Authors
Nader M. Hanna*1, Sunjay S. Kumar2, Amelia T. Collings3, Yagnik K. Pandya4, James Kurtz5, Keshav Kooragayala6, Meghan W. Barber7, Mykola Paranyak8, Marina Kurian9, Jeffrey Chiu10, Ahmed Abou-Setta11, Mohammed T Ansari12, Bethany J. Slater13, Geoff Kohn14, 15, Shaun Daly16
*Corresponding Author
ABSTRACT
Background: The surgical management of hiatal hernia remains controversial. We aimed to compare outcomes of mesh versus no mesh and fundoplication versus no fundoplication in symptomatic patients; surgery versus observation in asymptomatic patients; and redo hernia repair versus conversion to Roux-en-Y reconstruction in recurrent hiatal hernia.
Methods: We searched PubMed, Embase, CINAHL, Cochrane Library and the ClinicalTrials.gov databases between 2000 and 2022 for randomized controlled trials (RCTs), observational studies, and case series (asymptomatic and recurrent hernias). Screening was performed by two trained independent reviewers. Pooled analyses were performed on comparative data. Risk of bias was assessed using the Cochrane Risk of Bias tool and Newcastle Ottawa Scale for randomized and non-randomized studies, respectively.
Results: We included 45 studies from 5152 retrieved records. Only six RCTs had low risk of bias. Mesh was associated with a lower recurrence risk (RR=0.50, 95%CI 0.28, 0.88; I2 = 57%) in observational studies but not RCTs (RR=0.98, 95%CI 0.47, 2.02; I2 = 34%), and higher total early dysphagia based on five observational studies (RR=1.44, 95%CI 1.10, 1.89; I2 = 40%) but was not statistically significant in RCTs (RR=3.00, 95%CI 0.64, 14.16). There was no difference in complications, reintervention, heartburn, reflux, or quality of life. There were no appropriate studies comparing surgery to observation in asymptomatic patients. Fundoplication resulted in higher early dysphagia in both observational studies and RCTs ([RR=2.08, 95%CI 1.16, 3.76] and [RR=20.58, 95%CI 1.34, 316.69]) but lower reflux in RCTs (RR=0.31, 95%CI 0.17, 0.56, I2 = 0%). Conversion to Roux-en-Y was associated with a lower reintervention risk after 30 days compared to redo surgery.
Conclusions: The evidence for optimal management of symptomatic and recurrent hiatal hernia remains controversial, underpinned by studies with a high risk of bias. Shared decision making between surgeon and patient is essential for optimal outcomes.
Keywords: Hiatal; Hernia; Mesh; Fundoplication; Systematic review; Meta-analysis
INTRODUCTION
Surgical management of hiatal hernia is multifaceted. In the elective setting, patients often present with some combination of dysphagia, reflux, regurgitation, and chest pain [1]. Many will have tried medical therapy such as proton pump inhibitors (PPIs) to no avail. Patients seek treatment in the hopes of improving their quality of life [2]. Surgical management options include repair of hiatal hernia with or without the use of mesh and with or without a fundoplication [3].
There is conflicting evidence in the current literature regarding the superiority of routine mesh placement during hiatal hernia repair [4]. Some studies advocate its inclusion, suggesting that mesh use decreases post operative recurrence [5]. Others warn that recurrence rate and symptom resolution is the same with or without mesh [6], but that mesh use increases post operative complications [7, 8] and may make revisional surgery more challenging [9]. Most of the previous studies addressing these themes were retrospective in nature, thus prone to selection bias. Although there are several randomized controlled trials (RCTs), they are limited by small sample sizes and short follow up.
Given the high rate of recurrence following elective repair of hiatal hernia, strategies have been suggested to mitigate this complication [10-13]. Some advocate merely redoing the hiatal hernia repair, whereas others suggest converting the repair into a Roux-en-Y reconstruction. Proponents of the latter recommend this approach in patients obesity and indications for bariatric surgery. However, it is unclear whether a conversion to Roux-en-Y should be chosen for patients without obesity [14]. Further still, many patients have an asymptomatic hiatal hernia that is detected incidentally. The concern that this hernia may result in a gastric volvulus requiring emergency surgery is what prompts some surgeons to operate despite a lack of symptoms. This school of thought has been challenged recently, and others now advocate observation until symptoms occur. Previous Society of the American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines [3] attempted to address this controversy, but only a weak recommendation could be made to repair a completely asymptomatic hiatal hernia.
Our aim was to perform a systematic review and meta-analysis to compare the different surgical options when managing hiatal hernia. This review provides an analysis of the current literature that will steer an updated SAGES guideline with evidence-based recommendations, to improve the care of patients with hiatal hernia.
Methods and Materials
A working group comprised of SAGES guidelines committee members performed a systematic review and meta-analysis, steered by the Preferred Reporting Items in Systematic Reviews and Meta-Analyses (PRISMA) [15] guidelines, to determine the optimal management of both symptomatic and asymptomatic Type II, III, and IV, and recurrent hiatal hernias. We created four key questions (KQ) in the standard PICO format (Population, Intervention, Comparison, Outcomes) to address different aspects of hiatal hernia management.
Key Questions (KQs)
KQ1: Should mesh be used in adult patients with a symptomatic Type II, III, or IV hiatal hernia undergoing surgery?
KQ2: Should surgical management or continued surveillance be done in adult patients with an asymptomatic Type II, III, or IV hiatal hernia?
KQ3: Should fundoplication be performed in adult patients with symptomatic Type II, III, or IV hiatal hernia undergoing surgery?
KQ4: Should conversion to Roux-En-Y reconstruction be performed in adult patients without obesity with a recurrent Type II, III, or IV hiatal hernia?
Outcomes and Definitions
Outcomes were chosen based on importance to clinicians and patients. For recurrence, we included both symptomatic recurrence, and radiographic recurrence greater than 2 cm in any direction. We chose to include both measures as some studies reported hiatal hernia recurrence by size alone while others report recurrence by symptomatology. Post operative complications were those judged to be Clavien-Dindo Grade 3 or greater [16]. These included leaks, reintervention, and return to the operating room. Specific symptom outcomes were both subjectively reported (heartburn, regurgitation) and objectively measured (reflux, DeMeester Score). Dysphagia outcomes were analyzed separately for patients with and without preoperative dysphagia as well as by timepoint measured. Time-based outcomes were categorized as early if within one year of surgery, and late if beyond one year after surgery. Quality of life data were captured.
Literature Search and Eligibility Criteria
We performed a separate search of the PubMed, Embase, CINAHL, Cochrane Library and ClinicalTrials.gov databases for each KQ. Included articles were those on human studies, written in English, published between 2000 and 2021. Open cases were excluded. For all KQs, we included randomized control trials (RCTs) and non-randomized comparative studies. For KQ2 and KQ4, we allowed case series with at least 5 (KQ2) and 10 (KQ4) patients. Search records were uploaded to the Covidence platform to facilitate the review process. Duplicates were removed by hand prior to upload and automatically by the software. We performed an updated search on July 13, 2023, to identify relevant articles published after the original search. The full search strategy can be found in Appendix A.
Study Selection
A group of reviewers calibrated their responses by simultaneously reviewing the same 50 randomly selected abstracts using the Abstrackr (Brown University, Providence, Rhode Island) software. Disagreements and fine-tuning of inclusion and exclusion criteria were discussed during a conference call. Following this calibration, each abstract was then screened in Covidence by two independent reviewers and excluded if it did not meet eligibility criteria defined by the PICO elements. The full texts of the included abstracts were then screened for the same criteria. Any discrepancies between reviewers were resolved by a senior author. Here, published systematic reviews, society guidelines, and position papers were hand-searched for articles not identified in the initial search, then subsequently excluded from the pooled meta-analysis.
Risk of Bias in Individual Studies
All included studies were assessed for the risk of bias using either the Cochrane Risk of Bias 2.0 tool [17] (for RCTs) or the Newcastle Ottawa Scale [18] (for observational studies). Two reviewers independently rated each study. For RCTs, elements assessed included sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, incomplete data, performance bias, and detection bias. For all other studies, elements assessed included selection bias, comparability of groups, and reporting of outcomes. Discrepancies between reviewer ratings were resolved by discussion between the two reviewers or a third-party tiebreaker when necessary.
Data Extraction
We created data capture forms to include baseline demographics, details of the intervention and the comparator, and outcomes of interest. These forms were uploaded to Covidence where data extraction for each paper was performed by two independent reviewers. Any discrepancy was resolved with discussion between the original reviewers and mediated by a senior author. Examples of outcomes of interest included control of GERD and non-GERD symptoms (e.g., shortness of breath), objective reflux, PPI use, post-operative complications, hiatal hernia recurrence, need for re-intervention, quality of life, and mortality. Specific to KQ3 and KQ4 was postoperative dysphagia; specific to KQ4 was excessive weight loss and malnutrition.
Data Analysis
We performed random and fixed effects meta-analysis using the RevMan software (Version 5.4.1) [19]. We calculated pooled relative risk (RR) for each binary outcome from RCTs, odds ratios for each binary outcome from observational studies, and an inverse weighted mean difference for continuous outcomes. We calculated a standardized mean difference for continuous outcomes that used different scales. We quantified heterogeneity between studies using the I2 statistic and assessed statistical significance using the Chi2 test. Data from case series are presented as proportions.
RESULTS
We screened a total of 2620 studies from the original database search, handsearching, and the updated literature search. After exclusions based on the criteria above, there were 45 studies that fulfilled one or more of the four KQs (Table 1). The PRISMA diagrams (Figures 1-4) illustrate the reasons for exclusions.
Table 1: A summary of the included articles for the 3 key questions that contain data.
Fig 1: PRISMA diagram for KQ1
Key Question 1 – Mesh versus no mesh during hiatal hernia repair
31 comparative studies met the inclusion criteria for this question, comprising nine RCTs and 22 cohort studies.
Risk of Bias
Six of the nine RCTs were judged to be low risk of bias, and three were high risk of bias (Table 2). One observational study had a low risk of bias with the remaining 21 having a high risk of bias (Table 3).
Table 2: Risk of bias for the randomized controlled trials included in KQ1
Table 3: Risk of bias for the observational studies included in KQ1
Outcomes
Hiatal hernia recurrence was investigated by 15 observational studies [20–23, 25, 30–32, 34, 39, 42, 43, 47–49] and six RCTs [6, 24, 35–37, 45]. The combined observational studies compared 710 patients with mesh and 1452 patients without mesh and found a lower number of recurrences in those with mesh (RR=0.50, 95%CI 0.28, 0.88; I2 = 57%). The combined RCTs randomized 213 patients to mesh and 197 patients to no mesh. There was no difference in recurrence between the two groups (RR=0.98, 95%CI 0.47, 2.02; I2 = 34%) (Fig. 5a).
Fig 5a: Forest plot of mesh versus no mesh for symptomatic recurrence.
Radiographic recurrence was examined in five RCTs [6, 26, 29, 37, 45] with a total of 251 patients randomized to mesh and 225 randomized to no mesh and there was no statistically significant difference seen (RR=0.57, 95%CI 0.15, 2.12, I2 = 73%). Ten observational studies [20, 22, 25, 31–34, 42, 44, 46] compared this outcome between 603 patients with mesh and 789 without mesh and did not find a statistically significant difference in radiographic recurrence (RR=0.66, 95%CI 0.41, 1.06; I2 = 27%) (Fig. 5b).
Fig 5b: Forest plot of mesh versus no mesh for radiographic recurrence.
Four RCTs [6, 26, 29, 35] investigated serious postoperative complications. There was no significant difference in number of complications found between the two groups (RR=1.36, 95%CI 0.69, 2.69). Four observational studies [28, 39, 40, 44] included 9263 patients with mesh and 14,461 patients without mesh. Again, no difference in complication rate was found between both groups (RR=0.95, 95%CI 0.83, 1.08; I2 = 0%) (Fig. 5c).
Fig 5c: Forest plot of mesh versus no mesh for Clavein-Dindo Grade 3+ complications.
Postoperative leak was examined by four RCTs [6, 26, 35, 45]. No statistically significant difference was found (RR=0.75, 95%CI 0.12, 4.79). Three observational studies [28, 31, 39] were identified but only one [28] was analyzable. There was no statistically significant difference in leak rate between those with and without mesh (RR=0.33, 95%CI 0.01, 7.45; I2 = N/A) (Fig. 5d).
Fig 5d: Forest plot of mesh versus no mesh for anastomotic leak.
Returning to the operating room (OR) during the index admission was investigated by seven RCTs [6, 24, 26,
35–37, 45] (mesh = 313 versus no mesh = 274) and 15 observational studies [20, 22, 23, 25, 28, 31, 32, 34, 38–43, 48] (mesh = 13,592 versus no mesh = 21,760). Neither analysis demonstrated a difference in return to the OR between both groups (Fig. 5e).
Fig 5e: Forest plot of mesh versus no mesh for return to the operating room.
Postoperative heartburn was assessed by two RCTs [26, 37] (84 patients randomized to each arm) and three observational studies [25, 34, 46] (203 patients with mesh and 411 without mesh). Neither analysis identified a significant difference between both groups (RR=0.83, 95%CI 0.27, 2.54; I2 = 0%) and (RR=0.78, 95%CI 0.30, 2.02; I2 = 43%) respectively (Fig. 5f).
Fig 5f: Forest plot of mesh versus no mesh for heartburn.
Post operative regurgitation was examined by one RCT [26] and one observational study [26] and neither found a difference. (Fig. 5g).
Fig 5g: Forest plot of mesh versus no mesh for regurgitation.
One RCT [26] examined objective reflux recurrence. It randomized 50 patients into each arm, with four patients each experiencing the outcome (no difference between the groups) (Fig. 5h)
Fig 5h: Forest plot of mesh versus no mesh for objective reflux.
Post operative DeMeester score was analyzed by two RCTs [26, 29] (mesh = 84 and no mesh = 85) and found a lower postoperative score in those with a mesh (Mean Difference = -1.94, 95%CI -3.09, -0.79; I2 = 0%). Three observational studies [25, 31, 39] did not find a statistically significant difference between both groups regarding a postoperative DeMeester score (Mean Difference = -0.79, 95%CI -3.38, 1.80; I2 = 51%) (Fig. 5i)
Fig 5i: Forest plot of mesh versus no mesh for DeMeester score.
Ongoing post operative PPI use was assessed by three RCTs [6, 36, 37] (135 patients with mesh compared to 140 patients without mesh) and two observational studies [20, 34] (combined 57 patients with mesh and 80 patients without mesh). Neither analysis demonstrated a statistically significant difference in PPI use ([RR=0.89, 95%CI 0.62, 1.28] and [RR=1.65, 95%CI 0.82, 3.35] respectively) (Fig. 5j).
Fig 5j: Forest plot of mesh versus no mesh for PPI use.
New post operative dysphagia was investigated by two observational studies [22, 39] with a total of 28 patients with mesh and 33 patients without mesh. There was no statistically significant difference between both groups (RR=0.47, 95%CI 0.06, 3.85; I2 = 0%) (Fig. 5k).
Fig 5k: Forest plot of mesh versus no mesh for new dysphagia.
Early and late post operative dysphagia was separately analyzed by one RCT [27] and one observational study [43]. Neither identified a difference between those with and without mesh placed at time of hiatal hernia repair (Fig. 5l, 5m).
Fig 5l: Forest plot of mesh versus no mesh for early dysphagia.
Fig 5m: Forest plot of mesh versus no mesh for late dysphagia.
Resolution of dysphagia was assessed by one RCT [27] and one observational study [43] and neither demonstrated a difference between both groups (Fig. 5n).
Fig 5n: Forest plot of mesh versus no mesh for resolution of dysphagia.
Early unresolved dysphagia was higher in the mesh group according to one observational study [43] (RR=1.35, 95%CI 1.03, 1.76) but not in the two RCTs [27, 37] (19 patients in each arm) (RR=0.86, 95%CI 0.45, 1.64) (Fig. 5o).
Late unresolved dysphagia was investigated in the same two RCTs and no statistical difference was found (RR=1.51, 95%CI 0.71, 3.21; I2 = 0%) (Fig. 5p).
Fig 5o: Forest plot of mesh versus no mesh for early unresolved dysphagia.
Fig 5p: Forest plot of mesh versus no mesh for late unresolved dysphagia.
Total early dysphagia was higher in the mesh group according to five observational studies [25, 31, 42–44] (RR=1.44, 95%CI 1.10, 1.89; I2 = 40%), but not the only RCT [26] to report this (RR=3.00, 95%CI 0.64, 14.16) (Fig. 5q).
Fig 5q: Forest plot of mesh versus no mesh for total early dysphagia.
Total late dysphagia was lower in the mesh group according to three RCTs [26, 29, 45] that randomized 158 mesh and 118 no mesh patients (RR=0.49, 95%CI 0.28, 0.86; I2 = 0%) but not the five observational studies [25, 31, 34, 44, 46] that reported this outcome (RR=0.76, 95%CI 0.41, 1.42; I2 = 0%) (Fig. 5r).
Fig 5r: Forest plot of mesh versus no mesh for total late dysphagia.
Quality of life (QoL) was investigated by three RCTs [29, 37, 45] and seven observational studies [20, 31, 36, 38, 43, 44, 46]. Due to the difference in QoL scale used, we were not able to perform a meta-analysis for this outcome. Only one study [29] demonstrated a higher post-operative QoL in those with mesh compared to those without. The remainder reported an improvement in postoperative QoL compared to preoperative QoL in both groups but found no statistical significance between both groups postoperatively (Fig. 5s).
Fig 5s: Forest plot of mesh versus no mesh for quality of life
Key Question 2 – Observation versus surgery for asymptomatic hiatal hernia
There were no studies that met the inclusion criteria for this KQ.
Fig 2: PRISMA diagram for KQ2
Key Question 3 – Fundoplication versus no fundoplication during hiatal hernia repair
In total, eight comparative studies met the inclusion criteria with two RCTs and six cohort studies.
Fig 3: PRISMA diagram for KQ3
Risk of Bias
One RCT was determined to have a low risk of bias and the other a high risk of bias (Table 4). Of the six cohort studies, five had a high risk of bias, and the remaining study was deemed to have an unclear risk of bias (Table 5).
Table 4: Risk of bias for the randomized controlled trials included in KQ3
Table 5: Risk of bias for the observational studies included in KQ3
Outcomes
Symptomatic hiatal hernia recurrence risk was not statistically different in those with and without a fundoplication from the analysis of two RCTs [52, 54] (RR=0.55, 95%CI 0.20, 1.51; I2 = 0%) and four observational studies [23, 50, 53, 56] (RR=0.99, 95%CI 0.32, 3.13; I2 = 51%) (Fig. 6a).
Fig 6a: Forest plot of fundoplication versus no fundoplication for symptomatic recurrence.
Radiographic recurrence risk was found to be not statistically different in one RCT [54] (RR=0.50, 95%CI 0.14, 1.76). In one observational study [55], the risk was lower in those with a fundoplication (RR=0.42, 95%CI 0.21, 0.87) (Fig. 6b).
Fig 6b: Forest plot of fundoplication versus no fundoplication for radiographical recurrence.
Risk of reoperation was not statistically significantly different between those with and without a fundoplication according to two RCTs [52, 54] with high heterogeneity (RR=0.54, 95%CI 0.01, 23.15; I2 = 89%) and three observational studies [23, 53, 56] (RR=0.90, 95%CI 0.15, 5.51; I2 = 34%) (Fig. 6c).
Fig 6c: Forest plot of fundoplication versus no fundoplication for reoperation.
Postoperative leak was no different in one RCT [54] that randomized 20 patients to each arm (RR=0.33, 95%CI 0.01, 7.72) (Fig. 6d).
Fig 6d: Forest plot of fundoplication versus no fundoplication for anastomotic leak.
Heartburn was examined by four observational studies [51, 53, 55, 56] with a combined cohort of 234 patients with fundoplication and 79 patients without fundoplication. There was no statistically significant difference between both groups (OR=0.56, 95%CI 0.21, 1.50, I2 = 38%) (Fig. 6e).
Fig 6e: Forest plot of fundoplication versus no fundoplication for heartburn.
PPI use was investigated by one RCT [54] and two observational studies [55, 56], none of which found a difference between the groups (Fig. 6f).
Fig 6f: Forest plot of fundoplication versus no fundoplication for PPI use.
Objective reflux was found to be lower in those with fundoplication in the two RCTs [52, 54] that randomized 76 patients to fundoplication and 71 patients to no fundoplication (RR=0.31, 95%CI 0.17, 0.56, I2 = 0%). This was not replicated in the three observational studies [51, 53, 55] (RR=0.55, 95%CI 0.30, 1.03, I2 = 40%) (Fig. 6g).
Fig 6g: Forest plot of fundoplication versus no fundoplication for objective reflux.
A lower post operative DeMeester score was seen in those with a fundoplication was reported in two RCTs [52, 54] that randomized 46 patients to fundoplication and 43 patients to no fundoplication (Mean Difference=-5.63, 95%CI -9.69, -1.56) but with high heterogeneity at I2 = 73% (Fig. 6h).
Fig 6h: Forest plot of fundoplication versus no fundoplication for DeMeester score.
Early new dysphagia was investigated by two observational studies [51, 53], only one of which was analyzable [53]. That study found a higher risk of new dysphagia within 1 year in those who had a fundoplication (9 patients) compared to those who did not (12 patients) (OR=75.00, 95%CI 3.16, 1782.78) (Fig. 6i).
Fig 6i: Forest plot of fundoplication versus no fundoplication for early new dysphagia.
Late new dysphagia was reported in two observational studies [50, 56] with a combined 165 patients with fundoplication and 53 patients without fundoplication and there was no difference between both groups (Fig. 6j).
Fig 6j: Forest plot of fundoplication versus no fundoplication for late new dysphagia.
Unresolved dysphagia within 1 year and after 1 year was examined in only one observational study [51] and found no difference between the groups (Fig. 65) (Fig. 6k and 6l).
Fig 6k: Forest plot of fundoplication versus no fundoplication for early unresolved dysphagia.
Fig 6l: Forest plot of fundoplication versus no fundoplication for late unresolved dysphagia.
Total early dysphagia was examined by one RCT [52] (fundoplication = 61 patients, no fundoplication = 61 patients) and one observational study [53] (fundoplication = 11 patients, no fundoplication = 12 patients). Both analyses demonstrated a higher risk of total dysphagia within 1 year in those with a fundoplication ([RR=2.08, 95%CI 1.16, 3.76] and [RR=20.58, 95%CI 1.34, 316.69] respectively) (Fig. 6m).
Fig 6m: Forest plot of fundoplication versus no fundoplication for total early dysphagia.
Total late dysphagia was reported in two RCTs [52, 54] fundoplication = 78 patients, no fundoplication = 79 patients) and two observational studies [55, 56] (fundoplication = 188 patients, no fundoplication = 42 patients), neither of which demonstrated a difference in total dysphagia after 1 year between both groups (Fig. 6n).
Fig 6n: Forest plot of fundoplication versus no fundoplication for total late dysphagia.
