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

NCT ID: NCT04182178

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patient Satisfaction Relapse Dysphagia Bloating

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gastroesophageal reflux

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

10 years follow up

Intervention Type OTHER

Questionnaires

Interventions

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10 years follow up

Questionnaires

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria

Deceased patients patients who declined participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anders Thorell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Thorell, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Ersta Hospital

Stockholm, Region Stockholm, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 35442430 (View on PubMed)

Other Identifiers

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2019-03655

Identifier Type: -

Identifier Source: org_study_id

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