Esophageal Motility DisordersNCT01234428
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
A study testing Laparoscopic surgery and gastric banding in people with Esophageal Motility Disorders, run by Spital STS AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- Laparoscopic surgery and gastric banding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 1998to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI more than 40
Who cannot join
- BMI below 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.
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.
Read the detailed description
Using a yearly barium swallow the diameter of the esophagus will be monitored over the period.
- Conditions
- Esophageal Motility Disorders
- Being tested
- Laparoscopic surgery, gastric banding
- Keywords
- laparoscopy, adjustable gastric banding, morbid obesity, esophageal motility, esophageal dilatation
- Medical subject headings
- Esophageal Motility Disorders, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Gastric banding
gastric bandingProcedure or surgery
Also called morbid obesity
laparoscopic gastric banding
| Study group | Role | What they receive |
|---|---|---|
| surgery | Other | Not described Receives: Procedure: Laparoscopic surgery; Procedure: gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
esophageal dilatation
esophageal dilatation or dysfunction
Measured: yearly follow-up over 12 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJun 1998
- Primary completionJun 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spital STS AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Medicine, Spital STS AG Thun
- Investigators
- Markus Naef, MD, MBA, Principal investigator, Spital STS AG Thun, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234428
- Sponsor's protocol ID
- MOB-12-STS-AG
- Status last verified
- Nov 2010
- First submitted
- 2 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21169806
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Dysmotility Disorders Following Laparoscopic Gastric Banding - An Underestimated Complication.
- ClinicalTrials.gov ID
- NCT01234428
- Acronym / sponsor ID
- MOB-12-STS-AG
- Conditions
- Esophageal Motility Disorders
- Keywords
- laparoscopy, adjustable gastric banding, morbid obesity, esophageal motility, esophageal dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Spital STS AGIndustry (pharma, biotech, devices)
- Collaborators
- Department of Medicine, Spital STS AG Thun
- Study start
- Jun 1998
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Other | Procedure: Laparoscopic surgery, Procedure: gastric banding |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI more than 40
Key exclusion criteria (1 listed)
- BMI below 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgeryGastric banding | Procedure or surgery | surgery |
| gastric bandingAlso: morbid obesitylaparoscopic gastric banding | Procedure or surgery | surgery |
Primary outcome
esophageal dilatation
Time frame: yearly follow-up over 12 year period
esophageal dilatation or dysfunction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
- Derived from this study: PubMed 21169806Naef 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Naef, MD, MBA principal investigator
Spital STS AG Thun, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery and gastric banding in people with Esophageal Motility Disorders, run by Spital STS AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
esophageal dilatation (time frame: yearly follow-up over 12 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.