Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrec... | NCT01784510

Studies
Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy

NCT01784510

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Feb 6, 2013Estimated

Enrollment

73Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

distance of dissection of gastrocolic ligament from pylorus

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 2013

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

Not provided

Primary Completion Date

Jan 2013Actual

Completion Date

Not provided

First Submitted Date

Feb 2, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 6, 2013Estimated

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 5, 2013

Last Update Posted Date

Feb 6, 2013Estimated

Description Module

Brief Summary

Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.

Detailed Description

Not provided

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

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2 cm	Active Comparator		Procedure: distance of dissection of gastrocolic ligament from pylorus
6 cm	Experimental		Procedure: distance of dissection of gastrocolic ligament from pylorus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
distance of dissection of gastrocolic ligament from pylorus	Procedure		2 cm 6 cm

Measure	Description	Time Frame
weight loss		12 months postoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbid obesity with body mass index more than 40 or 35 with at least one comorbidity

Exclusion Criteria:

extreme of age less than 18 or over 65 years contraindications to laparoscopy

Accepts Healthy Volunteers

Not provided

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Surgical Center		Al Mansurah	Dakahlia Governorate	35516	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