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David S. Liu, MBBS (Hons), BMedSc, PhD, FRACS,yz Melissa Wee Yun, MD, BMedSc,y
and David I. Watson, MBBS, MD, PhD, FRACS, FRCSEd (Hon), FAHMS y
composed of 4 components to identify: the disease (eg, MeSH term 3. Total complications, with separate analyses of major complica-
‘‘hernia, hiatal’’ OR ‘‘esophageal hernia’’ OR ‘‘paraesophageal tions, defined as any return to the operating room, mortality, or
hernia’’ OR ‘‘sliding hernia’’ ‘‘gastroesophageal reflux’’ and lan- intensive care admission. An inclusive definition was also con-
guage variations of this), the surgical procedure (eg, MeSH term sidered for analysis where ‘‘major’’ complications included:
‘‘laparoscopy’’ OR ‘‘Laparoscop’’ OR ‘‘laparoscop surgery’’ OR cardiac, pulmonary, and gastric complications, in addition to
‘‘minimally invasive’’ OR ‘‘Nissen fundoplication’’ OR ‘‘fundopli- return to theatre and mortality.
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cation’’), the intervention (eg, MeSH term ‘‘Surgical mesh’’ OR 4. Incidence of dysphagia: dichotomous ‘‘yes/no’’ and visual analog
‘‘mesh’’ or ‘‘implant’’ or ‘‘patch’’) and the study type (eg, ‘‘random- score (VAS) analysis.
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ized control trial’’ and variations). Studies were included from 5. Operative time, measured in minutes.
January 1966 until November 2020. There was no language restric- 6. Meta-analysis of QOL measured by Short-Form 36 (SF-36).
tion applied. A manual search of the reference lists of other articles 7. Satisfaction score, measured using a 0 to 10 VAS.
was also performed to identify any missed studies.
e46 | www.annalsofsurgery.com ß 2021 Wolters Kluwer Health, Inc. All rights reserved.
(OR 0.56, 95% CI 0.24–1.35), with evidence of moderate heteroge- Long-term follow-up at 3 to 5 years, was available for 4 studies.
neity (x2 ¼ 14.26, P ¼ 0.03, I2 ¼ 58%). There was no statistically There was no significant difference between the mesh versus sutured
significant difference between these 2 groups (P ¼ 0.20). Subgroup repair groups (P ¼ 0.69), with a 30.7% recurrence rate in the mesh
analysis was undertaken to determine if there was a difference group versus 31.3% in the sutured repair group (OR 0.83, 95% CI
between the 2 mesh types compared to sutured repair. Two studies 0.34–2.05). There was evidence of moderate heterogeneity (x2 ¼ 6.71,
compared absorbable mesh to sutured repair and 6 studies compared P ¼ 0.08, I2 ¼ 55%). Subgroup analysis was undertaken to determine if
nonabsorbable mesh to sutured (one compared both).24 There was a there was a difference between the 2 mesh types compared to sutured.
7.6% recurrence in the nonabsorbable mesh group compared to Three studies compared nonabsorbable mesh to sutured repair and 2
14.3% in the sutured repair group (OR 0.53, 95% CI 0.17–2.51), studies compared absorbable mesh to sutured repair (1 compared
and 17.8% recurrence in the absorbable mesh compared to 21.9% in both).15 The nonabsorbable mesh subgroup analysis found an
the sutured repair group (OR 0.71 95% CI 0.16–3.21). There was no 18.2% recurrence rate in the mesh group compared to a 22.7%
difference in heterogeneity between these two arms (x2 ¼ 0.1, P ¼ recurrence in the sutured repair group (OR 0.66, 95% CI 0.17–
0.75, I2 ¼ 0%) or statistically significant differences for the primary 2.51). The absorbable mesh subgroup analysis found a 49.2% recur-
outcome (P ¼ 0.75). The corresponding Forest plots of ORs are rence in the mesh group compared to a 46.3% recurrence in the sutured
presented in Figure 2 and Figure S2, http://links.lww.com/SLA/D74. repair group (OR 1.16, 95% CI 0.41–3.27). The corresponding Forest
ß 2021 Wolters Kluwer Health, Inc. All rights reserved. www.annalsofsurgery.com | e47
plots of ORs are presented in Figure 3 and Figure S3, http://link- 0.16–1.46). The data showed no evidence of statistical heterogeneity
s.lww.com/SLA/D74. between the groups (x2 ¼ 0.31, P ¼ 0.86, I2 ¼ 0%). These results are
found in Figure 4.
Postoperative Complications
Overall complication rates (summation of all major and minor Dysphagia
complications which were reported) were 15.0% for the mesh repair Four out of 7 studies evaluated symptoms of dysphagia. All 4
group and 13.8% for the sutured repair group (OR 1.11, 95% CI used a VAS score, and 2 of the 4 also used a binary ‘‘yes/no’’ system.
0.72–1.71), with no significant difference between the groups (P ¼ Both were analyzed and data are shown in Figure 5 and Figure S6,
0.63) or heterogeneity (x2 ¼ 5.13, P ¼ 0.4, I2 ¼ 2%) (Figure S4, http://links.lww.com/SLA/D74. The binary data showed that the
http://links.lww.com/SLA/D74). When focusing on major compli- mesh group had a dysphagia rate of 7.0% and 9.2% for the sutured
cations, there were 2 definitions which were analyzed: one was repair group (P ¼ 0.56, OR 0.73, 95% CI 0.26–2.07). Similarly, there
inclusive and one more targeted. The inclusive analysis found no was no significant difference between the mesh and the sutured repair
significant difference between the mesh and sutured repair groups (P group for the VAS analysis (P ¼ 0.39), both sets of data showed no
¼ 0.22). The rates were 11.1% in the mesh group and 11.0% in the heterogeneity between comparison groups (I2 ¼ 0% for both sets of
sutured repair group (OR 1.01, 95% CI 0.63–1.62), with small levels data).
of heterogeneity between the groups (x2 ¼ 5.71, P ¼ 0.22, I2 ¼ 30%).
These results are available in Figure S5, http://links.lww.com/SLA/ Operative Time
D74. The targeted analysis yielded similar results with no significant The operative time was reported by 6 of the 7 studies, whereas
difference in the rate of major complications between the mesh one was ‘‘not estimable’’ for the analysis as there was insufficient
(1.6%) and sutured (2.3%) repair groups (P ¼ 0.20, OR 0.49, 95% CI data. There was a significant difference (P ¼ 0.05, OR 12.33, 95% CI
FIGURE 2. Forest plot of odds ratio of early hernia recurrence – subgroup analysis for nonabsorbable mesh groups compared to
suture groups (1.2.1), and absorbable mesh groups compared to suture groups (1.2.2). The total overall outcome for all mesh types
is also displayed.
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FIGURE 3. Forest plot of odds ratio of late hernia recurrence – subgroup analysis for nonabsorbable mesh groups compared to
sutured groups (2.2.1), and absorbable mesh groups compared to sutured groups (2.2.2). The total overall outcome for all mesh
types is also displayed.
0.03 to 24.69) between the mesh group and the sutured repair there was an improvement in the score from baseline, however, there
group, with the mesh group having a longer operative time. The data was no reported statistically significant difference between the mesh
had a high level of heterogeneity (I2 ¼ 76%) (Figure S7, http:// and sutured repair groups.22 A long-term follow-up of this RCT also
links.lww.com/SLA/D74). If the oldest study is removed from the concluded the same: that there was an improvement from baseline
analysis, as it was the only study showing a significant difference but no statistically significant difference between the groups.26 The
between its arms,18 a significant difference remains between the final study also found that all of study groups showed a difference in
mesh and sutured groups (P ¼ 0.05, OR 4.91, 95% CI 0.11–9.71). the physical and mental component scores from baseline to short-
There was no heterogeneity in this modified dataset (I2 ¼ 0%). All term follow-up, but there were no significant differences between the
analyses are available in Figure S8, http://links.lww.com/SLA/D74. study groups at short-term follow-up.27
FIGURE 4. Forest plot of odds ratio of all major complications (defined as any return to theatre OR mortality OR ICCU admission) for
mesh groups compared to sutured groups.
ß 2021 Wolters Kluwer Health, Inc. All rights reserved. www.annalsofsurgery.com | e49
FIGURE 5. Forest plot of odds ratio of occurrence of dysphagia (short-term VAS scores) for mesh groups compared to sutured
groups. ICCU indicates intensive coronary care unit.
FIGURE 6. Forest plot of odds ratio of patient satisfaction scores (a scale from 0 to 10) for mesh groups compared to sutured groups.
