Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03959020|
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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.
|Condition or disease||Intervention/treatment|
|GERD Reflux, Gastroesophageal Surgery||Procedure: Anti-reflux surgery|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||520 participants|
|Official Title:||Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||August 1, 2020|
Patients, undergoing anti-reflux surgery
Patients having undergone anti-reflux surgery at the Department of Surgery, Kolding Hospital, a part of Hospital Lillebaelt, from 1th January 2002 - 31th December 2013
Procedure: Anti-reflux surgery
Anti-reflux surgery for verified GERD
- Treatment failure [ Time Frame: From surgery to 1th January 2019 (Up to 17 years) ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959020
|Department of Surgery, Kolding Hospital|