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

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ClinicalTrials.gov Identifier: NCT03959020
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Sygehus Lillebaelt
Odense Patient Data Explorative Network
Information provided by (Responsible Party):
Jonas Sanberg Jensen, University of Southern Denmark

Brief 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.


Condition or disease Intervention/treatment
GERD Reflux, Gastroesophageal Surgery Procedure: Anti-reflux surgery

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: From surgery to 1th January 2019 (Up to 17 years) ]

    Failure of anti-reflux surgery defined as

    1. Having undergone reoperation (NSCP: KJBC00-02, KJBW96-98, KJBB00-01, KJBB96-97) between index date and end of follow-up.
    2. Having filled prescription of >60 DDD/year of PPI in any year between index date and end of follow-up.
    3. Having no measure >3 on GERD-HRQL indicating symptoms being bothersome every day.
    4. Having no measure >4 on Dysphagia Handicap index indicating symptoms being a moderate problem.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of all adult patients (age +18) having undergone laparoscopic anti-reflux surgery (Nomesco Classification of Surgical Procedures (NCSP): KJBC01) from January 1, 2002 to December 31, 2013 in The Department of Surgery, Kolding Hospital, a part of Hospital Lillebaelt Denmark (n=557). Patients will be identified through Lillebaelt Hospital's Patient Administrative System. Day of surgery will be considered index date.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Surgery, Kolding Hospital
Kolding, Denmark
Sponsors and Collaborators
University of Southern Denmark
Sygehus Lillebaelt
Odense Patient Data Explorative Network
  Study Documents (Full-Text)

Documents provided by Jonas Sanberg Jensen, University of Southern Denmark:

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Responsible Party: Jonas Sanberg Jensen, Ph.d.-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03959020     History of Changes
Other Study ID Numbers: JSJ_OP401
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases