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

NCT03959020 | Completed

• 1 other identifier: JSJ_OP401
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD; Reflux, Gastroesophageal; Surgery

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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.

  From surgery to 1th January 2019 (Up to 17 years)

Study Arms (1)

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

Interventions

Anti-reflux surgery PROCEDURE

Anti-reflux surgery for verified GERD

Patients, undergoing anti-reflux surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Southern Denmark: lead
• Sygehus Lillebaelt: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Department of Surgery, Kolding Hospital

Kolding, Denmark

Location

Related Publications (1)

• Sanberg Ljungdalh J, Rubin KH, Durup J, Houlind KC. 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. BMJ Open. 2020 Mar 16;10(3):e034257. doi: 10.1136/bmjopen-2019-034257.

  PMID: 32184312 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d.-student

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: March 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: October 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)