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Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery

NCT03959020 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 520

Last updated 2020-11-03

No results posted yet for this study

Summary

Introduction Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, most notably disruption of the fundoplication, post-fundoplication dysphagia and gas-bloat-syndrome, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression disorders can influence postoperative satisfaction and symptom relief. Previous studies have focused on short-term follow-up or only certain aspects of disease, resulting in a less than complete picture.

The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using comprehensive multimodal follow-up, and using the results of follow-up, to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.

Methods and analysis The study is a retrospective cohort study utilizing data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease specific quality-of-life and dysphagia will be identified from patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.

Ethics and dissemination For the study approval will be sought from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU current legislation. Inclusion in the study will require informed consent from participating subjects.

Conditions

  • GERD
  • Reflux, Gastroesophageal
  • Surgery

Interventions

PROCEDURE

Anti-reflux surgery

Anti-reflux surgery for verified GERD

Sponsors & Collaborators

  • Sygehus Lillebaelt

    collaborator OTHER

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-05-01
Completion
2020-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959020 on ClinicalTrials.gov