Laparoscopic Nissen Versus Anterior Partial Fundoplication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01669330
First received: November 22, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux
Procedure: Nissen fundoplication
Procedure: Laparoscopic antireflux surgery ad modum Watson

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Postoperative flatulence? [ Time Frame: Postoperative one year ] [ Designated as safety issue: No ]
    To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.


Secondary Outcome Measures:
  • Relapse? Complications? Functional problems? [ Time Frame: Postoperatively three months, one year and ten years ] [ Designated as safety issue: Yes ]
    To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.


Enrollment: 72
Study Start Date: January 2001
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669330

Locations
Sweden
Department of Surgery
Kalmar, Sweden
Department of Surgery
Lund, Sweden
Department of Surgery
Malmö, Sweden
Department of Surgery
Trollhättan, Sweden
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Pauline Djerf, Md Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01669330     History of Changes
Other Study ID Numbers: NW20012011
Study First Received: November 22, 2011
Last Updated: April 9, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Gastroesophageal Reflux
Fundoplication
Surgical Procedures

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014