Laparoscopic Nissen Versus Anterior Partial Fundoplication

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669330
• Other study ID #: NW20012011
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: April 9, 2014
• Start date: January 2001
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Nissen fundoplication
Laparoscopic Nissen fundoplication
• Laparoscopic antireflux surgery ad modum Watson
Laparoscopic anterior fundoplication

Locations

Country	Name	City	State
Sweden	Department of Surgery	Kalmar
Sweden	Department of Surgery	Lund
Sweden	Department of Surgery	Malmö
Sweden	Department of Surgery	Trollhättan

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative flatulence?	To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.	Postoperative one year	No
Secondary	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	Yes