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Long-term Outcome of Incisional Hernia Repairs Using the Erlangen Inlay Onlay Mesh (EIOM) Technique
j o u r n a l o f s u r g i c a l r e s e a r c h n o v e m b e r 2 0 1 9 ( 2 4 3 ) 1 4 e2 2
Available online at www.sciencedirect.com
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Long-term Outcome of Incisional Hernia Repairs Using the Erlangen Inlay Onlay Mesh (EIOM) Technique Nizameddin Ayik, MD,a,b Peter Klein, MD,b Robert Gru¨tzmann, MD,b and Resit Demir, MDa,b,* a b
Medical Care Center; MVZ PD Dr. Demir & Colleagues, Nu¨rnberg Department of Surgery, Friedrich-Alexander University Hospital Erlangen-Nu¨rnberg, Erlangen, Germany
article info
abstract
Article history:
Background: The objective of this study was to investigate the long-term outcome of inci-
Received 4 December 2018
sional hernias treated with the Erlangen Inlay Onlay Mesh (EIOM) repair technique, taking
Received in revised form
into account recurrence, complications, and patient satisfaction.
8 April 2019
Methods: A total of 163 patients treated in the surgical department of Erlangen university
Accepted 10 April 2019
hospital with the EIOM repair between the years 1996 and 2009 were evaluated
Available online 27 May 2019
retrospectively. Results: The collected data revealed a mean follow-up period of 70 (18-190) months. Inci-
Keywords:
sional hernia recurrence after EIOM repair was observed in 6 (3.7%) patients after a mean
Abdominal incisional hernia
observation period of 70 mo (18-190) postoperatively. The recurrence rate increased
Open mesh repair
significantly when the body mass index (BMI) was higher than 32 kg/m2. Here, a recurrence
Sublay Erlangen
rate of 10.5% for BMI> 32 versus 1.7% with BMI 32 was reported. There were no significant
Long-term
differences in hernia recurrence if haven been operated by an assistant under supervision
Inlay onlay
or by a consultant. In regard to patient satisfaction, 91% of patients included in this study were satisfied with the surgical outcome. Conclusions: The EIOM procedure is a safe surgical technique that can be used for the treatment of all, also for giant incisional abdominal wall hernias regardless of the size, BMI, or position of the incisional hernia. ª 2019 Elsevier Inc. All rights reserved.
Introduction The development of an incisional hernia after an abdominal surgery remains an unsolved problem worldwide. An incidence of up to 20% has been reported.1 Several surgical techniques to repair incisional hernias have been described in the literature. Suture repair of incisional hernia reported recurrence rates of 24%-46% after an observation period of 8.512 years.2 On the other hand, mesh repair results in
recurrence rates of 3 to 24%.3 The open mesh repair using the sublay technique is considered the gold standard for incisional hernias.4 Here, a mesh is placed in the posterior rectus sheath after dissecting the subcutaneous tissues and approximating the fascial margins. With this technique, the greater the overlapping of the defect walls, the lower the recurrence rate. For example, a 2 cm overlap reported 24% recurrence rate5; whereas 6 cm overlap resulted in a recurrence rate of 2.6%.6 However, the extended preparation of the
* Corresponding author. Medical Care Center; MVZ PD Dr. Demir & Colleagues, Nu¨rnberg, Erlangen, Germany. Tel.: þ49 911966170; fax: þ49 9119661735. E-mail address: [email protected] (R. Demir). 0022-4804/$ e see front matter ª 2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jss.2019.04.045
ayik et al incisional hernia repair
abdominal wall required in this technique as well as the oversized foreign material used, are mainly responsible for complications such as chronic pain, hematoma, seroma, etc.7 In addition, in case of large incisional hernias, the fascial margins are lateralized and contracted to the extent that an approximation of the fascial margins is almost impossible without substantial increase in abdominal pressure. To overcome these complications, and to improve the results of fascial closure by minimizing tension on the repair site, the University of Erlangen-Nu¨rnberg developed in the early 90s the so-called “Erlangen Inlay Onlay Mesh Repair” (EIOM repair). The EIOM repair tolerates the highest tension, up to 3.5 kp. With this method and a maximum tension of 3.5 kp, we achieved a complete functional reconstruction in 65% of cases and our rate of recurrence amounted to 2.3% in an early study.7 Here, an overlap of 2 cm fascia is required and suitable for all forms of incisional hernia. However, information about the long-term outcome of this technique is lacking. Therefore, the aim of the following study was to investigate the longterm outcome of incisional hernias treated with the EIOM repair technique, taking into account recurrence, complications, and patient satisfaction.
