Laparoscopic Internal Gastric Banding, New Simple and Cos... | NCT02878525

Studies
Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure

NCT02878525

Sponsor

Minia University

Status

Completed

Last Update Posted

Feb 5, 2018Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Laparoscopic internal gastric banding
laparoscopic sleeve gastrectomy

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

Jan 2018

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

Oct 2016

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 21, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 25, 2016Estimated

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

Jan 31, 2018

Last Update Posted Date

Feb 5, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Mstafa Hassan Sewefy, MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

Detailed Description

In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic internal gastric banding	Experimental	Laparoscopic internal gastric banding	Procedure: Laparoscopic internal gastric banding
Laparoscopic sleeve gastrectomy	Active Comparator	Laparoscopic sleeve gastrectomy	Procedure: laparoscopic sleeve gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic internal gastric banding	Procedure	Laparoscopic internal gastric banding	Laparoscopic internal gastric banding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety of the technique	the incidence of introperative and early postoperative complications	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
operative time	the operative time from skin to skin	12 hours
Hospital stay	Time of hospital stay	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
Approval to share in the study
Patients fit for laparoscopic surgery

Exclusion Criteria:

Patient age less than 18 or more than 50 years old
Refusal to share in the study
Unfit for surgery
patients with gastroesophageal reflux disease clinically or by investigation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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