Laparoscopic Nissen Versus Anterior Partial Fundoplication

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Procedure: Nissen fundoplication; Procedure: Laparoscopic antireflux surgery ad modum Watson

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Kalmar, Sweden
    • Department of Surgery
  • Lund, Sweden
    • Department of Surgery
  • Malmö, Sweden
    • Department of Surgery
  • Trollhättan, Sweden
    • Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total fundoplication; Procedure: Laparoscopic Nissen fundoplication	Procedure: Nissen fundoplication; Laparoscopic Nissen fundoplication
Active Comparator: Anterior partial fundoplication; Procedure: Laparoscopic anterior partial fundoplication	Procedure: Laparoscopic antireflux surgery ad modum Watson; Laparoscopic anterior fundoplication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Pauline Djerf, Md, Region Skane

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Fundoplication; Gastroesophageal Reflux; Surgical Procedures
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: NW20012011