Minimally invasive pancreatoduodenectomy is associated with a higher incidence of postoperative venous thromboembolism when compared to the open approach: A systematic review and meta-analysis.

BACKGROUND: Despite the increased use of minimally invasive approaches for pancreatoduodenectomy (PD), the association between surgical approach and venous thromboembolism (VTE) risk is still unknown. This study aims to compare VTE rates following open (OPD) and minimally invasive pancreatoduodenectomy (MIPD). METHOD: MEDLINE, Web of Sciences and EMBASE databases were searched to identify eligible studies. Studies were considered suitable if the incidence of postoperative VTE in open and minimally invasive (laparoscopic or robotic) pancreatic surgery was reported. The review was conducted following the PRISMA guidelines. RESULTS: Five studies including 12 984 patients met the inclusion criteria and were considered for meta-analysis. A total of 11 060 patients underwent OPD and 1924 MIPD. Overall, patients who underwent OPD had a lower rate of VTE compared to MIPD (3.6 % vs 4.6 %, OR (95 % CI) = 0.66 (0.52-0.85), p < 0.001). Subgroup analysis showed similar results for pulmonary embolism (PE) (1.1 % in OPD vs 1.9 % in MIPD, OR (95 % CI) = 0.54 (0.36-0.80), p 0.002) and deep venous thrombosis (DVT) (1.3 % in OPD vs 3.1 % in MIPD, OR (95 % CI) = 0.48 (0.29-0.79), p 0.004). CONCLUSION: Patients who undergo minimally invasive pancreatoduodenectomy have a higher incidence of postoperative VTE when compared to open pancreatoduodenectomy.

The multi-societal European consensus on the terminology, diagnosis and management of patients with synchronous colorectal cancer and liver metastases: an E-AHPBA consensus in partnership with ESSO, ESCP, ESGAR, and CIRSE.

BACKGROUND: Contemporary management of patients with synchronous colorectal cancer and liver metastases is complex. The aim of this project was to provide a practical framework for care of patients with synchronous colorectal cancer and liver metastases with a focus on terminology, diagnosis and management. METHODS: This project was a multi-organisational, multidisciplinary consensus. The consensus group produced statements which focused on terminology, diagnosis and management. Statements were refined during an online Delphi process and those with 70% agreement or above were reviewed at a final meeting. Iterations of the report were shared by electronic mail to arrive at a final agreed document comprising twelve key statements. RESULTS: Synchronous liver metastases are those detected at the time of presentation of the primary tumour. The term "early metachronous metastases" applies to those absent at presentation but detected within 12 months of diagnosis of the primary tumour with "late metachronous metastases" applied to those detected after 12 months. Disappearing metastases applies to lesions which are no longer detectable on MR scan after systemic chemotherapy. Guidance was provided on the recommended composition of tumour boards and clinical assessment in emergency and elective settings. The consensus focused on treatment pathways including systemic chemotherapy, synchronous surgery and the staged approach with either colorectal or liver-directed surgery as first step. Management of pulmonary metastases and the role of minimally invasive surgery was discussed. CONCLUSIONS: The recommendations of this contemporary consensus provide information of practical value to clinicians managing patients with synchronous colorectal cancer and liver metastases.

Multisocietal European consensus on the terminology, diagnosis, and management of patients with synchronous colorectal cancer and liver metastases: an E-AHPBA consensus in partnership with ESSO, ESCP, ESGAR, and CIRSE.

