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Completed

NCT Number: NCT01669330

Laparoscopic Nissen Versus Anterior Partial Fundoplication

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Kalmar, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nissen fundoplication

Procedure

Laparoscopic Nissen fundoplication

Laparoscopic antireflux surgery ad modum Watson

Procedure

Laparoscopic anterior fundoplication

Primary outcomes

  1. Postoperative flatulence?

    Time frame: Postoperative one year

    To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.

Secondary outcomes

  1. Relapse? Complications? Functional problems?

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2013
Study completion
2014
First posted
Aug 21, 2012
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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