Clip Ascent and Sleeve Gastrectomy

NCT03932968 | Completed

• 2 other identifiers: NI17015J2017-A01608-45
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleeve Gastrectomy; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Measure of clip ascent

  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.

  12 months

Secondary Outcomes (2)

• Frequency of clip ascent

  18 months

• Oesogastric reflux proved by phmetry

  12 months

Study Arms (2)

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

Control

patients after a sleeve gastrectomy without symptomatic pain

Interventions

pH-metry during 24 hours PROCEDURE

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

Symptomatic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients operated on a sleeve gastrectomy realizing their consultation at 12 months post sleeve

You may qualify if:

• sleeve gastrectomy operated for at least 1 year

You may not qualify if:

• acute abdominal pain,
• epigastric pain occuring after the surgery (no 6 months delay),
• pregnant women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PASCALE KARILA-COHEN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: May 1, 2019
• Study Start: December 17, 2017
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

FR (1)