Frederik Berrevoet

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial

BACKGROUND The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. METHODS This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. FINDINGS Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. INTERPRETATION Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome. FUNDING German Federal Ministry of Education and Research.

Criteria for definition of a complex abdominal wall hernia

AbstractPurpose A clear definition of “complex (abdominal wall) hernia” is missing, though the term is often used. Practically all “complex hernia” literature is retrospective and lacks proper description of the population. There is need for clarification and classification to improve patient care and allow comparison of different surgical approaches. The aim of this study was to reach consensus on criteria used to define a patient with “complex” hernia.MethodsThree consensus meetings were convened by surgeons with expertise in complex abdominal wall hernias, aimed at laying down criteria that can be used to define “complex hernia” patients, and to divide patients in severity classes. To aid discussion, literature review was performed to identify hernia classification systems, and to find evidence for patient and hernia variables that influence treatment and/or prognosis.ResultsConsensus was reached on 22 patient and hernia variables for “complex” hernia criteria inclusion which were grouped under four categories: “Size and location”, “Contamination/soft tissue condition”, “Patient history/risk factors”, and “Clinical scenario”. These variables were further divided in three patient severity classes (‘Minor’, ‘Moderate’, and ‘Major’) to provide guidance for peri-operative planning and measures, the risk of a complicated post-operative course, and the extent of financial costs associated with treatment of these hernia patients.ConclusionCommon criteria that can be used in defining and describing “complex” (abdominal wall) hernia patients have been identified and divided under four categories and three severity classes. Next step would be to create and validate treatment algorithms to guide the choice of surgical technique including mesh type for the various complex hernias.

Use of topical hemostatic agents during liver resection.

Despite all recent developments in surgical techniques during liver surgery, blood loss is still one of the main causes for postoperative morbidity and mortality. Other complications include bile leakage and fluid accumulation intraperitoneally. Fibrin sealants are able not only to enhance clot formation and wound healing but possibly work as a sealing device for postoperative leakage and fistula formation. In this overview the underlying mechanisms for these agents are discussed and several clinical data concerning liver surgery will be reported.

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study)

BackgroundDespite major improvements in the perioperative outcome of pancreas surgery, the prognosis of pancreatic cancer after curative resection remains poor. Adjuvant chemotherapy increases disease-free and overall survival, but this treatment cannot be offered to a significant proportion of patients due to the surgical morbidity. In contrast, almost all patients can receive (neo)adjuvant chemotherapy before surgery. This treatment is safe and effective, and has resulted in a median survival of 26.5 months in a recent phase II trial. Moreover, neoadjuvant chemotherapy improves the nutritional status of patients with pancreatic cancer. This multicenter phase III trial (NEOPAC) has been designed to explore the efficacy of neoadjuvant chemotherapy.Methods/DesignThis is a prospective randomized phase III trial. Patients with resectable cytologically proven adenocarcinoma of the pancreatic head are eligible for this study. All patients must be at least 18 years old and must provide written informed consent. An infiltration of the superior mesenteric vein > 180° or major visceral arteries are considered exclusion criteria. Eligible patients will be randomized to surgery followed by adjuvant gemcitabine (1000 mg/m2) for 6 months or neoadjuvant chemotherapy (gemcitabine 1000 mg/m2, oxaliplatin 100 mg/m2) followed by surgery and the same adjuvant treatment. Neoadjuvant chemotherapy is given four times every two weeks. The staging as well as the restaging protocol after neoadjuvant chemotherapy include computed tomography of chest and abdomen and diagnostic laparoscopy. The primary study endpoint is progression-free survival. According to the sample size calculation, 155 patients need to be randomized to each treatment arm. Disease recurrence will be documented by scheduled computed tomography scans 9, 12, 15, 21 and thereafter every 6 months until disease progression. For quality control, circumferential resection margins are marked intraoperatively, and representative histological sections will be centrally reviewed by a dedicated pathologist.DiscussionThe NEOPAC study will determine the efficacy of neoadjuvant chemotherapy in pancreatic cancer for the first time and offers a unique potential for translational research. Furthermore, this trial will provide the unbiased overall survival of all patients undergoing surgery for resectable cancer of the pancreatic head.Trial registrationclinicalTrials.gov NCT01314027

Recommendations for reporting outcome results in abdominal wall repair

BackgroundThe literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology.Materials and methodsThe EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction.ResultsA list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of “time-to-event analysis” to report data on “freedom-of-recurrence” rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods.ConclusionA set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

Pure laparoscopic full-left living donor hepatectomy for calculated small-for-size LDLT in adults: proof of concept.