Materials and methods Design of the study Medical records of 443 patients treated in the surgical department of Erlangen university hospital between 1996 and 2009 were collected. A total number of 410 patient data were determined via the digital database of the clinic, and the remaining 33 were collected via patient records. Only patients treated by means of the EIOM repair were included in the study (219 patients [49.4%]). No follow-up results could be obtained in 54 patients (24%) for various reasons. Forty-eight patients (22%) could neither be reached by telephone, nor could relatives be found. In addition, attempts to reach the patients through contacting the family physician or relatives were unsuccessful. Two patients suffered from dementia, one patient suffered from Down syndrome, and another patient refused to participate in the study. Two patients had moved abroad and therefore no follow-up could be carried out. Another two patients were excluded because of the short follow-up (<12 mo). Ultimately, 163 patients were included for statistical analyses. This corresponds to a response rate of 74%. The data were collected by means of standardized questions from the questionnaire designed specifically for this study. The patients were questioned exclusively via a telephone interview, which was always performed by the same interviewer. A number of 145 patients (88%) answered the questions themselves, whereas the other 20 patients (12%) had already passed away at the time of data collection. In these cases, the required information was successfully collected from the life partner or from family doctor. The obtained data were transferred directly from the interviewer to the questionnaire during the interview. Subsequently, the data were incorporated into the IBM SPSS statistics program version 19. The level of significance was determined by the chi-square test and set at P 0.05. The primary outcome was
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to evaluate the recurrence rate of this technique. The secondary outcomes were fistula formation for the bowel, subjective complaints, and patient satisfaction.
Ethical approval Institutional approval was obtained for this study. Informed consent was also obtained for enrollment into the study from patients or, when this was not possible, from their relatives.
Erlangen Inlay Onlay Mesh repair technique Figures 1e3 shows the EIOM repair technique also described in the study by Reingruber et al. 9 The sac and the healthy fascia at the margins of the hernia are dissected at least 2 cm free of adherent tissue. The hernia sac was resected and the peritoneum was mechanically freed as far as possible with scissors and scalpel of fat and placed in a physiological solution, for later on suturing to the inlay mesh with resorbable sutures. During maximal muscular relaxation by the anesthetist (defined by simultaneous radial nerve conduction measurements), the abdominal wall is forcefully stretched by hand (“stretching”). Then clamps are applied to the opposing margins of the fascia, and tensiometers are hooked on to their handles. The tension required to approximate the edges is measured. This maneuver is repeated at several points along the defect, and the highest value establishes the procedure to be followed.
Complete anatomical reconstruction (tension 1.5 to 3.5 kP) We use two layers of polypropylene (Marlex, C.R. Bard, Inc., Covington, GA) or Prolene (Ethicon Germany, Johnson & Johnson Medical GmbH, Norderstedt) mesh, the posterior one as an inlay (underlay) graft sometimes if possible the hernial sac or Vicryl mesh sutured to its visceral surface to avoid bowel adhesions and fistulas with a resorbable vicryl (Ethicon Germany, Johnson & Johnson Medical GmbH, Norderstedt) suture (Fig. 1). Untied double-armed, nonabsorbable, monofilament U-sutures (Seralene 1 (Serag-Wiessner GmbH & Co KG, Naila, Germany)), placed 1 cm from the edges of the fascia, hold the inlay (underlay) in position until the second layer is placed over the approximated fascia. In the next step, the double-armed U-sutures were pulled through the fascia. Subsequently, the fascia was sewn continuously with nonabsorbable, monofilament. The U-suture were then pulled through the onlay mesh and knotted (Fig. 3E). This technique results in an equal distribution of tension through the mesh to the fascia and so keeps the sutures from cutting through the tissue. To avoid seromas, the subcutaneous tissue is sutured to the underlying onlay mesh, drainage catheters are used, and suction is applied for the first 2 to 5 postoperative days.
