Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703002137406 Date of Approval: 24/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Video Assisted Thoracoscopic Surgery (VATS) versus Conventional Thoracotomy For management of empyema
Official scientific title Video Assisted Thoracoscopic Surgery (VATS) Versus Conventional Thoracotomy incision For management of empyema thoracis
Brief summary describing the background and objectives of the trial Empyema in Greek means; pus presence in pleural cavity. The precursor of empyema is bacterial pneumonia and subsequent parapneumonic effusion. Most patients with empyema present with clinical manifestations of bacterial pneumonia including; fever, pleuritic chest pain, cough and dyspnea. Physical findings and presentations may vary depending on the organism and duration of illness. Chest radiography, ultrasonography (US), computerized topography (CT) and pleural fluid analysis are the most important investigations. Pleural fluid analysis is important to confirm an empyema rather simple pleural effusion by the glucose, lactate dehydrogenase (LDH), protein level and PH. The aim of treatment in patients with empyema is to save lives, eliminate empyema, re-expand the trapped lung, restore mobility of the chest wall and diaphragm, return of respiratory function to normal, prevent complications or chronicity and reduce the duration of hospital stay. The pursuit of this aim has led to development of multiple therapeutic options including; repeated thoracocentesis closed tube thoracostomy, image directed inta-pleural catheter drainage, intra-pleural fibrinolytic therapy, VATS decortication, mini thoracotomy and standard thoracotomy with decortication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied empyema thoracis, VATS,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 19/03/2017
Actual trial start date 19/03/2017
Anticipated date of last follow up 19/02/2018
Actual Last follow-up date 26/02/2018
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 58
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group VATS Group postoperative patients will be managed by general anesthesia using double lumen endotracheal tube to achieve single lung ventilation and positioned in lateral decubitus position. Two or three 15-20 mm skin incisions will be made to pass the ports through which the camera head and instruments will be introduced into the chest. Pleural debridement will be made until full lung expansion obtained intraoperative 29
Experimental Group Conventional thoracotomy Group postoperative under general anesthesia using double lumen endotracheal tube and patients in lateral decubitus position, thoracotomy incision will extend from the anterior axillary line ending 3 cm below the inferior angle of the scapula at the level of 5th intercostal space, Finochietto- type rib retractor is applied then all thickened pleura will be peeled off the lung and chest wall until full lung expansion 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed to have empyema and indicated for decortication operation Inability to tolerate single lung ventilation. Ventilator dependency. contraindication for general anesthesia. known previous pleurdesis. Previous thoracoscopic surgery. 18 Year(s) 70 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2017 Faculty of medicine - Menoufia University
Ethics Committee Address
Street address City Postal code Country
Gamal abdel nasser street Shebin El-Kom - Menoufia Governerate 23154 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain using visual analogue score (VAS) Number of thoracic epidural analgesia (number and doses) required by the patient (patient-dose controlled method) Post-operative in the hospital. One week post discharge in outpatient clinic. One month post discharge in outpatient clinic.
Secondary Outcome Wound condition and cosmesis. Duration of hospital stay and Cost. Post-operative in the hospital. One week post discharge in outpatient clinic. One month post discharge in outpatient clinic.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University - Faculty of Medicine University hospitals Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Menoufia University Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cardiothoracic surgery department - Faculty of Medicine - Menoufia University Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amr Mohammad Allama Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Hesham Shafiq Abou-greda Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Mohammed Gouda Abdellatif Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
Mohammed Hamdy Abusree Gamal abdel nasser street Shebin El-Kom- Menoufia governerate 23154 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Mohammad Allama amrallama2005@yahoo.com 0201005198794 Gamal Abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia governate 23154 Egypt Assistant Professor and Acting Head of Cardiothoracic Surgery Department-Menoufia University
Role Name Email Phone Street address
Public Enquiries Mohammed Hamdy Abusree mohamedhamdy202026@gmail.com 0201008234021 Gamal Abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia governate 23154 Egypt Resident of Cardiothoracic Surgery
Role Name Email Phone Street address
Scientific Enquiries Mohammed Gouda Abdellatif drgouda710@yahoo.com 0201004256442 Gamal Abdel nasser street
City Postal code Country Position/Affiliation
Shebin El-Kom - Menoufia governate 23154 Egypt Lecturer of Cardiothoracic Surgery
REPORTING
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