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

Completed

• Conditions: Patient Satisfaction; Relapse; Bloating; Dysphagia

• Registration Number: NCT04182178
• Lead Sponsor: Karolinska Institutet

Brief Summary

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 Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria

Deceased patients patients who declined participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS)	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
SF-36 Quality of life	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.

Trial Locations

Locations (1)

Ersta Hospital; 🇸🇪 Stockholm, Region Stockholm, Sweden