A Comparative Study in Elective Repair of Large Incisional Hernia using On-lay Mesh Versus Sub-lay Mesh A Meta-Analysis

doi:10.21203/rs.3.rs-2623516/v1

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A Comparative Study in Elective Repair of Large Incisional Hernia using On-lay Mesh Versus Sub-lay Mesh A Meta-Analysis

https://doi.org/10.21203/rs.3.rs-2623516/v1

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Background: Ventral abdominal wall incisional hernia is defined as a defect in the musculo-fascial layers of the abdominal wall in the region of postoperative scar. There is a slight increase in the incidence of incisional hernia in the female gender. The higher percentage of incisional hernia in females might be due to laxity of abdominal wall muscles after multiple pregnancies and also increased incidence of obesity in females.

Objective: To assess incisional hernia repair using two different techniques: on-lay mesh and sub-lay mesh, as regards operative time, postoperative recurrence, wound infection, seroma, hematoma and flap necrosis.

Patients and Methods: The Pubmed, web of science and Scopus were searched on 15 March, 2022. The keywords incisional hernia, sub-lay mesh on-lay mesh, retromuscular mesh, polypropylene.

Results and Conclusion: According to our results, there is a statistical difference between onlay and sublay regarding intra-operative time as sublay mesh is more time consuming. Regarding post-operative complications there is no statistical difference in recurrence, seroma, hematoma, flap necrosis and infection but there is a statistical difference regarding in hospital stay as patients with sublay repair stays less than onlay.

Incisional hernia

sub-lay mesh on-lay mesh

retromuscular mesh

polypropylene

Ventral abdominal wall incisional hernia is defined as a defect in the musculo-fascial layers of the abdominal wall in the region of postoperative scar. ¹

There is a slight increase in the incidence of incisional hernia in the female gender. The higher percentage of incisional hernia in females might be due to laxity of abdominal wall muscles after multiple pregnancies and also increased incidence of obesity in females .²

The most common risk factor for development of incisional hernia was the occurrence of wound infection after the previous surgery that was found in 46.67% of their cases. Also obesity, smoking, chronic cough, diabetes mellitus and anemia were important risk factors for incisional hernia development .³

Incisional hernia repair can be done by either an open or a laparoscopic technique. The open technique can be a simple suture repair or a mesh repair .⁴

Mesh fixation technique is the gold standard procedure for incisional hernia repair. Restriction to the principles of repair reduces the post-operative complications and recurrence rates. These principles include: Strict aseptic technique, tension free repair, repair of the whole previous surgical scar, closure of the fascial defect with non-absorbable sutures taking good bites with narrow intervals, making at least 5cm mesh overlap of the hernial defect in all directions and prophylactic use of antibiotics post-operatively. ⁵ Open mesh repair is the standard procedure for incisional hernia repair. The mesh can be placed between the subcutaneous tissues of the abdominal wall and the anterior rectus sheath (on-lay repair) as well as it can be placed in the pre-peritoneal space or in the retro-muscular space created between the rectus muscle and posterior rectus sheath (sub-lay repair) .⁶

The mean operative time in the sub-lay technique is more than the mean operative time in the on-lay technique due to the time consumed in dissecting the retro-rectal or pre-peritoneal. ⁷ Seroma formation after drain removal is a common complication after incisional hernia repair. In many previous studies, the rate of seroma formation after the on-lay repair is much more than that after the sub-lay repair with statistical significant distribution .⁸

Studies have shown that 70–75% of incisional hernia recurrences develop within 2 years and 80–90% develops within 3 years .⁹

AIM OF THE WORK The aim of this study is to assess incisional hernia repair using two different techniques: on-lay mesh and sub-lay mesh, as regards operative time, postoperative recurrence, wound infection, seroma, hematoma and flap necrosis

Search strategy

The Pubmed, web of science and Scopus were searched on 15 March, 2022. The keywords incisional hernia,sub-lay mesh on-lay mesh, retromuscular mesh, polypropylene. The details of the search process and study selection are shown in Figure (42). Relevant articles referenced in these primary studies were also searched to enroll additional cases, some articles were searched from the references of some studies.

