Single-Anastomosis Plication Ileal Bypass for Morbid Obesity | NCT03428386

Studies
Single-Anastomosis Plication Ileal Bypass for Morbid Obesity

NCT03428386

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Feb 9, 2018Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Gastric plication ileal bypass

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jan 31, 2019Estimated

Completion Date

May 30, 2019Estimated

First Submitted Date

Feb 4, 2018

First Submission Date that Met QC Criteria

Feb 8, 2018

First Posted Date

Feb 9, 2018Actual

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 8, 2018

Last Update Posted Date

Feb 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sameh Emile, Lecturer of general surgery, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastric plication ileal bypass	Experimental	single-anastomosis plication ileal bypass	Procedure: Gastric plication ileal bypass

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric plication ileal bypass	Procedure	laparoscopic plication of the greater curvature of the stomach then the duodeno-jejunal junction is identified and 300 cm is measured downwards. The selected loop will be ascended without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just 3 cm away from the pylorus with a linear stapler charged with a green cartridge, the diameter of ileal antrum anastomosis is not exceeding 3 cm in diameter. The staple defect is closed with a two-layer running 3/0 polyglactin suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss	Percentage of excess weight loss at 6 months after the procedure	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study

Exclusion Criteria:

Patients with secondary obesity due to endocrine disorders
patient unfit for general anesthesia.
patients who had not attempted non-surgical weight loss treatment in the past
patients with psychological conditions that influence his/her perception of the study protocol
patients with previous surgery for morbid obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sameh H Emile, M.D.	Contact	+201006267150		sameh200@hotmail.com
Sameh H Emile	Contact			sameh200@hotmail.com

Overall Officials

Name	Affiliation	Role
Sameh H Emile, M.D.	Mansoura University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital	Recruiting	Al Mansurah	Dakahlia Governorate		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

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Browse Branches

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