RObotic versus conventional LAparoscopic Fundoplication: a randomised controlled double-blind assessment of quality of life
- Conditions
- Gastro-oesophageal reflux diseaseDigestive System
- Registration Number
- ISRCTN03806561
- Lead Sponsor
- niversity of Heidelberg (Germany)
- Brief Summary
1. 2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17353978 (added 31/05/2019) 2. 2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19165497 (added 31/05/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Males and females
2. Over 18 years of age
3. Informed consent
4. Ability to complete the quality of life questionnaires
5. History of chronic (greater than 6 months) symptomatic gastro-oesophageal reflux disease requiring proton pump inhibitor therapy (greater than 3 months) and/or oesophagitis (objectively documented by endoscopy)
1. History of upper abdominal surgery
2. Obesity with a body mass index (BMI) greater than 40 kg/sqm
3. Zollinger-Ellison syndrome
4. Primary oesophageal disorders:
4.1. Achalasia, scleroderma
4.2. Primary oesophageal spasms
4.3. Any oesophageal motility disorder
5. Gastric dysmotility
6. Inflammatory bowel disease
7. Dysplastic changes in a columnar lined oesophagus
8. Stricture of oesophagus
9. Malabsorption syndromes
10. Malignant diseases
11. Current unstable diabetes mellitus.
12. Severe cardiovascular, pulmonary, pancreatic, liver, renal or cerebro-vascular disease that might interfere with the evaluation of the study
13. Psychiatric disorders
14. Alcohol and/or drug abuse or any condition associated with poor compliance
15. Actual and past (greater than 3 months) treatment for Helicobacter pylori eradication (subjects should not be enrolled within 3 months after therapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method