Eligibility criteria: All trials about the usage include participants who are diagnosed with large incisional hernia and above 18 years Studies designed for comparing on-lay mesh and sub-lay mesh Randomized controlled trials and prospective or retrospective cohort studies were included. Provide sufficient details on the above outcome measures to allow comparison across studies and report quantitative data in addition to, published in full-text and in a peer-reviewed journal. Patients who are unfit for general anesthesia and refused surgery, in addition to papers with other languages than English and reviews, case reports or studies regarding animals were excluded.

Outcomes: Outcomes of this study included operative time, hospital stay postoperative recurrence, wound infection, seroma, hematoma and flap necrosis.

Quality assessment: Each article was assessed by two independent researchers based on the Cochrane Handbook 5.0.2 and data were extracted separately by the two researchers. The included trials were evaluated with the following criteria: adequate sequence generation, allocation concealment, blinding of participants and outcome assessors, incomplete outcome data, free of selective reporting and free of other bias. Each type of bias was defined by an answer (Yes/No/Unclear). “Yes” indicated low risk of bias, “No” represented high risk and “Unclear” represented unclear risk. In addition, the quality of evidence for each outcome was assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system(33). ¹⁰ Characteristics and quality assessment of enrolled studies are listed in Tables 5 and 6.

Table (1) Shows Quality Assessment in cohort studies

	Selection				Comparablibity	Outcome			Results
Study	Is the Case Definition Adequate?	Selection of Controls	Represent of the Cases	Definitin of Controls	Comparability of Cases and Controls on the Basis oF the Design Or Analysis	Assessment of Outcome	Was folow-up Long enough for outcomes To occur	Adequacyof follow-up of cohorts	GOOD \Fair \Poor
Soomro 2018	*		*		*	*	*	*	(6*)Fair
Saeed 2013	*	*	*	*	*	*	*	*	(8*)Good
ELBadawy 2020	*		*	*		*	*	*	(6*)Fair
Leithy 2013	*		*			*	*	*	(5*)Fair
Deen 2018	*		*	*		*	*	*	(6*)Fair
A.Iljin 2019	*		*			*	*	*	(5*)Fair

Table (2) Shows Quality Assessment in randomized controlled trials studies

Study	Adequate sequence generation	Allocation concealent	Blinding	Incomplete outcome data	Free of selective reporting	Free of other bias
Zaza Demetrashvili 2016	Yes	yes	Yes	Yes	unclear	unclear
Ahmed 2017	Yes	yes	Yes	Yes	yes	unclear
BarışSevinç 2018	Yes	yes	Yes	Yes	unclear	unclear
S.Natarajan 2017	yes	yes	Yes	Yes	yes	unclear

Statistical Analysis

Statistical analysis was performed by Open metanalyst version 5.3 software. The odds ratio (OR) with 95% confidence interval (95% CI) for dichotomous variables and the mean difference (MD) with 95% CI for continuous variables were computed in fixed-effect or random-effect model. Heterogeneity among trials was justified using Chi-squared test with P < 0.1 demonstrating statistical significance. The quantity of heterogeneity was measured by I2 and I2 > 50% indicated significant heterogeneity. If no significant heterogeneity was confirmed, we did the meta-analysis in fixed effect model. Or else, random-effect model was used

Ten trials included, regarding comparison between onlay and sublay mesh in large insicional hernia repair were selected from electronic databases .^{11,12,13,14,15,16,17,18,19,20}

The search process is shown in table (3).

Table(3):Outcome parameters: 1: recurrence 2: hospital stay 3: operative time 4: hematoma 5: seroma 6: infection 7: flap necrosis

Study	Study Design	Sample Size	Repair Method	FU/ Month	Outcome

Zaza Demetrashvili 2016	A randomised controlled trial	180	onlay vs sublay	72 ms	1,2,3,4,5,6
Ahmed 2017	A randomised controlled trial	65	onlay vs sublay	72 ms	1,2,3,5,6
Soomro 2018	prospective cohort	200	onlay vs sublay	24 ms	1,2,5,6,7
Saeed 2013	prospective cohort	80	onlay vs sublay	24 ms	1,2,3,4,5,6
Barış Sevinç 2018	A randomised controlled trial	100	onlay vs sublay	46 ms	2,3,4,5,6
EL BADAWY 2020	prospective cohort study	120	onlay vs sublay	24 ms	1,2,3,5,6
Leithy,2013	prospective cohort study	30	onlay vs sublay	12 ms	1,5,6,7
Deen 2018	prospective cohort study	40	onlay vs sublay	12 ms	1,2,3,4,5
S. Natarajan 2017	randonmized controlled trial	24	onlay vs sublay	6 ms	1,5,6
A. Iljin,2019	Retrospective cohort	40	onlay vs sublay	72 ms	1,2,3,4,5,6,7

Recurrence

Ten included studies described recurrence using onlay versus sublay with follow-up at least 3 months, Demetrashvili et al., Ahmed et al, somooro et al.,Saeed et al., Barış Sevinç et al., Badawy et al. in addition to,Leithy et al., Deen et al. S. Natarajan et al. and A. Iljin et al. with(P = 0.94, I2 = 0%) and OR 2.228, 95% CI 0.9, 5.378 and no statistically significance Fig.2

Infection

Ten included studies described infection using onlay versus sublay with follow-up at least 3 months, Demetrashvili et al., Ahmed et al, somooro et al.,Saeed et al., Barış Sevinç et al., in addition to,Leithy et al., Deen et al. S. Natarajan et al. and A. Iljin et al. with (P = 0.296, I2 = 16%) and OR 2.726, 95% CI 1.579, 4.705 and no statistically significance Fig. 3

Seroma

Seroma was assessed in nine included studies comparing between onlay verus sublay. Demetrashvili et al., Ahmed et al, somooroet al.,Saeed et al., Barış Sevinç et al., Badawy et al. in addition to, S. Natarajan et al. and A. Iljin et al. with (P = 0.917, I2 = 0%) and OR 4.962, 95% CI 3.038, 8.107 and no statistically significance Fig. 4

Hematoma

Hematoma was assessed in four included studies comparing between onlay verus sublay.

Demetrashvili et al. ,Saeed et al. ,Barış Sevinç et al. ,in addition to A.Iljin et al. with (P=0.534, I2=0%) and OR 0.860,95%CI 0.291,2.541 and no statistically significance Fig.5

Flap necrosis

Flap necrosis was assessed in four included studies comparing between onlay verus sublay with follow-up at least 3 months ,

Somooro etal., Badawy et al. in addition to, Leithy et al., and A.Iljin et al. with( P=0.923,I2=0%) and OR2.415,95% CI0.661,8.822 and no statistically significance Fig.6

Operative time

Eightincludedstudiesdescribedoperativetimeusingonlayversussublay,ZazaDemetrashvilietal.,Manzooretal,Imtiazetal.,Nadiaetal., BarışSevinçetal.,Hamedetal.inadditionto,Seifetal.andA.Iljinetal.with(P=0.001,I2=95.1%)andOR12.022,95%CI-31,460,5.616and thereisstatisticallysignificanceFig.7

Hospital stay

Seven included studies described hospital stay using onlay versus sublay, Demetrashvili et al., Ahmed et al, Saeed et al., Barış Sevinç et al., Badawy et al. in addition to, Deen et al. and A. Iljin et al. with (P = 0.001, I2 = 96.03%) and OR 2.726, 95% CI -1.250, 1.759 with statistically significance Fig. 8

Seroma Sensitivity

Regarding sensitivity in seroma in nine trials the overall effect is 4.729 by removing Demetrashvli et al. study overall effect is 6.640 and by removing Ahmed et al. study overall effect is 4.585 and by removing Somooro et al. overall effect is 4.172 by removing Barsevinc overall effect is 4.586, by removing Leithy et al. overall effect is 4.566, by removing Deen et al. overall effect is 4.808 and by removing A.ILjin overall effect is 4.709 there was a deviation on the result when leaving one paper out as seen in Fig.9

Recurrence Sensitivity

Regarding sensitivity in recurrence in ten trials the overall effect is 2.228 by removing Demetrashvli et al study overall effect is 2.296, and by removing Ahmed et al study overall effect is 2.335 and by removing Somooro et al overall effect is 2.066 by removing Saeed et al. overall effect is 1.985 Bar sevinc et al. overall effect is 2.601, by removing Badawy et al. overall effect is 2.103 Leithy et al. overall effect is 2.053, by removing seif et al. overall effect is 2.426, by removing S.Natarajan overall effect is 2.164 and by removing A.ILjin overall effect is 2.323 there was no deviation on the result when leaving one paper out as seein in Fig.10

Hematoma Sensivity

Regarding sensitivity in hematoma four trials the overall effect is 0.031 by removing Demetrashvli et al study overall effect is 0.044, and by removing Saeed et al. overall effect is 0.028 Bar sevinc et al. overall effect is 0.026 and by removing A.ILjin overall effect is 0.032 there was a deviation on the result when leaving one paper out as seein in Fig 11

Flap Necrosis Sensitivity

Regarding sensitivity in flap necrosis in four trials the overall effect is 2.415 by removing Saeedet al overall effect is 2.048, by removing Badawy et al. overall effect is 2.927 by removing Leithy et al. overall effect is 2.291 and by removing A.ILjin overall effect is 2.683 there was no deviation on the result when leaving one paper out as seen in Fig.12

Operative Time Sensitivity

Regarding sensitivity in operative time in eight trials the overall effect is 99.7 by removing Demetrashvli et al study overall effect is 96.23, and by removing Ahmed et al study overall effect is 98.35 and by removing Somooro et al overall effect is 97.025 by removing Saeed et al. overall effect is 99.209 Bar sevinc et al. overall effect is 105.88, by removing Badawy et al. overall effect is 100, by removing Deen et al. overall effect is 102.346 and by removing A.ILjin overall effect is 99.088 there was no deviation on the result when leaving one paper out as seein in Fig.13

Hospital Stay Sensitivity

Regarding sensitivity in hospital stay in seven trials the overall effect is 0.254 by removing Demetrashvli et al. study overall effect is 2.239, and by removing Ahmed et al. study overall effect is-0.322 and by removing Saeed et al. overall effect is 0.625 Barsevinc et al. overall effect is 0.328, by removing Badawy et al. overall effect is 0.188 by removing Deen et al. overall effect is -0.063

and by removing A.ILjin overall effect is 0.787 there was no deviation on the result when leaving one paper out as seen in Fig. 14

Infection Sensitivity

Regarding sensitivity in infection in ten trials the overall effect is 2.726 by removing Demetrashvli et al. study overall effect is 2.471, and by removing Ahmed et al. study overall effect is 2.786 and by removing Somooro et al. overall effect is 2.483 by removing Saeed et al. overall effect is 3.237 Barsevin et al. overall effect is 2.927, by removing Badawy et al. overall effect is 2.573 Leithy et al. overall effect is 2.544, by removing Deen et al. overall effect is 2.648, by removing

S.Natarajan overall effect is 2.710 and by removing A.ILjin overall effect is 2.912 there was no deviation on the result when leaving one paper out as seen in Fig.15

The current meta-analysis is to compare between intra-operative difficulties and post-operative complications in elective repair of large incisional hernias using on-lay mesh and sub-lay mesh. We have comprehensively searched and assessed the published literature regarding this topic. We have focused solely on the data regarding the comparison between on-lay mesh and sub-lay mesh using the random-effects model.

Repair of incisional hernia is regarded as one of the most challenging general surgical procedure, due to the high recurrence rate and post-operative morbidity. Open mesh repair (onlay and sublay technique) is proved to be superior to suture repair. However due to the presence of mesh this technique is not without morbidity such as wound complication like seroma formation and infection. ²¹ In our study ten trials included comparison between onlay and sublay mesh in large insicional hernia repair were selected from electronic databases.

