Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

Approaches to assessing the benefits and harms of medical devices for application in surgery.

BACKGROUND: The surgical community and the medical device industry enjoy a fruitful cooperation for the benefit of patients, but during the last years several high-risk products have led to problems and scandals, thus highlighting the need for reforms in European CE marking requirements. In October 2013, the European Parliament voted on a draft regulation on medical devices that intends to replace the current directives in 2014. PURPOSE: This article offers guidance to surgeons on how to select and assess medical devices for clinical use. Examples include artificial sphincters, surgical meshes, as well as single-incision and robot-assisted surgery. It is important that surgeons have a basic understanding of the requirements for CE marking of new medical devices. Because device performance rather than effectiveness is required for European market entry, surgeons (and their patients) are often left with the burden of using potentially harmful devices. In addition, potential problems concerning the safety or effectiveness of approved devices are concealed by the lack of data transparency. Because regulatory reforms were blocked at the European level, many member states will now seek other ways of restricting the use of medical devices with unknown effectiveness. One interesting model in this regard is to link the reimbursement of new medical devices to the conduct of clinical trials. CONCLUSIONS: Surgeons should develop a structured multidisciplinary approach to innovation management in their hospitals before using a new high-risk device. The key question is how to strike the right balance between innovation and safety.

Laparoscopic left colectomy combined with natural orifice access: operative technique and initial results.

BACKGROUND: Minimally invasive surgery for colon resection has improved patient outcome, but a minilaparotomy still is necessary to extract the specimen and place the anvil of the circular stapler into the proximal colon. This wound can cause postoperative pain, wound infection, and hernia. This report describes a new approach that combine classical laparoscopic left colon resection and natural orifice access using an operating rectoscope, with the aim to minimize abdominal wall trauma. METHODS: Laparoscopic left colon dissection for diverticular disease or small tumors was performed using a standard four-port technique. An operating rectoscope was transanally inserted into the rectum to remove the specimen and to pass the anvil of the circular stapler into the abdominal cavity. A straight needle was tied to the rod of the anvil to simplify its placement into the proximal colon so that a double-stapled anastomosis could be performed in the usual manner. Outcome parameters such as complications, conversions, operative time, and postoperative pain were prospectively recorded in a database. RESULTS: Surgery was performed for 15 patients with diverticular disease or small tumors. No intraoperative complications or conversions occurred. The median operating time was 145 min. The postoperative pain level was low, and only 3 of 15 patients needed opioid analgesia on postoperative day 1. The median postoperative hospital stay was 7 days. Blood oozing from the anastomotic site in one patient was the only recorded adverse event. For malignancies, tissue margins and lymphadenectomy were oncologically adequate. The 4-week follow-up period was uneventful. CONCLUSION: The described technique, a combination of laparoscopic and natural orifice surgery, has the potential to avoid incision-related morbidity of the minilaparotomy in laparoscopic left colon resections.

Function and quality of kidneys after cold storage, machine perfusion, or retrograde oxygen persufflation: results from a porcine autotransplantation model.

OBJECTIVES: Especially for preservation of marginal donor organs, machine perfusion (MP) and retrograde oxygen persufflation (ROP) are alternatives to cold storage (CS). Using a porcine kidney autotransplantation model we compared metabolic and morphologic effects of CS, ROP, and MP on kidneys exposed to warm ischemia. METHODS: Kidneys of 21 pigs were exposed in situ to warm ischemia for 60min. The kidneys were randomly allocated to three experimental groups, each receiving a 4-h treatment of either cold storage, machine perfusion, or retrograde oxygen persufflation. Tissue samples were examined for malondialdehyde and histological changes. Daily blood samples were examined for creatinine levels. RESULTS: Seven days after transplantation, the plasma creatinine levels in the CS and MP groups were still significantly elevated above the baseline values. In the ROP group, all animals exhibited nearly normal creatinine levels. Malondialdehyde, an indicator of lipidperoxidation, was dramatically increased in the machine perfused kidneys on day 7, whereas the malondialdehyde levels in the other two groups were near normal values. The MP kidneys exhibited the most striking histological changes. CONCLUSION: Though MP has been well introduced in organ transplantation, in our opinion, it must still be optimized and standardized. It is necessary to clarify questions such as whether there is a need for oxygenation during perfusion, the length of perfusion, the impact of pressure, and the effects of additional scavengers. The results of the present study suggest the reconsideration of the ROP-technique for the preservation of predamaged donor grafts especially of NHBD and further studies, comparing MP and ROP upon long term preservation are strongly encouraged.

Retrograde oxygen persufflation preservation of human livers: a pilot study.

Retrograde oxygen persufflation as a supplement of cold storage during the preservation period has the potential to better utilize ischemically damaged marginal livers in the experimental setting. Retrograde oxygen persufflation was applied in selected livers to demonstrate feasibility in the clinical setting and to investigate potential beneficial effects. Between 4/04 and 3/05 5 marginal otherwise discarded livers with warm ischemic damages from deceased donors (age 52 [37-64]) were accepted for transplantation. All organs were distantly procured and shipped to our center. Immediately after arrival, filtered humidified gaseous oxygen was given via the hepatic veins for at least 60 minutes with a pressure up to 18 mm mercury. Liver biopsies were analyzed for ATP content before and after persufflation. All patients (age 55 [46-66]) survived without retransplantation, had good initial function and are alive and well after minimum follow-up of two years. Bleeding from pinpricks stopped spontaneously after 5-10 minutes after reperfusion but was prolonged in one patient with severe coagulopathy until correction. One patient developed arterial thrombosis at postop day 0. He fully recovered after thrombectomy. Another patient developed subcapsular hematoma, which was removed at postop day 10. On routine postoperative biopsies vascular structures appeared undamaged. ATP levels in pre-reperfusion biopsies revealed a more than twofold increase of ATP content compared to biopsies before persufflation. Retrograde oxygen persufflation preservation is feasible and save in the clinical setting, improves early aerobic metabolism and therefore potentially improves primary organ function after liver transplantation.

Primary organ function of warm ischaemically damaged porcine kidneys after retrograde oxygen persufflation.

BACKGROUND: As warm ischaemic damage is a major reason for the loss of donor organs, an experimental study was performed in order to evaluate retrograde oxygen persufflation (ROP) as a method to extend the warm ischaemic tolerance of kidneys. METHODS: Kidneys of 32 pigs were exposed to warm ischaemia for 60, 90 or 120 min. Then, 16 kidneys were subjected to ROP for 4 h at 4 degrees C and 16 controls were stored in cold UW-solution, followed by autotransplantation. RESULTS: Only in the group with 60 min warm ischaemic time and ROP did all animals survive the observation period of 7 days. In all other groups some animals died due to anuria. Short-term survivors in these groups had significantly higher creatinine levels. CONCLUSIONS: In this setting, ROP was superior to cold storage when applied after 60 min of warm ischaemia. Clinical evaluation of ROP in the setting of marginal donors and non-heartbeating donation is recommended.