Laparoscopic Nissen Versus Anterior Partial Fundoplication
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nissen fundoplication
Laparoscopic antireflux surgery ad modum Watson
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Fundoplication, Surgical Procedures
Eligibility 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)
Sites / Locations
- Department of Surgery
- Department of Surgery
- Department of Surgery
- Department of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Total fundoplication
Anterior partial fundoplication
Arm Description
Procedure: Laparoscopic Nissen fundoplication
Procedure: Laparoscopic anterior partial fundoplication
Outcomes
Primary Outcome Measures
Postoperative flatulence?
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?
To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01669330
Brief Title
Laparoscopic Nissen Versus Anterior Partial Fundoplication
Official Title
Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Gastroesophageal Reflux, Fundoplication, Surgical Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total fundoplication
Arm Type
Active Comparator
Arm Description
Procedure: Laparoscopic Nissen fundoplication
Arm Title
Anterior partial fundoplication
Arm Type
Active Comparator
Arm Description
Procedure: Laparoscopic anterior partial fundoplication
Intervention Type
Procedure
Intervention Name(s)
Nissen fundoplication
Intervention Description
Laparoscopic Nissen fundoplication
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic antireflux surgery ad modum Watson
Intervention Description
Laparoscopic anterior fundoplication
Primary Outcome Measure Information:
Title
Postoperative flatulence?
Description
To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.
Time Frame
Postoperative one year
Secondary Outcome Measure Information:
Title
Relapse? Complications? Functional problems?
Description
To establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
Time Frame
Postoperatively three months, one year and ten years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Djerf, Md
Organizational Affiliation
Region Skane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Kalmar
Country
Sweden
Facility Name
Department of Surgery
City
Lund
Country
Sweden
Facility Name
Department of Surgery
City
Malmö
Country
Sweden
Facility Name
Department of Surgery
City
Trollhättan
Country
Sweden
12. IPD Sharing Statement
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Laparoscopic Nissen Versus Anterior Partial Fundoplication
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