Bariatric Surgery ComplicationsPhase 2/3NCT01860053
A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients
A Phase 2/3 study testing behavioral intervention in people with Bariatric Surgery Complications, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery Complications
- What is being tested?
- behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2011
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
- Report vomiting at least 3x/week.
- Agree to allow researchers to communicate with their surgeon regarding their care.
- Fulfilled all hospital surgery criteria.
Who cannot join
- Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease).
- Report planning to become pregnant during the time frame of the investigation.
- Report a history of upper gastrointestinal dismotility.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.
- Conditions
- Bariatric Surgery Complications
- Being tested
- behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
This intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients.
| Study group | Role | What they receive |
|---|---|---|
| behavioral intervention | Experimental | Not described Receives: Behavioral: behavioral intervention |
| no treatment control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
Measured: baseline to week 6
Secondary outcomes (1)
change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index
Measured: baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery ComplicationsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tricia M. Leahey, Ph.D., The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860053
- Sponsor's protocol ID
- 2030-09
- Status last verified
- May 2013
- First submitted
- 6 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients
- ClinicalTrials.gov ID
- NCT01860053
- Acronym / sponsor ID
- 2030-09
- Conditions
- Bariatric Surgery Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- First posted
- 22 May 2013 (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 reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral intervention | Experimental | Behavioral: behavioral intervention |
| no treatment control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years.
- Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
- Report vomiting at least 3x/week.
- Agree to allow researchers to communicate with their surgeon regarding their care.
- Fulfilled all hospital surgery criteria.
Key exclusion criteria (3 listed)
- Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease).
- Report planning to become pregnant during the time frame of the investigation.
- Report a history of upper gastrointestinal dismotility.
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 |
|---|---|---|
| behavioral interventionThis intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients. | Behavioural | behavioral intervention |
Primary outcome
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
Time frame: baseline to week 6
1 secondary outcome
change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index
Time frame: baseline to week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
Related trials for Bariatric Surgery Complications
Recruiting
Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery
Bariatric Surgery and Physical Activity, Obesity/Therapy
Enrolling by invitation
Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications.
Metabolic Surgery, Obesity & Overweight
RecruitingObservational study
Postoperative Nausea, Vomiting and Pain After Bariatric Surgery - a National Registry Study
Postoperative Nausea and Vomiting, Postoperative Pain
Recruiting
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Endometrial Carcinoma, Obesity
Not yet recruitingEarly Phase 1
Opportunistic Salpingectomy During Bariatric Surgery for Ovarian Cancer Prevention
Ovarian Cancer, Bariatric Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing behavioral intervention in people with Bariatric Surgery Complications, run by The Miriam Hospital at 1 site in United States.
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 5 inclusion and 3 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: paused, as of the sponsor's last update on 22 May 2013. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview (time frame: baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2013.