- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413237
Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy
Prospective Comparative Study Evaluating the Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
The most commonly performed bariatric surgery worldwide is the vertical sleeve gastrectomy (VSG), the Roux-en-Y gastric bypass (RYGB), and the One anastomosis (Mini) gastric bypass, which has been demonstrated to produce excellent bariatric and metabolic outcomes.
Single anastomosis sleeve ileal (SASI) bypass was introduced in 2015 as a modification of Santorini's operation in, as it keeps pass to the duodenum so the biliary tree and the whole gut and can be assessed by the endoscope; there are no blind loops, excluded segments or foreign bodies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11591
- Ain Shams University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients age from 18 to 60 years old.
- Both sexes.
- Patients with body mass index (BMI) ≥ 40.
- Patients with BMI (35 - 40) with obesity related comorbidities. (e.g. type 2 diabetes mellitus, obstructive sleep apnea, hypertension, hyperlipidemia, obesity hypoventilation syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux disease and severe arthritis).
- Able to be committed to follow-up.
Exclusion Criteria:
- Patients underwent previous Bariatric surgeries.
- Patients with severe systemic disease, such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago. Contraindications for insufflation as those with severe cardiovascular or severe restrictive respiratory diseases.
- Patients that refused to participate in the study.
- Patients with psychiatric illness.
- Preoperative upper GI endoscopy findings of GERD class C and Barrett's oesophagus
- Previous upper GIT surgery or liver cirrhosis.
- Patients on oral steroid therapy.
- Not fit for general anaesthesia (e.g. patients with severe heart disease or untreatable coagulopathies).
- Significant abdominal adhesions.
- Major psychiatric illness.
- Pregnant patients.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group (A) (SASJ Group)
Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.
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Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.
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|
Group (B) (Lap Gastric Sleeve Group)
Patients underwent laparoscopic sleeve gastrectomy(LGS) as a metabolic and weight loss surgery.
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Patients underwent laparoscopic sleeve gastrectomy (LGS) as a metabolic and weight loss surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss
Time Frame: 1 month after the procedure
|
Weight loss was recorded.
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1 month after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolic syndrome
Time Frame: 1 month after the procedure
|
Metabolic syndrome was recorded.
|
1 month after the procedure
|
|
Assessment of quality of life
Time Frame: 1 month after the procedure
|
quality of life was assessed using specific scoring system is a variation of the BAROS (Bariatric Analysis and Reporting Outcome System). The specific tiers you listed (High, Moderate, and Mild Improvement)
|
1 month after the procedure
|
|
Incidence of complications
Time Frame: 1 month after the procedure
|
Incidence of complications such as gastroesophageal reflux disease (GERD), bile reflux, gall stones, reoperations, and postoperative bleeding were recorded.
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1 month after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13/8/2023.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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