Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single... | NCT06530212

Studies
Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

NCT06530212

Sponsor

Minia University

Status

Recruiting

Last Update Posted

Mar 4, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Obesity, Morbid

Interventions

SGJIB
SAS-JB

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2024Actual

Primary Completion Date

Oct 20, 2025Estimated

Completion Date

Nov 20, 2025Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 27, 2024

First Posted Date

Jul 31, 2024Actual

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

Feb 28, 2025

Last Update Posted Date

Mar 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Mstafa Hassan Sewefy, professor of general and bariatric surgery, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

Detailed Description

200 patients will be randomly divided into to equal . Group 1 will be operated by sleeve gastrectomy with jejunoileal bypass with the anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction. and group 2 will be operated by single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SGJIB	Experimental		Procedure: SGJIB
SAS-JB	Active Comparator		Procedure: SAS-JB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGJIB	Procedure	sleeve gastrectomy with jejunoileal bypass with anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stoma complications	any complication due to sleeve jejunal anastomosis	one year

Secondary Outcomes

Measure	Description	Time Frame
weight loss at one year	the effect of the 2 procedures on weight measured by percentage of excess weight loss	one year
improvement of comorbidities	change in comorbidities

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

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa sewefy, professor	Contact	+201006448805		sewafy@yahoo.co.uk

Overall Officials

Name	Affiliation	Role
Alaa Sewefy, professor	Minia University	Principal Investigator
Taha Kayed, MD	Minia University	Study Director

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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