Abdominal PainNCT03455998
Chronic Abdominal Pain After Gastric Bypass
An observational study of Abdominal Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- questionnaires
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2014to 31 Oct 2020
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients planned for bariatric surgery (gastric bypass) at a single center
Who may be able to join
- Indication for gastric bypass surgery i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss
Who cannot join
- Other indications for gastric bypass surgery than obesity
- Previous bariatric surgery
- Other concomitant surgical procedures for abdominal pain such as cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity
The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.
Read the detailed description
This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.
The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.
The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).
- Conditions
- Abdominal Pain
- Being tested
- questionnaires
- Keywords
- morbid obesity, gastric bypass, pain, symptoms
- Medical subject headings
- Abdominal Pain, Obesity, Morbid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| post surgery | Patienst consultation Questionnaires Receives: Other: questionnaires | |
| pre and post surgery | Patient consultation Questionnaires Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic abdominal pain 2 years post gastric bypass surgery
questionnaire
Measured: Patient follow up complete 2020
Secondary outcomes (2)
Quality of life
questionnaire
Measured: patient follow up complete 2020
Objective evaluation of pain perception
skin sensors
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Feb 2014
- Primary completion30 Jun 2015
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Mala, Oslo University Hospital
- Investigators
- Tom Mala, MD.phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455998
- Sponsor's protocol ID
- Gastric bypass/pain
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity
- ClinicalTrials.gov ID
- NCT03455998
- Acronym / sponsor ID
- Gastric bypass/pain
- Conditions
- Abdominal Pain
- Keywords
- morbid obesity, gastric bypass, pain, symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 7 Mar 2018 (actual)
- 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 study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.
Detailed description
This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.
The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.
The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post surgery | – | Other: questionnairesPatienst consultation Questionnaires |
| pre and post surgery | – | Other: questionnairesPatient consultation Questionnaires |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients planned for bariatric surgery (gastric bypass) at a single center
Key inclusion criteria (1 listed)
- Indication for gastric bypass surgery i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss
Key exclusion criteria (3 listed)
- Other indications for gastric bypass surgery than obesity
- Previous bariatric surgery
- Other concomitant surgical procedures for abdominal pain such as cholecystectomy
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 |
|---|---|---|
| questionnaires | Other | post surgery, pre and post surgery |
Primary outcome
Chronic abdominal pain 2 years post gastric bypass surgery
Time frame: Patient follow up complete 2020
questionnaire
2 secondary outcomes
Quality of life
Time frame: patient follow up complete 2020
Objective evaluation of pain perception
Time frame: baseline and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Tom Mala, MD.phd principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain, run by Oslo University Hospital at 1 site in Norway.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2018. 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 Norway. 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?
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?
Chronic abdominal pain 2 years post gastric bypass surgery (time frame: Patient follow up complete 2020). 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 13 Mar 2018.