Clinical trial NCT03932968: Clip Ascent and Sleeve Gastrectomy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleeve Gastrectomy
Obesity
Keywords: sleeve gastrectomy
clip ascent
oesogastric reflux
sleeve gastrectomy follow-up
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated on a sleeve gastrectomy realizing their consultation at 12 months post sleeve

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.

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.

Eligibility 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

Primary outcomes:
measure: Measure of clip ascent
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of clip ascent
timeFrame: 18 months
measure: Oesogastric reflux proved by phmetry
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: PASCALE KARILA-COHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: