World J Surg (2014) 38:2233–2240 DOI 10.1007/s00268-014-2578-z
Laparoscopic Versus Open Incisional and Ventral Hernia Repair: A Systematic Review and Meta-analysis Yanyan Zhang • Haiyang Zhou • Yunsheng Chai Can Cao • Kaizhou Jin • Zhiqian Hu
•
Published online: 29 April 2014 Ó Socie´te´ Internationale de Chirurgie 2014
Abstract Background Laparoscopic incisional and ventral hernia repair (LIVHR) is an alternative approach to conventional open incisional and ventral hernia repair (OIVHR). A consensus on outcomes of LIVHR when compared with OIVHR has not been reached. Methods As the basis for the present study, we performed a systematic review and meta-analysis of all randomized controlled trials comparing LIVHR and OIVHR. Results Eleven studies involving 1,003 patients were enrolled. The incidences of wound infection were significantly lower in the laparoscopic group than that in the open group (laparoscopic group 2.8 %, open group 16.2 %; RR = 0.19, 95 % CI 0.11–0.32; P \ 0.00001). The rates of wound drainage were significantly lower in the laparoscopic group than that in the open group (laparoscopic group 2.6 %, open group 67.0 %; RR = 0.06, 95 % CI 0.03–0.09; P \ 0.00001). However, the rates of bowel injury were significantly higher in the laparoscopic group than in the open group (laparoscopic group 4.3 %, Yanyan Zhang, Haiyang Zhou, and Yunsheng Chai contributed equally to this work. Y. Zhang H. Zhou (&) Y. Chai K. Jin Z. Hu (&) Department of General Surgery, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai 200003, People’s Republic of China e-mail: [email protected] Z. Hu e-mail: [email protected] C. Cao State Key Laboratory of Molecular Biology, Institute of Biochemistry and Cell Biology, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, People’s Republic of China
open group 0.81 %; RR = 3.68, 95 % CI 1.56–8.67; P = 0.003). There were no significant differences between the two groups in the incidences of hernia recurrence, postoperative seroma, hematoma, bowel obstruction, bleeding, and reoperation. Descriptive analyses showed a shorter length of hospital stay in the laparoscopic group. Conclusions Laparoscopic incisional and ventral hernia repair is a feasible and effective alternative to the open technique. It is associated with lower incidences of wound infection and shorter length of hospital stay. However, caution is required because it is associated with an increased risk of bowel injury compared with the open technique. Given the relatively short follow-up duration of trials included in the systematic review, trials with longterm follow-up are needed to compare the durability of laparoscopic and open repair.
Introduction Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired (incisional). Incisional ventral hernia (IVH) is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds and in up to 20 % of patients who develop postoperative wound infections [1]. IVH is associated with complications such as pain, incarceration, and obstruction of the intestinal lumen, as well as strangulation and ischemia of the hernia contents. Therefore, it often requires surgical intervention. Unfortunately, the results of IVH repair are disappointing; in fact, IVH repaired by suturing has high recurrence rates in the range of 12–54 % [2–4]. Thanks to the use of meshes in tension-free repair of IVH, the
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recurrence rates have been greatly reduced to the range of 2–36 % [5–7]. Thus it has become the gold standard treatment. However, the conventional open incisional and ventral hernia repair (OIVHR) often requires significant soft-tissue dissection, which may cause several postoperative complications, such as wound infection, hematomas, and painful recovery. Hence, there is an ongoing search for better techniques. The use of laparoscopic technique in the treatment of IVH, first reported in 1993 by LeBlanc and Booth, marked a step forward [8]. After 20 years of development, laparoscopic incisional and ventral hernia repair (LIVHR) is now widely performed all over the world with the expectation of earlier recovery, fewer complications, and decreased recurrence rates [9]. As a consensus regarding outcome when comparing LVIHR with OVIHR has not been reached [10], we conducted a systematic review and meta-analysis to provide the current best evidence on this topic.
Materials and method Data sources and selection criteria Relevant studies were identified and selected by searching several databases, including Medline, Embase, Cochrane controlled trials register, and Science citation index (updated to July 2013) under the search terms ‘‘abdominal wall hernia’’ or ‘‘ventral hernia’’ or ‘‘incisional hernia,’’ and ‘‘laparoscopic’’ or ‘‘laparoscopy,’’ and ‘‘randomized controlled trial’’ or ‘‘RCT,’’ as well as a review of reference bibliographies from original research articles and reviews. Two authors (Y. Z. and H. Z.) reviewed the articles for the inclusion criteria as follows: (1) study design: RCTs; (2) study population: patients undergoing IVH repair (including congenital and acquired); (3) intervention: comparison between laparoscopic and open IVH repair; (4) outcomes: each study should contain information on the incidences of hernia recurrence; (5) the study must have been published in English. The exclusion criteria included repeat publication of a study, articles describing other types of hernias, and non-RCTs. Data extraction and outcomes of interest Data extractions were performed by two reviewers (Y. Z. and H. Z.) independently, and the results were checked by a third reviewer (Y. C.). Data extracted from the studies included the following: (1) patient characteristics [age, body mass index (BMI), gender ratio, defect size, types of prosthesis, surgical technique, and duration of follow-up]; (2) effectiveness outcomes (hernia recurrence, conversion to open surgery, operative time, and length of hospital
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stay); (3) safety outcomes (wound drainage usage, wound infection, bowel injury, postoperative seroma, hematoma, bowel obstruction, bleeding, reoperation, and pain). Quality appraisal and publication bias Methodological quality was assessed with the Jadad composite scale [11]. This is a 7-point quality scale, with lowquality studies scoring 1–3 points and high-quality studies scoring 4–7 points. Each study included in the systematic review was given an overall quality score based on the Jadad composite scale. To check publication bias, a funnel plot was constructed using Egger’s linear regression method [12]. Statistical methods The effect measures estimated were weighted mean difference (WMD) for continuous data and risk ratio (RR) for dichotomous data, both reported with 95 % confidence intervals (CI). Summary RR (or WMD) and their corresponding 95 % CI were estimated by a fixed effect model (Mantel–Haenszel) or a random effect (DerSimonian and Laird) model. Tests for heterogeneity were performed with each meta-analysis using the Cochran Q statistic and the I2 test, with P \ 0.05 indicating significant heterogeneity. The random effect model was used when heterogeneity was present. Statistical analyses were performed with the RevMan 5.0 and STATA 9.0 software packages. A P value\0.05 was considered statistically significant.
Results Characteristics of the included studies A total of 135 records were identified by the search strategy; 124 records were excluded for the reasons shown in Fig. 1. Finally, 11 RCTs were included in the meta-analysis (Table 1) [13–23]. The meta-analysis involved 1,003 patients: 501 were randomized to the laparoscopic group and 502 to the open group. The two groups were comparable with regard to patient age, BMI, and hernia size. The meshes were placed exceeding the edge of the incision by more than 3 cm in all the trials. The prosthetic grafts used in the studies included polypropylene and polytetrafluoroethylene (PTFE), among various other types of prosthesis. Suturing, stapling, or both techniques were applied in included studies. Follow-up ranged from 2 to 35 months. The methodological quality scores ranged from 2 to 5. Five studies were low-quality studies, with Jadad scores of 2–3 points. The other 6 were high-quality studies, with JADAD scores of 4–5 points (Table 2).
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Fig. 1 Flow chart shows the method of inclusion of trials in the meta-analysis
Table 1 Baseline characteristics of trials included in meta-analysis Author
Patients (LR/ OR)
Age (LR/ OR), years
BMI (LR/OR)
Hernia size (LR/OR)
Overlap (LR/OR), cm
Mesh type (LR/OR)
Fixed (LR/OR)
Conversion to OR
Follow-up (loss) (LR/OR), months
Carbajo et al. [19]
30/30
57.8/54.9
–
139.5/ 141.23 cm2
–
P2/ P1?P2
S?A/ S?A
–
27/27
Moreno-Egea et al. [20]
11/11
60.7/58.6
–
–
–
P1/P1
S/S
–
–
Misra et al. [22]
33/33
45.96/ 45.2
26.28/ 25.43
65.66/ 42.12 cm2
3–5/3
P1/P1
S/S
–
13.73(2)/ 12.9(5)
Barbaros et al. [17]
23/23
50.7/54.1
31.6/31.2
–
3/5
P1/P1
S?A/S
–
18/20
Olmi et al. [18]
85/85
60/65
28/28
9.7/10.5 cm
9.7/10.5
P3/P1
A/S
–
24/24
5/4–5
P1?P2/ P1
S/S
–
6/6
2
Navarra et al. [21]
12/12
59.3/64.1
–
37.2/45.2 cm
Pring et al. [23]
31/27
64.5/55
–
23.8/23.2 cm2
3–4/3–4
P2/P2
S/S
–
18/24
Asencio et al. [14]
45/39
58.02/ 60.55
31.35/ 30.61
9.51/10.18 cm
3/3
P2/P1
S?A/S
5
12(6)/12(4)
Itani et al. [16]
73/73
61.2/59.6
30.6/31.2
45.7/45.9 cm2
3/3
P2/P1
S?A/S
10
2(7)/2(6)
Eker et al. [15]
94/100
59.1/56.7
28.3/29.3
5/5 cm
5/5
P1/P1
S/S
8
35/35
5/5
P3/P1
S/A
5
2(0)/2(2)
Rogmark et al. [13]
64/69
58/58
29.3/29.3
36/25 cm
2
S sutures; A staples; S?A sutures and staples; – not reported; P1 polypropylene mesh; P2 polytetrafluoroethylene (PTFE); P3 others
Effectiveness outcomes Four studies reported that 28 of 276 procedures (10.1 %) were converted from laparoscopic repair to open repair during the operation [13–16]. Because of the heterogeneous data of included studies, pooled analyses of
operative time and length of hospital stay could not be performed. Six studies [14–19] showed a significant difference in duration of surgery (Table 3). Among those six studies, two [18, 19] reported that laparoscopic repair was faster, and four others [14–17] stated the opposite conclusion. Six studies [17–22] showed a significant difference in
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Table 2 Jadad quality score of trials included in meta-analysis
Author
Randomization
Concealment of allocation
Double blinding
Withdrawals and dropouts
Total score
Carbajo et al. [19]
1
1
0
0
2
Moreno-Egea et al. [20]
2
1
0
0
3
Misra et al. [22]
2
2
0
0
4
Barbaros et al. [17]
2
2
0
0
4
Olmi et al. [18]
1
1
0
0
2
Navarra et al. [21]
2
2
0
0
4
Pring et al. [23]
1
1
0
0
2
Asencio et al. [14]
1
1
0
0
2
Itani et al. [16]
2
2
0
0
4
Eker et al. [15]
2
2
0
0
4
Rogmark et al. [13]
2
2
0
1
5
Table 3 Operative time Table 4 Hospital stay Author
Mean operative time, min Author
Carbajo et al. [19] Moreno-Egea et al. [20]
Laparoscopic repair
Open repair
87 (30–180)a
111.5 (60–180)a
41 (29–65)
a
Laparoscopic repair \0.05
45 (27–65)a a
Misra et al. [22]
75 (25–245)
86 (30–150)
Barbaros et al. [17]
99 (32)c
72 (18)c
0.08 a
0.371
Olmi et al. [18]
2.7 (2.2, 3.2)b
88.7 (60–190)a
0.15
Pring et al. [23]
43.5 (14)c
42.5 (11.2)c
0.77
155
127 c
Eker et al. [15]
100 (49)
Rogmark et al. [13]
100 (70–139)a
a
Ranges
b
95 % confidence interval
c
76 (33)
\0.001 0.02
c
110 (78–137)a
0.001 \0.05
Standard deviation
length of hospital stay, consistently indicating a shorter length of hospital stay in the laparoscopic group (Table 4). There was no significant difference in the rates of hernia recurrence between the laparoscopic group and the open group (laparoscopic group 6.99 %, open group 4.82 %; RR = 1.21, 95 % CI 0.77–1.91; P = 0.41) (Fig. 2) Safety outcomes The incidence of wound infection was significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.8 %, open group 16.2 %; RR = 0.19, 95 % CI 0.11–0.32; P \ 0.00001) (Fig. 3). The rates of wound
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Navarra et al. [21] Pring et al. [23]
c
P value
9.06 (3–21)a
\0.05
5.2 (2–9)a
\0.001
6.3 (4.2)c
a
5.7 (1–13) 1 (1–2)
a
Open repair
3.43 (1–34)a
\0.005
73.7 (45–140)a
Itani et al. [16]
1.47 (1–3)a 2.5 (1.5)
Navarra et al. [21]
70.0 (62.9, 77.0)
1 (5 h–2 days)
Barbaros et al. [17]
150.9 (132.1, 169.7)b
101.9 (91.7, 112.1)b
Moreno-Egea et al. [20]
2.23 (1–15)a
Misra et al. [22]
61.0 (54.1, 68.9)b
b
Carbajo et al. [19]
\0.05
Olmi et al. [18]
Asencio et al. [14]
Mean length of hospital stay, days
P value
d
0.007 \0.05
9.9 (5.2, 14.6)b \0.005 10 (5–19)a
0.006
1 (1–1.8)d
0.43
Asencio et al. [14]
3.5 (2.7, 4.2)b
3.3 (2.8, 3.9)b
0.787
Itani et al. [16]
3.9 (3.1)c
4.0 (3.5)c
0.91
Eker et al. [15] Rogmark et al. [13] a
a
3 (2–4) 2 (1.5–3)a
a
3 (2–5) 2 (1–3)a
0.50 \0.861
Ranges
b
95 % confidence interval
c
Standard deviation
d
Interquartile range
drainage were significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.6 %, open group 67.0 %; RR = 0.06, 95 % CI 0.03–0.09; P \ 0.00001) (Fig. 4). However, the rates of bowel injury were significantly higher in the laparoscopic group than in the open group (laparoscopic group 4.3 %, open group 0.81 %; RR = 3.68, 95 % CI 1.56–8.67; P = 0.003) (Fig. 5). There was no significant difference between the two groups in the incidences of postoperative seroma, hematoma, bowel obstruction, bleeding, or reoperation (Table 5).
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Fig. 2 Forest plot shows meta-analysis of hernia recurrence rates
Fig. 3 Forest plot shows meta-analysis of wound infection rates
Fig. 4 Forest plot shows meta-analysis of wound drainage rates
Among the 11 included studies, 8 reported the results of postoperative pain (Table 6) [13–17, 21–23]. All of them showed no significant difference in postoperative pain between the laparoscopic and open groups. Heterogeneity and publication bias Significant heterogeneity was found in two outcomes (wound drainage usage, P = 0.007; seroma formation, P = 0.003). Thus we used the random effects model to pool results of the two outcomes. No significant heterogeneity was shown in other outcomes, for which we used the fixed effects model to pool the results. We assessed the publication bias based on the results of hernia recurrence. No evidence of publication bias existed in the studies included in the meta-analysis, based on the Egger’s publication bias plots (Fig. 6).
Discussion This systematic review and meta-analysis examined the current best evidence comparing the outcomes of laparoscopic and open incisional and ventral hernia repair. Eleven studies involving 1,003 patients were identified in the systematic review. Compared with open repair, the laparoscopic approach was found to have lower rates of wound infection and wound drainage, higher rates of bowel injury, and shorter length of hospital stay. There was no significant difference between the two groups in the incidences of hernia recurrence and other postoperative complications, as well as in postoperative pain. Four studies reported that 28 of 276 procedures (10.1 %) were converted from laparoscopic repair to open repair during the operation, which implied that LIVHR was a technically demanding procedure that might not be
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Fig. 5 Forest plot shows meta-analysis of bowel injury rates
Table 5 Results of metaanalysis comparing laparoscopic versus open repair for incisional ventral hernia
Model
RR/ WMD
0.91
Fix
1.21
10.26
Fix
0.19
0.003
Random
0.99
0.97
0.46, .10
0.45
Fix
0.94
0.82
0.53, .65
0.57
Fix
3.68
0.003
1.58, .67
1.72
0.79
Fix
1.58
0.40
0.55, .58
0.32
0.85
Fix
1.88
0.42
0.41, .71
Outcomes
No. of studies
No. of patients
Recurrence
11
1,003
2.66
Wound infection
11
1,003
0.25
Seroma
9
893
23.55
hematoma
8
768
6.77
Bowel injury
10
977
4.78
Bowel obstruction
6
711
RR risk ratio; WMD weighted mean difference; HG heterogeneity; Fix fix effect model; Random random effects model
Postoperative bleeding
3
473
Table 6 Postoperative pain
Author
4
431
2.79
0.42
Fix
0.42
Wound drainage
8
752
19.31
0.007
Random
0.06
P value 0.333
Laparoscopic repair
Open repair
3.77
3.50
P value 0.41 \0.00001
0.07 \0.00001
95 % CI 0.77, .91 0.11, .32
0.16, .09 0.03, .09
Injection analgesic doses in first 3 days (VAS score)
Barbaros et al. [17] [0.05
1.53
1.61
Postoperative pain scoring
Navarra et al. [21]
0.05
1.4 (range 0–3)
4.9 (range 2–8)
Analgesic requirement
Pring et al. [23]
0.2
5 (4–6.3)
5 (5–7)
Median pain score at 4 days (IR)
10.38 (1.98–10.01)
6 (4.93–5.83)
Mean VAS (0–100) (1 year) 95 % CI
Asencio et al. [14]
[0.05
Itani et al. [16]
0.07
19.2
18.0
Perception of worst pain (8 weeks)
Eker et al. [15]
0.54
23
24
Analgesia use
\10
\10
Mean VAS score (30 days)
Rogmark et al. [13] [0.05
appropriate in all cases. The conversion usually occurred because of intraoperative complications, such as bleeding or organ injury (bowel or bladder). In such situations, surgeons are advised to convert to an open procedure without hesitation, which could reduce the incidence of postoperative complications and lead to an uneventful recovery.
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HG, P value
Reoperative
Misra et al. [22]
VAS visual analog scale; IR interquartile range
HG, v2
Because of the heterogeneous data in the studies included, pooled analyses of operative time and length of hospital stay could not be performed. According to the descriptive analyses, included studies had conflicting operative times. One possible explanation is that many confounding factors, such as the surgeons’ experience, location and size of the hernias, and the surgical technique,
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Fig. 6 Egger’s publication bias plots for hernia recurrence
could affect the operative time. As for the length of hospital stay, the results seemed to be consistent among the studies. Laparoscopic repair reduced the length of hospital stay compared with open repair. This might be mainly owing to the disadvantages of the open technique that include the need for soft-tissue dissection and undermining to raise subcutaneous skin flaps, which have the potential for increased morbidity and prolonged convalescence [24]. There was no significant difference between the two groups in the incidence of hernia recurrence. Our metaanalysis found low incidences of recurrence after both procedures (laparoscopic group 7.0 %; open group 5.8 %). The results showed that laparoscopic repair if not better, was as efficient as open repair. However, the results were not conclusive because of the relatively short follow-up (2–35 months) and the heterogeneities of trials included in the systematic review. It deserves attention that the use of mesh and its proper placement, such as exceeding the edge of the incision by about 3–5 cm, could reduce hernia recurrence, no matter which approach is used [25]. The rates of wound drainage were significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.6 %, open group 67.0 %; P \ 0.00001). Because open repair is associated with more soft tissue damage, a larger surgical wound, and more bleeding, wound drainage is mandatory in most situations to clear seepage. However, drainage may increase the incidence of wound infection and the severity of postoperative pain, and it may also prolong the postoperative hospital stay [26]. The wound infection rates were significantly lower in the laparoscopic group than that in the open group (laparoscopic 2.8 %, open 16.2 %; P \ 0.00001). The minimally invasive approach eliminates the need for tissue undermining and wound drainage, thereby minimizes the inherent wound healing problems associated with the open technique.
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Despite the advantage of laparoscopic repair in reducing the incidence of wound infection, the risk of bowel injury was significantly higher in the laparoscopic group than that in the open group (laparoscopic group 4.3 %, open group 0.81 %; P = 0.003). Abdominal adhesion presents a particular problem during laparoscopic repair, with the attendant risk of bowel injury during establishment of pneumoperitoneum and in dissection around the neck of the hernia. If intraoperative bowel injury cannot be dealt with promptly, 30 % of patients may eventually die from intestinal perforation and acute peritonitis [27]. Thus, the surgeon must be careful, and recognize and repair the injury promptly. As for other postoperative complications, there were no significant differences between the two groups. Minimally invasive procedures are often assumed by patients and surgeons to be less painful. However, this did not prove to be true in LIVHR. There were consistent findings that postoperative pain was not different between the laparoscopic and open groups. Our own experience also suggest that patients often have considerable discomfort after laparoscopic repair. Although the exact reason is unclear, we may suppose that the postoperative pain should be mainly attributed to the hernioplasty, no matter which approach is used. Our study has several limitations. First, there was significant heterogeneity among the included trials. The first possible cause of heterogeneity is research bias, as all included trials were not performed under double-blind conditions. The second possible cause of heterogeneity is the presence of confounding variables [e.g., different hernia sizes and locations, different meshes, patients with variable surgical risks: patients of American Society of Anesthesiologists (ASA) categories I–IV]. A second limitation is that the trials included in the systematic review used dissimilar definitions of complications, making comparison across studies difficult. Third, there was significant variability in operative techniques among the trials, as shown in Table 1. Based on the systematic review and meta-analysis, we conclude that LIVHR is a feasible and effective alternative to the open technique. It is associated with lower incidences of wound infection and shorter length of hospital stay. However, caution is required because the laparoscopic procedure is associated with an increased risk of bowel injury compared with the open technique. Given the relatively short follow-up duration of trials included in the systematic review, trials with long-term follow-up are needed to compare the durability of laparoscopic and open repair. Acknowledgments This work was supported by the National Natural Science Foundation of China (No. 31100681), Shanghai Nanotechnology Program (No. 11nm0504800), Shanghai Basic Research
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Program (No. 12JC1411402), and Shanghai Rising Star Program (No. 11CG42). 14. Conflict of interest Yanyan Zhang, Haiyang Zhou, Yunsheng Chai, Can Cao, Kaizhou Jin, and Zhiqian Hu have no conflicts of interest or financial ties to disclose.
15.
16.
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(prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg 258:37–45 Asencio F, Aguilo J, Peiro S et al (2009) Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc 23:1441–1448 Eker HH, Hansson BM, Buunen M et al (2013) Laparoscopic vs. open incisional hernia repair: a randomized clinical trial. JAMA Surg 148:259–263 Itani KM, Hur K, Kim LT et al (2010) Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg 145:322–328 Barbaros U, Asoglu O, Seven R et al (2007) The comparison of laparoscopic and open ventral hernia repairs: a prospective randomized study. Hernia 11:51–56 Olmi S, Scaini A, Cesana GC et al (2007) Laparoscopic versus open incisional hernia repair: an open randomized controlled study. Surg Endosc 21:555–559 Carbajo MA, Martin del Olmo JC, Blanco JI et al (1999) Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh. Surg Endosc 13:250–252 Moreno-Egea A, Carrasco L, Girela E et al (2002) Open vs laparoscopic repair of spigelian hernia: a prospective randomized trial. Arch Surg 137:1266–1268 Navarra G, Musolino C, De Marco ML et al (2007) Retromuscular sutured incisional hernia repair: a randomized controlled trial to compare open and laparoscopic approach. Surg Laparosc Endosc Percutan Tech 17:86–90 Misra MC, Bansal VK, Kulkarni MP et al (2006) Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study. Surg Endosc 20:1839–1845 Pring CM, Tran V, O’Rourke N et al (2008) Laparoscopic versus open ventral hernia repair: a randomized controlled trial. ANZ J Surg 78:903–906 Perrone JM, Soper NJ, Eagon JC et al (2005) Perioperative outcomes and complications of laparoscopic ventral hernia repair. Surgery 138:708–715 Rudmik LR, Schieman C, Dixon E et al (2006) Laparoscopic incisional hernia repair: a review of the literature. Hernia 10:110–119 Gurusamy KS, Allen VB, Samraj K (2012) Wound drains after incisional hernia repair. Cochrane Database Syst Rev 2:CD005570 Pierce RA, Spitler JA, Frisella MM et al (2007) Pooled data analysis of laparoscopic vs. open ventral hernia repair: 14 years of patient data accrual. Surg Endosc 21:378–386
Laparoscopic Versus Open Incisional and Ventral Hernia Repair: A Systematic Review and Meta-analysis Yanyan Zhang • Haiyang Zhou • Yunsheng Chai Can Cao • Kaizhou Jin • Zhiqian Hu
•
Published online: 29 April 2014 Ó Socie´te´ Internationale de Chirurgie 2014
Abstract Background Laparoscopic incisional and ventral hernia repair (LIVHR) is an alternative approach to conventional open incisional and ventral hernia repair (OIVHR). A consensus on outcomes of LIVHR when compared with OIVHR has not been reached. Methods As the basis for the present study, we performed a systematic review and meta-analysis of all randomized controlled trials comparing LIVHR and OIVHR. Results Eleven studies involving 1,003 patients were enrolled. The incidences of wound infection were significantly lower in the laparoscopic group than that in the open group (laparoscopic group 2.8 %, open group 16.2 %; RR = 0.19, 95 % CI 0.11–0.32; P \ 0.00001). The rates of wound drainage were significantly lower in the laparoscopic group than that in the open group (laparoscopic group 2.6 %, open group 67.0 %; RR = 0.06, 95 % CI 0.03–0.09; P \ 0.00001). However, the rates of bowel injury were significantly higher in the laparoscopic group than in the open group (laparoscopic group 4.3 %, Yanyan Zhang, Haiyang Zhou, and Yunsheng Chai contributed equally to this work. Y. Zhang H. Zhou (&) Y. Chai K. Jin Z. Hu (&) Department of General Surgery, Changzheng Hospital, Second Military Medical University, No. 415 Fengyang Road, Shanghai 200003, People’s Republic of China e-mail: [email protected] Z. Hu e-mail: [email protected] C. Cao State Key Laboratory of Molecular Biology, Institute of Biochemistry and Cell Biology, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, People’s Republic of China
open group 0.81 %; RR = 3.68, 95 % CI 1.56–8.67; P = 0.003). There were no significant differences between the two groups in the incidences of hernia recurrence, postoperative seroma, hematoma, bowel obstruction, bleeding, and reoperation. Descriptive analyses showed a shorter length of hospital stay in the laparoscopic group. Conclusions Laparoscopic incisional and ventral hernia repair is a feasible and effective alternative to the open technique. It is associated with lower incidences of wound infection and shorter length of hospital stay. However, caution is required because it is associated with an increased risk of bowel injury compared with the open technique. Given the relatively short follow-up duration of trials included in the systematic review, trials with longterm follow-up are needed to compare the durability of laparoscopic and open repair.
Introduction Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired (incisional). Incisional ventral hernia (IVH) is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds and in up to 20 % of patients who develop postoperative wound infections [1]. IVH is associated with complications such as pain, incarceration, and obstruction of the intestinal lumen, as well as strangulation and ischemia of the hernia contents. Therefore, it often requires surgical intervention. Unfortunately, the results of IVH repair are disappointing; in fact, IVH repaired by suturing has high recurrence rates in the range of 12–54 % [2–4]. Thanks to the use of meshes in tension-free repair of IVH, the
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recurrence rates have been greatly reduced to the range of 2–36 % [5–7]. Thus it has become the gold standard treatment. However, the conventional open incisional and ventral hernia repair (OIVHR) often requires significant soft-tissue dissection, which may cause several postoperative complications, such as wound infection, hematomas, and painful recovery. Hence, there is an ongoing search for better techniques. The use of laparoscopic technique in the treatment of IVH, first reported in 1993 by LeBlanc and Booth, marked a step forward [8]. After 20 years of development, laparoscopic incisional and ventral hernia repair (LIVHR) is now widely performed all over the world with the expectation of earlier recovery, fewer complications, and decreased recurrence rates [9]. As a consensus regarding outcome when comparing LVIHR with OVIHR has not been reached [10], we conducted a systematic review and meta-analysis to provide the current best evidence on this topic.
Materials and method Data sources and selection criteria Relevant studies were identified and selected by searching several databases, including Medline, Embase, Cochrane controlled trials register, and Science citation index (updated to July 2013) under the search terms ‘‘abdominal wall hernia’’ or ‘‘ventral hernia’’ or ‘‘incisional hernia,’’ and ‘‘laparoscopic’’ or ‘‘laparoscopy,’’ and ‘‘randomized controlled trial’’ or ‘‘RCT,’’ as well as a review of reference bibliographies from original research articles and reviews. Two authors (Y. Z. and H. Z.) reviewed the articles for the inclusion criteria as follows: (1) study design: RCTs; (2) study population: patients undergoing IVH repair (including congenital and acquired); (3) intervention: comparison between laparoscopic and open IVH repair; (4) outcomes: each study should contain information on the incidences of hernia recurrence; (5) the study must have been published in English. The exclusion criteria included repeat publication of a study, articles describing other types of hernias, and non-RCTs. Data extraction and outcomes of interest Data extractions were performed by two reviewers (Y. Z. and H. Z.) independently, and the results were checked by a third reviewer (Y. C.). Data extracted from the studies included the following: (1) patient characteristics [age, body mass index (BMI), gender ratio, defect size, types of prosthesis, surgical technique, and duration of follow-up]; (2) effectiveness outcomes (hernia recurrence, conversion to open surgery, operative time, and length of hospital
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stay); (3) safety outcomes (wound drainage usage, wound infection, bowel injury, postoperative seroma, hematoma, bowel obstruction, bleeding, reoperation, and pain). Quality appraisal and publication bias Methodological quality was assessed with the Jadad composite scale [11]. This is a 7-point quality scale, with lowquality studies scoring 1–3 points and high-quality studies scoring 4–7 points. Each study included in the systematic review was given an overall quality score based on the Jadad composite scale. To check publication bias, a funnel plot was constructed using Egger’s linear regression method [12]. Statistical methods The effect measures estimated were weighted mean difference (WMD) for continuous data and risk ratio (RR) for dichotomous data, both reported with 95 % confidence intervals (CI). Summary RR (or WMD) and their corresponding 95 % CI were estimated by a fixed effect model (Mantel–Haenszel) or a random effect (DerSimonian and Laird) model. Tests for heterogeneity were performed with each meta-analysis using the Cochran Q statistic and the I2 test, with P \ 0.05 indicating significant heterogeneity. The random effect model was used when heterogeneity was present. Statistical analyses were performed with the RevMan 5.0 and STATA 9.0 software packages. A P value\0.05 was considered statistically significant.
Results Characteristics of the included studies A total of 135 records were identified by the search strategy; 124 records were excluded for the reasons shown in Fig. 1. Finally, 11 RCTs were included in the meta-analysis (Table 1) [13–23]. The meta-analysis involved 1,003 patients: 501 were randomized to the laparoscopic group and 502 to the open group. The two groups were comparable with regard to patient age, BMI, and hernia size. The meshes were placed exceeding the edge of the incision by more than 3 cm in all the trials. The prosthetic grafts used in the studies included polypropylene and polytetrafluoroethylene (PTFE), among various other types of prosthesis. Suturing, stapling, or both techniques were applied in included studies. Follow-up ranged from 2 to 35 months. The methodological quality scores ranged from 2 to 5. Five studies were low-quality studies, with Jadad scores of 2–3 points. The other 6 were high-quality studies, with JADAD scores of 4–5 points (Table 2).
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Fig. 1 Flow chart shows the method of inclusion of trials in the meta-analysis
Table 1 Baseline characteristics of trials included in meta-analysis Author
Patients (LR/ OR)
Age (LR/ OR), years
BMI (LR/OR)
Hernia size (LR/OR)
Overlap (LR/OR), cm
Mesh type (LR/OR)
Fixed (LR/OR)
Conversion to OR
Follow-up (loss) (LR/OR), months
Carbajo et al. [19]
30/30
57.8/54.9
–
139.5/ 141.23 cm2
–
P2/ P1?P2
S?A/ S?A
–
27/27
Moreno-Egea et al. [20]
11/11
60.7/58.6
–
–
–
P1/P1
S/S
–
–
Misra et al. [22]
33/33
45.96/ 45.2
26.28/ 25.43
65.66/ 42.12 cm2
3–5/3
P1/P1
S/S
–
13.73(2)/ 12.9(5)
Barbaros et al. [17]
23/23
50.7/54.1
31.6/31.2
–
3/5
P1/P1
S?A/S
–
18/20
Olmi et al. [18]
85/85
60/65
28/28
9.7/10.5 cm
9.7/10.5
P3/P1
A/S
–
24/24
5/4–5
P1?P2/ P1
S/S
–
6/6
2
Navarra et al. [21]
12/12
59.3/64.1
–
37.2/45.2 cm
Pring et al. [23]
31/27
64.5/55
–
23.8/23.2 cm2
3–4/3–4
P2/P2
S/S
–
18/24
Asencio et al. [14]
45/39
58.02/ 60.55
31.35/ 30.61
9.51/10.18 cm
3/3
P2/P1
S?A/S
5
12(6)/12(4)
Itani et al. [16]
73/73
61.2/59.6
30.6/31.2
45.7/45.9 cm2
3/3
P2/P1
S?A/S
10
2(7)/2(6)
Eker et al. [15]
94/100
59.1/56.7
28.3/29.3
5/5 cm
5/5
P1/P1
S/S
8
35/35
5/5
P3/P1
S/A
5
2(0)/2(2)
Rogmark et al. [13]
64/69
58/58
29.3/29.3
36/25 cm
2
S sutures; A staples; S?A sutures and staples; – not reported; P1 polypropylene mesh; P2 polytetrafluoroethylene (PTFE); P3 others
Effectiveness outcomes Four studies reported that 28 of 276 procedures (10.1 %) were converted from laparoscopic repair to open repair during the operation [13–16]. Because of the heterogeneous data of included studies, pooled analyses of
operative time and length of hospital stay could not be performed. Six studies [14–19] showed a significant difference in duration of surgery (Table 3). Among those six studies, two [18, 19] reported that laparoscopic repair was faster, and four others [14–17] stated the opposite conclusion. Six studies [17–22] showed a significant difference in
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Table 2 Jadad quality score of trials included in meta-analysis
Author
Randomization
Concealment of allocation
Double blinding
Withdrawals and dropouts
Total score
Carbajo et al. [19]
1
1
0
0
2
Moreno-Egea et al. [20]
2
1
0
0
3
Misra et al. [22]
2
2
0
0
4
Barbaros et al. [17]
2
2
0
0
4
Olmi et al. [18]
1
1
0
0
2
Navarra et al. [21]
2
2
0
0
4
Pring et al. [23]
1
1
0
0
2
Asencio et al. [14]
1
1
0
0
2
Itani et al. [16]
2
2
0
0
4
Eker et al. [15]
2
2
0
0
4
Rogmark et al. [13]
2
2
0
1
5
Table 3 Operative time Table 4 Hospital stay Author
Mean operative time, min Author
Carbajo et al. [19] Moreno-Egea et al. [20]
Laparoscopic repair
Open repair
87 (30–180)a
111.5 (60–180)a
41 (29–65)
a
Laparoscopic repair \0.05
45 (27–65)a a
Misra et al. [22]
75 (25–245)
86 (30–150)
Barbaros et al. [17]
99 (32)c
72 (18)c
0.08 a
0.371
Olmi et al. [18]
2.7 (2.2, 3.2)b
88.7 (60–190)a
0.15
Pring et al. [23]
43.5 (14)c
42.5 (11.2)c
0.77
155
127 c
Eker et al. [15]
100 (49)
Rogmark et al. [13]
100 (70–139)a
a
Ranges
b
95 % confidence interval
c
76 (33)
\0.001 0.02
c
110 (78–137)a
0.001 \0.05
Standard deviation
length of hospital stay, consistently indicating a shorter length of hospital stay in the laparoscopic group (Table 4). There was no significant difference in the rates of hernia recurrence between the laparoscopic group and the open group (laparoscopic group 6.99 %, open group 4.82 %; RR = 1.21, 95 % CI 0.77–1.91; P = 0.41) (Fig. 2) Safety outcomes The incidence of wound infection was significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.8 %, open group 16.2 %; RR = 0.19, 95 % CI 0.11–0.32; P \ 0.00001) (Fig. 3). The rates of wound
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Navarra et al. [21] Pring et al. [23]
c
P value
9.06 (3–21)a
\0.05
5.2 (2–9)a
\0.001
6.3 (4.2)c
a
5.7 (1–13) 1 (1–2)
a
Open repair
3.43 (1–34)a
\0.005
73.7 (45–140)a
Itani et al. [16]
1.47 (1–3)a 2.5 (1.5)
Navarra et al. [21]
70.0 (62.9, 77.0)
1 (5 h–2 days)
Barbaros et al. [17]
150.9 (132.1, 169.7)b
101.9 (91.7, 112.1)b
Moreno-Egea et al. [20]
2.23 (1–15)a
Misra et al. [22]
61.0 (54.1, 68.9)b
b
Carbajo et al. [19]
\0.05
Olmi et al. [18]
Asencio et al. [14]
Mean length of hospital stay, days
P value
d
0.007 \0.05
9.9 (5.2, 14.6)b \0.005 10 (5–19)a
0.006
1 (1–1.8)d
0.43
Asencio et al. [14]
3.5 (2.7, 4.2)b
3.3 (2.8, 3.9)b
0.787
Itani et al. [16]
3.9 (3.1)c
4.0 (3.5)c
0.91
Eker et al. [15] Rogmark et al. [13] a
a
3 (2–4) 2 (1.5–3)a
a
3 (2–5) 2 (1–3)a
0.50 \0.861
Ranges
b
95 % confidence interval
c
Standard deviation
d
Interquartile range
drainage were significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.6 %, open group 67.0 %; RR = 0.06, 95 % CI 0.03–0.09; P \ 0.00001) (Fig. 4). However, the rates of bowel injury were significantly higher in the laparoscopic group than in the open group (laparoscopic group 4.3 %, open group 0.81 %; RR = 3.68, 95 % CI 1.56–8.67; P = 0.003) (Fig. 5). There was no significant difference between the two groups in the incidences of postoperative seroma, hematoma, bowel obstruction, bleeding, or reoperation (Table 5).
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Fig. 2 Forest plot shows meta-analysis of hernia recurrence rates
Fig. 3 Forest plot shows meta-analysis of wound infection rates
Fig. 4 Forest plot shows meta-analysis of wound drainage rates
Among the 11 included studies, 8 reported the results of postoperative pain (Table 6) [13–17, 21–23]. All of them showed no significant difference in postoperative pain between the laparoscopic and open groups. Heterogeneity and publication bias Significant heterogeneity was found in two outcomes (wound drainage usage, P = 0.007; seroma formation, P = 0.003). Thus we used the random effects model to pool results of the two outcomes. No significant heterogeneity was shown in other outcomes, for which we used the fixed effects model to pool the results. We assessed the publication bias based on the results of hernia recurrence. No evidence of publication bias existed in the studies included in the meta-analysis, based on the Egger’s publication bias plots (Fig. 6).
Discussion This systematic review and meta-analysis examined the current best evidence comparing the outcomes of laparoscopic and open incisional and ventral hernia repair. Eleven studies involving 1,003 patients were identified in the systematic review. Compared with open repair, the laparoscopic approach was found to have lower rates of wound infection and wound drainage, higher rates of bowel injury, and shorter length of hospital stay. There was no significant difference between the two groups in the incidences of hernia recurrence and other postoperative complications, as well as in postoperative pain. Four studies reported that 28 of 276 procedures (10.1 %) were converted from laparoscopic repair to open repair during the operation, which implied that LIVHR was a technically demanding procedure that might not be
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Fig. 5 Forest plot shows meta-analysis of bowel injury rates
Table 5 Results of metaanalysis comparing laparoscopic versus open repair for incisional ventral hernia
Model
RR/ WMD
0.91
Fix
1.21
10.26
Fix
0.19
0.003
Random
0.99
0.97
0.46, .10
0.45
Fix
0.94
0.82
0.53, .65
0.57
Fix
3.68
0.003
1.58, .67
1.72
0.79
Fix
1.58
0.40
0.55, .58
0.32
0.85
Fix
1.88
0.42
0.41, .71
Outcomes
No. of studies
No. of patients
Recurrence
11
1,003
2.66
Wound infection
11
1,003
0.25
Seroma
9
893
23.55
hematoma
8
768
6.77
Bowel injury
10
977
4.78
Bowel obstruction
6
711
RR risk ratio; WMD weighted mean difference; HG heterogeneity; Fix fix effect model; Random random effects model
Postoperative bleeding
3
473
Table 6 Postoperative pain
Author
4
431
2.79
0.42
Fix
0.42
Wound drainage
8
752
19.31
0.007
Random
0.06
P value 0.333
Laparoscopic repair
Open repair
3.77
3.50
P value 0.41 \0.00001
0.07 \0.00001
95 % CI 0.77, .91 0.11, .32
0.16, .09 0.03, .09
Injection analgesic doses in first 3 days (VAS score)
Barbaros et al. [17] [0.05
1.53
1.61
Postoperative pain scoring
Navarra et al. [21]
0.05
1.4 (range 0–3)
4.9 (range 2–8)
Analgesic requirement
Pring et al. [23]
0.2
5 (4–6.3)
5 (5–7)
Median pain score at 4 days (IR)
10.38 (1.98–10.01)
6 (4.93–5.83)
Mean VAS (0–100) (1 year) 95 % CI
Asencio et al. [14]
[0.05
Itani et al. [16]
0.07
19.2
18.0
Perception of worst pain (8 weeks)
Eker et al. [15]
0.54
23
24
Analgesia use
\10
\10
Mean VAS score (30 days)
Rogmark et al. [13] [0.05
appropriate in all cases. The conversion usually occurred because of intraoperative complications, such as bleeding or organ injury (bowel or bladder). In such situations, surgeons are advised to convert to an open procedure without hesitation, which could reduce the incidence of postoperative complications and lead to an uneventful recovery.
