Gastro-oesophageal reflux disease Digestive System Gastro-oesophageal reflux disease
Conditions
Interventions
Patients were randomised to either robotic assisted (RALF) or conventional laparoscopic (CLF) Nissen fundoplication the day before surgery. Intraoperative randomisation was not applicable in the study
the movable robotic module with its three robotic arms was positioned directly cranial to the patient's head. The surgeon, sitting at the master console aside the operating table, was steered the actu
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of the study were to investigate the quality of life and functional outcome in patients undergoing either laparoscopic or robot-assisted fundoplication. The primary outcomes are measured after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| A set of surgical and non-surgical parameters related to the operation are analysed as secondary objectives, such as: 1. Operating time, assessed intraoperatively 2. Intraoperative blood loss, assessed intraoperatively 3. Complications, assessed intraoperatively 4. Conversions, assessed intraoperatively 5. Morbidity, recorded during the first postoperative months 6. Postoperative length of hospital stay, measured during the hospital stay 7. Costs, measured during the hospital stay | — |
Countries
Germany
Outcome results
None listed