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

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

Completed

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Key information

Conditions

Patient Satisfaction Behavior Bloating Deglutition Disorders Digestive System Diseases Disease Attributes Dysphagia Esophageal Diseases Gastrointestinal Diseases Health Behavior Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Recurrence Relapse Treatment Adherence and Compliance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ersta Hospital

Stockholm, Region Stockholm, 116 91, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion criteria

Deceased patients patients who declined participation

Treatment and study plan

10 years follow up

Other

Questionnaires

Primary outcomes

SF-36 Quality of life

Time frame: 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.
Gastrointestinal Symptom Rating Scale (GSRS)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 2, 2019
Registry last updated: Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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