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Clip Ascent and Sleeve Gastrectomy (POST-SLEEVE)

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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with chronic gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. Those symptoms appeared at least 6 months after the surgery. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss.

Condition or disease Intervention/treatment
Sleeve Gastrectomy Obesity Procedure: pH-metry during 24 hours

Detailed Description:
There is a strong association between gastric reflux and obesity. A severe reflux is a contraindication for a sleeve gastrectomy for some surgeons. However the impact of sleeve gastrectomy on reflux is not clear. A de novo reflux is described for 2 to 18% of patients and many patients have unclear epigastric symptoms. One of the cause could be clip ascent which could justify a second surgery. This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection, confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss. A medical information note is given to every patient at the first consultation.

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Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Symptomatic pain
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

Control
patients after a sleeve gastrectomy without symptomatic pain



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Frequency of clip ascent [ Time Frame: 18 months ]
    Clip ascent is noticed after sleeve surgery but data about it are unknown

  2. Oesogastric reflux proved by phmetry [ Time Frame: 12 months ]
    The frequency of oesogastric reflux proved by phmetry at 12 months after surgery is unknown



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients operated on a sleeve gastrectomy realizing their consultation at 12 months post sleeve
Criteria

Inclusion Criteria:

  • sleeve gastrectomy operated for at least 1 year

Exclusion Criteria:

  • acute abdominal pain,
  • epigastric pain occuring after the surgery (no 6 months delay),
  • pregnant women

Information from the National Library of Medicine

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


Locations
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France
Hopital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: PASCALE KARILA-COHEN, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03932968    
Other Study ID Numbers: NI17015J
2017-A01608-45 ( Other Identifier: ANSM )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
sleeve gastrectomy
clip ascent
oesogastric reflux
sleeve gastrectomy follow-up