World J Surg DOI 10.1007/s00268-015-3210-6
ORIGINAL SCIENTIFIC REPORT
Complications in Laparoscopic Versus Open Incisional Ventral Hernia Repair. A Retrospective Comparative Study Mirella Ahonen-Siirtola1 • Tero Rautio1 • Jaana Ward2 • Jyrki Ko¨ssi3,4 Pasi Ohtonen5 • Jyrki Ma¨kela¨1
•
Ó Socie´te´ Internationale de Chirurgie 2015
Abstract Purpose The objective of the study was to evaluate peri- and postoperative outcomes, especially severe complications in adult incisional ventral hernia repair performed by open or laparoscopic surgery. Methods Adult patients who were operated for incisional ventral hernias in two tertiary hospitals in Finland during 2006–2012 were included in the study. Clinical data were collected from patient registers. Peri- and postoperative parameters were gathered and compared between open and laparoscopic groups. Postoperative complications were analyzed, and the focus was on major complications. Results The results of 818 hernioplasties were evaluated: 291 (36.3 %) open and 527 (63.7 %) laparoscopic operations. In the laparoscopic group, the number of patients with postoperative complications was slightly lower (18.4 vs. 23.4 %, p = 0.090), and there were significantly fewer surgical site infections (3.2 vs. 8.6 %, p = 0.001). Twelve major complications occurred. In the laparoscopic group, four of the five major complications were consequences of undetected enterotomies, leading to reoperations, longer hospital stays, and death of one patient. Major complications in the open group consisted of four cardiac infarctions and three septic surgical site infections. Complex adhesions had a significant influence on major complications, enterotomies, and surgical site infections. Laparoscopic operations had a lower mean blood loss (13 vs. 31.5 ml, p = 0.028), and hospital stay (4 vs. 6 days, p = 0.001) compared to open operations. Conclusions Laparoscopic incisional ventral hernia repair has a low rate of postoperative complications but it is associated with an increased risk of undetected enterotomies, in particular during cases involving adhesiolysis.
Introduction & Mirella Ahonen-Siirtola [email protected] 1
Department of Surgery, Oulu University Hospital, PL21, 90029 Oulu, Finland
2
Department of Surgery, Pa¨ija¨t-Ha¨me Central Hospital, Lahti, Finland
3
Department of Surgery, Kanta-Ha¨me Central Hospital, Ha¨meenlinna, Finland
4
Department of Surgery, University of Turku, Turku, Finland
5
Division of Operative Care and Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland
Incisional ventral hernia (IVH) is a common complication that occurs in up to 13 % of patients with abdominal surgeries [1]. Because open hernioplasty can be an arduous and extensive procedure for patients, laparoscopic repair as a minimally invasive method has gained in popularity during the last decade due to improved outcome, which has been reported in several studies [2–5]. Although laparoscopic hernioplasty has a lower rate of minor complications, laparoscopic hernia surgery is associated with an increased risk of enterotomy compared to open procedures [6–8]. Extensive adhesions are known to be a risk factor for
123
World J Surg
enterotomy [9, 10]. The occurrence of bowel injury increases the rates of severe postoperative complications, reoperations, length of hospitalization, and operative time [11]. The mortality rate for ventral hernia repair is low: 0.05 % [7]. This report of a retrospective study of 818 patients who underwent IVH repair describes our short-term results, including peri- and postoperative complications, and 30-day mortality. Our main attention was to explore the severe complications associated with open and laparoscopic operations.
Patients and methods A total of 827 incisional ventral hernioplasties were performed on adult patients at Oulu University Hospital and at Pa¨ija¨t-Ha¨me Central Hospital during 2006–2012. Altogether, 818 operations were analyzed retrospectively; Fig. 1 contains the study design. Data were collected from patient registers in these hospitals, and procedures were identified by their ICD-10 codes. Patient demographic characteristics and clinical data were recorded, including age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) class, and number, irreducibility, and size of hernia. The collected operative details were operative technique, operative time, blood loss, and perioperative complications and their management. The 30-day morbidity, mortality, and the length of hospital stay and were also noted. We used Clavien–Dindo grading to classify complications [12]. The adhesions were classified as severe if these were extremely extensive and/or affected bowel. The choice of hernioplasty method was determined according to the preference and experience of each
surgeon. In open hernioplasties, a sublay mesh repair (Rives–Stoppa) was performed usually with a polypropylene nonabsorbable mesh. In laparoscopic operations, the hernia defect was covered with intraperitoneal onlay mesh (IPOM), which was fixed with sutures and tackers. In hybrid operations, the laparoscopic mesh repair was combined with closure of fascia from small incision. Numerous types of meshes were used during the study years. We compared and analyzed the results of open and laparoscopic operative groups. In order to explore the possible benefits of laparoscopic operations, we made an additional analysis between open group and a subgroup of purely laparoscopic operations. This study was approved by the Chief Physician of Oulu University Hospital. The material was collected from patient records and since no patient contact was used there was no need for approval of the ethics committee. The experiments comply with the current laws of Finland and human rights were not violated.
Statistical analysis Measurements are presented as mean and standard deviation (SD) unless other stated. Simple comparisons between open surgery and laparoscopic groups were performed with Student’s t test or Mann–Whitney U test (continuous variables, the latter for non-normally distributed data) and by v2 or Fisher’s exact test (categorical variables). A multivariable adjusted logistic regression model was built to get an unbiased estimate for the impact of operative technique on postoperative complications. Age (\50 vs. C50 years), size of the hernia (\15 vs. C15 cm2),
Incisional ventral hernioplasties, n = 827 (surgeons’ choice)
Exclusion: 9 emergency operations with bowel incarceration
Laparoscopic operations, n=450
Patients with complications, n=79 (18%)
Fig. 1 Study design
123
No complications, n=371 (82%)
Laparoscopically started operations, n= 527
Operative method changed to hybrid, n=41
Patients with complications n=9 (22%)
No complications n=32 (78%)
Open operations, n= 291
Conversion, n=36
Patients with complications n= 9 (25%)
Patients with complication, n=68 (23%)
No complications n=27 (75%)
No complications, n=223 (77%)
World J Surg
irreducible hernia, and usage of mesh in earlier operation were used as adjusting factors. Continuous variables age and size of hernia were classified due to non-linearity. Odds ratio (OR) with 95 % confidence interval (95 % CI) are presented as the result of logistic regression model. Area under the receiver operating characteristic (ROC) curve was performed to explore, if the size of the hernia could predict postoperative complications. Two-tailed p values are reported. All analyses were performed with SPSS for Windows (Version 21.0; IBM Corporation, Armonk, NY, USA).
Results The 818 operations were divided into open (291 operations, 35.6 %) and laparoscopic (527 operations, 64.4 %) groups. Patients in the laparoscopic group had significantly more hernia defects than patients in the open group, whereas there were significantly more irreducible hernias, and the mean hernia size was clearly greater in the open group. Table 1 shows the patients’ demographic data. In this study, 165 (20.2 %) patients had 205 postoperative complications. The distribution of postoperative complications is shown in Table 2. When we classified complications by Clavien–Dindo grading, we identified 94 (57.3 %) patients with mild complications (grade 1–2), 58 (35.4 %) with moderate complications (grade 3), and 12 (7.3 %) with major complications (grades 4–5). No significant differences between open and laparoscopic groups were apparent with this grading system. The postoperative complication rate was slightly lower in the laparoscopic group and surgical site infections were markedly infrequent (Table 2). According to logistic regression model, the risk
for postoperative complication was slightly elevated for the open group (OR = 1.4, 95 % CI 0.91–2.2, p = 0.13). The nine bowel injuries in the laparoscopic group occurred due to severe adhesions. Four of these enterotomies were left unnoticed and led to major, life-threatening complications. These patients had septic peritonitis and underwent reoperation. Three of the patients had a bowel resection and ended up with a stoma and a recurrent hernia. One of these patients died due to peritonitis. Another patient in the laparoscopic group developed an abdominal compartment syndrome and died due to multiorgan failure. The other major complications (7/12) occurred in patients who underwent open operations: four patients had cardiac infarctions, and one of them succumbed. Three patients had massive septic surgical site infections and multi-organ failures, and one of them died. Altogether, four operation-related deaths were noted, with an overall mortality of 0.5 %. Adhesiolysis was required in 253 (30.9 %) hernioplasties, and 58 (22.9 %) of them were followed by postoperative complications. In 93 (11.4 %) cases, the adhesions were severe; a third of these patients had complications. Ten of the eleven enterotomies occurred in operations in which adhesiolysis was described as troublesome (p \ 0.001). In addition to bowel injuries, complex adhesions were related to major complications [5 (5.4 %) vs. 7 (1.0 %), p = 0.007], immediate reoperations [7 (7.5 %) vs. 20 (2.8 %), p = 0.026], and surgical site infections [12 (12.9 %) vs. 30 (4.1 %), p = 0.001] compared to operations, in which adhesiolysis was easy or not required. Perioperative parameters are shown in Table 3. The mean blood loss and hospital stay were significantly lower in the laparoscopic group compared to the open group. The mean operative time was shorter as well, with significant
Table 1 Patient demographic parameters Parameters
Open group (n = 291)
Laparoscopy group (n = 527)
p
Male gender (%)
123 (42)
215 (41)
Age (years), mean ± SD (range)
61 ± 15 (25–95)
59 ± 14 (20–92)
0.069
BMI, mean ± SD (range)
30.7 ± 6 (18–49)
30.9 ± 6 (19–56)
0.75
0.68
ASA C3 (%)a
76 (47.8)
139 (39.6 %)
0.082
Smokers (%)
24 (8)
72 (13.7)
0.021
Hernia size (cm2) mean ± SD
41 ± 67
31 ± 45
0.068 \0.001
Multiple hernia defects (%)
25 (8.6)
142 (26.9)
Irreducible hernia (%)
52 (17.9)
63 (12)
0.021
Primary (%)
239 (82.1)
421 (79.9)
0.46
Secondary (%)
39 (13.4)
85 (16.1)
0.31
Tertiary (%)
13 (4.5)
21 (4.0)
0.72
Breakdown of hernioplasties
SD standard deviation; BMI body mass index; ASA American Society of Anesthesiologists class a
n = 510 (n = 159 in open group and n = 351 in laparoscopy group)
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World J Surg Table 2 Overall complicationsa of open and laparoscopic operations p
Laparoscopic operationsb, n = 450
p
Parameters
Open operations, n = 291
Laparoscopically started operations, n = 527
Patients with complications n (%)
68 (23.4)
97 (18.4)
0.090
Enterotomy, n (%)
2 (0.7)
9 (1.7)
0.34
5 (1)
Undetected, n (%)
0
4 (0.8)
0.14
4 (0.8)
0.16
Surgical site infection, n (%)
25 (8.6)
17 (3.2)
0.001
12 (2.7)
\0.001
Seroma/hematoma, n (%)
20 (6.9)
28 (5.3)
0.36
19 (4.2)
0.13
Ileus/obstruction, n (%)
5 (1.7)
15 (2.8)
0.32
12 (2.7)
0.46
Cardiac complication, n (%) Pneumonia, n (%)
8 (2.7) 4 (1.4)
4 (0.8) 10 (1.9)
0.032 0.78
4 (0.9) 6 (1.3)
0.071 [0.90 0.57
79 (17.6)
0.053 0.71
Wound dehiscence, n (%)
2 (0.7)
1 (0.2)
0.29
1 (0.2)
Pulmonary embolus, n (%)
2 (0.7)
2 (0.4)
0.62
2 (0.4)
0.65
Urinary tract infection, n (%)
2 (0.7)
3 (0.6)
0.3
3 (0.6)
0.33
Wound bleeding, n (%)
1 (0.3)
3 (0.6)
[0.90
2 (0.4)
[0.90
Miscellaneous, n (%)
4 (1.4)
8 (1.5)
[0.90
7 (1.6)
[0.90
Immediate recurrencec, n (%)
8 (2.7)
22 (4.2)
0.3
20 (4.4)
0.32
Major complications, n (%)
7 (2.4)
5 (0.9)
0.09
5 (1.1)
0.23
Mortality, n (%)
2 (0.7)
2 (0.4)
0.62
2 (0.4)
0.65
a
Some patients had more than one complications
b
Laparoscopic subgroup, in which hybrid operations and conversions to open are excluded
c
Recurrences during the hospital stay
Table 3 Outcomes of open and laparoscopic operations Laparoscopically started operations, n = 527
Open operations, n = 291
Duration min, mean ± SD (range)b
121 ± 83 (18–540)
105 ± 52.2 (26–278)
0.093
93 ± 48.2 (26–278)
0.003
Blood loss ml, mean ± SD (range)b
32 ± 78 (0–500)
13 ± 36 (0–300)
0.028
6 ± 17 (0–150)
0.003
Reoperation, n (%)
16 (5.5)
11(2.1)
Hospital stay days, mean ± SD (range)
6 ± 9 (1–98)
4 ± 4 (1–69)
p
Laparoscopic operationsa, n = 450
p
Parameters
0.013 \0.001
10 (2.2) 4 ± 4 (1–69)
0.018 \0.001
SD standard deviation a
Laparoscopic subgroup, in which hybrid operations and conversions to open are excluded
b
Data collected from Oulu University Hospital, total n = 416
difference, when comparing open group to the purely laparoscopic subgroup. In the open group, there were significantly more immediate reoperations compared to the laparoscopic group: 11 surgical site infection–related revisions, three hematoma evacuations, one resuturation of wound dehiscence, and one operation for massive pulmonary embolus. In the laparoscopic group, the eleven instant reoperations were due to four undetected bowel injuries, two surgical site infections, three wound bleedings, one cardiac bypass, and one cystoscopy. Sizes of the hernia defects varied from 0.2 to 530 cm2, and the mean hernia size was 33.6 cm2. According to ROC-curve analysis, the size of the hernia by itself could not be used to predict postoperative complications, the AUC value being 0.61 (95 % CI 0.55–0.67), interpreted
123
as ‘poor test accuracy’. Irreducible hernias were significantly more frequent in the open group and were related to bowel injuries [5 (4.3 %) vs. 6 (0.9 %), p = 0.012], cardiac complications [5 (4.3 %) vs. 7 (1.0 %), p = 0.018], and major complications [9 (7.8 %) vs. 3 (0.4 %), p \ 0.001] compared to operations performed for reducible hernias.
