Laparoscopic Nissen Versus Anterior Partial Fundoplication

NCT ID: NCT01669330

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total fundoplication

Procedure: Laparoscopic Nissen fundoplication

Group Type: ACTIVE_COMPARATOR

Nissen fundoplication

Intervention Type: PROCEDURE

Laparoscopic Nissen fundoplication

Anterior partial fundoplication

Procedure: Laparoscopic anterior partial fundoplication

Group Type: ACTIVE_COMPARATOR

Laparoscopic antireflux surgery ad modum Watson

Intervention Type: PROCEDURE

Laparoscopic anterior fundoplication

Interventions

Nissen fundoplication

Laparoscopic Nissen fundoplication

Intervention Type: PROCEDURE

Laparoscopic antireflux surgery ad modum Watson

Laparoscopic anterior fundoplication

Intervention Type: PROCEDURE

Eligibility 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline Djerf, Md

Role: PRINCIPAL_INVESTIGATOR

Region Skane

Locations

Department of Surgery

Kalmar, , Sweden

Department of Surgery

Lund, , Sweden

Department of Surgery

Malmo, , Sweden

Department of Surgery

Trollhättan, , Sweden

Countries

Sweden

Other Identifiers

NW20012011

Identifier Type: -

Identifier Source: org_study_id