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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total fundoplication | Active Comparator | Procedure: Laparoscopic Nissen fundoplication |
|
| Anterior partial fundoplication | Active Comparator | Procedure: Laparoscopic anterior partial fundoplication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nissen fundoplication | Procedure | Laparoscopic Nissen fundoplication |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative flatulence? | To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. | Postoperative one year |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse? Complications? Functional problems? | To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications. | Postoperatively three months, one year and ten years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Djerf, Md | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery | Kalmar | Sweden | ||||
| Department of Surgery |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Laparoscopic antireflux surgery ad modum Watson |
| Procedure |
Laparoscopic anterior fundoplication |
|
| Lund |
| Sweden |
| Department of Surgery | Malmö | Sweden |
| Department of Surgery | Trollhättan | Sweden |
| D004066 | Digestive System Diseases |