Mauro Podda1, Fernando Serventi2, Lorenzo Mortola3, Stefano Marini4, Danilo Sirigu5, Michela Piga6, Marcello Pisano7, Massimiliano Coppola8, Ferdinando Agresta9, Francesco Virdis10, Salomone Di Saverio11, Nicola Cillara12. 1. General, Minimally Invasive and Robotic Surgery Unit, San Francesco Hospital, Via Mannironi 1, 08100, Nuoro, Italy. mauropodda@ymail.com. 2. General Surgery Unit, Civil Hospital, Alghero, Italy. 3. Surgical Science Department, Cagliari University Hospital, Cagliari, Italy. 4. Radiology Department, Santissima Trinità Hospital, Cagliari, Italy. 5. Radiology Department, Brotzu Hospital, Cagliari, Italy. 6. Pathology Department, Santissima Trinità Hospital, Cagliari, Italy. 7. General and Emergency Surgery, San Marcellino Hospital, Muravera, Italy. 8. General and Emergency Surgery, Nostra Signora della Mercede Hospital, Lanusei, Italy. 9. General and Emergency Surgery, Adria Civil Hospital, Adria, Italy. 10. Department of General Surgery, King's College Hospital, NHS Foundation Trust, London, UK. 11. Emergency and Trauma Surgical Unit, Maggiore Hospital, Bologna, Italy. 12. General Surgery Unit, Santissima Trinità Hospital, Cagliari, Italy.
Abstract
PURPOSE: Acute appendicitis (AA) is among the most common causes of lower abdominal pain and admissions to the emergency department. Over the past 20 years, there has been a renewed interest in the conservative management of uncomplicated AA, and several studies demonstrated that an antibiotic-first strategy is a viable treatment option for uncomplicated AA. The aim of this prospective non-randomized controlled, multicenter trial is to compare antibiotic therapy and emergency appendectomy as treatment for patients with uncomplicated AA confirmed by US and/or CT or MRI scan. METHODS: All adult patients in the age range 18 to 65 years with suspected AA, consecutively admitted to the Surgical Department of the 13 participating Italian Hospitals, will be invited to take part in the study. A multicenter prospective collected registry developed by surgeons, radiologists, and pathologists with expertise in the diagnosis and treatment of uncomplicated acute appendicitis represents the best research method to assess the long-term role of antibiotics in the management of the disease. Comparison will be made between surgical and antibiotic-first approaches to uncomplicated AA through the analysis of the primary outcome measure of complication-free treatment success rate based on 1-year follow-up. Quality of life, length of hospital stay, pain evaluation, and time to return to normal activity will be evaluated as secondary outcome measures. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT03080103.
PURPOSE: Acute appendicitis (AA) is among the most common causes of lower abdominal pain and admissions to the emergency department. Over the past 20 years, there has been a renewed interest in the conservative management of uncomplicated AA, and several studies demonstrated that an antibiotic-first strategy is a viable treatment option for uncomplicated AA. The aim of this prospective non-randomized controlled, multicenter trial is to compare antibiotic therapy and emergency appendectomy as treatment for patients with uncomplicated AA confirmed by US and/or CT or MRI scan. METHODS: All adult patients in the age range 18 to 65 years with suspected AA, consecutively admitted to the Surgical Department of the 13 participating Italian Hospitals, will be invited to take part in the study. A multicenter prospective collected registry developed by surgeons, radiologists, and pathologists with expertise in the diagnosis and treatment of uncomplicated acute appendicitis represents the best research method to assess the long-term role of antibiotics in the management of the disease. Comparison will be made between surgical and antibiotic-first approaches to uncomplicated AA through the analysis of the primary outcome measure of complication-free treatment success rate based on 1-year follow-up. Quality of life, length of hospital stay, pain evaluation, and time to return to normal activity will be evaluated as secondary outcome measures. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT03080103.
Authors: An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher Journal: BMJ Date: 2013-01-08
Authors: T Rettenbacher; A Hollerweger; P Macheiner; L Rettenbacher; R Frass; B Schneider; N Gritzmann Journal: Radiology Date: 2000-01 Impact factor: 11.105
Authors: Julian C Harnoss; Isabelle Zelienka; Pascal Probst; Kathrin Grummich; Catharina Müller-Lantzsch; Jonathan M Harnoss; Alexis Ulrich; Markus W Büchler; Markus K Diener Journal: Ann Surg Date: 2017-05 Impact factor: 12.969
Authors: Joseph Cuschieri; Michael Florence; David R Flum; Gregory J Jurkovich; Paul Lin; Scott R Steele; Rebecca Gaston Symons; Richard Thirlby Journal: Ann Surg Date: 2008-10 Impact factor: 12.969
Authors: Salomone Di Saverio; Arianna Birindelli; Micheal D Kelly; Fausto Catena; Dieter G Weber; Massimo Sartelli; Michael Sugrue; Mark De Moya; Carlos Augusto Gomes; Aneel Bhangu; Ferdinando Agresta; Ernest E Moore; Kjetil Soreide; Ewen Griffiths; Steve De Castro; Jeffry Kashuk; Yoram Kluger; Ari Leppaniemi; Luca Ansaloni; Manne Andersson; Federico Coccolini; Raul Coimbra; Kurinchi S Gurusamy; Fabio Cesare Campanile; Walter Biffl; Osvaldo Chiara; Fred Moore; Andrew B Peitzman; Gustavo P Fraga; David Costa; Ronald V Maier; Sandro Rizoli; Zsolt J Balogh; Cino Bendinelli; Roberto Cirocchi; Valeria Tonini; Alice Piccinini; Gregorio Tugnoli; Elio Jovine; Roberto Persiani; Antonio Biondi; Thomas Scalea; Philip Stahel; Rao Ivatury; George Velmahos; Roland Andersson Journal: World J Emerg Surg Date: 2016-07-18 Impact factor: 5.469
Authors: Gaetano Poillucci; Lorenzo Mortola; Mauro Podda; Salomone Di Saverio; Laura Casula; Chiara Gerardi; Nicola Cillara; Luigi Presenti Journal: Updates Surg Date: 2017-11-03