Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease

• Register: ISRCTN
• Last refreshed on: 6 July 2015
• Main ID: ISRCTN58550318
• Date of registration: 28/01/2015
• Prospective Registration: No
• Primary sponsor: Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan
• Public title: Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease
• Scientific title: Laparoscopic Surgery for Severe Obesity combined with gastroesophageal reflux disease: a pilot single-centre single-blind two-arm randomised controlled study
• Date of first enrolment: 15/01/2010
• Target sample size: 114
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN58550318
• Study type: Interventional
• Study design: Pilot single-centre single-blind two-arm randomised controlled study (Treatment)

Countries of recruitment

Kazakhstan

Contacts

• Name: Oral Ospanov

Key inclusion & exclusion criteria

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.
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe obesity combined with gastroesophageal reflux disease
Digestive System
Obesity

Intervention(s)

Laparoscopic fundoplication + great curvature gastric plication compared to "Floppy Nissen" laparoscopic fundoplication

Primary Outcome(s)

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(s)

1. The DeMeester score reflecting ?? at gastroesohageal junction, within 1-24 months after the surgery
2. Bariatric effectiveness assessed by excessive weight loss percentage (%EWL)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan