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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203637285531 Date of Registration: 10/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short-term outcomes of double omentopexy in OAGB: A Controlled Clinical Trial
Official scientific title Short-term outcomes of double omentopexy in one anastomosis gastric bypass surgery: A Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Omentopexy is a novel technique performed during the laparoscopic sleeve gastrectomy. In general, in the method, the remnant stomach is fixed to the gastrosplenic and gastrocolic ligaments. Despite the obvious advantages of one anastomosis gastric bypass surgery, it also has its own complications. Leaks still represent the most common complication of this intervention (0.1% to 1.9%), once a leak is identified, aggressive management strategies must be implemented to avoid further complications. Bleeding is the second most common complication and presents usually in the early postoperative setting. It commonly originates from the staple lining along with the gastric pouch, gastric remnant, or gastro-jejunal (GJ) anastomosis, with a rate of less than 3%. Other complications may include small bowel obstruction and dumping syndrome, stomal stenosis, marginal ulcer along mal-absorptive complications. The purpose of this study is to assess the efficacy of implementing a novel technique of reinforcement of gastric pouch and remnant stomach staple line with omentopexy in patients undergoing one-anastomosis gastric bypass surgery and to evaluate its impact in reducing post-operative complications.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/03/2022
Actual trial start date 15/05/2022
Anticipated date of last follow up 15/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Double omentopexy group N/A Once laparoscopic one anastomosis gastric bypass with double omentopexy of thegastric pouch and remnant stomach staple lines. 42
Control Group Standard group N/A Once laparoscopic one anastomosis gastric bypass without double omentopexy. 42 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. - 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 severe cardiovascular or severe restrictive respiratory diseases. - Significant abdominal ventral hernia. - Major psychiatric illness. - Pregnancy Adult: 18 Year(s)-44 Year(s),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 02/03/2022 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 Post-operative bleeding During the postoperative hospital stay
Primary Outcome Gastric twist During three months postoperative follow up
Primary Outcome Hospital stay Postoperative hospital stay in days
Secondary Outcome post-operative reflux During three months postoperative follow up
Secondary Outcome Excess body weight loss During three months postoperative follow up
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
Karim sabry Abd el samee Atia 13 saada st Maadi Cairo 11728 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
Karim sabry Abd el samee Atia 13 saada st,Maadi cairo 11728 Egypt
Basem helmy Abdel aziz Elshayeb 11 Hassan assem st Zamalek Cairo 11561 Egypt
Ahmed Osman Mahmoud El Zmity 2 EL FAYOUM ST OFF CLEOPATRA ST APT 45 EL KORBA HELIOPOLIS Cairo 11757 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_res_ainsham@yahoo.com 00201090446013 Esmael Darderi st
City Postal code Country Position/Affiliation
kafr elzayat Gharbia 31612 Ecuador 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