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.: PACTR202303486425402 Date of Registration: 17/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single Anastomosis Sleeve Jejunal Bypass vs Long BPL Roux-en-Y Gastric Bypass: Comparative Prospective Randomized Study
Official scientific title Single Anastomosis Sleeve Jejunal Bypass vs Long BPL Roux-en-Y Gastric Bypass: Comparative Prospective Randomized Study
Brief summary describing the background and objectives of the trial Dr. Mason and Ito developed the gastric bypass for the treatment of obesity in 1960s based on the weight loss seen among patients who underwent partial gastrectomy for duodenal ulcer disease. The anastomosis was carried out in a Billroth II configuration but was later revised to a ‘Roux-en-Y’ configuration by Dr. Ward Griffen in an effort to reduce bile reflux experienced by these patients. Since then, Roux-en-Y gastric bypass (RNYGB) has been one of the most successful weight loss procedure for more than 20 years But, due to bypass of the biliopancreatic system, there is the problem of access to the biliary tree or excluded gastric remnant after RYGB. Endoscopic Retrograde Cholangiopancreatography (ERCP) is not possible via the mouth and esophagus,. A patient who has undergone RYGB and subsequently develops choledocholithiasis, duodenal, gastric remnant or pancreatic pathology must undergo one or more of a number of procedures pioneered to directly access the biliary system and excluded stomach. In addition, Santoro et al. have developed a novel procedure: the sleeve gastrectomy with transit bipartition (SG + TB). Long-term data on SG + TB revealed that this procedure increases the stimulation of the distal gut and diminishes the exposure of the proximal part of the small intestine to food. This was the first bariatric design with two outlets for the gastric content through the duodenum and the gastro-ileal anastomosis. This technique has the advantage of presenting stomach and intestine anatomy with more similarity to normal anatomy compared with other bariatric techniques, which maintains easy endoscopic access to the duodenum. The aim of this study is to assess the safety and efficacy of SAS-J bypass operation as regard weight loss and metabolic effects by comparing its results with Roux-en-Y gastric bypass results.
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 01/08/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 01/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Single anastomosis sleeve jejunal N/A N/A laparoscopic Sleeve gastrectomy with transit bipartition to jejunum 40
Control Group Roux en Y gastric bypass N/A N/A Gastrojejunostomy with diversion of bilio-pancreatic diversion in Roux-en-Y configuration 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Body mass index of over 35 plus the comorbidity presence Body mass index of over 40 with/without comorbidity Patients’ willingness to participate in the study Patients’ cooperation in follow-up researches Maladaptive eating syndrome Gastroesophageal reflux disease (GERD) grade C and D. Psychiatric illnesses on anti-psychotic medications. Refusal to follow up or to enroll in this study Previous surgical history of abdominal exploration Previous bariatric procedure 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 24/07/2022 Research Ethics Committee REC Faculty of Medicine Ain Shams University FWA 0006379
Ethics Committee Address
Street address City Postal code Country
56 ramsis street Abbasya Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of Excess Weight Loss at 2 weeks, 3, 6 and 12 months postoperatively
Primary Outcome Percentage of Total weight loss at 2 weeks, 3, 6 and 12 months postoperatively
Secondary Outcome Hospital stay Till patient discharge
Secondary Outcome Operative time Along the operation
Secondary Outcome Postoperative bleeding During the first week postoperatively
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
Mohamed Mohamed Ahmed Abdelsalam Gad 61 ElFattah Buildings Nasr City Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Surgery Ain shams university Ramsis Street Cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohey El Din Ragab Elbanna 27 Baghdad Street Heliopolis Cairo 11431 Egypt
Karim sabry Abd el samee Atia 13 saada street Maadi Cairo 11728 Egypt
Mohamed Farid Ahmed Building number 10 Group number 100 Flat number 22 AlRehaab 11841 Egypt
CONTACT PEOPLE
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
Role Name Email Phone Street address
Scientific Enquiries Karim Atia Karim_sabry@med.asu.edu.eg 00201033335498 13 saada st,Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Assistant Professor of Surgery Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Principal Investigator Mohey Elbanna mohyelbana@med.asu.edu.eg 00201222188922 27 Baghdad Steet Heliopolis
City Postal code Country Position/Affiliation
Cairo 11431 Egypt Professor of Surgery Ain Shams University Cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. The study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol diately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com 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