Esophageal Dysmotility and Dilatation After Laparoscopic... | NCT01234428

Studies
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding

NCT01234428

Sponsor

Spital STS AG

Status

Completed

Last Update Posted

Nov 4, 2010Estimated

Enrollment

167Actual

Phase

Not Applicable

Conditions

Esophageal Motility Disorders

Interventions

Laparoscopic surgery
gastric banding

Countries

Switzerland

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

Nov 2010

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

Jun 1998

Primary Completion Date

Jun 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 4, 2010Estimated

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

Nov 2, 2010

Last Update Posted Date

Nov 4, 2010Estimated

Name	Class
Department of Medicine, Spital STS AG Thun	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 determine whether esophageal dysmotility and dilatation is an important complication in the long term follow-up following laparoscopic gastric banding for morbid obesity.

Detailed Description

Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.

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

167Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery	Other		Procedure: Laparoscopic surgery Procedure: gastric banding

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
esophageal dilatation	esophageal dilatation or dysfunction	yearly follow-up over 12 year period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI more than 40

Exclusion Criteria:

BMI below 40

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

Not provided

Overall Officials

Name	Affiliation	Role
Markus Naef, MD, MBA	Spital STS AG Thun, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Spital STS AG Thun		Thun		3600	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21169806	Derived	Naef M, Mouton WG, Naef U, van der Weg B, Maddern GJ, Wagner HE. Esophageal dysmotility disorders after laparoscopic gastric banding--an underestimated complication. Ann Surg. 2011 Feb;253(2):285-90. doi: 10.1097/SLA.0b013e318206843e.

ID	Term
D015154	Esophageal Motility Disorders
D009767	Obesity, Morbid

ID	Term
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis