Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| post surgery | Patienst consultation Questionnaires |
| |
| pre and post surgery | Patient consultation Questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic abdominal pain 2 years post gastric bypass surgery | questionnaire | Patient follow up complete 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | questionnaire | patient follow up complete 2020 |
| Objective evaluation of pain perception | skin sensors | baseline and 2 years |
Not provided
Inclusion Criteria:
• 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
Exclusion Criteria:
Not provided
Not provided
Patients planned for bariatric surgery (gastric bypass) at a single center
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tom Mala, MD.phd | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo university Hopsital | Oslo | 0424 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2019 | |
| Reset | Jun 18, 2019 | |
| Release | Nov 22, 2020 | |
| Reset | Dec 15, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2019 | Jun 18, 2019 | |||
| Nov 22, 2020 |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D009767 | Obesity, Morbid |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Dec 15, 2020 |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |