Laparoscopic Nissen Versus Anterior Partial Fundoplication

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Nissen fundoplication; Procedure: Laparoscopic antireflux surgery ad modum Watson

• Registration Number: NCT01669330
• Lead Sponsor: Region Skane

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.

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 Timeline

• Study Start: 2001-01
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total fundoplication	Nissen fundoplication	Procedure: Laparoscopic Nissen fundoplication
Anterior partial fundoplication	Laparoscopic antireflux surgery ad modum Watson	Procedure: Laparoscopic anterior partial fundoplication

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Trollhättan, Sweden