Patient SatisfactionNCT04182178
Long-term Follow-up After Surgical Treatment for GERD (Gastroesophageal Reflux Disease)
An observational study of Patient Satisfaction and Relapse, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Patient Satisfaction, Relapse, Dysphagia
- What is being tested?
- 10 years follow up
- How many people
- 307 participants
- Where
- 1 siteSweden
- Study dates
- 5 Aug 2019to 31 Jan 2020
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastroesophageal Reflux Disease
Who may be able to join
- Gastroesophageal Reflux 10 years follow-up after surgery informed consent
Who cannot join
- Deceased patients patients who declined participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Patient Satisfaction, Reflux Control and Gastrointestinal Disorders in Patients Undergoing Laparoscopic Surgical Treatment for GERD, With Partial or Total Fundoplication
10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.
Read the detailed description
Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease.
Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.
Reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.
- Conditions
- Patient Satisfaction, Relapse, Dysphagia, Bloating
- Being tested
- 10 years follow up
- Medical subject headings
- Patient Satisfaction, Recurrence, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 years follow upOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal reflux | Laparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease. Receives: Other: 10 years follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Quality of life
The SF-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome.
Measured: 10 years
Gastrointestinal Symptom Rating Scale (GSRS)
GSRS Gastrointestinal Symptom Rating Scale Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
A mean value for the items in each dimension should be calculated:
Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation.
Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation
Measured: 10 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start5 Aug 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 Patient SatisfactionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 307 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 Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182178
- Sponsor's protocol ID
- 2019-03655
- Other IDs
- 2019
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805.
PubMed 35442430
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patient Satisfaction, Reflux Control and Gastrointestinal Disorders in Patients Undergoing Laparoscopic Surgical Treatment for GERD, With Partial or Total Fundoplication
- ClinicalTrials.gov ID
- NCT04182178
- Acronym / sponsor ID
- 2019-03655
- Conditions
- Patient Satisfaction, Relapse, Dysphagia, Bloating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 2 Dec 2019 (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.
10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.
Detailed description
Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease.
Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.
Reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal reflux | – | Other: 10 years follow upLaparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastroesophageal Reflux Disease
Key inclusion criteria (1 listed)
- Gastroesophageal Reflux 10 years follow-up after surgery informed consent
Key exclusion criteria (1 listed)
- Deceased patients patients who declined participation
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 |
|---|---|---|
| 10 years follow upQuestionnaires | Other | Gastroesophageal reflux |
Primary outcome
SF-36 Quality of life
Time frame: 10 years
The SF-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome.
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 10 years after operation
GSRS Gastrointestinal Symptom Rating Scale Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation. Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation
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 4 Feb 2021.
- Derived from this study: PubMed 35442430Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805.
- 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 Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Relapse, run by Karolinska Institutet at 1 site 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 1 inclusion and 1 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 4 Feb 2021. 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 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?
SF-36 Quality of life (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT04182178, 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 4 Feb 2021.