DISCUSSION with previous reports, the only outcome which was significantly
This meta-analysis found no differences in outcomes for different between the mesh and sutured groups was operative time,
patients who underwent HH repair with mesh compared to sutures which was shorter in the sutured group.9,10 This difference was most
alone. The lack of significant differences was for short-term out- evident in the study by Frantzides et al,28 which also happened to be
comes of hernia recurrence, postoperative complications, dysphagia, the oldest.28 From this perspective, it could be argued that perhaps
QOL and satisfaction scores, and also for longer term follow-up. the longer operating times in the mesh group may reflect the initial
Taken together, these findings failed to show a benefit for mesh- learning curve of mesh placement. Nonetheless, when this study was
augmented repair or that it is superior to sutured repair of the hiatus excluded a significant difference in operative time between the 2
alone. These findings do not support routine use of mesh around the groups remained. Therefore, it stands to reason that placing and
esophageal hiatus, and it follows that more compelling evidence is securing a mesh is more time consuming.
required before a position of routine mesh repair should be proposed. Traditionally, a risk of mesh-related complications such as
Our study is the first to analyze only RCTs comparing short- esophageal erosion has been accepted as a trade-off for the perceived
and long-term outcomes of mesh versus sutured repair of the hiatus. benefit of minimizing hernia recurrence. Previously case series have
Other meta-analyses typically merged randomized and nonrandom- described instances of mesh erosion, as well as more difficult
ized data, opening up these previous meta-analyses to selection revision surgery in individuals who had undergone previous repair
bias.10–12 Additionally, the previous studies presented short-term with mesh,7,28 although it should be recognized that mesh related
outcomes, and were limited in their analysis of QOL, dysphagia and complications were not reported in any of the trials included in the
patient satisfaction. Our study addressed these shortcomings by current meta-analysis. Nevertheless, as the findings from our study
including 2 new RCTs, which provided sufficient power to draw failed to demonstrate a benefit for routine mesh use, it still seems
conclusions from only the highest level of evidence.14,15 Addition- sensible to recommend an approach which minimizes the risk of
ally, for the first time we were also able to analyze longer term mesh related complications. The failure of mesh or sutured repair to
objective outcomes. Further, in contrast to previous meta-analyses, fully eliminate a risk of hernia recurrence, suggests an inevitable
our study compared different types of mesh-augmentation with reoperation risk of up to 5% to 10% for hernia recurrence persists
sutured hiatal closure, thus demonstrating that mesh reinforcement, irrespective of the repair technique applied. In view of this risk, it
regardless of material type, offers no added protection against hernia seems sensible to maximize the ease of reoperating around the hiatus.
recurrence in both the short- and long-term. This includes avoiding mesh during the primary hiatal repair to
Previous studies have concluded that mesh-augmented repair reduce the risk of dense adhesions which render revisional surgery
may be superior to sutured closure alone in preventing hernia more challenging. Moreover, we suggest surgeons should focus on
recurrence.9 –11 These studies, however, did not include all of the ensuring a sound sutured repair is achieved in the first instance. This
RCTs included in our study. Moreover, by solely focusing on RCTs involves complete dissection of the hernia sac away from the
our conclusions are methodologically more robust, than previous mediastinum, full reduction of sac and contents back into the
studies which have included nonrandomized studies. abdominal cavity, meticulous preservation of the fascial coverings
In this study, we performed a multifaceted meta-analysis of overlying the left and right hiatal pillars, hiatal apposition in a
postoperative complications. Consistent with other studies, we found tension-free manner, and an appropriate fundoplication to anchor
that there were no differences in overall adverse events between both the abdominal esophagus and stomach below the diaphragm.
groups.9,11,12 Similarly, rates of dysphagia, patient QOL, and satis- A limitation of our study is the heterogeneity between differ-
faction scores were also comparable between the 2 groups. In line ent RCTs. This includes surgical technique, definitions of hernia size,
e50 | www.annalsofsurgery.com ß 2021 Wolters Kluwer Health, Inc. All rights reserved.
complication grading, dysphagia assessment, and timing of follow- meta-analysis and systematic review of randomized controlled trials. Surg
Laparosc Endosc Percutan Tech. 2019;29:221–232.
up. Meta-analyzing only data from RCTs should balance these
10. Zhang C, Liu D, Li F, et al. Systematic review and meta-analysis of
variables across the trials. Two of the 7 trials included patients with laparoscopic mesh versus suture repair of hiatus hernia: objective and subjec-
smaller hernias, with 40% of the patients in the trial from Granderath tive outcomes. Surg Endosc. 2017;31:4913–4922.
et al having hernias measuring less than 5 cm in length,23 and 64% of 11. Sathasivam R, Bussa G, Viswanath Y, et al. ’Mesh hiatal hernioplasty’ versus
the patients Analatos et al’s trial having hernias measuring less than ’suture cruroplasty’ in laparoscopic para-oesophageal hernia surgery; a sys-
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4 cm.14 However, as the other 5 trials limited recruitment to patients tematic review and meta-analysis. Asian J Surg. 2019;42:53–60.
with very large hernias, a large majority of patients underwent repair 12. Campos V, Palacio DS, Glina F, et al. Laparoscopic treatment of giant hiatal
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