Clip Ascent and Sleeve Gastrectomy
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03932968 Active, not recruiting May 1, 2019 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
Estimated Enrollment : 223 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
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
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
Investigator
Principal Investigator : PASCALE KARILA-COHEN, MD Assistance Publique - Hôpitaux de Paris
More Information
Responsible Party : Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier : NCT03932968     
Other Study ID Numbers : NI17015J, 2017-A01608-45
First Posted : May 1, 2019
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