Abstract
Objective
Evaluating giant paraesophageal hernia (GPEH) repair requires long-term follow-up. GPEH repair can have associated high recurrence rates, yet this incidence depends on how recurrence is defined. Our objective was to prospectively evaluate patients undergoing GPEH repair with one-year follow-up.
Methods
Patients undergoing elective GPEH repair between 2011 and 2014 were prospectively enrolled. Postoperatively, patients were evaluated at one-month and one-year. Radiographic recurrence was evaluated by barium swallow and defined as a gastroesophageal junction located above the hiatus. Quality of life was evaluated pre- and post-operatively using a validated questionnaire.
Results
One-hundred six patients were enrolled. The majority of GPEH repairs were performed laparoscopically (80.2%) and 7.5% were redo repairs. At one-year follow-up, 63.4% of patients were symptom free and radiographic recurrence was 32.7%. Recurrence rate was 18.8% with standard definition (> 2cm of stomach above the diaphragm). Quality of life scores at one year were significantly better following operative repair, even in patients with radiographic recurrence (7.0 vs. 22.5 all patients, 13.0 vs 22.5 with recurrence (P<0.001). Patients with small radiographic recurrences have similar satisfaction and symptom severity to patients with > 2 cm recurrences.
Conclusions
GPEH repair can be performed with low operative mortality and morbidity. The rate of recurrence at one year depends on the definition used. Patient satisfaction and symptom severity are similar between patients with radiographic and >2cm hernia recurrences. Longer follow-up and critical assessment of our results are needed to understand the true impact of this procedure and better inform perioperative decision making.
Graphical abstract
Central Message: Small paraesophageal hernia recurrences at one-year follow-up have similar satisfaction and symptom scores as those with larger recurrences.
Central Picture:
Barium swallow study of a giant paraesophageal hernia.
Introduction
Paraesophageal hernias (PEH) are an uncommon finding that can adversely affect patient well-being. Approximately 5% of all hiatal hernias are considered to be a PEH, defined as the herniation of the fundus of the stomach through the esophageal hiatus in the diaphragm into a true hernia sac. Giant paraesophageal hernias (GPEH) are a paraesophageal hernia with greater than 30% of the stomach above the diaphragm. A GPEH constitutes a clinical challenge that requires advanced operative techniques to ensure consistent and lasting results. Over time, the safety and reliability of GPEH repair has improved, with laparoscopic results frequently reported in the literature (1-3). However, even with the best operative technique, hernia recurrence rates remain high, ranging from 15% to 66% in reported studies (1-4). In addition, questions remain regarding the most appropriate operative techniques to minimize hernia recurrence and to identify which patient population will benefit the most from techniques such as gastroplasty or mesh crural reinforcement (5-7).
Several prominent institutions have performed retrospective reviews of their experience treating GPEH (3, 8-11). However, few studies have examined the results of GPEH repair in a prospective manner with routine imaging post-operatively. The prospective data with routine post-operative barium swallow studies that do exist is hindered by small study populations or low patient participation at long-term follow-up (12, 13). Therefore, the objective of this trial was to prospectively evaluate all patients undergoing elective repair of GPEH, and to evaluate these patients for recurrence and measures of quality of life. We also wanted to determine the frequency of small radiographic recurrences, less than 2cm in size, which are frequently not reported in the literature.
Materials and Methods
Patient Selection
This prospective cohort study was approved by the University of Virginia Institutional Review Board (IRB #15872). All patients undergoing elective GPEH repair via any approach (laparoscopic, open laparotomy, or open thoracotomy) during the time period of November 2011 to December 2014 were identified pre-operatively. These individuals were prospectively enrolled in this study; exclusion criteria included any subject that underwent esophageal surgery for a malignant disease process, any subject unwilling to provide informed consent, or any individual who was unwilling to undergo the required follow-up barium swallow studies and questionnaires. For this analysis, only those patients identified with a GPEH were included in the analysis. GPEH was defined as gastric herniation of 30% or more through the diaphragmatic hiatus on pre-operative imaging (14).
Patient Demographics and GPEH Characterization
Pre-operative characteristics, medical co-morbidities, and clinical information regarding GPEH characteristics were all recorded prospectively by trained research personnel and recorded into a secure surgical outcomes database.
Surgical Technique
All operations were performed by four surgeons at a single institution. Our preferred operative approach was laparoscopic. Left thoracotomy (Belsey Mark IV (11)) or laparotomy were used for a majority of the redo hernia repairs or for patients with significant other intraabdominal surgery. Regardless of operative approach, we emphasized meticulous preservation of crural integrity, complete hernia sac excision, and routine gastroesophageal fat-pad dissection. If there was not 3 cm of tension free, intraabdominal esophagus, we performed a Collis gastroplasty (via left thoracotomy) or a totally intraabdominal Collis wedge gastroplasty (laparoscopy or laparotomy) to augment esophageal length (15). Use of a Nissen or partial fundoplication was based upon esophageal motility results and surgeon discretion. In our laparoscopic patients, we placed gastropexy sutures from the posterior left and right portions of the fundoplication to the right and left crus, respectively. No patient received mesh buttressing of the crura in this series.
Post-operatively, patients were typically started on a clear liquid diet and advanced quickly to a full liquid diet for two weeks postoperatively; a registered dietitian assisted with teaching in all patients prior to discharge.
Evaluation of Quality of Life and Satisfaction
All patients received a previously validated, gastroesophageal reflux disease quality of life questionnaire (GERD-HRQL) pre-operatively, and at post-operative time points of one month and one year (16). The questionnaire consists of 10 questions with a maximum score of 50 (6 questions related to GERD, 2 questions related to swallowing, 1 question related to bloating, and one for medication use). A higher score indicates a worse symptom severity. Patient satisfaction with their current condition was determined at each time point. These questionnaires were administered by trained personnel during scheduled clinic visits.
Patients routinely had a barium swallow postoperatively prior to discharge but did not undergo a barium swallow study at the one month time point unless indicated by symptoms. At one year all patients received a barium swallow study to ascertain the presence of a recurrence, regardless of symptoms. We defined recurrence in two ways in order to evaluate our results critically and be consistent with the majority of published series. Because the majority of prominent literature published on the repair of GPEH defines a recurrence as over 2 cm or 10% of the stomach above the diaphragm, this is defined as a “conventionally defined recurrence” (3, 12, 17). A “radiographic recurrence” is defined as any stomach present above the diaphragm that is less than 2 cm in size. To ensure consistency and objectivity, this was determined by a single radiologist blinded to the rest of the clinical data (D.L.).
Statistical Analyses
Data were described using counts and percentages for categorical data, and medians with interquartile ranges for continuous data. Changes in continuos variables for the entire cohort were compared using the Wilcoxon signed rank test, while differences in symptoms, stratified by hernia recurrence were compared using the Kruskal-Wallis test with change from baseline to 12 months as the outcome. All statistical analyses were performed using the statistical software R version 3.2.4.
Results
Patient Demographics and GPEH Characterization
Patient demographics and GPEH characterization are shown in Table 1. We enrolled 106 patients. Only one patient declined inclusion into the study and one prisoner was excluded. Median age of participants was 68 years. Pre-operative mean Body Mass Index (BMI) was 29.4; 45 patients (42.5%) were characterized as obese (BMI ≥ 30). The majority of patients (69%) had major medical comorbidities. Fifty-two patients (49.1%) had undergone a previous abdominal operation, and 8 patients (7.5%) underwent a re-operative GPEH repair.
Table 1. Demographics and Pre-Operative Presentation.
