Surgery Clinical Trial
Official title:
Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery
NCT number | NCT03959020 |
Other study ID # | JSJ_OP401 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | October 1, 2020 |
Verified date | November 2020 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 520 |
Est. completion date | October 1, 2020 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Having undergone any anti-reflux surgery at Department of Surgery, Kolding Hospital, a part of Hospital Lillebaelt, Denmark from January 1, 2002 to December 31, 2013 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Surgery, Kolding Hospital | Kolding |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Odense Patient Data Explorative Network, Sygehus Lillebaelt |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment failure | Failure of anti-reflux surgery defined as
Having undergone reoperation (NSCP: KJBC00-02, KJBW96-98, KJBB00-01, KJBB96-97) between index date and end of follow-up. Having filled prescription of >60 DDD/year of PPI in any year between index date and end of follow-up. Having no measure >3 on GERD-HRQL indicating symptoms being bothersome every day. Having no measure >4 on Dysphagia Handicap index indicating symptoms being a moderate problem. |
From surgery to 1th January 2019 (Up to 17 years) |
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