As regards recurrence, ten included studies described recurrence using onlay versus sublay with follow-up at least 3 months, Demetrashvili et al. stated 4 patients suffered from recurrence in 72 months follow-up using onlay method and 2 patients using sublay method, Ahmed r et al. stated zero patients suffered from recurrence in 72 months follow-up using onlay method and also zero patients using sublay method, Somooro et al. stated 2 patients suffered from recurrence in 24 months follow-up using onlay method and zero patients using sublay method and

Saeed et al. stated 3 patients suffered from recurrence in 24 months follow-up using onlay method and zero patients using sublay method, Barış Sevinç et al. stated zero patients suffered from recurrence in 46 months follow-up using onlay method and one patients using sublay method, Badawy et al. stated three patients suffered from recurrence in 24 months follow-up using onlay method and one patient using sublay method,

In addition to,Leithy et al. stated 2 patients suffered from recurrence in 12 months follow-up using onlay method and zero patient using sublay method, Deen et al. stated one patient suffered from recurrence in 12 months follow-up using onlay method and one patient using sublay method S. Natarajan et al. stated one patient suffered from recurrence in 6 months follow-up using onlay method and zero patient using sublay method and A. Iljin et al. stated zero patient suffered from recurrence in 72 months follow-up using onlay method and zero patient using sublay method (P = 0.94, I2 = 0%) and OR 2.228, 95% CI 0.9, 5.378 and no statistically significance.

Regarding infection, ten included studies described infection using onlay versus sublay with follow-up at least 3 months, Demetrashvili et al. stated 39 patients in 72 months follow-up using onlay method and 17 patients using sublay method, Ahmed et al. stated 6 patients in 72 months follow-up using onlay method and also 3 patients using sublay method, Somooro et al. stated 18 patients in 24 months follow-up using onlay method and 2 patients using sublay method and Saeed et al. stated 2 patients in 24 months follow-up using onlay method and 4 patients using sublay method, Barış Sevinç et al. stated 2 patients in 46 months follow-up using onlay method and 2 patients using sublay method Badawy et al. stated 7 patients in 24 months follow-up using onlay method and 2 patient using sublay method. In addition to, Leithy et al. stated 6 patients in 12 months follow-up using onlay method and 1 patient using sublay method, Deen et al. stated 3 patients in 12 months follow-up using onlay method and one patient using sublay method, S. Natarajan et al. stated 2 patients in 6 months follow-up using onlay method and 1 patient using sublay method and

A. Iljin et al. stated 2 patients in 72 months follow-up using onlay method and 2 patients using sublay method (P = 0.296, I2 = 16%) and OR 2.726, 95% CI 1.579, 4.705 and no statistically significance.

In addition to, Seroma was assessed in nine included studies comparing between onlay verus sublay.

Demetrashvili et al. stated 32 patients in 72 months follow-up using onlay method and 13 patients using sublay method, Ahmed et al. stated 13 patients in 72 months follow-up using onlay method and also 3 patients using sublay method, Somooro et al. stated 24 patients in 24 months follow-up using onlay method and 4 patients using sublay method andSaeed et al. stated 3 patients in 24 months follow-up using onlay method and zero patient using sublay method, Barış Sevinç et al. stated 7 patients in 46 months follow-up using onlay method and 1 patient using sublay method.

In addition to, Leithy et al. stated 6 patients in 12 months follow-up using onlay method and 1 patient using sublay method, Deen et al. stated 3 patients in 12 months follow-up using onlay method and one patient using sublay method, S. Natarajan et al. stated 5 patients in 6 months follow-up using onlay method and zero patient using sublay method and A. Iljin et al. stated 212 patients in 72 months follow-up using onlay method and zero patient using sublay method (P = 0.917, I2 = 0%) and OR 4.962, 95% CI 3.038, 8.107 and no statistically significance.

While, hematoma was assessed in four included studies comparing between onlay verus sublay.

Demetrashvili et al. stated 2 patients using onlay method and 2 patients using sublay method,Saeed et al. stated 2 patients using onlay method and 5 patients using sublay method, Barış Sevinç et al. stated 3 patients using onlay method and 1 patient using sublay method.

In addition to, A. Iljin et al. stated zero patient using onlay method and zero patient using sublay method (P = 0.534, I2 = 0%) and OR 0.860, 95% CI 0.291, 2.541 and no statistically significance.

Flap necrosis was assessed in four included studies comparing between onlay verus sublay.

Somooro et al. stated 2 patients in 24 months follow-up using onlay method and zero patient using sublay method and Badawy et al. stated 4 patients in 24 months follow-up using onlay method and 2 patients using sublay method.

