Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease
ISRCTN | ISRCTN58550318 |
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DOI | https://doi.org/10.1186/ISRCTN58550318 |
Secondary identifying numbers | N/A |
- Submission date
- 14/01/2015
- Registration date
- 28/01/2015
- Last edited
- 27/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Obesity often leads to problems of heartburn (burning sensation in chest) and regurgitation (taste of acid in throat or mouth), which fall under the category of gastroesophageal reflux disease (GERD). The study compares two types of procedures and the aim is to identify if it is possible to treat both obesity and GERD at the same time.
Who can participate?
Adults with severy obesity combined GERD symptoms.
What does the study involve?
Participants are randomly allocated to one of two groups:
Group 1 - laparoscopic great curvature plication (which reduces the stomach by creating an internal fold) and laparoscopic fundoplication (for GERD)
Group 2 - laparoscopic fundoplication only.
What are the possible benefits and risks of participating?
Direct benefit will be healing of heartburn and other symptoms of GERD. Possible side effect is the risk of persistent difficulty in swallowing (called dysphagia).
Where is the study run from?
Single center of Akmola Regional Hospital № 2 (Kazakhstan).
When is the study starting and how long is it expected to run for?
From January 2010 to December 2015
Who is funding the study?
Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan
Who is the main contact?
Professor Dr.Oral Ospanov
oospanov@icloud.com
Contact information
Scientific
Syganak str.,5/1, kv.48
Astana (Aqmola)
010016
Kazakhstan
Phone | +77015287734 |
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Ospanov.o@amu.kz |
Study information
Study design | Pilot single-centre single-blind two-arm randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease: a pilot single-centre single-blind two-arm randomised controlled study |
Study objectives | 1. An elevated body mass index (BMI) frequently results in the development of gastroesophageal reflux disease (GERD) symptoms, amongst which heartburn and regurgitation are the most common complaints, 2. Laparoscopic great curvature plication and laparoscopic fundoplication provide an anti-reflux effect similar to the standard Nissen laparoscopic fundoplication, at the same time significantly surpassing it in terms of bariatric effectiveness. |
Ethics approval(s) | Ethics Committee of the Medical University of Astana 15/01/2010 |
Health condition(s) or problem(s) studied | Severe obesity combined with gastroesophageal reflux disease |
Intervention | Laparoscopic fundoplication + great curvature gastric plication compared to "Floppy Nissen" laparoscopic fundoplication |
Intervention type | Procedure/Surgery |
Primary outcome measure | 1. X-ray test performed with barium contrast 2. Esophagogastroscopy before the surgery and 1, 3, 6, 12 and 24 months after the surgery 3. 24hr pH monitoring of the esophagus lower third post-surgery 4. Body weight in kg |
Secondary outcome measures | 1. The DeMeester score reflecting рН at gastroesohageal junction, within 1-24 months after the surgery 2. Bariatric effectiveness assessed by excessive weight loss percentage (%EWL) |
Overall study start date | 12/01/2010 |
Completion date | 15/12/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 114 |
Key inclusion criteria | 1. Male and female adult participants aged over 16 2. Severe obesity combined with gastroesophageal reflux disease: BMI 35 - 39 kg/m2 (obesity class II) and no previous abdominal surgeries in the past. |
Key exclusion criteria | 1. The refusal of a patient to have surgery and/or to participate in the ongoing study at any stage of the study 2. Conversion of laparoscopic surgery to open (traditional) surgery 3. Diseases of other organs and systems, the treatment of which could affect the course of reflux disease. 4. BMI less than 30 and more than 39 kg/m2. 5. Presence of a large diaphragmatic hernia 6. The degree of shortening of the esophagus 2 7. Patients who have had surgery in the cardioesophageal area 8. Patients who have had surgery within the abdominal cavity 9. No need for other simultaneous operations |
Date of first enrolment | 15/01/2010 |
Date of final enrolment | 15/12/2014 |
Locations
Countries of recruitment
- Kazakhstan
Study participating centre
Sponsor information
Charity
Syganak str., 5/1, kv.48
Astana (Aqmola)
010016
Kazakhstan
Funders
Funder type
Charity
No information available
Results and Publications
Intention to publish date | 15/03/2015 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Stored in repository |
Publication and dissemination plan | Calculation of primary data and results of analysis. |
IPD sharing plan |