Short summary

Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of gastro-esophageal reflux disease (GERD).  Although laparoscopic anti-reflux have a high rate of success, reoperation can be necessary. The aim of this study to explore the course of illness leading to reoperation following primary anti-reflux surgery and evaluating outcome using 20 years of data from a population-based nationwide cohort. Secondly, using the data from this study, trends in utilization of anti-reflux surgery including annual operative rate (using census data), type of anti-reflux surgery and rate of reoperative surgery will be examined and compared to population-based use of anti-secretory drugs. 

Rationale

Gastroesophageal reflux disease (GERD) is episodic reflux of gastric contests to the esophagus accompanied by bothersome symptoms, typically heartburn, regurgitation or retrosternal pain and is a complex and multifaceted disease, affecting 10-20% of the Western population. Worldwide, the prevalence of GERD has been increasing.

Treatment of GERD consists of anti-secretory drugs, mainly proton pump inhibitors (PPI), 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.

Although laparoscopic anti-reflux have a high rate of success, reoperation can be necessary. The indication for reoperation is most often recurrence of GERD-symptom or postoperative dysphagia and reoperation should be preceded by thorough workup and possibly endoscopic dilation of the fundic wrap (62). Laparoscopic reoperation is both technically feasible and safe, but has been reported to be associated with higher morbidity, higher risk of conversion to open surgery and longer duration of stay. Outcomes do seem to be less satisfactory compared to primary surgery, but evidence is limited by a significant risk of bias, as failed cases may be frequently underreported (20, 63).

An American study reported cumulative 5 and 10 year incidences of reoperation were 5,2% and 6,9% respectively. Reoperation rate was highest within the first year of primary surgery. Interestingly, 30% of reoperations were performed at another facility than the primary anti-reflux operation. Funch-Jensen et al examined reoperation rates in Denmark between 1997-2005 and found a total reoperation rate of 5% with no significant difference in length of stay, complications or mortality. However, reoperation had a significantly higher risk of being converted to or performed as open surgery, compared to primary surgery, with a trend of lower volume centers more often resorting to open surgery. In the Danish study, a large number of reoperations were also performed at another facility than primary surgery however, it is unknown whether this is due to patient preference or centralization in the Danish healthcare system.

Our hypothesis is, that reoperation is possible to perform as laparoscopic surgery and does not result in a significantly higher frequency of complications or longer duration of hospital stay compared to primary surgery. There has been an increase in skill and therefore decrease in morbidity associated with reoperation. Upper endoscopy with intervention delays reoperation, but does not prevent it.

The aim of this study to explore the course of illness leading to reoperation following primary anti-reflux surgery and evaluating outcome using 20 years of data from a population-based nationwide cohort. Secondly, using the data from this study, trends in utilization of anti-reflux surgery including annual operative rate (using census data), type of anti-reflux surgery and rate of reoperative surgery will be examined and compared to population-based use of anti-secretory drugs. 

Description of the cohort

Patient selection will be done through the Danish National Patient Register. Included will be the period 1996-2016.  All adult Danish patients undergoing anti-reflux surgery will be identified (Nomesco: KJBC00-02). First surgical procedure registered will be considered index-contact and to be included, should be followed by any other anti-reflux procedure or any operation for para-esophageal or hiatal hernia (Nomesco: KJBC00-02, KJBB00-01, KJBB96-97), thereby including any patient having undergone redo-surgery. 

Data and biological material

Age, sex, length of stay associated with the each anti-reflux surgery and mortality within 30 days or admission will be recorded, using the National Patient Register and National Civic Registry.  Any upper endoscopy with (KJCA05-55) or without intervention (KUJD02-05) following primary anti-reflux surgery will be registered. Any hospitalization within 30 days following anti-reflux surgery will be considered a complication to surgery and registered as 30-day morbidity. 

Data on patient comorbidity and whether surgery was planned or emergency surgery will be recorded for each included anti-reflux procedure will be included from The Danish Anesthesia Database. 

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, Department of Clinical Research, University of Southern Denmark

• Associate professor Katrine Hass Rubin, PhD, MHS

Department of Surgery, Odense University Hospital

• Jesper Durup, MD, PhD