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.: PACTR202203850216757 Date of Registration: 30/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Single Anastomosis Sleeve Jejunal Bypass versus One Anastomosis Gastric Bypass in Treatment of Obesity and Metabolic Diseases: A Randomized Controlled Trial
Official scientific title Single Anastomosis Sleeve Jejunal Bypass versus One Anastomosis Gastric Bypass in Treatment of Obesity and Metabolic Diseases: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Several conventional and novel methods of bariatric surgery-termed metabolic surgeries - induce long-term remission of type 2 diabetes mellitus (T2DM) and dramatically improve other metabolic syndrome, such as hyperlipidemia and hypertension, independent of the patients’ weight. Some previous studies demonstrated that these metabolic effects are not only attributable to drastic weight loss and diminished caloric intake, but also to endocrine changes that result from surgical manipulation of the gastrointestinal tract. The one anastomosis gastric bypass (OAGB) procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. One anastomoses gastric bypass involves making of a long narrow tube of the stomach along its right border, the lesser curvature. A loop of the small gut is brought up and hooked to this tube at about 200 cms from the start of the intestine (ligament of Treitz). Santoro’s operation is a sleeve gastrectomy with transit bipartition. The aim of the procedure is to keep pass to the duodenum to decrease nutritional deficiency and to allow endoscopic management of obstructive jaundice. To be easier, this procedure was rapidly altered to a single anastomosis sleeve ileal bypass (SASI). In this study, we shifted the anastomosis up to the jejunum to evaluate the effect of laparoscopic single anastomosis sleeve jejunal (SASJ) bypass as a treatment for morbid obesity and related co-morbidities. In addition, the effect of the SASJ procedure on nutritional deficiency was examined. The aim of this work is to compare the outcomes of Single Anastomosis Sleeve Jejunal Bypass as a modified technique from Single Anastomosis Sleeve Ileal bypass and One Anastomosis Gastric Bypass as treatment option for morbid obesity as regard weight loss and co-morbidities resolution.  
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization 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 Single Anastomosis Sleeve Jejunal Bypass N/A Once Laparoscopic Single Anastomosis Sleeve Jejunal Bypass. 34
Control Group One Anastomosis Gastric Bypass N/A Once Laparoscopic one anastomosis gastric bypass . 34 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- BMI ≥ 40 ( Without Co-morbidities ). - BMI 35 – 40 with obesity related comorbidities (e.g. hypertension,hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea, obesity, hypoventilation syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux disease and severe arthritis). - Able to be committed to follow-up. - Preoperative upper GI endoscopy findings of GERD class C and Barrett’s esophagus. - Previous upper GIT surgery or liver cirrhosis. - On oral steroid therapy. - Previous bariatric surgery. - Not fit for general anesthesia (e.g. patients with severe heart disease or untreatable coagulopathies). - Contraindications for insufflation as those with sever cardiovascular or sever restrictive respiratory diseases. - Significant abdominal ventral hernia. - Major psychiatric illness. - Pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 13/03/2022 Ain shams university General surgery department research ethical committee
Ethics Committee Address
Street address City Postal code Country
56 ramsis st Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weight Loss 1 month, 6 months, 12 months postoperative
Primary Outcome Comorbidities resolution 1 month, 6 months, 12 months postoperative
Secondary Outcome post-operative reflux 6 months, 12 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery department Ain Shams University Ramsis Street Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yehia Khaled Said Mohamed Salem Villa 2, Block 17034, 8th Distrect , Al Obour Qalyubia 11828 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor General Surgery department Ain Shams University Ramsis Street Cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sameh Abd Allah Maaty Bulding 3, dr. Ahmed Mohamed Kamal Street, Abbas El Akkad, Nasr City Cairo 11341 Egypt
Karim sabry Abd el samee Atia 13 saada st,Maadi Cairo 11728 Egypt
Ahmed Magdy Farrag 14th Sheikh Mohamed Refaat Street, Heliopolis Cairo 11757 Egypt
Yehia Khaled Said Mohamed Salem Villa 2, Block 17034, 8th Distrect , Al Obour Qalyubia 11828 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Atia Karim_sabry@med.asu.edu.eg 00201033335498 13 saada st,Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Associate professor of General Surgery Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Yehia Salem Y_k_said@hotmail.com 00201000949404 Villa 2, Block 17034, 8th Distrect , Al Obour
City Postal code Country Position/Affiliation
Qalyubia 11828 Egypt General Surgery Specialist Department of General Surgery Ain Shams University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information