| Demographics | ||
|
| ||
| n=106 | % | |
| Female Sex | 79 | 74.5 |
| Median age (years) | 68 (IQR 59 - 74) | |
| Body Mass Index | ||
|
| ||
| Pre-operative BMI | n=106 | % |
| Underweight (BMI < 18.5) | 0 | 0 |
| Ideal weight (BMI 18.5 up to 25) | 20 | 18.9 |
| Overweight (BMI 25 up to 30) | 41 | 38.7 |
| Obese (BMI 30 up to 35) | 30 | 28.3 |
| Super Obese (BMI > 35) | 15 | 14.2 |
| Mean BMI (± SD) | 29.4 ± 4.8 | |
| Comorbidities | ||
|
| ||
| n=106 | % | |
| Major comorbid disease present | 69 | 65.1 |
| Comorbidity type | n = | |
| Hypertension | 52 | |
| Respiratory disease | 16 | |
| Coronary artery disease | 13 | |
| Cerebrovascular accident | 6 | |
| Renal insufficiency | 6 | |
| Congestive heart failure | 3 | |
| Peripheral vascular disease | 1 | |
| n=106 | % | |
| Prior abdominal operation | 52 | 49.1 |
| Re-do paraesophageal hernia repair | 8 | 7.5 |
| Hernia Characteristics | ||
|
| ||
| Paraesophageal Hernia Type | n=106 | % |
| Type II | 6 | 5.7 |
| Type III | 86 | 81.1 |
| Type IV | 14 | 13.2 |
| Percent of Stomach Herniated | ||
| 30 - 49% | 20 | 19.2 |
| 50 - 74% | 38 | 36.5 |
| 75 - 99% | 21 | 20.2 |
| 100% | 18 | 17.3 |
| Mean % stomach in chest (± SD) | 61 ± 25.1 | |
Preoperative workup for most patients included barium swallow (78 patients); 54 received computed tomography scans (usually referred with the study already performed), and 26 patients received multiple imaging studies. Type III hernias predominated (n = 86, 81.1%), with 14 patients (13.2%) found to have a Type IV hernia; colon was the most common organ found in these hernias. The GPEH were large, with an average of 60% of the stomach herniated through the diaphragmatic hiatus into the mediastinum. Fifty-nine patients (37.5%) had over 75% of their stomach in their chest.
Operative Approach
The majority of patients (n = 85, or 80.2%) had their operation completed laparoscopically, while only one patient (0.9%) required conversion to an open procedure. Two patients (1.9%) had a planned laparotomy. Eighteen patients (17.0%) were repaired via a thoracic approach with a Belsey Mark IV procedure. The majority of patients who received a thoracotomy had previous upper gastrointestinal surgery. We performed a partial fundoplication in 80.2% of patients (n = 85) and an esophageal lengthening procedure was performed in 66% (n= 70) of patients.
Perioperative Morbidity and Mortality
Postoperative morbidity and mortality results are shown in Table 2. In-hospital or 30-day mortality was zero. One patient died on day 55, after discharge on day 35, and before his follow-up appointment. Four other patients died within one year of operation; two from myocardial infarction, one from aspiration pneumonia, and one from metastatic ovarian cancer (known at the time of surgery but treated due to severe symptomatic gastric volvulus).
Table 2. Post-Operative Results.
| Mortality: | ||
|
| ||
| n=106 | % | |
| In-hospital 30-day mortality | 0 | 0 |
| Mortality after one month | 1 | 0.9 |
| Mortality after one year | 5 | 4.7 |
| Complications: | ||
|
| ||
| n=106 | % | |
| No Complication | 78 | 73.6 |
| Minor | 25 | 23.5 |
| Arrhythmia (11), transient hypoxia (3), Delirium (2), UTI (2), dysphagia (2), Pleural effusion (2), Pneumothorax (1), DVT (1), Gastroparesis (1) | ||
| Major | 6 | 5.6 |
| Re-operation (4), Stroke (1), Post-operative leak (1) | ||
The majority of patients, 73.6% (n = 78), had no immediate post-operative complication. Minor in hospital complications occurred in 20.8% (n = 22); atrial fibrillation accounted for half of these. Major complications were rare as well: 4 patients required re-operation (2 for immediate recurrence of the hernia, one for feeding tube placement for malnourishment and gastroparesis, and one for a retained wedge fundectomy). One patient had a small staple line leak that was managed non-operatively with an interventional drain and one patient suffered a stroke.
Post-Operative Follow-Up
Patients were seen at one month and at one year following their surgery. The median time to one-year follow-up was 397 days (IQR 380 – 437). At one month, patients were evaluated for symptoms, and if indicated, an additional barium swallow was performed to evaluate for recurrence (Table 3). The one-month follow-up was conducted on the 105 (of 106) surviving participants. Of these, only 5 patients stated their symptoms had recurred (4.8%). Two had received a barium swallow that indicated a recurrence; both of these were small recurrences with less than 2 cm of stomach above the diaphragm. 4 patients (3.8%) required endoscopic re-intervention (3 esophageal dilations, 1 stent placement) at one month.