Quality of life was reported in one observational study [51] using the GERD-HRQL score. Despite both those with and without a fundoplication experiencing better post operative quality of life compared to preoperatively, there was no statistically significant difference in post operative score between the two groups (Mean Difference=-1.50, 95%CI -5.66, 2.66) (Fig. 6o).
Fig 6o: Forest plot of fundoplication versus no fundoplication for quality of life.
Key Question 4 – Roux-en-Y versus redo repair in patients without obesity with a recurrent hernia
We identified seven studies with two cohort studies and the remainder being case series.
Fig 4: PRISMA diagram for KQ4
Risk of Bias
Of the two cohort studies, one was deemed to have an unclear risk of bias, and one had a high risk of bias. The five included case series all were judged to have a high risk of bias (Table 6).
Table 6: Risk of bias for all studies included in KQ4
Outcomes
Symptomatic hiatal hernia recurrence was reported in two case series in patients undergoing redo repair. One reported recurrence in 8% (2/25) of patients [63], and the other in 10.5% (20/190) of patients [57].
Early reintervention was reported in one cohort study [60] and three case series [57, 59, 61]. In the cohort study, 3 of 101 patients with conversion to open and 0 of 79 patients undergoing redo repair required reintervention, but this difference was not statistically significant (OR=5.65, 95%CI 0.29, 111.00). In one case series [57], early reintervention occurred in 6.8% of patients (13/190) after redo repair. The other two case series reported early reintervention in 5.3% (1/19) and 8% (4/50) in patients undergoing redo repair.
Late reintervention was examined in one cohort study [60] and four case series [57, 59, 61, 63]. The cohort study found a higher risk of reintervention in patients with conversion to Roux-en-Y compared to those without (OR=6.72, 95%CI 1.49, 30.31). Two case series in patients with conversion reported a late reintervention in 14% (7/50) and 28% (5/18) of patients, whereas two other case series in patients undergoing redo repair reported a late reintervention in 5.8% (11/190) and 16% (4/25) of patients.
Postoperative leak requiring intervention was investigated in two cohort studies [60, 63] and four case series [57–59, 61]. There was no statistically significant difference between both groups in the two cohort studies (OR=7.81, 95%CI 0.87, 69.68; I2 = 0%). Two case series in patients with conversion to Roux-en-Y reported a leak in 4% (2/50) and 5.2% (1/19) of patients, whereas two other case series in patients undergoing redo repair reported a leak in 1.6% (3/190) and 6.8% (5/73) of patients. (Fig. 7)
Fig 7: Forest plot of RYGB versus redo surgery for anastomotic leak
Heartburn was investigated by one cohort study [60] with 101 patients with conversion to Roux-en-Y and 79 patients undergoing redo repair and found no statistical difference between both groups (OR=1.40, 95%CI 0.60, 3.25). PPI use was reported by two case series; 47.9% of patients with redo repair [57] and 50% of patients with Roux-en-Y [61] experienced this outcome.
Multiple outcomes were reported in only one case series [57] on patients undergoing redo repair. The authors report radiographic hiatal hernia recurrence occurred in 5.8% (11/190) of patients, total dysphagia after 1 year in 41.6% (79/190), and gas bloat syndrome in 41.6% (79/190).
Quality of life was reported in two case series in patients after redo repair. One used the GERD-HRQL score [57] and the other used a composite score made of esophageal and non-esophageal symptom questions [62]. Post operative scores were 43.7 and 1.6 respectively.
No studies reported on excessive weight loss or malnutrition.
DISCUSSION
Hiatal hernia remains a common ailment in North America and globally. There still exists controversy regarding the management of asymptomatic hernias, the use of mesh and fundoplication during a hiatal hernia repair, and the optimal surgical approach to a recurrent hiatal hernia. This systematic review synthesized available literature, and a pooled meta-analysis, when possible, aimed to answer these questions to develop a better understanding of hiatal hernia management and inform future guidelines.
Summary of Evidence
When we compared patients who had a mesh placed during the hiatal hernia repair with those without mesh, our analysis showed that there were fewer symptomatic recurrences in the group with mesh. This finding came from the pooled data of 17 observational cohort studies, with a moderate level of heterogeneity (I2 = 55%). The same analysis of four RCTs did not show a difference in recurrence risk, however those studies also had a moderate level of heterogeneity (I2 = 52%). We further chose to examine a radiological recurrence outcome separately to a symptomatic recurrence. There was no statistically significant difference between the two groups, however the 95% confidence interval for the pooled analysis of observational studies was marginally over the null value. This trend of a recurrence being more likely in patients with mesh in the cohort studies but not RCTs may reflect the selection bias that is present in observational studies, supported by the fact that 21 of 22 studies were assessed as a high risk of bias, with most being flagged in the selection and comparability domain. There was no difference between both groups in terms of post operative complications, need for reintervention / return to the OR, and most postoperative symptoms such as regurgitation, reflux, heartburn, and new onset early and late dysphagia. Unresolved and total early dysphagia was more likely in patients with mesh (in the observational studies but not the RCTs), whereas total late dysphagia was more likely in those without a mesh (in the RCTs but not the observational studies). Early dysphagia could in part be explained by the extra post operative edema due to mesh placement that takes some time to resolve. It may also be due to the selection biases within those cohort studies. Three of the four RCTs had a low risk of bias.
A comparison of surgery and observation for asymptomatic Type II-IV hiatal hernia was not possible due to a lack of appropriate studies. Most were excluded based on their inclusion of some symptomatic patients; thus, no real conclusions could be drawn on the best management approach for truly asymptomatic patients.
Results of the literature search for a comparison of fundoplication with no fundoplication yielded two RCTs (one with a low risk of bias) and six cohort studies (five with a high risk of bias). Unsurprisingly, patients who received a fundoplication experienced more new-onset early and total dysphagia, based on the results of both the RCT pooled analysis and the observational studies pooled analysis. As expected, those without a fundoplication experienced more objective reflux compared to those with a fundoplication. Those with a fundoplication had a lower post operative DeMeester score. Radiographic recurrence was higher in those without a fundoplication according to the observational study pooled analysis, but not the sole RCT with a low risk of bias. Symptomatic recurrence was no different between both groups. There was no difference between the groups in terms of late dysphagia, unresolved dysphagia, PPI use, leak, reoperation, or quality of life.
Finally, for the best surgical management of recurrent hiatal hernia in patients without obesity, we compared a conversion to a Roux-en-Y with a redo operation. The comparison was limited by having no RCTs, four cohort studies, and three case series, all with a high or unclear risk of bias. The only head-to-head comparisons that could be made were in post operative leak, need for reintervention within 30 days, and need for reintervention beyond 30 days. The only difference between the groups was a higher need for reintervention beyond 30 days in the redo hiatal hernia group.
Relationship to Literature
The results of our systematic review are similar to recent systematic reviews that address the same themes. Mesh use was the predominant topic. One such study [5] pooled six RCTs and 13 observational studies and found a lower early recurrence risk in those with a mesh, but similar late recurrence risk and complication risk. Those included studies also had a high level of heterogeneity. Another systematic review of only RCTs [64] also found a lower early recurrence risk in the mesh group, but no difference in late recurrence or complications. Finally, a network meta-analysis of seven RCTs [65] failed to find a difference in any outcome between those with and without a mesh. A recent systematic review [66] of the need for fundoplication enrolled 8600 patients. As in our study, these authors reported that patients who had a fundoplication as part of their procedure experienced a lower risk of reflux, but a higher risk of dysphagia. Whilst we included RCTs in our analysis, those authors did not. However, like our study, theirs was limited by heterogeneity. No systematic review compared surgery with observation for asymptomatic hiatal hernia, or conversion to Roux-en-Y with redo hiatal hernia for recurrence in patients without obesity. Our systematic review updates the current literature on mesh use and fundoplication during primary hiatal hernia repair and synthesizes the known literature on management of recurrent hiatal hernia.
Limitations
Despite our thorough methodology, this systematic review suffers from some inherent limitations. Almost all key questions included studies with a high risk of bias when assessed using the Newcastle-Ottawa Scale and the Cochrane Risk of Bias tool. The observational studies were predominantly biased by their selection of patients and their comparability. This is likely due to the retrospective nature of the studies and may reflect baseline differences in patients being selected for each group. Our analysis that examined mesh use included nine RCTs, six of which were deemed to have a low risk of bias. Despite this, there was significant heterogeneity amongst the included studies. The inclusion of case series in two of four questions prevented a head-to-head comparison for many of the included outcomes.
Similarly, our definitions of early and late post operative symptoms did not exactly mirror those of the included studies. We chose to define early / late as 3 months to 1 year / after 1 year, to reflect clinical practice. Some studies collected outcome data at three months, and others at six months. Classifying both as early symptoms may have accounted for the lack of statistically significant results seen in many analyses. Other misclassifications may have occurred because of outcome definitions: few studies used objective measures such as the DeMeester score. Most studies that reported post operative symptoms used subjective measures or quality of life questionnaires, some of which were not validated. This imprecision in defining outcomes may have precluded accurate comparisons during the pooled analyses.
Finally, inherent to systematic reviews is the potential to miss relevant articles. To circumvent this, we used the assistance of an experienced librarian, hand searched all systematic reviews and society guidelines for articles not included in the original search, and performed an updated literature search to capture more recent articles that had been published subsequently.
Relevance to Clinical Practice
The results of our systematic review emphasize the need for careful patient discussion prior to any surgical procedure for hiatal hernia. The controversial use of mesh remains so. We have demonstrated that post operative complications, post operative symptoms, and long-term recurrence are similar with or without mesh. There is a suggestion that mesh use may reduce the risk of early recurrence. Clinicians can use this information when counseling patients on surgical options.
Similarly, use of fundoplication during hiatal hernia repair should be tailored to individual patient needs, desires, and presenting symptoms. Those who undergo a fundoplication should be warned that even though risk of reflux is lower, the risk of early dysphagia is higher, with no real difference in symptomatic recurrence of the hernia itself. Patients would benefit from a thorough discussion about the trade-off between one symptom and another.
Caution should be exercised when deciding between surgery and observation in patients with an asymptomatic hiatal hernia. Evidence for the superiority of one over another is severely lacking, thus clinicians should continue to engage patients in shared decision making. It remains unclear which surgical option is the best for recurrent hiatal hernia in patients without obesity. All outcomes were comparable across both groups except late reintervention; thus, clinicians should rely on their own expertise and comfort levels when deciding on the procedure.
Future Research Recommendations
This systematic review has demonstrated a lack of high-quality studies in the surgical management of hiatal hernia, with very few being judged to have a low risk of bias. Given the relative prevalence of symptomatic hiatal hernia and the continued controversy of mesh use, a large RCT with methodological rigor may shed light on whether mesh should be routinely used. Such a study should separate MIS and open procedures, have all operations performed by the same surgeon(s), and collect objective outcomes data. Reporting outcome data in a standardized fashion, with objective measurements where possible, would improve the comparability of techniques and studies, and may result in more precise pooled analyses. Similarly, quality of life was poorly investigated, measured, and reported in several included studies. Recommendations to ensure consistency in symptom assessment have been suggested [67]. which is of utmost importance when performing an elective operation for troublesome symptoms. Lastly, the best management of asymptomatic hiatal hernia and recurrent hiatal hernia remains unknown, and these decisions would benefit from being addressed in future research endeavors.
Conclusion
This systematic review demonstrates that mesh placement during primary repair of hiatal hernia results in fewer early recurrences but does not impact late recurrences, complications, or post operative symptoms. We found that fundoplication during hiatal hernia repair increases early dysphagia but decreases post operative reflux without reducing symptomatic recurrence risk. More research is required to determine the best strategy for managing asymptomatic hiatal hernia, and recurrent hiatal hernias.
Acknowledgements
Acknowledgements: The authors would like to acknowledge Holly Ann Burt for her contribution in performing the literature search for all included studies. We would also like to acknowledge Sarah Colón for her help in organizing the guidelines committee meetings and communications.
Funding: No external funding was used for this study. SAGES provided partial salary support for the fellows, statistician, and librarian involved in the project.
Disclosures: Dr Kohn reports expert opinion fees from Avant Medical. Dr Slater reports consulting fees from Hologic and from Cook Medical. Dr Chiu reports consulting fees from Altrazeal Life Sciences Inc. Dr Kurian reports honoraria from WL Gore. Nader M. Hanna, Sunjay S. Kumar, Amelia T. Collings, Yagnik K. Pandya, James Kurtz, Keshav Kooragayala, Meghan W. Barber, Mykola Paranyak, Ahmed Abou-Setta, Mohammed T Ansari, and Shaun Daly have no conflicts of interest or financial ties to disclose.
Authors and Affiliations
Nader M. Hanna1, Sunjay S. Kumar2, Amelia T. Collings3, Yagnik K. Pandya4, James Kurtz5, Keshav Kooragayala6, Meghan W. Barber7, Mykola Paranyak8, Marina Kurian9, Jeffrey Chiu10, Ahmed Abou-Setta11, Mohammed T Ansari12, Bethany J. Slater13, Geoff Kohn14, 15, Shaun Daly16
- Department of Surgery, Queen’s University, Kingston, ON, Canada
- Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA
- Hiram C. Polk, Jr Department of Surgery, University of Louisville, KY, USA
- Department of Surgery, MetroWest Medical Center, Framingham, MA, USA
- Department of Surgery, Providence Portland Medical Center, Portland, OR, USA
- Department of Surgery, Cooper University Hospital, Camden, NJ, USA
- Department of Surgery, University of Toledo College of Medicine, Toledo, OH, USA
- Department of General Surgery, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine
- Department of Surgery, NYU Langone Health, New York, NY, USA
- AdventHealth Orlando, Orlando, FL, USA
- Centre for Healthcare Innovation, University of Manitoba, Winnipeg, MB, Canada
- Independent Researcher, Ottawa, ON, Canada
- Department of Surgery, University of Chicago, Chicago, IL, USA
- Department of Surgery, Monash University, Melbourne, Australia
- Melbourne Upper GI Surgical Group, Melbourne, Australia
- Department of Surgery, University of California Irvine, Irvine, CA, USA
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