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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT04182178

Collaborator

(none)

307

Enrollment

Location

5.9

Actual Duration (Months)

52.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction Relapse Dysphagia Bloating	Other: 10 years follow up

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 Design

Study Type:

Observational

Actual Enrollment :

307 participants

Observational Model:

Other

Time Perspective:

Retrospective

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

Actual Study Start Date :

Aug 5, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria:

Deceased patients patients who declined participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ersta Hospital	Stockholm	Region Stockholm	Sweden	116 91

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: Anders Thorell, professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Thorell, Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT04182178

Other Study ID Numbers:

2019-03655

First Posted:

Dec 2, 2019

Last Update Posted:

Feb 4, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Recurrence

Study Results

No Results Posted as of Feb 4, 2021