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HG, P value
Reoperative
Misra et al. [22]
VAS visual analog scale; IR interquartile range
HG, v2
Because of the heterogeneous data in the studies included, pooled analyses of operative time and length of hospital stay could not be performed. According to the descriptive analyses, included studies had conflicting operative times. One possible explanation is that many confounding factors, such as the surgeons’ experience, location and size of the hernias, and the surgical technique,
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Fig. 6 Egger’s publication bias plots for hernia recurrence
could affect the operative time. As for the length of hospital stay, the results seemed to be consistent among the studies. Laparoscopic repair reduced the length of hospital stay compared with open repair. This might be mainly owing to the disadvantages of the open technique that include the need for soft-tissue dissection and undermining to raise subcutaneous skin flaps, which have the potential for increased morbidity and prolonged convalescence [24]. There was no significant difference between the two groups in the incidence of hernia recurrence. Our metaanalysis found low incidences of recurrence after both procedures (laparoscopic group 7.0 %; open group 5.8 %). The results showed that laparoscopic repair if not better, was as efficient as open repair. However, the results were not conclusive because of the relatively short follow-up (2–35 months) and the heterogeneities of trials included in the systematic review. It deserves attention that the use of mesh and its proper placement, such as exceeding the edge of the incision by about 3–5 cm, could reduce hernia recurrence, no matter which approach is used [25]. The rates of wound drainage were significantly lower in the laparoscopic group than in the open group (laparoscopic group 2.6 %, open group 67.0 %; P \ 0.00001). Because open repair is associated with more soft tissue damage, a larger surgical wound, and more bleeding, wound drainage is mandatory in most situations to clear seepage. However, drainage may increase the incidence of wound infection and the severity of postoperative pain, and it may also prolong the postoperative hospital stay [26]. The wound infection rates were significantly lower in the laparoscopic group than that in the open group (laparoscopic 2.8 %, open 16.2 %; P \ 0.00001). The minimally invasive approach eliminates the need for tissue undermining and wound drainage, thereby minimizes the inherent wound healing problems associated with the open technique.
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Despite the advantage of laparoscopic repair in reducing the incidence of wound infection, the risk of bowel injury was significantly higher in the laparoscopic group than that in the open group (laparoscopic group 4.3 %, open group 0.81 %; P = 0.003). Abdominal adhesion presents a particular problem during laparoscopic repair, with the attendant risk of bowel injury during establishment of pneumoperitoneum and in dissection around the neck of the hernia. If intraoperative bowel injury cannot be dealt with promptly, 30 % of patients may eventually die from intestinal perforation and acute peritonitis [27]. Thus, the surgeon must be careful, and recognize and repair the injury promptly. As for other postoperative complications, there were no significant differences between the two groups. Minimally invasive procedures are often assumed by patients and surgeons to be less painful. However, this did not prove to be true in LIVHR. There were consistent findings that postoperative pain was not different between the laparoscopic and open groups. Our own experience also suggest that patients often have considerable discomfort after laparoscopic repair. Although the exact reason is unclear, we may suppose that the postoperative pain should be mainly attributed to the hernioplasty, no matter which approach is used. Our study has several limitations. First, there was significant heterogeneity among the included trials. The first possible cause of heterogeneity is research bias, as all included trials were not performed under double-blind conditions. The second possible cause of heterogeneity is the presence of confounding variables [e.g., different hernia sizes and locations, different meshes, patients with variable surgical risks: patients of American Society of Anesthesiologists (ASA) categories I–IV]. A second limitation is that the trials included in the systematic review used dissimilar definitions of complications, making comparison across studies difficult. Third, there was significant variability in operative techniques among the trials, as shown in Table 1. Based on the systematic review and meta-analysis, we conclude that LIVHR is a feasible and effective alternative to the open technique. It is associated with lower incidences of wound infection and shorter length of hospital stay. However, caution is required because the laparoscopic procedure is associated with an increased risk of bowel injury compared with the open technique. Given the relatively short follow-up duration of trials included in the systematic review, trials with long-term follow-up are needed to compare the durability of laparoscopic and open repair. Acknowledgments This work was supported by the National Natural Science Foundation of China (No. 31100681), Shanghai Nanotechnology Program (No. 11nm0504800), Shanghai Basic Research
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Program (No. 12JC1411402), and Shanghai Rising Star Program (No. 11CG42). 14. Conflict of interest Yanyan Zhang, Haiyang Zhou, Yunsheng Chai, Can Cao, Kaizhou Jin, and Zhiqian Hu have no conflicts of interest or financial ties to disclose.
15.
16.
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