Laparoscopic Nissen Versus Anterior Partial Fundoplication
Study Details
Study Description
Brief Summary
The most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. This operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. An anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. The aim with this study is to compare the results postoperatively, both short time and long time results.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Aim: To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. The secondary aims are to establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are randomised between the two operations. Postoperatively, telephone interview is performed weekly the first two months. One year and ten years postoperatively. The patients are investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom evaluation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Total fundoplication Procedure: Laparoscopic Nissen fundoplication |
Procedure: Nissen fundoplication
Laparoscopic Nissen fundoplication
|
| Active Comparator: Anterior partial fundoplication Procedure: Laparoscopic anterior partial fundoplication |
Procedure: Laparoscopic antireflux surgery ad modum Watson
Laparoscopic anterior fundoplication
|
Outcome Measures
Primary Outcome Measures
- Postoperative flatulence? [Postoperative one year]
To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.
Secondary Outcome Measures
- Relapse? Complications? Functional problems? [Postoperatively three months, one year and ten years]
To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age:18-65 years.
-
Good results of PPI treatment (<3 months) resulting in reduced heart burn and acid regurgitations.
-
Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring.
Exclusion Criteria:
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Previous surgery on the stomach
-
Patients with IBS (criteria ROM II)
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Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement
-
Patients with active ulcer disease
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Paraesophageal hernia
-
Patient that are incapable to understand the study information (for example mentally disorder, drug abuse)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery | Kalmar | Sweden | ||
| 2 | Department of Surgery | Lund | Sweden | ||
| 3 | Department of Surgery | Malmö | Sweden | ||
| 4 | Department of Surgery | Trollhättan | Sweden |
Sponsors and Collaborators
- Region Skane
Investigators
- Principal Investigator: Pauline Djerf, Md, Region Skane
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NW20012011