Efficacy of laparoscopic Nissen -Rossetti fundoplication in the treatment of gastroesophageal reflux disease.
Phase 2
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Registration Number
- RPCEC00000108
- Lead Sponsor
- ational Center for Minimal Access Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Patients with typical symptoms of GERD and esophageal motor disorders, who had indication for surgical treatment. 2. Adult patients gave their written consent to participate. 3. Patients aged between 18 and 80 years inclusive
Exclusion Criteria
1. Patients with atypical symptoms of GERD. 2. Patients with recurrence of GERD after antireflux surgery. 3. Patients with peptic esophageal stricture as a complication of GERD. 4. Patients who refused to participate in the study. 5. Persons with mental disability, severe mental disorders or both. 6. Pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heartburn: Presence of a burning sensation behind the sternum. Measuring time: 1, 3, 6 and 12 months. Regurgitation: Sensing the flow of gastric contents into the oral cavity or pharynx. Measuring time: 1, 3, 6 and 12 months. Postoperative dysphagia: Feeling like a difficult to swallow food, to pass from mouth to stomach for solids, it can be exclusively or simultaneously for solids and liquids. Measuring time: 1, 3, 6 and 12 months.
- Secondary Outcome Measures
Name Time Method Surgical time, surgical timing in minutes required to perform the procedure, from the creation of pneumoperitoneum until the moment when surgical access was closed. Measuring time: at the end of surgery. Adverse Event: Any sign or symptom that appears in the patient related or unrelated to the procedure used. Measuring time: Since the inclusion of the patient until the final evaluation (12 months).