Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Professor Ospanov Oral Ospanov
ORCID ID
Contact details
Syganak str.,5/1
kv.48
Astana (Aqmola)
010016
Kazakhstan
+77015287734
Ospanov.o@amu.kz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease: a pilot single-centre single-blind two-arm randomised controlled study
Acronym
Study hypothesis
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
Ethics Committee of the Medical University of Astana 15/01/2010
Study design
Pilot single-centre single-blind two-arm randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe obesity combined with gastroesophageal reflux disease
Intervention
Laparoscopic fundoplication + great curvature gastric plication compared to "Floppy Nissen" laparoscopic fundoplication
Intervention type
Procedure/Surgery
Phase
Drug names
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 trial start date
12/01/2010
Overall trial end date
15/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
114
Participant 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
Recruitment start date
15/01/2010
Recruitment end date
15/12/2014
Locations
Countries of recruitment
Kazakhstan
Trial participating centre
Astana Medical University
Kazakhstan
Funders
Funder type
Charity
Funder name
Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Calculation of primary data and results of analysis.
Intention to publish date
15/03/2015
Participant level data
Stored in repository
Basic results (scientific)
Publication list