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Clip Ascent and Sleeve Gastrectomy

Observational Study of Epigastric Symptoms Chronicles, the Rise of the Line of Clips and Their Management in Obese Patients One Year Later Sleeve Gastrectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03932968
Acronym
POST-SLEEVE
Enrollment
223
Registered
2019-05-01
Start date
2017-12-17
Completion date
2019-06-13
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Sleeve Gastrectomy

Keywords

sleeve gastrectomy, clip ascent, oesogastric reflux, sleeve gastrectomy follow-up

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.

Interventions

PROCEDUREpH-metry during 24 hours

For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of clip ascent12 monthsAll 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

MeasureTime frameDescription
Frequency of clip ascent18 monthsClip ascent is noticed after sleeve surgery but data about it are unknown
Oesogastric reflux proved by phmetry12 monthsThe frequency of oesogastric reflux proved by phmetry at 12 months after surgery is unknown

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026