BACKGROUND: Contemporary management of patients with synchronous colorectal cancer and liver metastases is complex. The aim of this project was to provide a practical framework for care of patients with synchronous colorectal cancer and liver metastases, with a focus on terminology, diagnosis, and management. METHODS: This project was a multiorganizational, multidisciplinary consensus. The consensus group produced statements which focused on terminology, diagnosis, and management. Statements were refined during an online Delphi process, and those with 70 per cent agreement or above were reviewed at a final meeting. Iterations of the report were shared by electronic mail to arrive at a final agreed document comprising 12 key statements. RESULTS: Synchronous liver metastases are those detected at the time of presentation of the primary tumour. The term 'early metachronous metastases' applies to those absent at presentation but detected within 12 months of diagnosis of the primary tumour, the term 'late metachronous metastases' applies to those detected after 12 months. 'Disappearing metastases' applies to lesions that are no longer detectable on MRI after systemic chemotherapy. Guidance was provided on the recommended composition of tumour boards, and clinical assessment in emergency and elective settings. The consensus focused on treatment pathways, including systemic chemotherapy, synchronous surgery, and the staged approach with either colorectal or liver-directed surgery as first step. Management of pulmonary metastases and the role of minimally invasive surgery was discussed. CONCLUSION: The recommendations of this contemporary consensus provide information of practical value to clinicians managing patients with synchronous colorectal cancer and liver metastases.

Preliminary experience in laparoscopic distal pancreatectomy using the AEON™ endovascular stapler.

Background: The aim of this study is to investigate the effects of using a new innovative endovascular stapler, AEON™, on the pancreatic leak rates and other outcome measures. Methods: In a retrospective review of prospectively collected data from a secure tertiary unit registry, patients undergoing distal or lateral pancreatectomy were analyzed for any differences on pancreatic fistula rates, length of stay, comprehensive complication index (CCI), and demographics after using AEON™ compared with other commonly used staplers. Statistical significance was defined as <0.05. Results: There were no differences in the demographics between the two groups totaling 58 patients over 2 years from 2019 to 2021. A total of 43 and 15 patients underwent pancreatic transection using other staplers and AEON™ endovascular stapler, respectively. The comparison of the two groups revealed a significantly reduced rate of mean drain lipase at postoperative day 3 with AEON™ (446 U/L) versus the other staplers (4,208 U/L) (p = 0.018) and a subsequent reduction of postoperative pancreatic fistula (POPF) from 65% to 20%. A reduction in the mean CCI, from 13.80 when other staplers were used to 4.97 when AEON™ was used, was also observed (p = 0.087). Mean length of stay was shorter by 3 days in the AEON™ group compared with that in the other staplers (6 and 9 days, respectively; p = 0.018). Conclusion: AEON™ stapler when used to transect the pancreas demonstrated a significantly reduced pancreatic fistula rate, length of stay in hospital, and a leaning towards a reduced CCI. Its use should be further evaluated in larger cohorts with the encouraging results to determine whether this is possibly related to the technology used in the design of the AEON™ stapler.

Venous thromboembolism (VTE) after open hepatectomy compared to minimally invasive liver resection: a systematic review and meta-analysis.

BACKGROUND: Even though the risk of postoperative venous thromboembolism (VTE) after liver resection is well recognized, the association between surgical approach and VTE risk is unknown. This study aims to compare VTE rates following open liver resection (OLR) and minimally invasive liver resection (MILR). METHODS: MEDLINE, Web Of Sciences and EMBASE databases were interrogated to identify eligible studies published between February 2016 and August 2022. Studies were considered suitable if they reported a comparison between OLR and MILR (including laparoscopic liver resection [LLR] or robotic liver resection [RLR]). RESULTS: Fourteen studies including 11 356 patients met the inclusion criteria. 5622 patients underwent OLR and 5734 patients underwent MILR. The VTE rate was higher among patients who underwent OLR compared to MILR (2.8% vs 1.4%, OR (95% CI) = 1.84, p=<00001). Similarly, the subgroup analysis showed a higher rate of deep venous thrombosis (DVT) (1.4% vs 0.7%, OR (95% CI) = 1.98, p = 0.02) and pulmonary embolism (PE) (1.3% vs 0.7%, OR (95% CI) = 1.88, p = 0.002) in patients who underwent OLR compared to MILR. DISCUSSION: Patients who undergo open hepatectomy have a higher incidence of postoperative VTE when compared to those undergoing minimally invasive liver resection. This finding was consistent for both DVT and PE.

Work-Up and Outcome of Hepatic Resection for Peri-Hilar Cholangiocarcinoma (PH-CCA) without Staging Laparoscopy.

Background: This study reports the outcome of a work-up programme for resection of peri-hilar cholangiocarcinoma (PH-CCA) without the use of staging laparoscopy. Methods: This is a clinical case cohort series of patients undergoing surgical resection of PH-CCA without the use of staging laparoscopy in the work-up algorithm. During the 13 years from 1 January 2009 to 1 January 2022, 32 patients underwent laparotomy for planned surgical resection of PH-CCA. Data were collected on demographic profile, admission biochemistry, radiology, pre-operative intervention, operation and outcome, together with post-operative complications and disease-free and overall survival. Results: All patients underwent pre-operative contrast-enhanced CT. Twenty-four (75%) underwent pre-operative MR. Twenty-three (72%) underwent pre-operative biliary drainage. Twenty-nine patients (91%) had either type III or IV peri-hilar cholangiocarcinoma. One patient (3%) in this series underwent a non-resectional laparotomy. Twenty-nine (91%) had a final histopathological diagnosis of PH-CCA. One further patient had a final diagnosis of an intraductal papillary neoplasm of the biliary tree (IPNB) with high-grade dysplasia but no invasive cancer. Eleven patients (36%) received chemotherapy after surgery. The median (95% CI) time to recurrence was 14 (7-31) months. The median survival was 25 (18-upper limit not reached) months. Conclusion: This cohort of 32 patients undergoing attempted resection for PH-CCA without the use of staging laparoscopy in the work-up algorithm indicates that with careful attention to patient fitness and cross-sectional and interventional radiologic/endoscopic imaging, a very low non-therapeutic laparotomy rate of 3% can be achieved and sustained.

A fast-track surgery programme leads to timelier treatment and higher resection rates in pancreatic cancer.

BACKGROUND: The aim was to perform a propensity-matched comparison of patients with pancreatic cancer undergoing surgery, with and without biliary stenting and an intention to treat analysis of long-term survival between the two groups. METHODS: This was an observational study of a cohort of consecutive patients presenting with obstructive jaundice and undergoing pancreatoduodenectomy for pancreatic and periampullary malignancies between November 2015 and May 2019. RESULTS: In this study of 216 consecutive operable patients, 70 followed the fast-track pathway and 146 had pre-operative biliary drainage. All 70 patients in the FT group and 122 out of 146 in the PBD group proceeded to surgery (100% and 83.6% respectively, p = 0.001). Interval time from diagnostic CT scan to surgery and from MDT decision to treat to surgery was shorter in the FT group, (median 8 vs 43 days p < 0.001 and 3 vs 36 days p < 0.001 respectively) as was the overall time from diagnostic CT to adjuvant treatment (88 vs 121 days p < 0.001). Postoperative outcomes including complications, readmission and mortality rates were comparable in the two groups. There was no difference in survival. CONCLUSION: For a person with pancreatic cancer who is proceeding to surgery, the best approach is to avoid pre-operative biliary drainage.

The Impact of a Dedicated "Hot List" on the In-Patient Management of Patients With Acute Gallstone-Related Disease.

Background: Index admission laparoscopic cholecystectomy is the standard of care for patients admitted to hospital with symptomatic acute cholecystitis. The same standard applies to patients suffering with mild acute biliary pancreatitis. Operating theatre capacity can be a significant constraint to same admission surgery. This study assesses the impact of dedicated theatre capacity provided by a specialist surgical team on rates of index admission cholecystectomy. Methods: This clinical cohort study compares the management of patients with symptomatic gallstone disease admitted to a tertiary care university teaching hospital over two equal but chronologically separate time periods. The periods were before and after service reconfiguration including a specialist HPB service with dedicated operating theatre time allocation. Results: There was a significant difference in the number of admissions over the two time periods with a greater proportion of patients having index admission surgery in the second time period with correspondingly fewer having more than one admission during this latter time period. In the second time period 43% of patients underwent index admission cholecystectomy compared to 23% in the first (P < 0.001). The duration of surgery was shorter for patients undergoing surgery during the second time period [135 (102-178) min in the first period and in the second period 106 (89-145) min] (P = 0.02). Discussion: This paper shows that the concentration of theatre resources and surgical expertise into regular theatre access for patients undergoing urgent laparoscopic cholecystectomy is an effective and safe model for dealing with acute biliary disease.

Endovascular Hepatic Artery Stents in the Modern Management of Postpancreatectomy Hemorrhage.

Background: Postoperative hemorrhage is a potentially lethal complication of pancreatoduodenectomy. This study reports on the use of endovascular hepatic artery stents in the management of postpancreatectomy hemorrhage. Methods: This is a retrospective analysis of a prospectively maintained, consecutive dataset of 440 patients undergoing pancreatoduodenectomy over 68 months. Data are presented on bleeding events and outcomes, and contextualized by the clinical course of the denominator population. International Study Group of Pancreatic Surgery terminology was used to define postpancreatectomy hemorrhage. Results: Sixty-seven (15%) had postoperative hemorrhage. Fifty (75%) were male and this gender difference was significant (P = 0.001; 2 proportions test). Postoperative pancreatic fistulas were more frequent in the postoperative hemorrhage group (P = 0.029; 2 proportions test). The median (interquartile range [IQR]) delay between surgery and postoperative hemorrhage was 5 days (2-14 days). Twenty-six (39%) required intervention comprising reoperation alone in 12, embolization alone in 5, and endovascular hepatic artery stent deployment in 5. Four further patients underwent more than 1 intervention with 2 of these having stents. Endovascular stent placement achieved initial hemostasis in 5 of 7 (72%). Follow-up was for a median (IQR) of 199 days (145-400 days) poststent placement. In 2 patients, the stent remained patent at last follow-up. The remaining 5 stents occluded with a median (IQR) period of proven patency of 10 days (8-22 days). Conclusions: This study shows that in the specific setting of postpancreatoduodenectomy hemorrhage with either a short remnant gastroduodenal artery bleed or a direct bleed from the hepatic artery, where embolization risks occlusion with compromise of liver arterial inflow, endovascular hepatic artery stent is an important hemostatic option but is associated with a high risk of subsequent graft occlusion.

Improving knowledge and confidence in foundation doctors during specialty changeover.

QUALITY PROBLEM: Foundation year junior doctors rotate every 4 months into different specialties. They are often expected to manage patients with complex underlying conditions despite inadequate clinical induction. INITIAL ASSESSMENT: No structured induction was offered to junior doctors rotating to hepato-pancreatico-biliary surgery, a complex and highly specialized discipline within general surgery. We hypothesized that junior doctors will be lacking in both knowledge and confidence when managing these patients. CHOICE OF SOLUTION: Create a structured induction programme and evaluate its effectiveness in improving knowledge and confidence amongst doctors. IMPLEMENTATION: Plan Do Study Act methodology was used along with driver diagrams to map change. A learning resource was developed in the form of a booklet, which included relevant clinical information, processes for escalation and referral as well as guidance for managing acutely unwell patients. A structured 1-hour teaching programme was delivered to junior doctors alongside this. Pre- and post-session questionnaires and statistical analysis were used to determine effect. EVALUATION: Marked improvements in both knowledge and confidence were seen. The intervention showed a statistically significant improvement. LESSONS LEARNED: Clinical induction resources can improve junior doctors' knowledge and confidence in managing their patients. Such induction is both valuable and necessary. Similar interventions can be used with allied health professionals and can involve the use of technology and virtual learning.

The Influence of Patients' Age on the Outcome of Treatment for Pancreatic Ductal Adenocarcinoma.

