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.: PACTR202010845316667 Date of Approval: 12/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized Controlled Trial On the Effect of Laparoscopic One Anastomosis Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy in Treatment of Obese Type 2 Diabetic Patients.
Official scientific title Randomized Controlled Trial On the Effect of Laparoscopic One Anastomosis Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy in Treatment of Obese Type 2 Diabetic Patients.
Brief summary describing the background and objectives of the trial IRecent guidelines on diabetes treatment advocate weight loss as the most effective means of controlling type 2 diabetes (T2DM). Bariatric surgery had demonstrated its ability to achieve significant and durable weight loss, as well as a remarkable resolution of T2DM. Objectives: To compare laparoscopic one anastomosis gastric bypass vs laparoscopic sleeve gastrectomy regarding the efficacy of control of T2DM in obese patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2015
Actual trial start date 01/12/2015
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants)
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 randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Laparoscopic sleeve gastrectomy 3 years Laparoscopic sleeve gastrectomy operation 80 Active-Treatment of Control Group
Experimental Group laparoscopic one anastomosis gastric bypass 3 years laparoscopic one anastomosis gastric bypass operation 82
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Having T2DM Being above the age of 18 years. Having a body mass index (BMI) ≥ 30 kg/m2. Being willing to sign an informed consent and comply with the evaluation and treatment schedules. Patients with any endocrine abnormalities (e.g., hypothyroidism and Cushing’s syndrome). Patients who have undergone previous bariatric operations or major upper abdominal surgery. Patients with type 1 DM. Patients younger than 18 years of age. Pregnant or lactating females. Patients with any contraindications for insufflation, such as those with severe cardiovascular or severe restrictive respiratory diseases. Patients with significant abdominal ventral hernia. Patients with major psychiatric illness . 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 29/03/2015 Research ethics committee at general surgery department. Faculty of medicine. Ain Shams university.
Ethics Committee Address
Street address City Postal code Country
General surgery department, Ain Shams University Hospitals 318 Ramsis St., Abbasia, Cairo Egypt. Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HbA1C and fasting blood sugar 12 months after the operation
Secondary Outcome HbA1C and fasting blood sugar 3, 6, 9 months after the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals General surgery department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University 318 Ramsis St., Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University 318 Ramsis St., Abbasia Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hossam S. Abdelrahim General surgery department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
Ahmed Mohamed BahaaEldin Internal medicine department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
Alyaa Ahmed Elsherbeny Internal medicine department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
Maram M. M. Aboromia Internal medicine department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
Ahmed Elnabil Mortada General surgery department, Ain Shams University Hospitals 318 Ramsis St., Abbasia Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Elmaleh dr_haitham_elmaleh@med.asu.edu.eg +201006383143 126 elmerghany St., Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of general and bariatric surgery. Faculty of medicine. Ain Shams University
Role Name Email Phone Street address
Public Enquiries Hossam Abdelrahim hosam_l_n@yahoo.com +201110540267 General surgery department, Ain Shams University Hospitals 318 Ramsis St., Abbasia
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of general and bariatric surgery. Faculty of medicine. Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Haitham Elmaleh dr_haitham_elmaleh@med.asu.edu.eg +201006383143 126 elmerghany St., Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of general and bariatric surgery. Faculty of medicine. Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial will be available, after de-identification. Clinical Study Report Immediately following publication The data will be available to anyone who wishes to access the data, for Any purpose. Proposal should be directed to dr_haitham_elmaleh@med.asu.edu.eg. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/10/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/10/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information