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

Completed

• Conditions: Patient Satisfaction; Relapse; Bloating; Dysphagia
• Interventions: Other: 10 years follow up

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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Exclusion Criteria

Deceased patients patients who declined participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastroesophageal reflux	10 years follow up	Laparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.

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