Clip Ascent and Sleeve Gastrectomy

Completed

• Conditions: Obesity; Sleeve Gastrectomy
• Interventions: Procedure: pH-metry during 24 hours

• Registration Number: NCT03932968
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-12-17
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-05-01
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic pain	pH-metry during 24 hours	For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry during 24 hours will be performed.

Primary Outcome Measures

Name	Time	Method
Measure of clip ascent	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

Name	Time	Method
Oesogastric reflux proved by phmetry	12 months	The frequency of oesogastric reflux proved by phmetry at 12 months after surgery is unknown
Frequency of clip ascent	18 months	Clip ascent is noticed after sleeve surgery but data about it are unknown

Trial Locations

Locations (1)

Hopital Bichat; 🇫🇷 Paris, France