Clip Ascent and Sleeve Gastrectomy (POST-SLEEVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03932968|
Recruitment Status : Unknown
Verified February 2019 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment|
|Sleeve Gastrectomy Obesity||Procedure: pH-metry during 24 hours|
|Study Type :||Observational|
|Actual Enrollment :||223 participants|
|Official Title:||Observational Study of Epigastric Symptoms Chronicles, the Rise of the Line of Clips and Their Management in Obese Patients One Year Later Sleeve Gastrectomy|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry during 24 hours will be performed.
Procedure: pH-metry during 24 hours
For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed
patients after a sleeve gastrectomy without symptomatic pain
- Measure of clip ascent [ Time Frame: 12 months ]All patients at one year after a sleeve gastrectomy will be included. They will all have a CT scan and symptomatic patients will have a phmetry. Observational between epigastric symptoms, clip ascent at one year after a sleeve gastrectomy.
- Frequency of clip ascent [ Time Frame: 18 months ]Clip ascent is noticed after sleeve surgery but data about it are unknown
- Oesogastric reflux proved by phmetry [ Time Frame: 12 months ]The frequency of oesogastric reflux proved by phmetry at 12 months after surgery is unknown
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932968
|Paris, France, 75018|
|Principal Investigator:||PASCALE KARILA-COHEN, MD||Assistance Publique - Hôpitaux de Paris|