In addition to, Leithy et al. stated 1 patient in 12 months follow-up using onlay method and zero patient using sublay method, A. Iljin et al. stated zero patient in 72 months follow-up using onlay method and zero patient using sublay method (P = 0.923, I2 = 0%) and OR 2.415, 95% CI 0.661, 8.822and no statistically significance.

Regarding operative time, eight included studies described operative time using onlay versus sublay, Demetrashvili et al. stated 124 minutes mean time with standard deviation 34 using onlay mesh and 155 minutes with standard deviation 42 using sublay mesh, Ahmed et al. stated 110 minutes mean time with standard deviation 30 using onlay mesh and 80 minutes with standard deviation 32 using sublay mesh, Somooro et al. stated 120 minutes mean time with standard deviation 26 using onlay mesh and 100 minutes with standard deviation 30 using sublay mesh and, Barış Sevinç et al. stated 56 minutes mean time with standard deviation 7 using onlay mesh and 73 minutes with standard deviation 17 using sublay mesh, Deen et al. stated 83 minutes mean time with standard deviation 10 using onlay mesh and 89 minutes with standard deviation 7 using sublay mesh and A. Iljin et al. stated 105 minutes mean time with standard deviation 30 using onlay mesh and 180 minutes with standard deviation 30 using sublay mesh (P = 0.001, I2 = 95.1%) and OR 12.022, 95% CI -31,460, 5.616 and there is statistically significance.

Regarding hospital stay, seven included studies described hospital stay using onlay versus sublay, Demetrashvili et al. stated 5.5 mean time with standard deviation 2.5 using onlay mesh and 5 mean with standard deviation 2.5 using sublay mesh, Ahmed et al. stated 8 days mean time with standard deviation 4 using onlay mesh and 4 mean time with standard deviation 2 using sublay mesh, Saeed et al. stated 2 days mean time with standard deviation 0.8 using onlay mesh and 3.9 mean time with standard deviation 1.9 using sublay mesh and, Barış Sevinç et al. stated 3.3 mean time with standard deviation 1.9 using onlay mesh and 3.5 mean with standard deviation 2.56 using sublay mesh, Badawy et al. stated 4.3 mean time with standard deviation 3.7 using onlay mesh and 3.6 mean with standard deviation 2 using sublay mesh and Deen et al. stated 4.6 mean time with standard deviation 0.3 using onlay mesh and 2.6 mean time with standard deviation 0.7 using sublay mesh and A. Iljin et al. stated 5 mean time with standard deviation 3 using onlay mesh and 8.5 mean time with standard deviation 3 using sublay mesh (P = 0.001, I2 = 96.03%) and OR 2.726, 95% CI -1.250, 1.759 with statistically significance.

Limitations

This meta- analysis is limited by the level of evidence and qualities of the studies analyzed. Although most studies did report similar objective criteria to measure treatment outcomes, many studies employed different grading systems. Only small number of studies performed power analyses. Moreover, it was difficult to reach a greater sample size and we did not have complete homogeneity with the method of scintigraphy because the studies were done in different institutions. Selection bias was also present, as many of these studies were retrospective reviews.

According to our results, there is a statistical difference between onlay and sublay regarding intra-operative time as sublay mesh is more time consuming.

Regarding post-operative complications there is no statistical difference in recurrence, seroma, hematoma, flap necrosis and infection but there is a statistical difference regarding in hospital stay as patients with sublay repair stays less than onlay.

Ethical approval and consent to participate :

Not applicable as my thesis is a meta-analysis

Availability of data and materials:

Ten trials included, regarding comparison between onlay and sublay mesh in large insicional hernia repair were selected from electronic databases .^{11,12,13,14,15,16,17,18,19,20}

Conflict of interests :

Not applicable

Funding :

Not applicable

Authors' contribution:

B.H and K.L and P.A . have made a substantial contribution to the concept , design of the article , the acquisition, analysis, and interpretation of data for the article

B.E and F.F and S.M have revised the article critically for important intellectual content and approved the version to be published.

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No competing interests reported.

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A Comparative Study in Elective Repair of Large Incisional Hernia using On-lay Mesh Versus Sub-lay Mesh A Meta-Analysis

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