Effect of sleeve gastrectomy on patients with or without preoperative gastroesophageal reflux disease
| ISRCTN | ISRCTN15208502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15208502 |
| Protocol serial number | N/A |
| Sponsor | CHU Ambroise Paré |
| Funder | Investigator initiated and funded |
- Submission date
- 24/03/2015
- Registration date
- 15/04/2015
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Departement of Nutrition
CHU Ambrosie Paré
Boulogne-Billancourt
92100
France
Public
Departement of Nutrition
CHU Ambrosie Paré
Boulogne-Billancourt
92100
France
 ORCID ID |
0000-0002-7361-9811 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Patients scheduled for sleeve gastrectomy were offered to undergo 24-h pH monitoring in the preoperative time and 6 months after surgery. |
| Secondary study design | |
| Scientific title | Effect of sleeve gastrectomy on patients with or without preoperative gastroesophageal reflux disease: a pH-metry based study |
| Study objectives | 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(s) | Observational study |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Percentage with esophageal pH<4 for total time ≥4.2%. |
| Key secondary outcome measure(s) |
Percentage with esophageal pH<4 for upright and supine time ≥4.2%. |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 89 |
| Key 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 |
| Key exclusion criteria | 1. Refusal 2. Huge Hiatal Hernia 3. History of hiatal surgery 4. Pregnancy |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 15/09/2014 |
Locations
Countries of recruitment
- France
Study participating centre
92100
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | 24/07/2020 | Yes | No |
Editorial Notes
24/07/2020: Publication reference and total final enrolment number added.
