About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Clip Ascent and Sleeve Gastrectomy

Clinicaltrials.gov identifier NCT03932968

Recruitment Status Active, not recruiting

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

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:Sleeve Gastrectomy
    Obesity
  • Intervention/Treatment: Procedure: pH-metry during 24 hours
  • Phase: N/A
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.

Study Design
  • 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
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

France
Hopital Bichat
Paris

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: PASCALE KARILA-COHEN, MD Assistance Publique - Hôpitaux de Paris

More Information
  • Responsible Party: Assistance Publique - Hôpitaux de Paris
  • ClinicalTrials.gov Identifier: NCT03932968 History of Changes
  • Other Study ID Numbers: NI17015J, 2017-A01608-45
  • 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
  • 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: oesogastric reflux
    sleeve gastrectomy
    clip ascent
    sleeve gastrectomy follow-up