Discussion The main finding of our study was that the laparoscopic hernioplasties have non-significantly lower overall complication rate, but a higher risk of enterotomy compared to open operations.
World J Surg
Open hernioplasties were associated more often with postoperative complications, particularly surgical site infections, compared to the laparoscopic group; this finding is consistent with other studies [2, 13–16]. The reoperation rate has previously been found to be higher after open repairs [2, 14, 17]. In our study, this finding was statistically significant. The benefits of the laparoscopic technique were apparent in the lower blood loss and shorter operation and hospital stay times compared to the open group; these findings are in line with previous studies [13, 14, 18, 19]. However, our analysis of major complications highlighted the risks known to be associated with laparoscopic operations. One of the most severe complications is enterotomy, which can lead to life-threatening events, reoperations, and longer hospital stays, especially if the lesion remains undetected [20]. This was confirmed according to our results. Severe adhesions were found to be a risk factor for bowel injuries, as observed previously [21, 22]. The occurrence of major complications did not differ between operative groups. Still the character of these complications was clearly different. All of the major complications in the laparoscopic group were the consequences of bowel injuries. Three out of the four undetected enterotomies occurred during the first 2 years of this study, which may be related to the learning curve, since at this time the laparoscopic hernioplasty method was relatively new. This has been recognized in other studies as well [23, 24]. In the open group, major complications were systemic; septic surgical site infections or cardiac infarctions. Four operation-related deaths occurred, leading to a mortality rate of 0.5 %, which is high compared to other studies, where the average mortality rate is 0.05 % [7]. However, it has been shown that the occurrence of enterotomy can increase mortality to up to 2.5 % [7, 21]. This study has several limitations, because the data were gathered retrospectively from two hospitals. Information bias may exist depending on surgeons’ choice of the operative method and the differing quality of individual operative notes. We did not have adequate data with respect to postoperative pain, and reliable hernia recurrence rates could not be collected due to a lack of relevant follow-up data. However, the outcomes reflect normal clinical practice in our hospitals. The long-term results for the data used in this study will be reported later.
Conclusions Laparoscopic hernia surgery has a low rate of postoperative complications but is related to risk of undetected enterotomies and therefore severe consequences especially when handling complex adhesions.
Acknowledgments We thank Dr. Heikki Takala for participating in the design of the study. Compliance with ethical standards Conflict of interest
All authors declare no conflict of interest.
References 1. Mudge M, Hughes LE (1985) Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg 72:70–71 2. Zhang Y, Zhou H, Chai Y, Cao C, Jin K, Hu Z (2014) Laparoscopic versus open incisional and ventral hernia repair: a systematic review and meta-analysis. World J Surg 38:2233–2240. doi:10.1007/s00268-014-2578-z 3. Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L, Veterans Affairs Ventral Incisional Hernia Investigators (2010) Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg 145:322–328 discussion 328 4. Mason RJ, Moazzez A, Sohn HJ, Berne TV, Katkhouda N (2011) Laparoscopic versus open anterior abdominal wall hernia repair: 30-day morbidity and mortality using the ACS-NSQIP database. Ann Surg 254:641–652 5. Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J (1999) Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg 65: 827–831 discussion 831–2 6. Forbes SS, Eskicioglu C, McLeod RS, Okrainec A (2009) Metaanalysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg 96:851–858 7. LeBlanc KA, Elieson MJ, Corder JM 3rd (2007) Enterotomy and mortality rates of laparoscopic incisional and ventral hernia repair: a review of the literature. JSLS 11:408–414 8. Awaiz A, Rahman F, Hossain MB, Yunus RM, Khan S, Memon B, Memon MA (2015) Meta-analysis and systematic review of laparoscopic versus open mesh repair for elective incisional hernia. Hernia 19:449–463 9. ten Broek RP, Schreinemacher MH, Jilesen AP, Bouvy N, Bleichrodt RP, van Goor H (2012) Enterotomy risk in abdominal wall repair: a prospective study. Ann Surg 256:280–287 10. Turner PL, Park AE (2008) Laparoscopic repair of ventral incisional hernias: pros and cons. Surg Clin North Am 88:85–100 11. Gray SH, Vick CC, Graham LA, Finan KR, Neumayer LA, Hawn MT (2008) Risk of complications from enterotomy or unplanned bowel resection during elective hernia repair. Arch Surg 143:582–586 12. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213 13. Sajid MS, Bokhari SA, Mallick AS, Cheek E, Baig MK (2009) Laparoscopic versus open repair of incisional/ventral hernia: a meta-analysis. Am J Surg 197:64–72 14. Davies SW, Turza KC, Sawyer RG, Schirmer BD, Hallowell PT (2012) A comparative analysis between laparoscopic and open ventral hernia repair at a tertiary care center. Am Surg 78: 888–892 15. McGreevy JM, Goodney PP, Birkmeyer CM, Finlayson SR, Laycock WS, Birkmeyer JD (2003) A prospective study comparing the complication rates between laparoscopic and open ventral hernia repairs. Surg Endosc 17:1778–1780 16. Arita NA, Nguyen MT, Nguyen DH, Berger RL, Lew DF, Suliburk JT, Askenasy EP, Kao LS, Liang MK (2014) Laparoscopic
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17.
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repair reduces incidence of surgical site infections for all ventral hernias. Surg Endosc 29(7):1769–1780 Sauerland S, Walgenbach M, Habermalz B, Seiler CM, Miserez M (2011) Laparoscopic versus open surgical techniques for ventral or incisional hernia repair. Cochrane Database Syst Rev 16(3):CD007781 Misra MC, Bansal VK, Kulkarni MP, Pawar DK (2006) Comparison of laparoscopic and open repair of incisional and primary ventral hernia: results of a prospective randomized study. Surg Endosc 20:1839–1845 Tsuruta A, Hirai T, Nakamura M (2014) Retrospective comparison of open versus laparoscopic ventral and incisional hernia repair. Asian J Endosc Surg 7:246–250 Wright BE, Niskanen BD, Peterson DJ, Ney AL, Odland MD, Odland MD, VanCamp J, Zera RT, Rodriguez JL (2002) Laparoscopic ventral hernia repair: are there comparative
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ORIGINAL SCIENTIFIC REPORT
Complications in Laparoscopic Versus Open Incisional Ventral Hernia Repair. A Retrospective Comparative Study Mirella Ahonen-Siirtola1 • Tero Rautio1 • Jaana Ward2 • Jyrki Ko¨ssi3,4 Pasi Ohtonen5 • Jyrki Ma¨kela¨1
•
Ó Socie´te´ Internationale de Chirurgie 2015
Abstract Purpose The objective of the study was to evaluate peri- and postoperative outcomes, especially severe complications in adult incisional ventral hernia repair performed by open or laparoscopic surgery. Methods Adult patients who were operated for incisional ventral hernias in two tertiary hospitals in Finland during 2006–2012 were included in the study. Clinical data were collected from patient registers. Peri- and postoperative parameters were gathered and compared between open and laparoscopic groups. Postoperative complications were analyzed, and the focus was on major complications. Results The results of 818 hernioplasties were evaluated: 291 (36.3 %) open and 527 (63.7 %) laparoscopic operations. In the laparoscopic group, the number of patients with postoperative complications was slightly lower (18.4 vs. 23.4 %, p = 0.090), and there were significantly fewer surgical site infections (3.2 vs. 8.6 %, p = 0.001). Twelve major complications occurred. In the laparoscopic group, four of the five major complications were consequences of undetected enterotomies, leading to reoperations, longer hospital stays, and death of one patient. Major complications in the open group consisted of four cardiac infarctions and three septic surgical site infections. Complex adhesions had a significant influence on major complications, enterotomies, and surgical site infections. Laparoscopic operations had a lower mean blood loss (13 vs. 31.5 ml, p = 0.028), and hospital stay (4 vs. 6 days, p = 0.001) compared to open operations. Conclusions Laparoscopic incisional ventral hernia repair has a low rate of postoperative complications but it is associated with an increased risk of undetected enterotomies, in particular during cases involving adhesiolysis.
Introduction & Mirella Ahonen-Siirtola [email protected] 1
Department of Surgery, Oulu University Hospital, PL21, 90029 Oulu, Finland
2
Department of Surgery, Pa¨ija¨t-Ha¨me Central Hospital, Lahti, Finland
3
Department of Surgery, Kanta-Ha¨me Central Hospital, Ha¨meenlinna, Finland
4
Department of Surgery, University of Turku, Turku, Finland
5
Division of Operative Care and Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland
Incisional ventral hernia (IVH) is a common complication that occurs in up to 13 % of patients with abdominal surgeries [1]. Because open hernioplasty can be an arduous and extensive procedure for patients, laparoscopic repair as a minimally invasive method has gained in popularity during the last decade due to improved outcome, which has been reported in several studies [2–5]. Although laparoscopic hernioplasty has a lower rate of minor complications, laparoscopic hernia surgery is associated with an increased risk of enterotomy compared to open procedures [6–8]. Extensive adhesions are known to be a risk factor for
123
World J Surg
enterotomy [9, 10]. The occurrence of bowel injury increases the rates of severe postoperative complications, reoperations, length of hospitalization, and operative time [11]. The mortality rate for ventral hernia repair is low: 0.05 % [7]. This report of a retrospective study of 818 patients who underwent IVH repair describes our short-term results, including peri- and postoperative complications, and 30-day mortality. Our main attention was to explore the severe complications associated with open and laparoscopic operations.
Patients and methods A total of 827 incisional ventral hernioplasties were performed on adult patients at Oulu University Hospital and at Pa¨ija¨t-Ha¨me Central Hospital during 2006–2012. Altogether, 818 operations were analyzed retrospectively; Fig. 1 contains the study design. Data were collected from patient registers in these hospitals, and procedures were identified by their ICD-10 codes. Patient demographic characteristics and clinical data were recorded, including age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) class, and number, irreducibility, and size of hernia. The collected operative details were operative technique, operative time, blood loss, and perioperative complications and their management. The 30-day morbidity, mortality, and the length of hospital stay and were also noted. We used Clavien–Dindo grading to classify complications [12]. The adhesions were classified as severe if these were extremely extensive and/or affected bowel. The choice of hernioplasty method was determined according to the preference and experience of each
surgeon. In open hernioplasties, a sublay mesh repair (Rives–Stoppa) was performed usually with a polypropylene nonabsorbable mesh. In laparoscopic operations, the hernia defect was covered with intraperitoneal onlay mesh (IPOM), which was fixed with sutures and tackers. In hybrid operations, the laparoscopic mesh repair was combined with closure of fascia from small incision. Numerous types of meshes were used during the study years. We compared and analyzed the results of open and laparoscopic operative groups. In order to explore the possible benefits of laparoscopic operations, we made an additional analysis between open group and a subgroup of purely laparoscopic operations. This study was approved by the Chief Physician of Oulu University Hospital. The material was collected from patient records and since no patient contact was used there was no need for approval of the ethics committee. The experiments comply with the current laws of Finland and human rights were not violated.
Statistical analysis Measurements are presented as mean and standard deviation (SD) unless other stated. Simple comparisons between open surgery and laparoscopic groups were performed with Student’s t test or Mann–Whitney U test (continuous variables, the latter for non-normally distributed data) and by v2 or Fisher’s exact test (categorical variables). A multivariable adjusted logistic regression model was built to get an unbiased estimate for the impact of operative technique on postoperative complications. Age (\50 vs. C50 years), size of the hernia (\15 vs. C15 cm2),
Incisional ventral hernioplasties, n = 827 (surgeons’ choice)
Exclusion: 9 emergency operations with bowel incarceration
Laparoscopic operations, n=450
Patients with complications, n=79 (18%)
Fig. 1 Study design
123
No complications, n=371 (82%)
Laparoscopically started operations, n= 527
Operative method changed to hybrid, n=41
Patients with complications n=9 (22%)
No complications n=32 (78%)
Open operations, n= 291
Conversion, n=36
Patients with complications n= 9 (25%)
Patients with complication, n=68 (23%)
No complications n=27 (75%)
No complications, n=223 (77%)
World J Surg
irreducible hernia, and usage of mesh in earlier operation were used as adjusting factors. Continuous variables age and size of hernia were classified due to non-linearity. Odds ratio (OR) with 95 % confidence interval (95 % CI) are presented as the result of logistic regression model. Area under the receiver operating characteristic (ROC) curve was performed to explore, if the size of the hernia could predict postoperative complications. Two-tailed p values are reported. All analyses were performed with SPSS for Windows (Version 21.0; IBM Corporation, Armonk, NY, USA).
Results The 818 operations were divided into open (291 operations, 35.6 %) and laparoscopic (527 operations, 64.4 %) groups. Patients in the laparoscopic group had significantly more hernia defects than patients in the open group, whereas there were significantly more irreducible hernias, and the mean hernia size was clearly greater in the open group. Table 1 shows the patients’ demographic data. In this study, 165 (20.2 %) patients had 205 postoperative complications. The distribution of postoperative complications is shown in Table 2. When we classified complications by Clavien–Dindo grading, we identified 94 (57.3 %) patients with mild complications (grade 1–2), 58 (35.4 %) with moderate complications (grade 3), and 12 (7.3 %) with major complications (grades 4–5). No significant differences between open and laparoscopic groups were apparent with this grading system. The postoperative complication rate was slightly lower in the laparoscopic group and surgical site infections were markedly infrequent (Table 2). According to logistic regression model, the risk
for postoperative complication was slightly elevated for the open group (OR = 1.4, 95 % CI 0.91–2.2, p = 0.13). The nine bowel injuries in the laparoscopic group occurred due to severe adhesions. Four of these enterotomies were left unnoticed and led to major, life-threatening complications. These patients had septic peritonitis and underwent reoperation. Three of the patients had a bowel resection and ended up with a stoma and a recurrent hernia. One of these patients died due to peritonitis. Another patient in the laparoscopic group developed an abdominal compartment syndrome and died due to multiorgan failure. The other major complications (7/12) occurred in patients who underwent open operations: four patients had cardiac infarctions, and one of them succumbed. Three patients had massive septic surgical site infections and multi-organ failures, and one of them died. Altogether, four operation-related deaths were noted, with an overall mortality of 0.5 %. Adhesiolysis was required in 253 (30.9 %) hernioplasties, and 58 (22.9 %) of them were followed by postoperative complications. In 93 (11.4 %) cases, the adhesions were severe; a third of these patients had complications. Ten of the eleven enterotomies occurred in operations in which adhesiolysis was described as troublesome (p \ 0.001). In addition to bowel injuries, complex adhesions were related to major complications [5 (5.4 %) vs. 7 (1.0 %), p = 0.007], immediate reoperations [7 (7.5 %) vs. 20 (2.8 %), p = 0.026], and surgical site infections [12 (12.9 %) vs. 30 (4.1 %), p = 0.001] compared to operations, in which adhesiolysis was easy or not required. Perioperative parameters are shown in Table 3. The mean blood loss and hospital stay were significantly lower in the laparoscopic group compared to the open group. The mean operative time was shorter as well, with significant
Table 1 Patient demographic parameters Parameters
Open group (n = 291)
Laparoscopy group (n = 527)
p
Male gender (%)
123 (42)
215 (41)
Age (years), mean ± SD (range)
61 ± 15 (25–95)
59 ± 14 (20–92)
0.069
BMI, mean ± SD (range)
30.7 ± 6 (18–49)
30.9 ± 6 (19–56)
0.75
0.68
ASA C3 (%)a
76 (47.8)
139 (39.6 %)
0.082
Smokers (%)
24 (8)
72 (13.7)
0.021
Hernia size (cm2) mean ± SD
41 ± 67
31 ± 45
0.068 \0.001
Multiple hernia defects (%)
25 (8.6)
142 (26.9)
Irreducible hernia (%)
52 (17.9)
63 (12)
0.021
Primary (%)
239 (82.1)
421 (79.9)
0.46
Secondary (%)
39 (13.4)
85 (16.1)
0.31
Tertiary (%)
13 (4.5)
21 (4.0)
0.72
Breakdown of hernioplasties
SD standard deviation; BMI body mass index; ASA American Society of Anesthesiologists class a
n = 510 (n = 159 in open group and n = 351 in laparoscopy group)
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World J Surg Table 2 Overall complicationsa of open and laparoscopic operations p
Laparoscopic operationsb, n = 450
p
Parameters
Open operations, n = 291
Laparoscopically started operations, n = 527
Patients with complications n (%)
68 (23.4)
97 (18.4)
0.090
Enterotomy, n (%)
2 (0.7)
9 (1.7)
0.34
5 (1)
Undetected, n (%)
0
4 (0.8)
0.14
4 (0.8)
0.16
Surgical site infection, n (%)
25 (8.6)
17 (3.2)
0.001
12 (2.7)
\0.001
Seroma/hematoma, n (%)
20 (6.9)
28 (5.3)
0.36
19 (4.2)
0.13
Ileus/obstruction, n (%)
5 (1.7)
15 (2.8)
0.32
12 (2.7)
0.46
Cardiac complication, n (%) Pneumonia, n (%)
8 (2.7) 4 (1.4)
4 (0.8) 10 (1.9)
0.032 0.78
4 (0.9) 6 (1.3)
0.071 [0.90 0.57
79 (17.6)
0.053 0.71
Wound dehiscence, n (%)
2 (0.7)
1 (0.2)
0.29
1 (0.2)
Pulmonary embolus, n (%)
2 (0.7)
2 (0.4)
0.62
2 (0.4)
0.65
Urinary tract infection, n (%)
2 (0.7)
3 (0.6)
0.3
3 (0.6)
0.33
Wound bleeding, n (%)
1 (0.3)
3 (0.6)
[0.90
2 (0.4)
[0.90
Miscellaneous, n (%)
4 (1.4)
8 (1.5)
[0.90
7 (1.6)
[0.90
Immediate recurrencec, n (%)
8 (2.7)
22 (4.2)
0.3
20 (4.4)
0.32
Major complications, n (%)
7 (2.4)
5 (0.9)
0.09
5 (1.1)
0.23
Mortality, n (%)
2 (0.7)
2 (0.4)
0.62
2 (0.4)
0.65
a
Some patients had more than one complications
b
Laparoscopic subgroup, in which hybrid operations and conversions to open are excluded
c
