Staple-line Reinforcement During Laparoscopic Sleeve Gast... | NCT01459471

Studies
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

NCT01459471

Sponsor

University of Rome Tor Vergata

Status

Completed

Last Update Posted

Oct 25, 2011Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Complication of Surgical Procedure
Leak; Blood

Interventions

Bariatric surgery

Countries

Not provided

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

Oct 2011

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

Apr 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 4, 2011

First Submission Date that Met QC Criteria

Oct 21, 2011

First Posted Date

Oct 25, 2011Estimated

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

Oct 21, 2011

Last Update Posted Date

Oct 25, 2011Estimated

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 main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Detailed Description

The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bleeding, leak, operative time	Experimental		Procedure: Bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bariatric surgery	Procedure	Staple line reinforcement during sleeve gastrectomy	bleeding, leak, operative time

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.	a comparison between three techniques of staple line reinforcement. The number of adverse events will be registered and analyzed	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

BMI<35 Kg/m2,
Important comorbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paolo Gentileschi, MD	University of Tor Vergata, Rome, Italy	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050110	Bariatric Surgery
D005743	Gastrectomy

Ancestor Terms

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided