SAS-J Compared to OAGB and LSG as a Treatment for Morbid... | NCT03821688

Studies
SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity

NCT03821688

Sponsor

Minia University

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

210Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

SAS-JB
OAGB
LSG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2019Actual

Primary Completion Date

Aug 10, 2020Actual

Completion Date

Aug 10, 2020Actual

First Submitted Date

Jan 19, 2019

First Submission Date that Met QC Criteria

Jan 26, 2019

First Posted Date

Jan 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2021

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAS-JB	Experimental	laparoscopic single anastomosis sleeve jejunal bypass	Procedure: SAS-JB
MGB	Active Comparator	laparoscopic mini gastric bypass	Procedure: OAGB
LSG	Active Comparator	laparoscopic sleeve gastrectomy	Procedure: LSG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAS-JB	Procedure	single anastomosis sleeve jejunal bypass	SAS-JB
OAGB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of excess weight loss	percentage of excess weight loss in kilogram	12 months

Secondary Outcomes

Measure	Description	Time Frame
the incidence of nutritional deficiency	the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.	2 years
the rate of improved co morbidity	the effect of the operation on co morbidity like diabetes and hypertension

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
patients fit for laparoscopic surgery
give approval to share in the study

Exclusion Criteria:

patients refused to share in the study
patients unfit for surgery
patients aged less than 18 and older than 60
patient with previous upper abdominal surgery either for obesity or other diseases
revisional bariatric procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alaa M Sewefy, MD	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine		Minya		61511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided