Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/03/2015
Date assigned
15/04/2015
Last edited
14/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gastroesophageal reflux disease (GERD) is a common condition where stomach acids leak out into the oesophagus (gullet). Symptoms include heartburn, acid reflux (acid coming back up into the mouth), and difficulty and pain when swallowing. People who are overweight or obese are at high risk of developing GERD. In some cases, 24-hour pH monitoring is recommended to help diagnose the condition. This measures pH levels around the oesophagus to test for excess acid. Laparoscopic sleeve gastrectomy (LSG), where the stomach is made smaller to restrict the amount of food that can be eaten, has been found to work well in treating morbid (life-endangering) obesity based on both short and mid-term studies. However, there are concerns that LSG may lead to GERD or worsen existing GERD. There has not yet been any rigorous large studies investigating this using 24-hour pH monitoring. The aim of this study is to observe pH levels in the oesophagus in people having LSG using 24-hour pH monitoring.

Who can participate?
Adults who are obese and scheduled to have LSG surgery.

What does the study involve?
Each participant undergoes 24-hour pH monitoring just before they have their LSG surgery. Six months following surgery, they then have a usual full clinical and biological examination and are invited to undergo 24-h pH monitoring again to test for GORD.

What are the possible benefits and risks of participating?
Participants enjoy the benefit of a gold standard test to test for GERD in clinical practice. No major adverse outcomes have been reported with such a test.

Where is the study run from?
The University Nutrition Department at Ambroise Paré University Hospital, West Paris (France)

When is the study starting and how long is it expected to run for?
January 2012 to April 2015

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Sébastien Czernichow

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sébastien Czernichow

ORCID ID

Contact details

Departement of Nutrition
CHU Ambrosie Paré
Boulogne-Billancourt
92100
France

Type

Public

Additional contact

Dr Jérémie Thereaux

ORCID ID

http://orcid.org/0000-0002-7361-9811

Contact details

Departement of Nutrition
CHU Ambrosie Paré
Boulogne-Billancourt
92100
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of sleeve gastrectomy on patients with or without preoperative gastroesophageal reflux disease: a pH-metry based study

Acronym

Study hypothesis

Gastroesophageal reflux disease is a frequent obesity-related co-morbidity which is objectively assessed by 24-h pH monitoring. Sleeve gastrectomy (LSG) has been found as an effective treatment for morbid obesity based on short and mid term studies. However, some concerns have been raised on LSG with the unpredictable risk of de novo or worsening GERD. Rigorous large studies using 24-h pH monitoring are lacking. The aim of our study was to assess post operative influence of sleeve gastrectomy (LSG) on GERD in obese morbid patients with or without preoperative GERD.

Ethics approval

Observational study

Study design

Patients scheduled for sleeve gastrectomy were offered to undergo 24-h pH monitoring in the preoperative time and 6 months after surgery.

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Grade 3 obesity

Intervention

Laparoscopic sleeve gastrectomy:
The aim of our study is to determine whether sleeve gastrectomy leads to de novo gastroesophageal reflux disease or exacerbates preoperative GERD in morbidly obese patients.
Ambulatory esophageal pH monitoring is the gold standard for the diagnosis of gastroesophageal reflux disease. The nasoesophageal catheter was placed 5 cm above upper border of the lower esophageal sphincter. Esophageal pH monitoring was performed for 24 hours. There were recorded total, supine and upright time with esophageal pH<4. Patients were offered to undergo the 24-h pH monitoring preoperatively and 6 months after the bariatric procedure.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Percentage with esophageal pH<4 for total time ≥4.2%.

Secondary outcome measures

Percentage with esophageal pH<4 for upright and supine time ≥4.2%.

Overall trial start date

01/01/2012

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults patients
2. Body Mass Index >35 kg/m²
3. Eligible for bariatric surgery
4. Preoperative medical management > 6 months
5. According to NIH/HAS criteria for bariatric surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Refusal
2. Huge Hiatal Hernia
3. History of hiatal surgery
4. Pregnancy

Recruitment start date

01/07/2012

Recruitment end date

15/09/2014

Locations

Countries of recruitment

France

Trial participating centre

CHU Ambroise Paré
Boulogne-Billancourt
92100
France

Sponsor information

Organisation

CHU Ambroise Paré

Sponsor details

Avenue Charles de Gaulle
Boulogne-billancourt
92100
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the study will be published in a peer-reviewed scientific journals and presented at conferences (years 2015-2016)

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes