Key Points
Question
Does an anterior gastropexy reduce 1-year recurrence after minimally invasive paraesophageal hernia repair?
Findings
This randomized clinical trial of 240 patients found that anterior gastropexy reduced 1-year paraesophageal hernia recurrence by 21%.
Meaning
These results suggest that anterior gastropexy during minimally invasive paraesophageal hernia repair is superior to no gastropexy in regard to 1-year recurrence.
This randomized clinical trial investigates whether anterior gastropexy reduces 1-year recurrence after minimally invasive paraesophageal hernia repair among adult patients.
Abstract
Importance
Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair—an anterior gastropexy—may reduce recurrence, but this adjunct is currently not the standard of care.
Objective
To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR.
Design, Setting, and Participants
This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024.
Intervention
Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121).
Main Outcome
The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year.
Results
A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups.
Conclusions and Relevance
This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair.
Trial Registration
ClinicalTrials.gov Identifier: NCT04007952
Introduction
Paraesophageal hernias comprise 5% of hiatal hernias that have progressed until at least a portion of the stomach has herniated into the chest, frequently presenting with severe limitations in quality of life such as dysphagia, regurgitation, or chest pain after meals.1,2 In rare cases, these patients can also present with life-threatening obstruction, ischemia, or perforation. As such, surgical counseling for minimally invasive paraesophageal hernia repair (MIS-PEHR) is typically recommended.3 Even for minimally symptomatic patients, recent longitudinal data have shown that elective MIS-PEHR increases life expectancy in most cases.4
Despite the growing consensus on the safety and effectiveness of MIS-PEHR, anatomic recurrence rates remain notoriously high. A meta-analysis of 7 randomized clinical trials evaluating the effectiveness of mesh reinforcement at the time of MIS-PEHR reported radiographic recurrence rates as high as 59% for patients with at least 1-year follow-up.5 While mesh does not appear to prevent recurrence, other adjuncts such as the addition of a fundoplication or various ways of mechanically fixating the stomach in the peritoneal cavity have not been as rigorously studied. Several retrospective series have suggested that suturing the stomach to the anterior abdominal wall at the end of the repair—an anterior gastropexy—could reduce recurrence rates (Figure 1).6,7 Although an anterior gastropexy is technically simple, quick, and inexpensive, there is no high-level evidence to demonstrate its effectiveness. In this clinical trial, we aimed to test our hypothesis that MIS-PEHR with an anterior gastropexy would reduce 1-year paraesophageal hernia recurrence.
Figure 1. Transfascial Anterior Gastropexy Suture Placement.
Published with permission from the Cleveland Clinic Foundation.
Methods
Design, Eligibility, and Randomization
After obtaining Cleveland Clinic institutional review board (IRB) approval and registering the study on ClinicalTrials.gov (NCT04007952), we performed a registry-based, randomized clinical trial testing the superiority of anterior gastropexy to no gastropexy in MIS-PEHR. This study was conducted and analyzed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline and was performed at 3 academic hospitals within the Cleveland Clinic Foundation (CCF Main Campus, CCF Fairview Hospital, and CCF Hillcrest Hospital). We previously published our trial protocol, which is also available in Supplement 1.8 The protocol was amended after initiation of the trial to clarify that both laparoscopic and robotic approaches constituted minimally invasive MIS-PEHR.
Adult patients with paraesophageal hernias deemed appropriate candidates for MIS-PEHR were screened for inclusion. Inclusion criteria consisted of primary paraesophageal hernias determined to be at least 5 cm in height on preoperative evaluation (computed tomography, upper gastrointestinal single contrast radiographs, or upper endoscopy). Exclusion criteria included recurrent paraesophageal hernias, prior or concomitant gastric operations (eg, gastric sleeve, partial gastrectomy, Collis gastroplasty), emergency repairs, and need for hiatal mesh during the repair.
Patients were enrolled by treating physicians preoperatively. A randomization table was generated by a statistician (C.T.) using a random number of blocks and the concealed randomization scheme housed in our institution’s REDCap software. Allocation occurred intraoperatively (via randomization button on REDCap) by a study coordinator. Patients remained blinded until the conclusion of the study period. Patient-reported outcomes and radiographic assessments for recurrence were performed by blinded clinicians. As an exception, surgeons who decided to reoperate for recurrence were not blinded to the intervention they performed.
Operative Details
All procedures were performed by 10 qualified surgeons (C.C.P., L.R.A.B., D.M.K., D.A., A.S.P., B.T.M., K.B., A.F., J.R., and M.J.R.) with training in minimally invasive and foregut surgery. A laparoscopic or robotic paraesophageal hernia repair was performed in all patients. The technique for crural closure and consideration of fundoplication with crural fixation were left up to the discretion of the surgeon. Standardized operative steps included excision of the hernia sac from the mediastinum, at least 3 cm of intra-abdominal esophageal length after mobilization, and cruroplasties performed with permanent suture. Use of a bougie was allowed but not required. Patients who received mesh for crural closure or a gastric resection (such as a Collis gastroplasty) were excluded as screen failures prior to randomization. At the completion of the operation, inclusion and exclusion criteria were confirmed, and the study coordinator confirmed that the repair was complete before randomization. Patients randomized to anterior gastropexy (intervention) received transfascial fixation of the anterior body of the stomach near the greater curve to the left upper quadrant of the abdominal wall (using a Carter-Thomason suture passer) with 2 2-0 polypropylene sutures.7 At this point, or if the patient was randomized to the no-gastropexy (control) group, the operation was considered complete.
Outcome Measures
In addition to the blinded collection of patient-reported outcomes and blinded radiographic assessments, clinical evaluation was conducted by the operating surgeon at 30 days (±15 days) and 1 year (±6 months), or additionally if complications occurred. Long-term follow-up was attempted in all patients. Patients were deemed lost to follow-up after 6 telephone calls without a response as well as failed attempts to reach patients’ emergency contacts and exhaustive review of our own electronic medical records, along with those we have access to from other hospital systems.
The primary outcome of this study was the superiority of the anterior gastropexy technique compared with no gastropexy with regard to recurrence at 1 year following MIS-PEHR. Recurrence was determined by either reoperation or consensus review of routine 1-year imaging and defined as presence in the stomach greater than 2 cm above the diaphragm, a definition used in previous clinical trials.9 One-year computed tomography (CT) scans or upper gastrointestinal series radiographs were recommended to all participants and were read by 3 enrolling surgeons who were all blinded to the operating surgeon and the interventional group. Consensus of 2 of 3 surgeons was required to determine recurrence or no recurrence. The participants alternatively met the primary end point of the study if they underwent reoperation at any time for recurrence.
Secondary outcomes included the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) assessment, including patient satisfaction and a survey of additional foregut symptoms not captured by the GERD-HRQL, all measured at baseline, 30-day, and 1-year postoperative time points. The GERD-HRQL survey is a validated 11-item instrument to quantify GERD symptom severity, dysphagia, odynophagia, and gas bloat symptoms, as well as patient satisfaction (satisfied, dissatisfied, or neutral with present condition) where higher scores indicate worse quality of life.10 In addition, at each time point, the patients completed a Visual Analog Scale (VAS) to assess the following hernia-related symptoms: regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. This scale recorded symptoms over the prior 7 days by drawing a line on a 10-cm scale with 0 representing “no effect on life” and 10 representing “extreme effect on life.”11
Other perioperative variables of interest included preoperative morbidities, length of stay, readmissions, and reoperations.12,13 Reoperation was left to the clinical discretion of the primary surgeon, taking patient symptoms and radiographic findings into consideration. Assessment of safety and adverse events was performed in conjunction between the operating surgeon, study coordinators, and the IRB. All safety and adverse events were documented and reported in concordance with the IRB guidelines. There was no data safety monitoring board.
Statistical Analysis
Prior to beginning this study, the reported recurrence rates in the literature for paraesophageal hernia repair without gastropexy ranged from 7% to 66% with the majority falling between 13% to 42%.14,15,16,17,18,19 Therefore, we estimated the recurrence rate in the no-gastropexy group to be approximately 24%. With a power of 80%, holding α at .05, and assuming a 20% loss to follow-up rate, we calculated a sample size of 240 to demonstrate a 15% absolute reduction in 1-year paraesophageal hernia recurrence.
All analyses were performed using the intention-to-treat (ITT) population and were done under the normality assumption. Patient characteristics were summarized overall and by randomized group, and differences were described as standardized effects. All tests were 2-sided and considered significant at a 5% level. All statistical analyses were performed with SAS software version 9.4 (SAS Institute) or R software version 4.0.0 (R Project for Statistical Computing).
Differences between the 2 groups were tested and described using a binomial regression model with identity link and robust variance estimation. Prespecified covariates included fundoplication vs no fundoplication, type IV (including an additional visceral organ herniated into the chest) vs II/III hiatal hernia, body mass index (BMI [calculated as weight in kilograms divided by height in meters squared]), patient gender, and surgeon, with the surgeons modeled as a cluster effect. Primary analyses were performed on the ITT sample population, assuming patients without follow-up did not recur. The per-protocol (PP) sample population used for binomial regression and the Kaplan-Meier plot included patients with documented follow-up. To account for patients lost to follow-up, a sensitivity analysis was also performed to explore the validity of our results. We used the tipping point analysis method, which shows all possible results if each loss to follow-up patient turns out to be recurrence positive to determine how our primary analysis would potentially be altered.
Secondary outcomes were analyzed by generalized linear mixed-effect models to compare categorical outcomes, and linear mixed-effect models were used to compare numeric continuous score outcomes. In these models, groups were analyzed using fixed-effect parameters and surgeons were analyzed using random-effect parameters.
Results
Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility and 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR (Figure 2). All eligible participants completed follow-up by February 28, 2024. Treatment groups were well matched with respect to baseline demographics and symptoms attributed to their paraesophageal hernia. There were also no significant differences in operative characteristics between the 2 groups, particularly in regard to hernia size, operative approach (laparoscopic vs robotic), division of the short gastric vessels, or use of a fundoplication (Table 1).
Figure 2. Flow Diagram of Participants.
AVM indicates arteriovenous malformation.
Table 1. Patient Baseline and Operative Characteristics.
| Characteristics | Patients, No. (%) | P value | |
|---|---|---|---|
| Gastropexy (n = 119) | No gastropexy (n = 121) | ||
| Gender | |||
| Women | 104 (87) | 97 (80) | NA |
| Men | 24 (20) | 15 (13) | NA |
| Age, median (IQR), y | 70 (64-75) | 68 (62-73) | NA |
| BMI, median (IQR) | 28.9 (26.1-32.4) | 29.2 (26.7-32) | NA |
| Reflux | 80 (67) | 77 (64) | NA |
| Dysphagia | |||
| None | 83 (70) | 83 (69) | NA |
| Solids | 1 (0.8) | 0 | NA |
| Liquids | 20 (17) | 15 (12) | NA |
| Both | 15 (13) | 23 (19) | NA |
| Odynophagia | 4 (3.4) | 7 (5.8) | NA |
| Regurgitation | 37 (31) | 31 (26) | NA |
| Obstruction | 17 (14) | 18 (15) | NA |
| Respiratory symptoms | 23 (19) | 31 (26) | NA |
| Chest pain after meals | 59 (50) | 62 (51) | NA |
| Early satiety | 30 (25) | 28 (23) | NA |
| Anemia | 9 (7.6) | 7 (5.8) | NA |
| Barrett esophagus | 9 (7.6) | 8 (6.6) | NA |
| Esophageal stricture | 3 (2.5) | 1 (0.8) | |
| Operative details | |||
| Approach | |||
| Laparoscopic | 110 (92) | 114 (94) | .77 |
| Robotic | 9 (8) | 7 (6) | |
| ASA class | |||
| 2 | 24 (20.2) | 23 (19) | .51 |
| 3 | 91 (76.5) | 90 (74.4) | |
| 4 | 4 (3.4) | 8 (6.6) | |
| Hernia type (intraoperative assessment) | |||
| I | 2 (2) | 0 | .24 |
| II | 1 (1) | 4 (3) | |
| III | 98 (82) | 103 (85) | |
| IV | 18 (15) | 14 (12) | |
| Short gastrics divided | 55 (46) | 49 (40) | .45 |
| Intraoperative complications | 3 (3) | 0 | .50 |
| Gastric injury | 1 | 0 | |
| Liver | 1 | 0 | |
| Bowel injury | 1 | 0 | |
| Fundoplication | 27 (23) | 28 (23) | >.99 |
| Fundoplication type | |||
| Dor | 0 | 1 | NA |
| Nissen | 10 | 10 | NA |
| Toupet | 17 | 17 | NA |
| Conversion to open | 0 | 0 | >.99 |
| Operative time, median (IQR) | 140 (116.5-176.5) | 134 (105-166) | .10 |
| EBL, median (IQR) | 10 (10-20) | 10 (10-20) | .99 |
| Length of stay, median (IQR) | 2 (2-4) | 2 (2-3) | .55 |
| Readmissions | 4 (3) | 7 (6) | .56 |
Abbreviations: ASA, American Society of Anesthesiologists; EBL, estimated blood loss.
At 1 year, 188 of 240 (78%) completed follow up by means of reoperation or radiographic assessment: 80% (94 of 119) in the gastropexy group and 78% (94 of 121) in the no-gastropexy group. Of the patients that followed up within 1 year, 3 (2.5%) in the gastropexy group and 10 (8.2%) in the no-gastropexy group met the primary end point by means of reoperation for recurrence (P = .052). Of these reoperations, 1 (0.8%) in the gastropexy group and 5 (4.1%) in the no-gastropexy group occurred within the first 30 days after surgery. The remaining patients (175 of 188) were evaluated by means of radiographic imaging and blinded consensus determined an additional 15 (13%) in the gastropexy group and 34 (28%) in the no-gastropexy group had developed a radiographic recurrence greater than 2 cm by 1 year (P = .005). By intention-to-treat analysis of our primary end point, total 1-year paraesophageal hernia recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]; P < .001), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). A Kaplan-Meier plot demonstrates recurrence-free survival in Figure 3.
Figure 3. Kaplan-Meier Plot for Paraoesophageal Hernia Recurrence.
Table 2 summarizes recurrence risk for ITT analysis. Unadjusted and adjusted estimates are provided including our prespecified covariates. BMI, use of a fundoplication, and hernia size (type IV vs II/III), were neither associated with reduced risk or harmfully associated with recurrence, although male gender was associated with reduced risk of recurrence. Per-protocol analysis results are consistent (eTable 1 in Supplement 2).
Table 2. Recurrence Risk and Prespecified Risk Adjustment.
| Variable | Intention-to-treat |
|---|---|
| Raw risk difference (95% CI) | −0.21 (−0.33 to −0.09) |
| Raw risk ratio (95% CI) | 0.42 (0.22 to 0.67) |
| No. needed to treat | −4.7 |
| Adjusted risk difference (95% CI) | −0.23 (−0.32 to −0.13) |
| Adjusted RR (95% CI) | 0.394 (0.22 to 0.58) |
| No. needed to treat | −4.4 |
| Prespecified covariates, OR (95% CI)a | |
| Gastropexy | 0.27 (0.15 to 0.47) |
| Gender (male) | 0.30 (0.14 to 0.63) |
| BMI | 0.99 (0.93 to 1.1) |
| Fundoplication | 0.70 (0.41 to 1.20) |
| Type IV (vs III) | 1.29 (0.62 to 2.70) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); OR, odds ratio; RR, risk ratio.
Surgeon modeled as cluster effect; intention-to-treat assumes all patients without follow-up are recurrence free.
There were 52 patients lost to follow-up, 25 in the anterior gastropexy group and 27 in the no-gastropexy group. The tipping point analysis (eFigure 1 in Supplement 2) found that 11 of 25 anterior gastropexy patients (44%) lost to follow up would need to have recurrences to overturn the superiority result.
Patients were assessed for foregut-associated quality of life by the GERD-HQRL and additional foregut symptom questionnaires. There were no differences at baseline, 1 month, and 1 year (eFigure 2 in Supplement 2) between patients with and without a gastropexy. Likewise, patient satisfaction was not different at 30 days and 1 year, with 9% (8 of 85) and 11% (10 of 91) of anterior gastropexy and no-gastropexy patients reporting dissatisfaction with their repair 1-year later, respectively (P = .38; eTable 2 in Supplement 2).
There were 3 intraoperative complications during index procedures, all of which occurred in the gastropexy group but unrelated to gastropexy placement. None required a conversion to open surgery or additional procedures.
There were also 3 additional reoperations related to the index operation but not for recurrence. One patient in the no-gastropexy group underwent a reoperation for postoperative dysphagia without a recurrence requiring removal of a crural stitch. Two reoperations were required for removal of the anterior gastropexy sutures for pain.
Discussion
This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR reduced 1-year recurrence by 21%. The technical adjunct is safe, technically simple, quick, and inexpensive.
The clinical importance of the primary outcome—1-year paraesophageal hernia recurrence—warrants discussion. While the most clinically important recurrences required reoperation, these only represented 21% of the documented recurrences, and the difference between treatment groups regarding reoperation alone did not reach statistical significance. The vast majority of the overall recurrence rates were determined radiographically using the definition used by Oelschlager et al,9 which is a reherniation of the stomach greater than 2 cm above the diaphragm. As suggested by the relatively similar quality of life, additional symptom scores, and patient satisfaction outcomes, many of these radiographic recurrences are not clinically significant enough to warrant reoperation in the first year. These findings are consistent with the largest retrospective series of 662 MIS-PEHR by Luketich et al,14 who also found that recurrences often did not correlate with quality-of-life symptoms, and their reoperation rate for symptomatic recurrences of 3.2% is similar to ours (2.5% for anterior gastropexy and 8.2% for no anterior gastropexy). Given the discrepancy of our radiographic and quality-of-life outcomes, it seems likely that the used definition of radiographic recurrence is overly sensitive. As such, future work will include a post hoc assessment of our radiographic and quality-of-life findings to perhaps redefine recurrence in a way that is more clinically meaningful for future studies. Alternatively, it is possible that these small radiographic recurrences will eventually become more symptomatic and are a harbinger for additional reoperations. Additional follow-up is required to validate this signal.
A more tempered interpretation of the results would acknowledge the possibility that an anterior gastropexy—akin to previous assessments of mesh augmentation of MIS-PEHR—delays rather than prevents paraesophageal hernia recurrence.5 An important distinction is that, in contrast to mesh placed at the hiatus adjacent to the esophagus, an anterior gastropexy would not introduce the same level of complexity while reoperating at the hiatus. As such, there is little disincentive to using anterior gastropexy, even if it is just to delay a clinically significant recurrence.
In regard to the scale of our recurrence rates, additional large series have generated a wide range as high as 59% depending on the inclusion of smaller hiatal hernias, duration of follow-up, and definition of recurrence.5 Our recurrence rates fall within those previously reported ranges, and the inconsistent use of anterior gastropexy in other retrospective series could account for some of the variability in reported recurrence rates. That said, some of the most referenced series from high-volume centers report lower recurrence rates from 12%-16% but include use of a Collis gastroplasty in 40%-63% of cases.14,20 In cases of a shortened esophagus, a Collis gastroplasty tubularizes the stomach at the gastroesophageal junction to artificially lengthen the esophagus with a portion of the fundus using a stapler. A meta-analysis of paraesophageal hernia repair series excluding small hiatal hernias with at least 6 months of follow-up also found an overall recurrence rate of 25.5%, specifically noting the protective effect of a Collis gastroplasty.21 Our findings suggest that similar low recurrence rates can be achieved without the addition of a Collis and its rare but detrimental leak rate at the staple line (3.3%).14 Whether the concomitant use of an anterior gastropexy with routine Collis gastroplasty would provide the most durable outcome should be the subject of future prospective study.
It is worth mentioning that we sincerely contemplated how to address the many potential operative confounders in the design of this endeavor, particularly involving so many surgeons and practice patterns. Because of the high-level evidence that does not show mesh prevents recurrence, our routine practice does not include the use of mesh at the hiatus.5 As such, mesh use for us would be a marker of increased complexity and for that reason some patients were excluded. Likewise, as the use of a Collis gastroplasty is also rare in our practice, and the aforementioned retrospective data suggests a potential confounding impact, we excluded these patients as well. Additionally, it was not possible to standardize the type and use of a fundoplication, as that operative decision-making is typically multifactorial and variable between surgeons. Furthermore, we are not aware of conclusive data that fundoplication is protective against recurrence in this setting. As such, we allowed surgeons to use their discretion and planned for a prespecified risk-adjustment that ultimately did not show an independent harmful or protective impact for concomitant fundoplication. Importantly, designing this trial to assess the effectiveness of anterior gastropexy in the setting of pervasive technical variability among surgeons (eg, Collis gastroplasty, fundoplication, use of the robot, various techniques for crural closure), taught us that it will take time and thoughtful trial design to systematically assess each of these adjuncts in order to determine what is best for patients.
Two patients required removal of their gastropexy sutures for pain. While any reoperation is important, the infrequent need to remove these sutures (1.7%) seems to be clinically acceptable relative to avoiding the potential operative complexity of redo foregut surgery. That said, the nature of the pain and occasional need for removal of gastropexy sutures should be discussed with patients. Interestingly, neither of those patients whose sutures were removed developed a recurrence by 1 year. That observation, coupled with the higher incidence of early postoperative recurrence in the no-gastropexy group before 30 days (5 vs 1), suggests that the early mechanical fixation of the stomach while healing may be the most crucial part of the anterior gastropexy’s mechanism of action.