Recurrences during the hospital stay
Table 3 Outcomes of open and laparoscopic operations Laparoscopically started operations, n = 527
Open operations, n = 291
Duration min, mean ± SD (range)b
121 ± 83 (18–540)
105 ± 52.2 (26–278)
0.093
93 ± 48.2 (26–278)
0.003
Blood loss ml, mean ± SD (range)b
32 ± 78 (0–500)
13 ± 36 (0–300)
0.028
6 ± 17 (0–150)
0.003
Reoperation, n (%)
16 (5.5)
11(2.1)
Hospital stay days, mean ± SD (range)
6 ± 9 (1–98)
4 ± 4 (1–69)
p
Laparoscopic operationsa, n = 450
p
Parameters
0.013 \0.001
10 (2.2) 4 ± 4 (1–69)
0.018 \0.001
SD standard deviation a
Laparoscopic subgroup, in which hybrid operations and conversions to open are excluded
b
Data collected from Oulu University Hospital, total n = 416
difference, when comparing open group to the purely laparoscopic subgroup. In the open group, there were significantly more immediate reoperations compared to the laparoscopic group: 11 surgical site infection–related revisions, three hematoma evacuations, one resuturation of wound dehiscence, and one operation for massive pulmonary embolus. In the laparoscopic group, the eleven instant reoperations were due to four undetected bowel injuries, two surgical site infections, three wound bleedings, one cardiac bypass, and one cystoscopy. Sizes of the hernia defects varied from 0.2 to 530 cm2, and the mean hernia size was 33.6 cm2. According to ROC-curve analysis, the size of the hernia by itself could not be used to predict postoperative complications, the AUC value being 0.61 (95 % CI 0.55–0.67), interpreted
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as ‘poor test accuracy’. Irreducible hernias were significantly more frequent in the open group and were related to bowel injuries [5 (4.3 %) vs. 6 (0.9 %), p = 0.012], cardiac complications [5 (4.3 %) vs. 7 (1.0 %), p = 0.018], and major complications [9 (7.8 %) vs. 3 (0.4 %), p \ 0.001] compared to operations performed for reducible hernias.
Discussion The main finding of our study was that the laparoscopic hernioplasties have non-significantly lower overall complication rate, but a higher risk of enterotomy compared to open operations.
World J Surg
Open hernioplasties were associated more often with postoperative complications, particularly surgical site infections, compared to the laparoscopic group; this finding is consistent with other studies [2, 13–16]. The reoperation rate has previously been found to be higher after open repairs [2, 14, 17]. In our study, this finding was statistically significant. The benefits of the laparoscopic technique were apparent in the lower blood loss and shorter operation and hospital stay times compared to the open group; these findings are in line with previous studies [13, 14, 18, 19]. However, our analysis of major complications highlighted the risks known to be associated with laparoscopic operations. One of the most severe complications is enterotomy, which can lead to life-threatening events, reoperations, and longer hospital stays, especially if the lesion remains undetected [20]. This was confirmed according to our results. Severe adhesions were found to be a risk factor for bowel injuries, as observed previously [21, 22]. The occurrence of major complications did not differ between operative groups. Still the character of these complications was clearly different. All of the major complications in the laparoscopic group were the consequences of bowel injuries. Three out of the four undetected enterotomies occurred during the first 2 years of this study, which may be related to the learning curve, since at this time the laparoscopic hernioplasty method was relatively new. This has been recognized in other studies as well [23, 24]. In the open group, major complications were systemic; septic surgical site infections or cardiac infarctions. Four operation-related deaths occurred, leading to a mortality rate of 0.5 %, which is high compared to other studies, where the average mortality rate is 0.05 % [7]. However, it has been shown that the occurrence of enterotomy can increase mortality to up to 2.5 % [7, 21]. This study has several limitations, because the data were gathered retrospectively from two hospitals. Information bias may exist depending on surgeons’ choice of the operative method and the differing quality of individual operative notes. We did not have adequate data with respect to postoperative pain, and reliable hernia recurrence rates could not be collected due to a lack of relevant follow-up data. However, the outcomes reflect normal clinical practice in our hospitals. The long-term results for the data used in this study will be reported later.
Conclusions Laparoscopic hernia surgery has a low rate of postoperative complications but is related to risk of undetected enterotomies and therefore severe consequences especially when handling complex adhesions.
Acknowledgments We thank Dr. Heikki Takala for participating in the design of the study. Compliance with ethical standards Conflict of interest
All authors declare no conflict of interest.
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