Gastroesophageal RefluxNCT01669330
Laparoscopic Nissen Versus Anterior Partial Fundoplication
A study testing Nissen fundoplication and Laparoscopic antireflux surgery ad modum Watson in people with Gastroesophageal Reflux, run by Region Skane at 4 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Nissen fundoplication and Laparoscopic antireflux surgery ad modum Watson
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesSweden
- Study dates
- Jan 2001to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Department of Surgery
Kalmar
Department of Surgery
Lund
Department of Surgery
Malmö
Department of Surgery
Trollhättan
About this study
Official title: Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Nissen fundoplication, Laparoscopic antireflux surgery ad modum Watson
- Keywords
- Gastroesophageal Reflux, Fundoplication, Surgical Procedures
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nissen fundoplicationProcedure or surgery
Laparoscopic Nissen fundoplication
Laparoscopic antireflux surgery ad modum WatsonProcedure or surgery
Laparoscopic anterior fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Total fundoplication | Active comparator | Procedure: Laparoscopic Nissen fundoplication Receives: Procedure: Nissen fundoplication |
| Anterior partial fundoplication | Active comparator | Procedure: Laparoscopic anterior partial fundoplication Receives: Procedure: Laparoscopic antireflux surgery ad modum Watson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative flatulence?
To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.
Measured: Postoperative one year
Secondary outcomes (1)
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.
Measured: Postoperatively three months, one year and ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJan 2001
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Djerf, Md, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669330
- Sponsor's protocol ID
- NW20012011
- Status last verified
- Apr 2014
- First submitted
- 22 Nov 2011
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01669330
- Acronym / sponsor ID
- NW20012011
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, Fundoplication, Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total fundoplication | Active comparator | Procedure: Nissen fundoplicationProcedure: Laparoscopic Nissen fundoplication |
| Anterior partial fundoplication | Active comparator | Procedure: Laparoscopic antireflux surgery ad modum WatsonProcedure: Laparoscopic anterior partial fundoplication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nissen fundoplicationLaparoscopic Nissen fundoplication | Procedure or surgery | Total fundoplication |
| Laparoscopic antireflux surgery ad modum WatsonLaparoscopic anterior fundoplication | Procedure or surgery | Anterior partial fundoplication |
Primary outcome
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.
1 secondary outcome
Relapse? Complications? Functional problems?
Time frame: Postoperatively three months, one year and ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Djerf, Md principal investigator
Region Skane
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen fundoplication and Laparoscopic antireflux surgery ad modum Watson in people with Gastroesophageal Reflux, run by Region Skane at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative flatulence? (time frame: Postoperative one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.