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.: PACTR202204809082266 Date of Approval: 07/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Early Outcomes of Banded versus Non-banded One Anastomosis Gastric Bypass: A Randomized Controlled Trial
Official scientific title Early Outcomes of Banded versus Non-banded One Anastomosis Gastric Bypass: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial It is now widely acknowledged that one anastomosis gastric bypass (OAGB) is at least as effective as Roux-en-Y gastric bypass (RYGB), if not more effective when it comes to weight loss and comorbidity resolution. Although it has its own advantages, weight regain remains a significant concern after OAGB, weight loss may diminish by gastric pouch dilation. One other phenomenon is dumping syndrome in OAGB patients that reduces the patient`s quality of life. The placement of a band around the gastric pouch to increase the restriction of food intake is acknowledged as a possible way to maximize weight loss after RYGB. On the other hand, the incidence of food intolerance appears to be higher among individuals who underwent banded bypass. Recent works suggest that weight regain along with dumping syndrome might be limited by the placement of a silicone ring around the gastric pouch during the procedure. The placement of a band around the upper segment of the OAGB is thought to limit the volume of food intake and slow down the passage of food and prevent dilatation of the pouch distal to the ring in the long term. The band may hopefully help in maintaining the patient’s weight and can potentially prevent dumping syndrome. The purpose of this randomized controlled trial is to compare the early outcomes after banded versus non-banded OAGB as regard to weight loss and comorbidities resolution.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Morbid Obesity,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/04/2022
Actual trial start date
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Banded OAGB group N/A Once laparoscopic one anastomosis gastric bypass with band placement around the gastric pouch 21
Control Group Non banded OAGB group N/A Once Laparoscopic one anastomosis gastric bypass without Gastric band. 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- BMI ≥ 40. - 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. - Pre-operative upper GI endoscopy findings of GERD class B, class C, barrett's esophagus or any hiatus hernia. - Previous upper GIT surgery or liver cirrhosis. - On oral steroid therapy. - Previous bariatric surgery. - Not fit for general anaesthesia (e.g. patients with severe heart disease or untreatable coagulopathies). - Contraindications for insufflation as those with sever cardiovascular or severe restrictive respiratory diseases. - Significant abdominal ventral hernia. - Major psychiatric illness. - Pregnant patients. 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 Co-morbidities resolution 1 month, 6 months, 12 months postoperative
Secondary Outcome Post-operative reflux symptoms 1 month, 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
Waleed Abdelsalam Abdelatty Anber Esmael Darderi street Kafr elzayat Gharbia 31612 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
Fawzi Salah Fawzi Villa 103, Al Narges 6, Fifth settlement Cairo 11835 Egypt
Waleed Abdelsalam Abdelatty Anber Esmael Darderi st kafr elzayat Gharbia 31612 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 Waleed Anber Waleed.anber30@gmail.com 00201090446013 Esmael Darderi st
City Postal code Country Position/Affiliation
kafr elzayat Gharbia 31612 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