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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182178
• Other study ID #: 2019-03655
• Status: Completed
• Start date: August 5, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Bloating
• Deglutition Disorders
• Dysphagia
• Patient Satisfaction
• Recurrence
• Relapse

Intervention

Other:
• 10 years follow up
Questionnaires

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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