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
Sponsor study identifier
Secondary identifiers
NIH
observational
307
1 country
1
Study Start
August 5, 2019
Actual (reported)Primary Completion
January 31, 2020
Actual (reported)Study Completion
January 31, 2020
Actual (reported)10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2019
Actual (reported)November 7, 2019
Actual (reported)December 2, 2019
Actual (reported)January 31, 2020
Actual (reported)January 31, 2020
Actual (reported)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.
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
10 years after operation
Laparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Questionnaires
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gastroesophageal Reflux Disease
Ersta Hospital
Stockholm, Region Stockholm, 116 91, Sweden
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.
Anders Thorell, professor
Karolinska Institutet
307 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2019
First Posted
December 2, 2019
Study Start
August 5, 2019
Actual (reported)Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Contact the study team to confirm eligibility.
Primary Completion
January 31, 2020
Actual (reported)Study Completion
January 31, 2020
Actual (reported)Last Updated
February 4, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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