OBJECTIVE: The aim of the study was to determine the impact of age on curative management and outcomes of patients with pancreatic ductal adenocarcinoma. METHODS: Patients who underwent resection for pancreatic ductal adenocarcinoma at 2 units were retrospectively reviewed (between 2005 and 2017) and stratified by age (older patients ≥70 years). Regression analysis was used to explore factors impacting administration of adjuvant chemotherapy and survival. The Kaplan-Meier method was used to estimate overall survival (time from surgery to death). Statistical significance was set at P < 0.05. RESULTS: From 2005 to 2014, 222 patients were identified (<70 years, n = 128; ≥70 years, n = 94). Elderly patients were less likely to receive adjuvant chemotherapy compared with younger patients (odds ratio, 0.57, P = 0.041). Tumor stage, margin, and year of surgery (post-2011 vs pre-2011) were not predictors for chemotherapy receipt (P > 0.05). Frailty was the commonest reason (36.8%) to decline chemotherapy in elderly patients. In patients receiving adjuvant chemotherapy, completion rates (P = 0.32) and overall survival (24 months vs 30 months, P = 0.50) were no different. CONCLUSIONS: Elderly patients demonstrate similar outcomes to younger yet are less likely to commence chemotherapy because of frailty. Holistic preoperative assessment may improve selection for curative treatment.

PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): study protocol for a randomised controlled trial.

BACKGROUND: Differentiating infection from inflammation in acute pancreatitis is difficult, leading to overuse of antibiotics. Procalcitonin (PCT) measurement is a means of distinguishing infection from inflammation as levels rise rapidly in response to a pro-inflammatory stimulus of bacterial origin and normally fall after successful treatment. Algorithms based on PCT measurement can differentiate bacterial sepsis from a systemic inflammatory response. The PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP) trial tests the hypothesis that a PCT-based algorithm to guide initiation, continuation and discontinuation of antibiotics will lead to reduced antibiotic use in patients with acute pancreatitis and without an adverse effect on outcome. METHODS: This is a single-centre, randomised, controlled, single-blind, two-arm pragmatic clinical and cost-effectiveness trial. Patients with a clinical diagnosis of acute pancreatitis will be allocated on a 1:1 basis to intervention or standard care. Intervention will involve the use of a PCT-based algorithm to guide antibiotic use. The primary outcome measure will be the binary outcome of antibiotic use during index admission. Secondary outcome measures include: safety non-inferiority endpoint all-cause mortality; days of antibiotic use; clinical infections; new isolates of multiresistant bacteria; duration of inpatient stay; episode-related mortality and cause; quality of life (EuroQol EQ-5D); and cost analysis. A 20% absolute change in antibiotic use would be a clinically important difference. A study with 80% power and 5% significance (two-sided) would require 97 patients in each arm (194 patients in total): the study will aim to recruit 200 patients. Analysis will follow intention-to-treat principles. DISCUSSION: When complete, PROCAP will be the largest randomised trial of the use of a PCT algorithm to guide initiation, continuation and cessation of antibiotics in acute pancreatitis. PROCAP is the only randomised trial to date to compare standard care of acute pancreatitis as defined by the International Association of Pancreatology/American Pancreatic Association guidelines to patients having standard care but with all antibiotic prescribing decisions based on PCT measurement. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number, ISRCTN50584992. Registered on 7 February 2018.

Laparoscopic Hepatectomy for Colorectal Liver Metastases: The Current State of the Art.

Hepatectomy together with systemic chemotherapy is the treatment of choice for patients with liver-limited colorectal metastases. Although the open approach to hepatectomy remains a standard option, there is increasing recognition of the potential advantages of laparoscopic hepatectomy. Laparoscopic approaches have become standardized and are the subject of two international consensus conferences. Major laparoscopic hepatectomy is currently being evaluated in international multi-center trials. The available data to date would indicate that there is oncological equivalence between open and laparoscopic approaches but that the latter is associated with less post-operative pain, shorter hospital stay and an earlier recovery of full function. Surgeons embarking on this approach must be experienced both in the techniques of advanced liver surgery and in laparoscopic surgery.

