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NCT03959020
Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery
trial testing Anti-reflux surgery in GERD in 520 participants. Completed in 1 October 2020.
1 May 2019
Quick facts
| Lead sponsor | University of Southern Denmark |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 520 |
| Start date | 1 March 2018 |
| Primary completion | 1 May 2019 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Anti-reflux surgery
Conditions studied
- GERD — all drugs for GERD →
- Reflux, Gastroesophageal — all drugs for Reflux, Gastroesophageal →
- Surgery — all drugs for Surgery →
Sponsor
University of Southern Denmark
Who can join
18 and older, any sex, with GERD or Reflux, Gastroesophageal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection.
Sanberg Ljungdalh J, Rubin KH, Durup J, Houlind KC. · · 2020 · cited 1× · PMID 32184312 · DOI 10.1136/bmjopen-2019-034257
Verify or expand the search:
- PubMed search for NCT03959020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03959020 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern Denmark
- Last refreshed: 3 November 2020
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