Reflux, GastroesophagealRefluxIINCT03659487
Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
A study testing Nissen and Toupét in people with Reflux, Gastroesophageal, run by Karolinska Institutet.
Trial summary
460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reflux, Gastroesophageal
- What is being tested?
- Nissen and Toupét
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgery treatment for GERD
- laparoscopic surgery
Who cannot join
- previous surgery for GERD
- ASA classification >3
- paraesophageal hernias or large hiatal
About this study
460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.
Read the detailed description
Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.
- Conditions
- Reflux, Gastroesophageal
- Being tested
- Nissen, Toupét
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NissenProcedure or surgery
Laparoscopic total (Nissen) fundoplication
ToupétProcedure or surgery
Laparoscopic posterior 270 degrees partial fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Nissen | Active comparator | Surgery of GERD with 360 degrees total fundoplication Receives: Procedure: Nissen |
| Toupét | Active comparator | Surgery of GERD with 270 degrees partial fundoplication Receives: Procedure: Toupét |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal acid exposure
24-hour pH measurement
Measured: Change from baseline at 6 weeks, 12 and 36 month
Secondary outcomes (2)
Recurrens rates
Medical journal or patients description
Measured: Change from baseline at 6 weeks, 12, 36 and 60 month
Dysphagia scoring
Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.
Measured: Change from baseline at 6 weeks, 12, 36 and 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startNov 2001
- Primary completionApr 2011
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reflux, GastroesophagealStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Model description
- Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, professor, Principal investigator, Karolinska Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659487
- Sponsor's protocol ID
- EPN 225/01
- Acronym
- RefluxII
- Status last verified
- Oct 2018
- First submitted
- 30 Aug 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hakanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270 degrees Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):479-486. doi: 10.1001/jamasurg.2019.0047.
PubMed 30840057
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03659487
- Acronym / sponsor ID
- RefluxII / EPN 225/01
- Conditions
- Reflux, Gastroesophageal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2001 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.
Detailed description
Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Laparoscopic total (Nissen) vs posterior 270 degrees (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
| Arm | Type | Receives |
|---|---|---|
| Nissen | Active comparator | Procedure: NissenSurgery of GERD with 360 degrees total fundoplication |
| Toupét | Active comparator | Procedure: ToupétSurgery of GERD with 270 degrees partial fundoplication |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- surgery treatment for GERD
- laparoscopic surgery
Key exclusion criteria (3 listed)
- previous surgery for GERD
- ASA classification >3
- paraesophageal hernias or large hiatal
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 |
|---|---|---|
| NissenLaparoscopic total (Nissen) fundoplication | Procedure or surgery | Nissen |
| ToupétLaparoscopic posterior 270 degrees partial fundoplication | Procedure or surgery | Toupét |
Primary outcome
Esophageal acid exposure
Time frame: Change from baseline at 6 weeks, 12 and 36 month
24-hour pH measurement
2 secondary outcomes
Recurrens rates
Time frame: Change from baseline at 6 weeks, 12, 36 and 60 month
Dysphagia scoring
Time frame: Change from baseline at 6 weeks, 12, 36 and 60 month
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 29 Oct 2018.
- Derived from this study: PubMed 30840057Hakanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270 degrees Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):479-486. doi: 10.1001/jamasurg.2019.0047.
- Individual participant dataSharing planned: No
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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.
Anders Thorell, professor principal investigator
Karolinska Institut
Questions about this trial
What is this clinical trial studying?
A study testing Nissen and Toupét in people with Reflux, Gastroesophageal, run by Karolinska Institutet.
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 2 inclusion and 3 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Esophageal acid exposure (time frame: Change from baseline at 6 weeks, 12 and 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659487, which also lists 1 linked publication.
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 29 Oct 2018.