Gastroesophageal Reflux DiseaseNCT05647668
Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
A study testing Laparoscopic fundoplication in people with Gastroesophageal Reflux Disease, run by Mykola Paranyak at 1 site in Ukraine.
Trial summary
One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Mar 2018to 6 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- extraesophageal symptoms of gastroesophageal reflux disease
- undergoing surgery for gastroesophageal reflux disease
- at least 18 years old
Who cannot join
- patients under the age of 18 years
- previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction
- major psychiatric illness
- unstable chronic illnesses (such as diabetes)
- inability of the patient to complete the survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Laparoscopic fundoplication
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic fundoplicationProcedure or surgery
Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic Nissen fundoplication | Active comparator | Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie. Receives: Procedure: Laparoscopic fundoplication |
| laparoscopic Toupet fundoplication | Active comparator | Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie. Receives: Procedure: Laparoscopic fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
Measured: 24 month
Secondary outcomes (2)
Reflux symptom index (RSI) score
The reflux symptom index (RSI) questionnaire is a nine-item, 45-point survey used in the evaluation of symptoms of laryngopharyngeal reflux. A RSI score higher than 13 is considered abnormal and indicates the presence of laryngopharyngeal reflux.
Measured: 24 months
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
The LPR-HRQL questionnaire is a 43-item survey, designed to assess the effects of extraesophageal reflux symptoms on social and occupational functioning, vitality, well-being and perceived health.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Mar 2018
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mykola Paranyak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mykola Paranyak, Danylo Halytsky Lviv National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647668
- Sponsor's protocol ID
- 2708A
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be decided after publication of the article
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05647668
- Acronym / sponsor ID
- 2708A
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mykola ParanyakUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 12 Dec 2022 (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.
One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic Nissen fundoplication | Active comparator | Procedure: Laparoscopic fundoplicationCreation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie. |
| laparoscopic Toupet fundoplication | Active comparator | Procedure: Laparoscopic fundoplicationCreation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- extraesophageal symptoms of gastroesophageal reflux disease
- undergoing surgery for gastroesophageal reflux disease
- at least 18 years old
Key exclusion criteria (5 listed)
- patients under the age of 18 years
- previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction
- major psychiatric illness
- unstable chronic illnesses (such as diabetes)
- inability of the patient to complete the survey.
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 |
|---|---|---|
| Laparoscopic fundoplicationCreation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie. | Procedure or surgery | laparoscopic Nissen fundoplication, laparoscopic Toupet fundoplication |
Primary outcome
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
Time frame: 24 month
2 secondary outcomes
Reflux symptom index (RSI) score
Time frame: 24 months
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
Time frame: 24 months
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 13 Dec 2022.
- Individual participant dataSharing planned: Undecided. Will be decided after publication of the article
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic fundoplication in people with Gastroesophageal Reflux Disease, run by Mykola Paranyak at 1 site in Ukraine.
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 5 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. 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?
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes. (time frame: 24 month). 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 13 Dec 2022.