Bmc Surg
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Randomized Controlled Trial Multicenter Study
Wound infection following implant removal of foot, ankle, lower leg or patella; a protocol for a multicenter randomized controlled trial investigating the (cost-)effectiveness of 2 g of prophylactic cefazolin compared to placebo (WIFI-2 trial).
Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. ⋯ If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.
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Randomized Controlled Trial Multicenter Study
Improving enhanced recovery after surgery (ERAS): ERAS APPtimize study protocol, a randomized controlled trial investigating the effect of a patient-centred mobile application on patient participation in colorectal surgery.
Perioperative care in colorectal surgery is systematically defined in the Enhanced Recovery After Surgery (ERAS) protocol. The ERAS protocol improves perioperative care in a multimodal way to enhance early and safe release from the hospital. Adequate compliance to the elements of the ERAS protocol is multifactorial. There are still opportunities to improve compliance of the protocol by actively involving the patient. The main objective of this study is to investigate whether compliance of selected items in the ERAS protocol can be improved through actively involving patients in the ERAS care pathway through the use of a patient-centred mobile application. ⋯ We hypothesize that by providing patients with a patient-centred mobile application, compliance to the active elements of ERAS protocol can be improved, resulting in an increased health-related quality of life, physical activity, and patient satisfaction.
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Randomized Controlled Trial Multicenter Study
Optimising the antibiotic treatment of uncomplicated acute appendicitis: a protocol for a multicentre randomised clinical trial (APPAC II trial).
Based on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70-80%) or complicated (20-30%) disease. Recent studies have shown that antibiotic therapy is both safe and cost-effective for a CT-scan confirmed uncomplicated acute appendicitis. However, based on the study protocols to ensure patient safety, these randomised studies used mainly broad-spectrum intravenous antibiotics requiring additional hospital resources and prolonged hospital stay. As we now know that antibiotic therapy for uncomplicated acute appendicitis is feasible and safe, further studies evaluating optimisation of the antibiotic treatment regarding both antibiotic spectrum and shorter hospital stay are needed to evaluate antibiotics as the first-line treatment for uncomplicated acute appendicitis. ⋯ To our knowledge, APPAC II trial is the first randomised controlled trial comparing per oral antibiotic monotherapy with intravenous antibiotic therapy continued by per oral antibiotics in the treatment of uncomplicated acute appendicitis. The APPAC II trial aims to add clinical evidence on the debated role of antibiotics as the first-line treatment for a CT-confirmed uncomplicated acute appendicitis as well as to optimise the non-operative treatment for uncomplicated acute appendicitis.
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Randomized Controlled Trial Comparative Study
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack™ v ProTack™ (TACKoMesh) - A double-blind randomised controlled trial.
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. ⋯ 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.
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Randomized Controlled Trial Comparative Study
Comparison of intraoperative handling and wound healing between (NEOSORB® plus) and coated polyglactin 910 suture (NEOSORB®): a prospective, single-blind, randomized controlled trial.
Coated polyglactin 910 suture with chlorhexidine (NEOSORB® Plus) has recently been developed to imbue the parent suture with antibacterial activity against organisms that commonly cause surgical site infections (SSI). This prospective, single-blinded, randomized trial, was performed to compare the intraoperative handling and wound healing characteristics of NEOSORB® Plus with those of the traditional polyglactin 910 suture (NEOSORB®) in urologic surgery patients. ⋯ NEOSORB® Plus is not inferior to traditional sutures in terms of intraoperative handling and wound healing, potentially making NEOSORB® Plus a beneficial alternative for patients at increased risk of SSI.