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.: PACTR202310506240189 Date of Approval: 12/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single anastomosis sleeve jejunal bypass compared to sleeve gastrectomy and to one anastomosis gastric bypass
Official scientific title Single anastomosis sleeve jejunal bypass compared to sleeve gastrectomy and to one anastomosis gastric bypass
Brief summary describing the background and objectives of the trial Single anastomosis sleeve jejunal (SASJ) bypass is a modification of single anastomosis sleeve ileal (SASI) using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications. The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics. The aim of the study was to assess the safety and efficacy of SASJ regarding weight loss, quality of life, resolution of obesity-related diseases, and gastro esophageal reflux disease. This study included 90 morbidly obese patients seeking weight loss surgery at Cairo University Hospitals. Laparoscopic sleeve gastrectomy was done for 30 patients, laparoscopic one anastomosis gastric bypass (OAGB) was done for 30 patients and laparoscopic SASJ bypass was done for 30 patients. Data obtained from patients were compared regarding the three different techniques. OAGB was associated with more excess body weight loss at 3, 6, and 12 months compared with the other two procedures. The mean score for SASJ was 28.2, 47.66, and 64.33; for OAGB was 31, 47.7, and 67; and for sleeve gastrectomy was 29.8, 46.2, and 65.6, respectively. All patients in the three groups experienced some degree of improvement regarding obesity related co-morbidities (statistically insignificant difference). When applying the GIQLI in the three groups it showed better results for SASJ patients than the other two procedures with statistical significance results (P value <0.001, < 0.001, <0.001). SASJ is a safe procedure with comparable results to sleeve gastrectomy and OAGB in terms of weight loss and resolution of obesity related comorbidities; however, SASJ was associated with significantly better results regarding GIQL and reflux with the advantage of being simple and reversible procedure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 31/12/2021
Actual trial start date 31/12/2021
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date 30/04/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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 Randomised Simple randomization using a randomization table created by a computer software program 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 Anastmosis Sleeve Jejunal Bypass average 75 minutes The operation was performed in reverse Trendelenburg position on an operating table with an angle of 30° and the surgeon took position between the legs of the patient. Pneumo-peritoneum was performed with the Veress needle in the left upper quadrant. The five-trocar technique was used. Dissection begun by dividing the greater omentum 5 cm proximal to the pylorus near the incisor angularis. The dissection was continued to completely divide the gastrophrenic ligament and mobilize the angle of His to identify the left crus of the diaphragm. The omentum has been separated from the greater curvature allowing access into the lesser sac. The stomach is grasped and lifted anteriorly to expose its posterior wall. All adhesions to the lesser sac are taken down up until the most medial aspect of the stomach at the lesser curvature. Stapling started 4-6 cm distal to the pylorus. After separation of the stomach , A methylene blue dye was inserted through the bougie to confirm water tightness and absence of leakage. Gastrojejunostomy anastomosis was made within 150-200 cm of the ligament of Treitz, and the selected loop was stapled side to side within 4 to 6 cm away from the pylorus at the incisura angularis level, almost similar to omega gastric bypass. Eventually, the defect was linearly sutured. A drain was placed between stomach and spleen. 30
Control Group Sleeve Gastrectomy average 50 minutes The operation was performed in reverse Trendelenburg position. Pneumo-peritoneum was performed with the Veress needle in the left upper quadrant. Dissection began by dividing the greater omentum 5 cm proximal to the pylorus near the incisor angularis. The dissection was continued to completely divide the gastrophrenic ligament and mobilize the angle of His to identify the left crus of the diaphragm. All adhesions to the lesser sac are taken down up until the most medial aspect of the stomach at the lesser curvature. Stapling started 4-6 cm distal to the pylorus. After separation of the stomach, a methylene blue dye was inserted to confirm water tightness and absence of leakage. 30 Active-Treatment of Control Group
Control Group One Anastmosis Gastric Bypass average 90 minutes The patient was placed on the operating table in the supine position with the operating surgeon standing between the legs of the patient. The operating table was inclined to maximum reverse Trendelenburg and maximum left side up. A carbon dioxide (CO2) pneumoperitoneum was established to 15-mmHg pressure using veress needle. Direct optical entry to the abdominal cavity was carried out under vision using a 0-degree laparoscope. This laparoscope was then changed to a 30-degree scope. Ports were placed in a “diamond-shaped” pattern in the upper abdomen. The angle of His was identified and the fat pad at the esophagogastric(EG) junction was explicitly dissected in order to visualize the diaphragm’s left crus. The omentum at crow’s foot (the junction between the antrum and the body) on the lesser curvature was dissected for 2 cm, making a window into the lesser sac. Fatty tissue and fibrous adhesions between the posterior gastric wall and pancreas were dissected. Then, using the right hand working port or the patient’s left side port, an endoscopic stapler loaded with 60-mm(blue or gold) cartridges was consecutively applied (usually three times) parallel to the lesser curvature, sectioning the stomach vertically, completing the gastric reservoir. OAGB was completed by creating an ante-colic Gastrojeujenostomy (GJ) 200 cm from DJ flexure. The integrity of the GJ was assessed by Methylene blue test. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Morbidly obese patients with body mass index more than 40 or > 35 with obesity-related comorbidities with acceptable operative risks (ASA I & II) Age between 18 and 65 years Previously successfully instituted and supervised but failed adequate conservative program (diet, exercise, and/or medication) for at least 6 months Ability to comply with nutritional supplementation and long-term follow up Previous open abdominal surgery related to gastrointestinal tract including revision bariatric surgeries Endocrine disorders for obesity excluding diabetes mellitus and thyroid disorders Pregnancy Lactation Psychiatric illness Recent diagnosis of malignancy Non-compliance to postoperative nutritional management, supplementation therapy regimen and strict follow up for life Gastroesophageal reflux disease Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 23/12/2021 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weight loss 3, 6, and 12 months after surgery
Primary Outcome Quality of life 3, 6, and 12 months after surgery
Secondary Outcome Resolution of obesity-related co morbidities 3, 6, and 12 months after surgery
Secondary Outcome Gastro Esophageal Reflux Disease 3, 6, and 12 months after surgery
Secondary Outcome Early postoperative complications One week and one month after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moheb Fikry Bebawy Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospital Kasr Al Ainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Ayad a.m.ayad@gmail.com 000000000000000 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of General Surgery Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Sameh Aziz sameh.aziz@gmail.com 00000000000000 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of General Surgery Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Moheb Bebawy moheb.f.bebawy@gmx.com +201208541119 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt General Surgery Department Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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