Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease

ISRCTN ISRCTN58550318
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Professor Ospanov Oral Ospanov
Scientific

Syganak str.,5/1, kv.48
Astana (Aqmola)
010016
Kazakhstan

Phone +77015287734
Email Ospanov.o@amu.kz

Study information

Study designPilot single-centre single-blind two-arm randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleLaparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease: a pilot single-centre single-blind two-arm randomised controlled study
Study objectives1. 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) studiedSevere obesity combined with gastroesophageal reflux disease
InterventionLaparoscopic fundoplication + great curvature gastric plication compared to "Floppy Nissen" laparoscopic fundoplication
Intervention typeProcedure/Surgery
Primary outcome measure1. 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 measures1. 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 date12/01/2010
Completion date15/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants114
Key inclusion criteria1. 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 criteria1. 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 enrolment15/01/2010
Date of final enrolment15/12/2014

Locations

Countries of recruitment

  • Kazakhstan

Study participating centre

Astana Medical University
Kazakhstan

Sponsor information

Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan
Charity

Syganak str., 5/1, kv.48
Astana (Aqmola)
010016
Kazakhstan

Funders

Funder type

Charity

Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan

No information available

Results and Publications

Intention to publish date15/03/2015
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planCalculation of primary data and results of analysis.
IPD sharing plan