NCT01234428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
Last Updated

November 4, 2010

Status Verified

November 1, 2010

Enrollment Period

11 years

First QC Date

November 2, 2010

Last Update Submit

November 2, 2010

Conditions

Esophageal Motility Disorders

Keywords

laparoscopyadjustable gastric bandingmorbid obesityesophageal motilityesophageal dilatation

Outcome Measures

Primary Outcomes (1)

  • esophageal dilatation

    esophageal dilatation or dysfunction

    yearly follow-up over 12 year period

Study Arms (1)

surgery

OTHER
Procedure: Laparoscopic surgeryProcedure: gastric banding

Interventions

Laparoscopic surgeryPROCEDURE

Gastric banding

surgery
gastric bandingPROCEDURE

laparoscopic gastric banding

Also known as: morbid obesity
surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI more than 40

You may not qualify if:

  • BMI below 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Spital STS AG Thun

Thun, 3600, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21169806DERIVED

MeSH Terms

Conditions

Esophageal Motility DisordersObesity, Morbid

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Markus Naef, MD, MBA

    Spital STS AG Thun, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 4, 2010

Study Start

June 1, 1998

Primary Completion

June 1, 2009

Study Completion

March 1, 2010

Last Updated

November 4, 2010

Record last verified: 2010-11

Locations

CH(1)