Condition category
Digestive System
Date applied
14/01/2015
Date assigned
28/01/2015
Last edited
27/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan

Sponsor details

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

Sponsor type

Charity

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes