Laparoscopic Nissen Versus Anterior Partial Fundoplication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Nissen fundoplication
* Procedure: Laparoscopic antireflux surgery ad modum Watson


Participation Criteria
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Eligibility Criteria
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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: Previous surgery on the stomach Patients with IBS (criteria ROM II) Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement Patients with active ulcer disease Paraesophageal hernia Patient that are incapable to understand the study information (for example mentally disorder, drug abuse)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total fundoplication<br>Procedure: Laparoscopic Nissen fundoplication | Procedure: Nissen fundoplication<br>* Laparoscopic Nissen fundoplication<br>|
| Active Comparator: Anterior partial fundoplication<br>Procedure: Laparoscopic anterior partial fundoplication | Procedure: Laparoscopic antireflux surgery ad modum Watson<br>* Laparoscopic anterior fundoplication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux, Fundoplication, Surgical Procedures