Abdominal PainNCT03456024
Abdominal Pain and Symptoms Post Gastric Sleeve
An observational study of Abdominal Pain and Quality of Life, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Pain, Quality of Life
- What is being tested?
- Questinnaire
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2015to 31 Dec 2022
- 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
- No healthy volunteers
- Adult
Study population: Patients scheduled for sleeve gastrectomy for morbid obesity at Oslo University Hospital and Voss sykehus
Who may be able to join
- Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.
- Signed written and informed consent for study enrollment
Who cannot join
- Patients who dont understand Norwegian language
- Previous bariatric surgery
- Indication for sleeve gastrectomy for other reasons than for morbid obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Abdominal Pain and Discomfort in Morbid Obese Patients Before and After Sleeve Gastrectomy
Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients
Read the detailed description
The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.
Primary endpoints/outcomes:
- Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy
Secondary endpoints/outcomes:
- Evaluate and characterise chronic abdominal pain in regard to:
- Weight development
- Obesity-related comorbidities
- Health-related quality of life
- Postoperative complications
- Metabolic effects after surgery
- Nutritional status
- Socioeconomic status
- Conditions
- Abdominal Pain, Quality of Life
- Being tested
- Questinnaire
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestinnaireOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic abdominal pain 2 years after gastric sleeve
questionnaire
Measured: 2 years
Secondary outcomes (1)
Quality of life related to abdominal pain and symptoms
questionnaire (SF-36v2, OP scale)
Measured: 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 Nov 2015
- Primary completion30 Aug 2020
- Study completion31 Dec 2022 (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
- Collaborators
- Voss Sykehus
- Responsible party
- Principal investigator, Tom Mala, Oslo University Hospital
- Investigators
- Tom Mala, MD,Phd, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456024
- Sponsor's protocol ID
- Sleeve and abdominal pain
- Status last verified
- Nov 2020
- First submitted
- 28 Feb 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Abdominal Pain and Discomfort in Morbid Obese Patients Before and After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03456024
- Acronym / sponsor ID
- Sleeve and abdominal pain
- Conditions
- Abdominal Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Voss Sykehus
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2022 (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.
Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients
Detailed description
The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.
Primary endpoints/outcomes:
- Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy
Secondary endpoints/outcomes:
- Evaluate and characterise chronic abdominal pain in regard to:
- Weight development
- Obesity-related comorbidities
- Health-related quality of life
- Postoperative complications
- Metabolic effects after surgery
- Nutritional status
- Socioeconomic status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients scheduled for sleeve gastrectomy for morbid obesity at Oslo University Hospital and Voss sykehus
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| Questinnaire | Other | – |
Primary outcome
Chronic abdominal pain 2 years after gastric sleeve
Time frame: 2 years
questionnaire
1 secondary outcome
Quality of life related to abdominal pain and symptoms
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 study director
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 and Quality of Life, 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 2 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 24 Nov 2020. 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 after gastric sleeve (time frame: 2 years). 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 24 Nov 2020.