Reflux, Gastroesophageal
Conditions
Brief summary
460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.
Detailed description
Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status) class\> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.
Interventions
Laparoscopic total (Nissen) fundoplication
Laparoscopic posterior 270 degrees partial fundoplication
Sponsors
Study design
Intervention model description
Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Eligibility
Inclusion criteria
* surgery treatment for GERD * laparoscopic surgery
Exclusion criteria
* previous surgery for GERD * ASA classification \>3 * paraesophageal hernias or large hiatal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal acid exposure | Change from baseline at 6 weeks, 12 and 36 month | 24-hour pH measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrens rates | Change from baseline at 6 weeks, 12, 36 and 60 month | Medical journal or patients description |
| Dysphagia scoring | Change from baseline at 6 weeks, 12, 36 and 60 month | Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery. |