Table 3. Post-Operative Follow Up.
| 1 mo. | 12 mo. | |||
|---|---|---|---|---|
| n=105 | % | n=101 | % | |
| Symptom recurrence | 5 | 4.8 | 37 | 36.6 |
| Radiographic hernia recurrence | ||||
| (GE junction above diaphragm on barium study) | 2 | 1.9 | 33 | 32.7 |
| Conventionally defined hernia recurrence | ||||
| (> 2 cm of stomach above diaphragm on barium study) | 0 | 0 | 19 | 18.8 |
| Reintervention required | 4 | 3.8 | 12 | 11.9 |
Barium swallow results at one-year follow-up are shown in Table 3. The one year follow-up was conducted on the 101 (of 106) surviving patients. Thirty-seven patients (36.6%) reported symptom recurrence at their follow-up. The radiographic recurrence rate was 32.7% (33 patients), defined as the GE junction or any other portion of the stomach above the diaphragm. We then looked for recurrences as they have traditionally been defined in the pertinent literature, or greater than 2 cm or 10% of the stomach above the diaphragm (“Conventionally defined recurrences”). With this definition, recurrence rate was 18.8% (19 patients). At one year, 12 patients required re-intervention. Most re-interventions were due to stricture: 5 required esophageal dilation, one was treated with endoscopic stent placement at an outside hospital. One patient was treated with botulinum toxin injection of the pylorus for poor gastric emptying. Three patients with symptomatic recurrence underwent reoperation.
Patient Satisfaction and Quality of Life Measures
To gauge how patient's symptoms changed over time, all patients received the previously validated GERD-HRQL questionnaire. Postoperative satisfaction results are shown in Table 4. Every patient was asked about their satisfaction with their condition at all time points. Pre-operatively, only 3 out of 105 patients (2.9%) stated that they were satisfied with their health condition. At one-month follow-up, this number significantly increased to 87 patients (85.3%) (p < 0. 001 vs pre-operative satisfaction). At one year, satisfaction decreased to 71.4%, (p < 0. 001). For those patients without a hernia recurrence at one year, their rate of satisfaction was similar to that reported 1 month following surgery (80%, p < 0.001). When only those patients with a recurrence were examined, satisfaction did not stay at such a high level, but was still higher than pre-operative satisfaction levels. At one month, only two patients had a recurrence, and both of these were small (less than 2 cm) radiographic recurrences. No comparison could be made with this small cohort. At 12-month follow-up, 14 small radiographic recurrences were found on barium swallow. Importantly, 8 of these 14 patients (57.1%) were still satisfied with their condition but this is lower than patients without a small radiographic recurrence (p < 0.001). When large hernia recurrences of greater than 2 cm of stomach over the diaphragm were examined, there was no statistical difference between these and small hernia recurrences. Ten of these 19 patients were still satisfied with their current health status (52.6%). This remained significantly higher than their pre-operative condition (p < 0.001).
Table 4. Patient Satisfaction.
| Pre-Operative | 1 mo. | 12 mo. | ||||
|---|---|---|---|---|---|---|
| Satisfaction: | n = | % | n = | % | n = | % |
| All Patients | 3/106 | 2.8 | 87/102 | 85.3* | 70/98 | 71.4* |
| No Hernia Recurrence | 85/100 | 85.0* | 52/65 | 80.0* | ||
| With Small Radiologic Recurrence (< 2 cm) | 2/2 | 100 | 8/14 | 57.1* | ||
| With Conventional Definition of Recurrence (> 2 cm) | 0/0 | 0 | 10/19 | 52.6* | ||
p < 0.001 vs Pre-Operative Satisfaction
Finally, the GERD-HRQL questionnaire was administered pre-operatively and at the one-month and one-year follow-up visits (Table 5). The median total symptom score in all patients pre-operatively was 22.5 (interquartile range [IQR] 9.3 - 31.0). One month following the operation, the total score had significantly decreased to 3.0 (IQR 1.0 - 8.0; p < 0.001). After one year, this score rose to a median of 7.0 (IQR 2.0 - 16.5), but was still significantly below pre-operative levels (p < 0.001). When those patients who did not have a recurrence were examined at one year, the GERD-HRQL symptom severity score was no different than the one-month severity score with a median value of 3.5 (IQR 2.0 - 11.0), and was significantly different from the pre-operative symptom score (p < 0.001). When the median score of those patients who suffered any recurrence was examined, this was lower than the pre-operative levels (13.0, IQR 8.0 - 27.0), but much higher than those patients with no recurrence. To try and understand the significance of small radiographic recurrences, we then examined if there was a difference in the GERD-HRQL score between the smaller radiographic recurrences less than 2 cm and the larger recurrences that have been reported in the literature. Our data show that the GERDHRQL scores were similar in the small (< 2 cm) recurrences (median 12, IQR 8.5 - 28.0), and the larger (>2 cm) recurrences (median 14, IQR 8.5 - 25.5); both types of recurrences had higher symptom scores when compared to those with no recurrence at 12 months (median 3.5, IQR 2.0 – 11.0).
Table 5. Symptom Severity Score (GERD-HRQL).
| Median | IQR | |
|---|---|---|
| Pre-operative GERD-HRQL Score | 22.5 | (9.3 - 31.0) |
| One-month GERD-HRQL Score (All patients) | 3.0* | (1.0 - 8.0) |
| One-year GERD-HRQL Score | 7.0* | (2.0 - 16.5) |
| Without recurrence | 3.5* | (2.0 - 11.0) |
| With any recurrence | 13.0 | (8.0 - 27.0) |
| Small (≤ 2 cm) recurrence | 12.0 | (8.5 - 28.0) |
| Large (> 2 cm) recurrence | 14.0 | (8.5 - 25.5) |
p < 0.001 vs Pre-Operative Satisfaction
The GERD-HRQL score also can be used to examine what symptoms of GPEH were experienced at each time point. The preoperative and 1 year postoperative results are shown in Table 6. Although the median scores for reflux, swallowing and bloating appear clinically improved at 1 year for the group of patients without recurrence, these improvements were not statistically significant.
Table 6. Details of Symptom Recurrence Following PEH Repair.
| Symptom Timepoint (n) |
Number of Patients (%) | Reflux (6 questions) | Swallowing (2 questions) | Bloating (1 question) |
|---|---|---|---|---|
|
| ||||
| Preoperative Value | 106 (100) | 15.0 (6.3, 21.8) | 3.0 (0.0,5.0) | 3.0 (2.0,4.0) |
|
| ||||
| 1 year no recurrence | 68 (67.3) | 1.0 (0.0, 7.0) | 0.0 (0.0,2.0) | 1.0 (0.0,3.0) |
|
| ||||
| 1 year with recurrence | 33 (32.7) | 11.0 (4.0,17.0) | 1.0 (0.0,4.0) | 2.0 (2.0,3.0) |
| Small (≤ 2 cm) | 14 (13.9) | 10.5 (5.5,16.8) | 0.0 (0.0,2.5) | 2.0 (1.3,3.0) |
| Large (> 2 cm) | 19 (18.8) | 11.0 (3.5,16.5) | 2.0 (0.0,5.0) | 3.0 (2.0,3.0) |
|
| ||||
| p-value | 0.2624 | 0.4899 | 0.2080 | |
Discussion
Several excellent studies have been written describing the long-term outcomes of GPEH repair (3, 8, 9, 11). The current study attempted to examine the impact of radiologic recurrences and the impact of recurrence on symptoms one year following surgery. Aggressive follow-up of these patients was performed to ensure accurate data collection of patient satisfaction and symptom recurrence and severity. This trial showed that the patient population seen at our institution is complex. The majority of patients were in their seventh or eighth decade, were obese, and had major comorbidities that complicated their perioperative care. The majority of patients also had previous abdominal operations, and 7.5% had a previous PEH repair. The hernias repaired in this series were also large, with an average of 61% of the stomach located above the diaphragm. Despite the complexity of these patients, the majority of GPEH repairs were performed laparoscopically (80%). Overall, these operations were done safely with an in-hospital mortality rate of zero and a major complication rate of 8.5%.
Due to the prospective nature of this study, we were able to examine almost all patients (101 patients out of 105) at one year with a barium swallow. Utilizing a strict definition of recurrence (gastroesophageal junction above the diaphragmatic hiatus), the recurrence rate was 32.7% at one year. This is similar to previously reported radiographic recurrence rates such as Hashemi et al with laparoscopic GPEH recurrence rate of 42% (18). However, most of the prominent publications that have examined recurrence rates after GPEH repair have defined a recurrence as greater than 2 cm or 10% of stomach above the hiatus (3, 5, 12, 17). When this definition was utilized in our study, the recurrence rate decreased to 18.8% at 1 year. This is similar with previously published recurrence rates using this common definition. Lidor et al in their series of Type III hernias noted a one-year recurrence rate of 27% with this definition (13). In the largest review of laparoscopic GPEH repair, Luketich et al examined their decade of experience, and noted a recurrence rate of 15.7% at a median of 22 months after repair.
