Short summary

Gastro-esophageal reflux disease (GERD) affects 10-20% of the Western population and reduces quality of life significantly. Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of GERD and with careful patient selection based on thorough preoperative workup; symptom control and patient satisfaction are high compared to medical therapy. Despite a tailored approach, laparoscopic anti-reflux surgery is not without risks of adverse effects and there are no uniform guidelines for patient-selection as most long-term follow-up studies are small and have suboptimal design. The purpose of this study is to use registry-based data and long-term quality of life follow up after anti-reflux surgery to quantify efficacy of treatment and to propose a clinically applicable tool to improve patient selection for surgery.

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Rationale

Episodic reflux of gastric contests to the esophagus is physiological but is considered gastroesophageal reflux disease (GERD) when accompanied by bothersome symptoms, typically heartburn, regurgitation or retrosternal pain. Extra-esophageal symptoms such as asthma, laryngitis and chronic cough may also occur. GERD is a complex and multifaceted disease.

GERD affects 10-20% of the Western population and has been shown to significantly reduce the quality of life. Worldwide, the prevalence of GERD has been increasing. Treatment of GERD consists of anti-secretory drugs, mainly proton pump inhibitors, or anti-reflux surgery. Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of gastro-esophageal reflux disease and with careful patient selection based on thorough preoperative workup; symptom control and patient satisfaction are high compared to medical therapy. Despite a tailored approach, laparoscopic anti-reflux surgery 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. Furthermore non-surgical factors such as pre-existing anxiety or depression disorders can influence postoperative satisfaction and symptom relief when compared to patients without concomitant psychological disorders.  

Although few studies conclude that medical and surgical treatment of GERD have similar effectiveness, disease-specific quality of life generally improves after anti-reflux surgery and patient satisfaction is high. Depending on surgical procedure, the postoperative quality of life, ranges from significantly increased compared to preoperative measurements, to "normal" values as found in subjects devoid of GERD. 73-98% are satisfied with their condition after surgery and would choose surgery again. There is however no uniform guideline for patient-selection and most long-term follow-up studies are small and has suboptimal design.

The purpose of this study is to use registry-based data and long-term quality of life follow up after anti-reflux surgery to quantify efficacy of treatment and to propose a clinically applicable tool to improve patient selection for surgery. 

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Description of the cohort

Included in the study will be all patients in the period 2002-2013 that had anti-reflux surgery at Department of Surgery, Kolding Hospital. Primary indication for surgery must be GERD (Nomesco: KJBC00-02). 

Data and biological material

Preoperative data including demographic data, symptoms, results of endoscopy, 24-hour pH-measurement and esophageal manometry are collected from patient records as well as peri- and postoperative data.

All patients are contacted and asked to fill out questionnaires regarding their quality of life, use of anti-secretory drugs and possible dysphagia.

Reoperation, use of anti-secretory drugs, comorbidity and socioeconomic data are extracted from national registries. 

Collaborating researchers and departments

Department of Surgery, Kolding Hospital

• PhD-student Jonas Sanberg Jensen, MD

Department of Vascular Surgery, Kolding Hospital

• Professor Kim Christian Houlind, MD, PhD

OPEN Odense Patient data Explorative Network, Odense University Hospital

• Associate professor Katrine Hass Rubin, PhD, MHS

Department of Surgery, Odense University Hospital

• Jesper Durup, MD, PhD