Comparison of Outcomes Between Open Major Hepatectomy Using CUSA and Laparoscopic Major Hepatectomy Using "Lotus" Liver Blade. A Propensity Score Matched Analysis.

Introduction: Evolution in laparoscopic liver surgery during the past two decades is an indisputable fact. According to the second international consensus conference for laparoscopic liver resection held in Morioka, Japan in 2014 major resections are still regarded as innovative procedures in the exploration phase. On this basis, our study aims to explore the efficacy and safety of laparoscopic vs. open major liver resection and therefore increase the existing evidence on major laparoscopic liver surgery. Methods: All consecutive patients who underwent major liver resection, open and laparoscopic from January 2016 to May 2018 were identified from our prospectively maintained database. Propensity score matching analysis was performed using R statistical tool in SPSS to isolate matched open and laparoscopic cases which were compared for intraoperative and postoperative short-term outcomes. Lotus ultrasonic energy device was used for parenchymal transection in laparoscopic cases vs. CUSA in open procedures. Results: Propensity score matching analysis was performed on 82 consecutive patients (61 open and 21 laparoscopic major hepatectomies) resulting in 40 matched patients, 20 in each group. The mean total duration of surgery and duration of parenchymal transection were slightly longer in the laparoscopic group (p = 0.419, p = 0.348). There was no difference in the intraoperative and postoperative transfusion rates. Patients after laparoscopic surgery were discharged 2 days earlier on average (p = 0.310). No difference was observed in complication rates and mortality. Conclusion: Our data did not reveal inferiority of the laparoscopic major hepatectomy vs. the open approach in any parameter compared. The use of the Lotus ultrasonic energy device appeared to be efficient and safe for parenchymal transection in the laparoscopic procedures.

Outcome of the "Manchester Groin Repair" (Laparoscopic Totally Extraperitoneal Approach With Fibrin Sealant Mesh Fixation) in 434 Consecutive Inguinal Hernia Repairs.

Introduction: This study looks at the outcome of 352 patients that underwent the "Manchester groin repair" in the period from 2007 to 2016. The effect of laterality on chronic groin pain and the reduction of pain scores post-surgery are evaluated as well as the rate of hernia recurrence for the inguinal hernia repairs. Methods: The "Manchester groin repair" is a modification of a laparoscopic totally extra-peritoneal approach with fibrin sealant mesh fixation. Data were collected prospectively. In addition to demographic data and the European Hernia Society classification grading of each hernia, pain scores were assessed prior to surgery and at 4-6 weeks post-operatively using a ten-point visual analog pain scale. Data were collected on a bespoke database and differences between time-points analyzed by non-parametric Wilcoxon signed rank tests with Kruskal-Wallis rank sum test for three-group comparisons. Significance was at the P < 0.05 level. The study was undertaken as an institutional audit. Results: Three hundred and fifty two patients underwent TEP repair as per the "Manchester Groin Repair" modification during the period of interest with a median follow-up period of 109.5 (IQR 57.0-318.5) weeks. Of these 274 (77.8%) were for the repair of true hernias and 78 (22.2%) were for inguinal disruptions. All inguinal hernia repairs patients were evaluated (254 m, 20 f); median [interquartile range] age 50 (39-65) years. There were 75 right inguinal hernias (27.4%), 39 Left inguinal hernias (14.2%), and 160 bilateral inguinal hernias (58.4%), giving a total of 434 hernia repairs. During follow-up there were 6 recurrences (1.4%).Of the 274 patients evaluated, 145 (52.9%) had both pre and post-operative pain scores available. Median pre-operative pain score was 5 [IQR 4-7]. Median post-operative pain score was 1 [IQR 1-2]. This difference was significant (P < 0.001). Pre-operative pain scores were higher for those with a bilateral hernia (median 6 vs. 5 and 4, respectively; P = 0.005), but there was no difference in post-operative scores (P = 0.347). One patient (0.3%) presented with chronic groin pain (pain after 3 months). Conclusion: This study demonstrates that the "Manchester groin repair" provides an excellent repair with a low rate of recurrence and low incidence of chronic pain. Longer-term evaluation and larger patient series will add to the understanding of the role of this procedure in groin hernia repair.