Patient satisfaction with their current condition was much improved following GPEH repair. At one month, the number of patients that were satisfied with their status jumped from 2.9% to 85.3%. There was some drop-off over the next 11 months, with 71.4% of patients satisfied at one year. Importantly, small radiographic recurrences had similar satisfaction levels to patients with larger, >2 cm recurrences (57% vs. 52.6%). This same relationship is seen in the data gathered from the GERD-HRQL questionnaire at 12 months. Patients without recurrence had low total symptom severity scores, while those with any recurrence (small radiologic or greater than 2 cm) had a four-fold increase in the severity of their symptoms.
These data suggest that any recurrence, no matter the size, negatively impacts patient satisfaction and overall upper gastrointestinal symptoms. The reasoning for the traditional definition of recurrence as > 2 cm is a pragmatic one. Oelschlager et al in their 2011 randomized trial of biologic mesh reinforcement in laparoscopic GPEH repair defined recurrence as greater than 2 cm of stomach above the diaphragm because recurrences could be overestimated due to the variability in radiologist interpretation (19). Lidor et al in 2013 determined that a recurrence of over 2 cm was significant based on symptoms. However, the only symptom that significantly differed between a large recurrence and a smaller < 2 cm recurrence was pain with swallowing. Condition satisfaction and overall symptom burden were unchanged when large and small recurrences were compared, a similar finding as in this current prospective study (12). A change in symptoms following GPEH repair would suggest that a recurrence of the hernia, small or large, may have occurred. Re-evaluation with imaging may be needed at that time if symptoms are causing a detriment to routine function.
Study Limitations
While this is a prospective cohort study with complete data, there are some limitations that influence our findings. We were able to capture essentially all consecutive patients that received an elective GPEH repair. However, these results may not apply to urgent or emergent patients that were transferred directly to the hospital without being seen in our outpatient clinic. A second limitation is that although we have excellent one year follow-up, 5 and 10 year follow-up is required to truly define the natural history of these GPEH repairs, and determine factors that can be related to perioperative morbidity and hernia repair durability. Third, due to our sample size of 106 patients, we did not attempt to perform any multivariable regression models to identify predictors of recurrence, patient satisfaction, or symptom severity. A larger, multi-center study would be needed to provide this type of sample size with generalizable results. Our sample size also makes this study underpowered to see any differences between the small recurrence cohort (≤ 2 cm) and the conventionally defined recurrences (> 2cm). Additionally, because an experience at a single institution is described, the results may not be able to be generalizable to all practices.
Conclusions
Using a prospective approach, we examined our experience with GPEH repair with one year follow-up. While the patient population had large, complex paraesophageal hernias, these were able to be repaired safely with reasonable surgical morbidity. Patient satisfaction and quality of life significantly improved postoperatively. Importantly, when small radiographic recurrences were compared to larger, “conventionally defined” recurrences, there were no differences in one-year quality of life or patient satisfaction results. Small recurrences were associated with almost identical symptom severity scores as those seen in larger, more traditionally-defined hernia recurrences. These data suggest that all paraesophageal recurrences, no matter the size, may negatively affect symptoms and overall patient satisfaction after GPEH repair. These small recurrences may be important clinically, yet have been understudied in the literature.
Perspective Statement.
Giant paraesophageal hernias pose a significant challenge to the surgeon, with high recurrence rates. Patients with small recurrences at one-year follow-up have similar satisfaction and symptom scores as those with >2cm recurrences. These smaller recurrences are not widely reported in the literature, and may be under-studied.
Acknowledgments
No source of funding was utilized to support the work contained herein.
Glossary of Abbreviations
- PEH
Paraesophageal Hernia
- GPEH
Giant Paraesophageal Hernia
- BMI
Body Mass Index
- GERD-HRQL
Gastroesophageal Reflux Disease - Health Related Quality of Life
Biographies
Footnotes
No author has any conflict of interest.
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