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.: PACTR202310644487566 Date of Approval: 10/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ReSleeve or Revisional One Anastomosis Gastric Bypass For Failed Primary Sleeve Gastrectomy With Dilated Gastric Tube: A Retrospective Study.
Official scientific title ReSleeve or Revisional One Anastomosis Gastric Bypass For Failed Primary Sleeve Gastrectomy With Dilated Gastric Tube: A Retrospective Study.
Brief summary describing the background and objectives of the trial Revisional Bariatric Surgery (RBS) has been increasingly performed due to weight loss failure (WLF). Many revisional procedures have been proposed after primary Laparoscopic Sleeve Gastrectomy (pLSG) failure, including ReSleeve (ReLSG), and Laparoscopic One Anastomosis Gastric Bypass (LOAGB). Choosing the RBS post-pLSG failure represents a challenge. WLF without gastric tube (GT) dilation is undoubtedly converted to a malabsorptive procedure, but the presence of GT dilation makes it more difficult to select a RBS. This study aimed to compare two relatively simple revisional procedures after pLSG failure with dilated GT to help decision making on which procedure better done to which patient.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2019
Actual trial start date 01/01/2019
Anticipated date of last follow up 01/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
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 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
Control Group revisional laparoscopic sleeve gastrectomy 4 years Laparoscopic sleeve (vertical) resection of the stomach after failure of previous sleeve gastrectomy 27 Active-Treatment of Control Group
Experimental Group revisional laparoscopic one anastomosis gastric bypass 4 years After failure of laparoscopic sleeve gastrectomy, laparoscopic redo surgery was done by transverse stapling of the gastric pouch then vertical resection of the pouch then anastomosis was done between the pouch and the small intestine. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All failed laparoscopic sleeve gastrectomy with radiological evidence of gastric tube dilation, either diffuse (RGV>250 mL) or fundus dilation (with or without gastric tube diffuse dilation) Patients with laparoscopic sleeve gastrectomy complicated by leak and patients who had Laparoscopic RY gastric bypass (LRYGB) within the first year due to complications (refractory biliary reflux or severe stricture) were excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 22 Year(s) 58 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 17/09/2023 Ethical committee of general surgery department Ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbassia street Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome percentage of excess weight loss median 23 months follow up
Secondary Outcome operative data and postoperative complications median 23 months follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Al abbassia street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Contributing Authors Abbassia street Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor General surgery department at Ain shams university Abbassia street Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wadie Gerges wadie.boshra@med.asu.edu.eg 00201222795940 Abbassia street
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Ain shams universiry
Role Name Email Phone Street address
Public Enquiries Fady Makram Fedomak@med.asu.edu.eg 00201225047204 Abbassia street
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hossam Abdelrahim dr_hossamsobhy@med.asu.edu.eg 00201110540267 Abbassia street
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data are restricted not allowed for sharing. Informed Consent Form Our data are restricted. Controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Hosam_l_n@yahoo.com 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