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

NCT04182178 | Completed

• 1 other identifier: 2019-03655
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Relapse; Dysphagia; Bloating

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Gastroesophageal reflux

Laparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.

Other: 10 years follow up

Interventions

10 years follow up OTHER

Questionnaires

Gastroesophageal reflux

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroesophageal Reflux Disease

You may qualify if:

• Gastroesophageal Reflux 10 years follow-up after surgery informed consent

You may not qualify if:

• Deceased patients patients who declined participation

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ersta Hospital

Stockholm, Region Stockholm, 116 91, Sweden

Location

Related Publications (1)

• Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805.

  PMID: 35442430 DERIVED

MeSH Terms

Conditions

Patient Satisfaction; Recurrence; Deglutition Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Anders Thorell, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: December 2, 2019
• Study Start: August 5, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)