Long-term Follow-up After Surgical Treatment for GERD (Gastroesophageal Reflux Disease)

Karolinska Institutet307 enrolled

Overview

10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.

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 Type

OBSERVATIONAL

Enrollment

307

Conditions

Patient Satisfaction Relapse Dysphagia Bloating

Interventions

10 years follow upOTHER

Questionnaires

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: Gastroesophageal Reflux 10 years follow-up after surgery informed consent Exclusion Criteria: Deceased patients patients who declined participation

Locations (1)

Ersta Hospital

Stockholm, Region Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 10 years after operation

Data from ClinicalTrials.gov

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