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.: PACTR201704002188293 Date of Approval: 10/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasonographic evaluation of the effect of positive End expiratory pressure on diaphragmatic functions in patients undergoing Laparoscopic colorecta
Official scientific title Ultrasonographic evaluation of the effect of positive End expiratory pressure on diaphragmatic functions in patients undergoing Laparoscopic colorectal surgery: a randomized comparative study
Brief summary describing the background and objectives of the trial Introduction: After the introduction of laparoscopic procedures, laparoscopic techniques are the most common procedures in surgery worldwide [1]. Nowadays, laparoscopic approach for colorectal disease has to be considered the gold-standard for colonic resection and the optimal approach for rectal surgery [2]. Laparoscopic surgery is usually performed by intraabdominal insufflation of carbon dioxide, i.e.,CO2 pneumoperitoneum [ 3] ,this insufflation leads to an increase in intraabdominal pressure [ 4]. The CO2-pneumoperitoneum may cause several respiratory changes, e.g. decreased functional residual capacity (FRC) and vital capacity (VC) [ 5], formation of atelectasis [ 6], reduced respiratory compliance [ 7] . Pneumoperitoneum and Trendelenburg position may influence intraoperative respiratory mechanics in anesthetic management [ 8] Both the increase in abdominal pressure as a result of carbon dioxide inflation and the head down body position have been shown to impair the respiratory function during the procedure, mainly inducing atelectasis formation in the dependent lung regions.[9,10,11]
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied colorectal surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 16/12/2017
Actual Last follow-up date 16/12/2017
Anticipated target sample size (number of participants) 153
Actual target sample size (number of participants) 153
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 closed opaque envelope technique sealed envelop Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group 1 who will be mechanically ventilated without PEEP group 1 who will be mechanically ventilated without PEEP intraoperative group 1 who will be mechanically ventilated without PEEP 51 Active-Treatment of Control Group
Experimental Group group 2(n=51) will receive PEEP of 5 cm H2O group 2(n=51) will receive PEEP of 5 cm H2O intraopertaive group 2(n=51) will receive PEEP of 5 cm H2O 51
Experimental Group group 3(n=51) will receive PEEP of 10 cm H2O group 3(n=51) will receive PEEP of 10 cm H2O intraopertaive group 3(n=51) will receive PEEP of 10 cm H2O 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of either sex aged between 30 and 70 years, of ASA I or II physical status, and will be undergoing elective laparoscopic colorectal surgery under combined general anaesthesia and epidural analgesia will be included in the study. Patient refusal, age less than 30 years or more than 70 years, BMI above 30, ASA III or ASA IV physical status, emergency surgery, complicated or recurrent abdominal surgeries, or conversion to laparotomy are the exclusion criteria. Also, patients with history of chronic respiratory disease, diaphragmatic disease or any contraindication to laparoscopic surgery or head down position or regional anaesthesia ,and any allergy to the drug used in the study will be excluded 30 Year(s) 70 Year(s) Both
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
No 15/04/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
BeniSuief University hospital,Egypt BeniSuief Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome dighragmatic excursion intra and postoperative
Secondary Outcome Other signs of diaphragmatic affection including areas of atelectasis, consolidation These measurements will be taken before induction of anesthesia, after pneumoperitoneum ,after head down position and then every hour until evacuation of the abdomen, after recovery and 6 hours after completion of surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef university hospital BeniSuief Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor doaa rashwan ,Egypt giza 000 Egypt Hospital
Secondary Sponsor doaa rashwan ,Egypt giza 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hatem Elmoutaz BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
doaa rashwan ,Egypt giza 000 Egypt
Walid Hamed Nofal cairo Egypt
Eman Ahmed Shawky Sabek cairo cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 00201011270763 ,Egypt
City Postal code Country Position/Affiliation
giza 000 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information