Limitations
This study had limitations. Admittedly, patient operative notes were also not blinded in reference to their intervention, and as such patients could have unblinded themselves. While this is a limitation of the trial design, the primary outcome was based on a radiographic finding and not necessarily a patient-reported outcome that would be biased by the patient’s knowledge of their intervention. Next, the substantial number of patients excluded from enrollment is a major limitation. This was due to the subjective component of determining operative complexity (hernia size, defect size, quality of crus) where surgeons felt comfortable randomizing patients, and there was inherent variability among surgeons regarding their threshold for equipoise regarding the need for mesh reinforcement of the hiatus, which was an exclusion. A third limitation of this trial was the low enrollment of men (16%), which potentially limits some of the findings and their applicability. Specifically, it is likely that the effect of male gender on reduced risk identified in our recurrence risk assessment was prone to statistical variation because there were so few men enrolled. Conversely, our limitation in 1-year follow-up (22% lost), is less prone to statistical variation given the size of the trial, 21% recurrence difference between treatment groups, and consistent findings in our per-protocol analyses. To that end, our sensitivity analysis showed that 11 of 25 (44%) of anterior gastropexy patients lost to follow-up would need to have recurrences to overcome the superiority result, underscoring that these results are not fragile. Additionally, while we did allow for 1-year follow-up to begin after 6 months, more than 70% of those 1-year assessments were done after 300 days (Figure 3), reflecting our effort to get those patients to return for imaging closer to 1-year than 6 months. Furthermore, interpretation of our additional foregut symptom questionnaire and patient satisfaction question are limited since they are not validated in this patient population. Additionally, the technical specifics of our anterior gastropexy—placing 2 permanent transfascial sutures through the abdominal wall—cannot necessarily be equated to alternative minimally invasive techniques to fixate the stomach using partial thickness bites of the abdominal wall, diaphragmatic fixation, or barbed/absorbable sutures.
Conclusions
This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PERH significantly reduced paraesophageal hernia recurrence at 1 year. These results suggest that an anterior gastropexy should be routinely used in this context.
Trial Protocol
eTable 1. Per Protocol Paraoesophageal Hernia Recurrence Risk and Pre-specified Risk Adjustment
eTable 2. Patient Satisfaction
eFigure 1. Tipping Point Analysis of Treatment Effect on Risk Difference Comparison
eFigure 2. A. GERD-HQRL Total Score. B. GERD-HQRL Heartburn Score. C. Additional Foregut Symptom Total Score
Data Sharing Statement
References
- 1.Kriley IR, Bing S, Puri R. Paraesophageal Hernias. In: Patel AD, Aryaie A, Grams J, Khaitan L, eds. The SAGES Manual of Physiologic Evaluation of Foregut Diseases. Springer International Publishing; 2023:463-482. doi: 10.1007/978-3-031-39199-6_34 [DOI] [Google Scholar]
- 2.Lidor AO, Steele KE, Stem M, Fleming RM, Schweitzer MA, Marohn MR. Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia. JAMA Surg. 2015;150(5):424-431. doi: 10.1001/jamasurg.2015.25 [DOI] [PubMed] [Google Scholar]
- 3.Wong LY, Parsons N, David EA, Burfeind W, Berry MF. The impact of age and need for emergent surgery in paraesophageal hernia repair outcomes. Ann Thorac Surg. 2023;116(1):138-145. doi: 10.1016/j.athoracsur.2023.01.017 [DOI] [PubMed] [Google Scholar]
- 4.DeMeester SR, Bernard L, Schoppmann SF, Kloosterman R, Roth JS. Elective laparoscopic paraesophageal hernia repair leads to an increase in life expectancy over watchful waiting in asymptomatic patients: an updated Markov analysis. Ann Surg. 2024;279(2):267-275. [DOI] [PubMed] [Google Scholar]