Adult‐to‐adult living donor liver transplantation (A2ALDLT) is an accepted mode of treatment for end‐stage liver disease. Right‐lobe grafts have usually been preferred in view of the higher graft volume, which lowers the risk of a small‐for‐size syndrome. However, donor left hepatectomy is associated with less morbidity than when it is compared to right hepatectomy. Laparoscopic donor hepatectomy (LDH) has been considered almost exclusively in pediatric transplantation. The results of laparoscopic left‐liver graft procurement for calculated small‐for‐size A2ALDLT in four donors are presented. The graft‐to‐recipient body weight ratio was <0.8 in all recipients. The mean portal vein flow and the pressure and hepatic artery flows were measured at 190 ± 56 mL/min/100 g, 13 ± 1.4 mm/Hg and 109 ± 19 mL/min, respectively. No early postoperative donor complications were recorded. One graft was lost due to intrahepatic abscesses. Asymptomatic stenosis of a right posterior duct was treated with a Roux‐en‐Y loop 4 months later in one donor. We show that LDH of the full‐left lobe is feasible. LDH is a very demanding operation, potentially decreasing donor morbidity. Standardization of this procedure, making it accessible to the growing number of experienced laparoscopic liver surgeons, could help renewing the interest for A2ALDLT in the Western world.

Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial.

Background:The incidence of incisional hernias after abdominal aortic aneurysm repair is high. Prophylactic mesh-augmented reinforcement during laparotomy closure has been proposed in patients at high risk of incisional hernia. Methods:A multicenter randomized trial was conducted on patients undergoing elective abdominal aortic aneurysm repair through a midline laparotomy (Clinical.Trials.gov: NCT00757133). In the study group, retromuscular mesh-augmented reinforcement was performed with a large-pore polypropylene mesh (Ultrapro, width 7.5 cm). The primary endpoint was the incidence of incisional hernias at 2-year follow-up. Results:Between February 2009 and January 2013, 120 patients were recruited at 8 Belgian centers. Patients’ characteristics at baseline were similar between groups. Operative and postoperative characteristics showed no difference in morbidity or mortality. The cumulative incidence of incisional hernias at 2-year follow-up after conventional closure was 28% (95% confidence interval [CI], 17%–41%) versus 0% (95% CI, 0%–6%) after mesh-augmented reinforcement (P < 0.0001; Fisher exact test). The estimated “freedom of incisional hernia” curves (Kaplan-Meier estimate) were significantly different across study arms (&khgr;2 = 19.5, P < 0.0001; Mantel-Cox test). No adverse effect related to mesh-augmented reinforcement was observed, apart from an increased mean time to close the abdominal wall for mesh-augmented reinforcement compared with the control group: 46 minutes (SD, 18.6) versus 30 minutes (SD, 18.5), respectively (P < 0.001; Mann-Whitney U test). Conclusions:Prophylactic retromuscular mesh-augmented reinforcement of a midline laparotomy in patients with abdominal aortic aneurysm is safe and effectively prevents the development of incisional hernia during 2 years, with an additional mean operative time of 16 minutes.

Hepato-venous reconstruction in orthotopic liver transplantation with preservation of the recipients' inferior vena cava and veno-venous bypass.

Abstract. Background and aims: The potential advantages of vena cava-preserving recipient hepatectomy in orthotopic liver transplantation are reduced hemorrhage, improved cardiovascular stability and preserved renal perfusion without the requirement of veno-venous bypass as compared with recipient hepatectomy including the vena cava. No detailed information is available on the use of veno-venous bypass during complicated vena cava preserving recipient hepatectomy and liver transplantation. In the present study, the peri- and postoperative courses of adult liver transplant recipients in whom the hepatovenous reconstruction was performed according to three different techniques with and without the use of veno-venous bypass were investigated. Patients/Methods: During primary orthotopic liver transplantation, an end-to-end (ETE) cavo-caval interposition of the donor vena cava to the recipient’s vena cava was performed in 75 patients (group I). In 15 patients, a termino-terminal piggyback (PB) anastomosis was constructed to the remnant of the recipient’s hepatic vein (group II), and in 72 transplantations a latero-lateral cavo-cavostomy (LLC) of donor-to-recipient’s vena cava (group III) was performed. The use of bypass, operative time and cold ischemia time, perioperative blood product requirements, incidence of relaparotomy, the evolution of postoperative renal function, technical complications and the survival were analyzed and compared using multivariate statistics and actuarial techniques for statistical evaluation. Results: No differences could be found in preoperative patient conditions, donor conditions, operating time, anastomosing time or cold ischemia time. In groups I–III, the veno-venous bypass was used in 50 (67%), 8 (53%) and 6 (8%) cases respectively (P=0.02 for group III). The mean preoperative packed cells requirements were 20.4 vs 29.6 vs 10.8 units (P=0.01 for group III), while postoperative blood product requirements (first 24 h) were 2.6 vs 5.0 vs 0.20 units of packed cells (P=0.02 for group III). Relaparotomy for diffuse retropertioneal hemorrhage was performed 14 times (19%) in group I, 3 times (20%) in group II and 7 times (8.3%) in group III (P=0.002). The incidence of posteropative early renal dysfunction (increase of ≥1.3 mg% serum creatinine) in group I vs group II vs group III was 24% vs 60% vs 16.7% (P=0.001 for group II) for patients without the use of veno-venous bypass. No significant difference was observed concerning early renal dysfunction in patients where a veno-venous bypass was used. The survival at 12 months was 81% for group I, 86% for group II and 93.0% for group III. In group III there were four complications (P=0.03) at the hepatovenous anastomosis of which two were eventually fatal. Conclusion: Preservation of the recipient’s vena cava and LLC can reduce, but not avoid, the requirement for veno-venous bypass. In orthotopic liver transplantation, postoperative hemorrhage, as measured by surgical revisions and requirement for blood products, is significantly reduced with LLC with and without bypass. Early renal dysfunction also occurs in the group of LLC as compared with the termino-terminal cavostomy independent of the bypass. A technical failure resulting in patient death can be associated with LLC.

Hypomagnesemia and the risk of new‐onset diabetes after liver transplantation

New‐onset diabetes after transplantation (NODAT) is a frequent complication after liver transplantation and has a negative impact on both patient and graft survival. In analogy with the previous finding of an association between posttransplant hypomagnesemia and NODAT in renal transplant recipients, the relation between both pretransplant and posttransplant hypomagnesemia and NODAT was studied in liver transplant recipients (LTRs). One hundred sixty‐nine adult LTRs (>18 years old) without diabetes who underwent transplantation between 2004 and 2009 were studied (mean age = 52.11 ± 12.6 years, proportion of LTRs who were male = 67.5%, body mass index = 25.5 ± 4.4 kg/m2, proportion receiving tacrolimus = 90.0%). NODAT was defined according to the American Diabetes Association criteria. The association of NODAT with both pretransplant and posttransplant serum magnesium (Mg) was examined. Overall, 52 of 169 patients (30.8%) developed NODAT, and 57.7% of these (30 patients) were treated with antidiabetic drugs. Both pretransplant Mg levels and Mg levels in the first month after transplantation were lower in patients developing NODAT (P = 0.008 and P = 0.001, respectively). A multivariate regression model (adjusted for weight, pretransplant glucose levels, hyperglycemia in the first week after transplantation, gender, hepatitis C, and corticosteroid dosing) demonstrated both pretransplant Mg levels (hazard ratio = 0.844 per 0.1 mg/dL increase, 95% confidence interval = 0.764‐0.932, P = 0.001) and posttransplant Mg levels (hazard ratio = 0.659, 95% confidence interval = 0.518‐0.838, P = 0.001) to be independent predictors of NODAT together with age, biopsy‐proven acute rejection, and cytomegalovirus (CMV) infection in the first year after transplantation. In conclusion, pretransplant hypomagnesemia and early posttransplant hypomagnesemia are independent predictors of new‐onset diabetes after liver transplantation. Other risk factors are age, biopsy‐proven acute rejection, and CMV infection. Liver Transpl 16:1278‐1287, 2010.

Open intraperitoneal versus retromuscular mesh repair for umbilical hernias less than 3cm diameter

BACKGROUND mesh techniques are the preferable methods for repair of small ventral hernias, as a primary suture repair shows high recurrence rates. The aim of this prospective study was to compare the retromuscular sublay technique with the intraperitoneal underlay technique for primary umbilical hernias. METHODS from February 2004 to April 2007, all patients treated for umbilical hernias with maximum diameters of 3 cm were prospectively followed. During the first period of 15 months, all patients were treated with retromuscular repair using a large pore mesh (Vypro). After that period, for all patients, mesh repair using an intraperitoneal Ventralex patch was performed. All patients underwent general anesthesia. This analysis included 116 patients, of whom 56 had retromuscular repair (group I; mean age, 54.8 years; mean body mass index, 28.2 kg/m(2)) and 60 had open intraperitoneal repair (group II; mean age, 48.1 years; mean body mass index, 29.4 kg/m(2)). Operating time was evaluated as skin-to-skin time, and drain management was noted for both techniques. Follow-up was ≥ 2 years for all patients, and both early and late complications were registered, including seroma and hematoma formation, wound infection, fistula formation, and recurrence rates. Preoperative and postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit; on postoperative days 1, 7, and 21; and after 1 year. Quality of life was estimated using the EQ-5D questionnaire 1 year after surgery. All data were analyzed using SPSS version 15 software. Wilcoxons rank-sum test was used to analyze continuous variables, and repeated-measures analysis of variance was used for visual analogue scale scores. The χ(2) test and Fishers exact test were used to assess the differences between categorical data. P values < .05 were considered statistically significant. RESULTS the mean operative times were 79.9 minutes in group I and 33.9 minutes in group II (P < .001). The mean hospital stay was significantly longer in group I (3.8 vs 2.1 days, P < .001). Seromas and superficial wound infections in the early postoperative period were not different between both groups, although seromas occurred more frequent in the retromuscular group. Postoperative visual analogue scale scores were significantly lower with the intraperitoneal technique at all time points (P < .003, repeated-measures analysis of variance). However, 3 patients with the Ventralex patch had to be readmitted for severe pain. The recurrence rate was higher with the intraperitoneal repair (n = 5 [8.3%] vs n = 2 [3.6%]) than for the retromuscular mesh repair, but not statistically significant. Quality of life was comparable in the two groups after 1 year. CONCLUSIONS the open intraperitoneal technique using a Ventralex mesh for umbilical hernias seems a very elegant and quick technique. However, possibly because of the less controllable mesh deployment, recurrence rates seem higher. In case open mesh repair is the preferred treatment, a retromuscular repair should be the first choice.