Clip Ascent and Sleeve Gastrectomy (POST-SLEEVE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sleeve Gastrectomy; Obesity

Treatments: Procedure: pH-metry during 24 hours

Study type: Observational

Funder types: Other

Identifiers

NCT03932968

2017-A01608-45 (Other Identifier)

NI17015J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

223 participants in 2 patient groups

Symptomatic pain

Description:

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

Treatment:

Procedure: pH-metry during 24 hours

Control

Description:

patients after a sleeve gastrectomy without symptomatic pain