- 5.Angeramo CA, Schlottmann F. Laparoscopic paraesophageal hernia repair: to mesh or not to mesh. systematic review and meta-analysis. Ann Surg. 2022;275(1):67-72. doi: 10.1097/SLA.0000000000004913 [DOI] [PubMed] [Google Scholar]
- 6.Poncet G, Robert M, Roman S, Boulez JC. Laparoscopic repair of large hiatal hernia without prosthetic reinforcement: late results and relevance of anterior gastropexy. J Gastrointest Surg. 2010;14(12):1910-1916. doi: 10.1007/s11605-010-1308-6 [DOI] [PubMed] [Google Scholar]
- 7.Ponsky J, Rosen M, Fanning A, Malm J. Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003;17(7):1036-1041. doi: 10.1007/s00464-002-8765-2 [DOI] [PubMed] [Google Scholar]
- 8.Blake KE, Zolin SJ, Tu C, et al. Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial. Trials. 2022;23(1):616. doi: 10.1186/s13063-022-06571-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Oelschlager BK, Pellegrini CA, Hunter J, et al. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg. 2006;244(4):481-490. doi: 10.1097/01.sla.0000237759.42831.03 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-134. doi: 10.1111/j.1442-2050.2007.00658.x [DOI] [PubMed] [Google Scholar]
- 11.Rosen MJ, Borao FJ, Binenbaum SJ, et al. A multi-center, prospective clinical trial of a hepatic derived porcine surgical mesh for the laparoscopic repair of symptomatic paraesophageal hernias. Am J Surg. 2019;218(2):315-322. doi: 10.1016/j.amjsurg.2019.03.025 [DOI] [PubMed] [Google Scholar]
- 12.Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205-213. doi: 10.1097/01.sla.0000133083.54934.ae [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Slankamenac K, Nederlof N, Pessaux P, et al. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014;260(5):757-762. doi: 10.1097/SLA.0000000000000948 [DOI] [PubMed] [Google Scholar]
- 14.Luketich JD, Nason KS, Christie NA, et al. Outcomes after a decade of laparoscopic giant paraesophageal hernia repair. J Thorac Cardiovasc Surg. 2010;139(2):395-404.e1. doi: 10.1016/j.jtcvs.2009.10.005 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Diaz S, Brunt LM, Klingensmith ME, Frisella PM, Soper NJ. Laparoscopic paraesophageal hernia repair, a challenging operation: medium-term outcome of 116 patients. J Gastrointest Surg. 2003;7(1):59-67. doi: 10.1016/S1091-255X(02)00151-8 [DOI] [PubMed] [Google Scholar]
- 16.Wiechmann RJ, Ferguson MK, Naunheim KS, et al. Laparoscopic management of giant paraesophageal herniation. Ann Thorac Surg. 2001;71(4):1080-1086. doi: 10.1016/S0003-4975(00)01229-7 [DOI] [PubMed] [Google Scholar]
- 17.Dallemagne B, Kohnen L, Perretta S, Weerts J, Markiewicz S, Jehaes C. Laparoscopic repair of paraesophageal hernia. long-term follow-up reveals good clinical outcome despite high radiological recurrence rate. Ann Surg. 2011;253(2):291-296. doi: 10.1097/SLA.0b013e3181ff44c0 [DOI] [PubMed] [Google Scholar]
- 18.Mattar SG, Bowers SP, Galloway KD, Hunter JG, Smith CD. Long-term outcome of laparoscopic repair of paraesophageal hernia. Surg Endosc. 2002;16(5):745-749. doi: 10.1007/s00464-001-8194-7 [DOI] [PubMed] [Google Scholar]
- 19.Hashemi M, Peters JH, DeMeester TR, et al. Laparoscopic repair of large type III hiatal hernia: objective followup reveals high recurrence rate. J Am Coll Surg. 2000;190(5):553-560. doi: 10.1016/S1072-7515(00)00260-X [DOI] [PubMed] [Google Scholar]
- 20.Zehetner J, Demeester SR, Ayazi S, et al. Laparoscopic versus open repair of paraesophageal hernia: the second decade. J Am Coll Surg. 2011;212(5):813-820. doi: 10.1016/j.jamcollsurg.2011.01.060 [DOI] [PubMed] [Google Scholar]
- 21.Rathore MA, Andrabi SI, Bhatti MI, Najfi SM, McMurray A. Metaanalysis of recurrence after laparoscopic repair of paraesophageal hernia. JSLS. 2007;11(4):456-460. [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol
eTable 1. Per Protocol Paraoesophageal Hernia Recurrence Risk and Pre-specified Risk Adjustment
eTable 2. Patient Satisfaction
eFigure 1. Tipping Point Analysis of Treatment Effect on Risk Difference Comparison
eFigure 2. A. GERD-HQRL Total Score. B. GERD-HQRL Heartburn Score. C. Additional Foregut Symptom Total Score
Data Sharing Statement
