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

February 3, 2021 updated by: Anders Thorell, Karolinska Institutet

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Region Stockholm
      • Stockholm, Region Stockholm, Sweden, 116 91
        • Ersta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gastroesophageal Reflux Disease

Description

Inclusion Criteria:

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria:

Deceased patients patients who declined participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastroesophageal reflux
Laparoscopic total (Nissen) or posterior 270 degree (Toupét) partial fundoplication for the treatment of gastroesophageal reflux disease.
Other: 10 years follow up
Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years
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
10 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 5, 2019

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (ACTUAL)

December 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-03655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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