Laparoscopic Nissen Versus Anterior Partial Fundoplication

Region Skane

Status

Completed

Conditions

Gastroesophageal Reflux

Treatments

Procedure: Laparoscopic antireflux surgery ad modum Watson

Procedure: Nissen fundoplication

Study type

Interventional

Funder types

Other

Identifiers

NCT01669330

NW20012011

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)