Mis-use of antibiotics in acute pancreatitis: Insights from the United Kingdom's National Confidential Enquiry into patient outcome and death (NCEPOD) survey of acute pancreatitis.

BACKGROUND: International guidelines for the management of acute pancreatitis state that antibiotics should only be used to treat infectious complications. Antibiotic prophylaxis is not recommended. The aim of this study was to analyse antibiotic use, and its appropriateness, from a national review of acute pancreatitis. METHODS: Data were collected from The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) study into the management of acute pancreatitis. Adult patients admitted to hospitals in England and Wales between January and June 2014 with a coded diagnosis of acute pancreatitis were included. Clinical and organisational questionnaires were used to collect data and these submissions subjected to peer review. Antibiotic use, including indication and duration were analysed. RESULTS: 439/712 (62%) patients received antibiotics, with 891 separate prescriptions and 23 clinical indications. A maximum of three courses of antibiotics were prescribed, with 41% (290/712) of patients receiving a second course and 24% (174/712) a third course. For the first antibiotic prescription, the most common indication was "unspecified" (85/439). The most common indication for the second course was sepsis (54/290), "unspecified" was the most common indication for the third course (50/174). In 72/374 (19.38%) the indication was deemed inappropriate by the clinicians and in 72/393 (18.3%) by case reviewers. CONCLUSIONS: Inappropriate use of antibiotics in acute pancreatitis is common. Healthcare providers should ensure that antimicrobial policies are in place as part of an antimicrobial stewardship process. This should include specific guidance on their use and these policies must be accessible, adherence audited and frequently reviewed.

Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack™ v ProTack™ (TACKoMesh) - A double-blind randomised controlled trial.

BACKGROUND: Minimally invasive incisional hernia repair has been established as a safe and efficient surgical option in most centres worldwide. Laparoscopic technique includes the placement of an intraperitoneal onlay mesh with fixation achieved using spiral tacks or sutures. An additional step is the closure of the fascial defect depending upon its size. Key outcomes in the evaluation of ventral abdominal hernia surgery include postoperative pain, the presence of infection, seroma formation and hernia recurrence. TACKoMESH is a randomised controlled trial that will provide important information on the laparoscopic repair of an incisional hernia; 1) with fascial closure, 2) with an IPOM mesh and 3) comparing the use of an articulating mesh-fixation device that deploys absorbable tacks with a straight-arm mesh-fixation device that deploys non-absorbable tacks. METHODS: A prospective, single-centre, double-blinded randomised trial, TACKoMESH, will establish whether the use of absorbable compared to non-absorbable tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Eligible and consenting patients will be randomized to surgery with one of two tack-fixation devices and followed up for a minimum one year. Secondary outcomes to be explored include wound infection, seroma formation, hernia recurrence, length of postoperative hospital stay, reoperation rate, operation time, health related quality of life and time to return to normal daily activity. DISCUSSION: With ongoing debate around the best management of incisional hernia, continued trials that will add substance are both necessary and important. Laparoscopic techniques have become established in reducing hospital stay and rates of infection and report improvement in some patient centered outcomes whilst achieving similarly low rates of recurrence as open surgical techniques. The laparoscopic method with tack fixation has developed a reputation for its tendency to cause post-operative pain. Novel additions to technique, such as intraoperative-sutured closure of a fascial defect, and developments in surgical technology, such as the evolution of composite mesh design and mesh-fixation devices, have brought about new considerations for patient and surgeon. This study will evaluate the efficacy of several new technical considerations in the setting of elective laparoscopic incisional hernia repair. TRIAL REGISTRATION: Name of registry - ClinicalTrials.gov Registration number: NCT03434301 . Retrospectively registered on 15th February 2018.