Laparoscopic Nissen Versus Anterior Partial Fundoplication

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669330

Enrollment

Registered

2012-08-21

Start date

2001-01-31

Completion date

2014-01-31

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux, Fundoplication, Surgical Procedures

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.

Interventions

PROCEDURENissen fundoplication

Laparoscopic Nissen fundoplication

PROCEDURELaparoscopic antireflux surgery ad modum Watson

Laparoscopic anterior fundoplication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026