PubMed and Medline were systematically searched for publications on transanal total mesorectal excision (taTME) and transanal minimally invasive surgery (TAMIS). Relevant studies were selected and further research based on the reference lists was undertaken. RESULTS: A total of 16 studies analyzing 3782 patients were identified. The taTME does not lead to a higher rate of complete TME-resected specimens compared to the standard procedure. So far, superiority could not be demonstrated for complication rates or for functional or oncological results. Serious complications secondary to dissection in incorrect planes were observed. The anastomotic level generally seems to be closer to the sphincter after taTME versus anterior lapTME. CONCLUSION: Considering current evidence, taTME failed to show superiority compared to conventional anterior lapTME. Although taTME has some potential advantages, it carries substantial risks. If performed outside of clinical trials, it should therefore only be used in carefully selected patients with a high possibility of conversion, following adequate patient informed consent and after intense and systematic training of the surgeon.

[Evidence for robotic surgery in oncological visceral surgery]. / Evidenz der Roboter-Chirurgie in der onkologischen Viszeralchirurgie.

The superiority of minimally invasive operative methods compared to open surgery with respect to various parameters of short-term outcome with adequate oncological long-term results has already been confirmed for many tumor entities in high-quality studies. The continuously expanding robotic surgery offers certain additional benefits in minimally invasive oncological visceral surgery, such as a high-resolution stable 3­dimensional view, optimal freedom of movement in situ, elimination of natural tremor and better ergonomics. This article evaluates whether these postulated advantages are reflected in an improvement of the short-term perioperative and long-term oncological results compared to conventional minimally invasive surgery in oncological visceral surgery (rectum, colon, stomach, esophagus, pancreas, liver) according to the criteria of evidence-based medicine. With the exception of colorectal surgery, there are currently no randomized controlled studies comparing robotic to laparoscopic surgery in oncological visceral surgery. There is still a clear imbalance between the exponentially expanding application of robotic surgery and the existing lack of high-quality evidence. Further randomized controlled clinical trials urgently need to be performed especially considering the great technological development potential of robotic surgery.

Randomized clinical trial of stapler hepatectomy versus LigaSure™ transection in elective hepatic resection.

BACKGROUND: Previous studies have demonstrated stapler hepatectomy and use of various energy devices to be safe alternatives to the clamp-crushing technique in elective hepatic resection. In this randomized trial, the effectiveness and safety of stapler hepatectomy were compared with those of parenchymal transection with the LigaSure™ vessel sealing system. METHOD: Patients scheduled for elective liver resection at two tertiary-care centres were randomized during surgery to stapler hepatectomy or transection with the LigaSure™ device. Total intraoperative blood loss was the primary efficacy endpoint. Transection time, duration of operation, perioperative complications and length of hospital stay were recorded as secondary endpoints. RESULTS: A total of 138 patients were analysed, 69 in the LigaSure™ and 69 in the stapler hepatectomy group. Baseline characteristics were well balanced between the groups. Mean intraoperative blood loss was significantly higher in the LigaSure™ group than the stapler hepatectomy group: 1101 (95 per cent c.i. 915 to 1287) versus 961 (752 to 1170) ml (P = 0·028). The parenchymal transection time was significantly shorter in the stapler group (P = 0·005), as was the total duration of operation (P = 0·027). Surgical morbidity did not differ between the groups, nor did the grade of complications. CONCLUSION: Stapler hepatectomy was associated with reduced blood loss and a shorter duration of operation than the LigaSure™ device for parenchymal transection in elective partial hepatectomy. Registration number: NCT01858987 (http://www.clinicaltrials.gov).