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.: PACTR201501000996229 Date of Registration: 13/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The influence of fluids on bariatric surgery patients
Official scientific title The influence of fluid therapy on patient outcome in laparoscopic gastric bypass surgery. A randomized controlled trial.
Brief summary describing the background and objectives of the trial One of the anesthesia related factors that affect postoperative outcome in bariatric surgery is the amount of fluid administered intraoperatively. There are no evidence based studies that have detailed the most prudent method for fluid replacement in patients with extreme obesity undergoing laparoscopic bariatric surgery. There is evidence that restricted fluid strategy reduces the risk of overloading the circulation and would probably lead to better patient outcome regarding the time to regain full consciousness, the need for postoperative oxygen therapy, and ventilator support and lastly the return of normal intestinal function. So we aimed to compare the effects of optimized and conventional fluid strategies in the management of of obese patients undergoing laparoscopic gastric bypass surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied fluid therapy, obese, gastric bypass
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/01/2015
Actual trial start date 15/01/2015
Anticipated date of last follow up 15/07/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 280
Actual target sample size (number of participants)
Recruitment status Recruiting
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 randomization using computer generated table of randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group optimized fluid therapy 40 + lean body weight in ml per hour Operative time 140
Control Group Control group conventional fluid therapy - 10 ml/kg/h Operative time 140 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Obese, BMI >45, laparoscopic gastric bypass previous bariatric surgery 18 Year(s) 60 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
Yes 08/12/2014 Department of Anesthesia Ethical committee
Ethics Committee Address
Street address City Postal code Country
Kasr AlAiny Cairo 13322 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome length of stay in post anesthesia care unit postoperative
Secondary Outcome intaoperative hemodynamics Preoperative, postinduction every 5 minutes
Secondary Outcome length of hospital stay post operative
Secondary Outcome time to first intestinal motion postoperative
Secondary Outcome pulmonary functions postoperative
Secondary Outcome Need for CPAP postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Yosry Gohar Hospital 25 Abd ElAzeez Al Saoud st. Manial 13322 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Anesthesia Kasr AlAiny Cairo 12332 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Cairo University Kasr AlAiny Cairo 12332 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Osama Taha Assiut Univ Assiut` 15332 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Waleed Hamimy hamimy2002@gmail.com +201111420111 13, ElMathaf Elziraii st. Agouza
City Postal code Country Position/Affiliation
Giza 12331 Egypt Professor
Role Name Email Phone Street address
Public Enquiries Ahmed Zaghloul a_zaghloul@yahoo.com +201001839591 Anesthesia Department, Faculty of Medicine Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Dr
Role Name Email Phone Street address
Scientific Enquiries Mie Afify mieafify@gmail.com +201065152888 National Research center, Tahrir St., Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor
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