Inlay/onlay prosthetic implant (max. tension ¼ 3.5 kP) In the same fashion as aforementioned, two layers of polypropylene mesh were used to bridge the defect in a sandwich
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j o u r n a l o f s u r g i c a l r e s e a r c h n o v e m b e r 2 0 1 9 ( 2 4 3 ) 1 4 e2 2
Fig. 1 e Closure of the abdominal wall without fascia gap (anatomical reconstruction): After preparation of the fascia margins of at least 2 cm, the size of the hernia in cm and the force (tensiometer) needed to bring the fascia margins together were measured. When the tensiometry <3.5 kp became true, anatomical reconstruction was performed. With 2 cm supernatant to the fascia margin two meshes were cut out. To the visceral surface of the inlay mesh (dorsal to the peritoneum), Vicryl resorbable mesh was sutured with resorbable Vicryl suture to avoid visceral surface to avoid bowel adhesions and fistulas. Further double-armed U-sutures were placed first at a distance of 1 cm from the fascia edge and at 1 cm at the ends of the next suture. In the next step, the double-armed U-sutures were pulled through the fascia. Subsequently, the fascia was sewn continuously. The U-suture were then pulled through the onlay mesh and knotted. Over Redon drainage then the subcutaneous tissue and the skin was closed. (Color version of figure is available online.)
fashion (Fig. 2). The fascia margins were tightened with the tensiometer to 3.5 kP. If the fascia edges did not come together with this pulling force exactly, this gap was left and the EIOM repair was carried out without anatomical reconstruction of the fascia via continuous suture.
Results A total of 163 patients with incisional hernias and treated between 1996 and 2009 with the EIOM repair were reached. Table 1 shows an overview of the data of the patients included in the study. One-third of the patients were operated by assistant doctors under guidance (Table 2). An anatomical reconstruction of the fascia was omitted in 48 (29%) patients to
avoid excessive tension on the fascia. The mean fascia gap was 5 cm (range 1-15 cm) with a median tensiometry of 2.2 kP. The mean follow-up period was 70 mo (range 18-190). The average age of the included patients was 60 y, including slightly more male (53% [n ¼ 87]) than female patients (47% [n ¼ 76]). The average body mass index (BMI) was 30 (range 16-57). In the primary surgery, median upper and lower abdominal laparotomies were performed in 84% of the patients (n ¼ 138). Twenty-four of them received only one upper abdominal incision, whereas in 16 patients, only one lower abdominal laparotomy was performed. The incisional hernia occurred on average after 38 mo (range 1-384) after the primary procedure (Table 1). In 44 patients, it was a recurrent incisional hernia (Table 3), whereby at least nine patients were treated with a nonresorbable mesh of another technique.
Fig. 2 e Closure of the abdominal wall with fascia gap: The fascia margins were tightened with the tensiometer to 3.5 kP. If the fascia edges did not come together with this pulling force, this gap was left and the EIOM repair was carried out. (Color version of figure is available online.)
ayik et al incisional hernia repair
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Fig. 3 e Implantation of the EIOM. First step 1 (A): After the free preparation of the fascia margins, the hernia size is measured. An appropriate Prolene or Marlex mesh cut out as an inlay. The double-armed suture (nonresorbable Prolene 1) is threaded in 1-cm intervals in a U-shape and hung with clamps (1a). Dorsal of the mesh is sewn either a Vicryl net or the peritoneum of the hernial sack. Second step 1 (B, C): The double-armored threads are now stabbed carefully from dorsal to the fascia to the ventral and fixed again with a clamp. Third step 1 (D): The onlay mesh is stabbed through by the U-seams. Forth step 1E: After cutting the needle, threads are now knotted and drainages are inserted. (Color version of figure is available online.)
Thirteen patients were a second recurrence. The average size of the abdominal defect was 119 cm2 (range, 4-900 cm2) (Table 1). The duration of the surgery was 105 min (range, 21-353). General complications included pulmonary complications (two patients), cardiovascular complications (four patients), and neurological problems (one patient), which were grade I complications to Clavien Dindo scale. One patient developed superficial redness and another had a serous
drainage from the incision that ceased over time without specific treatment. Both patients were treated conservatively. In six patients, a hematoma was observed postoperatively. In one of these, the hematoma had to be removed. With regard to the postoperative intestinal activity, a subileus was observed in one patient and was treated conservatively. Only one patient had a small bowel fistula 9 mo after the incisional hernia, which had to be restored surgically (Table 4).
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Table 1 e Baseline characteristics of the patients with incisional hernia, according to the study group (1996-2009). Variable Gender, M/F
n ¼ 163
Variable
87/76
Main reason for laparotomy before repair
Age in years Median Range
Gastrointestinal operation (%)
83 (51)
60
Cholecystectomy (%)
15 (9)
6-86
Gynecology (%)
16 (10)
Thoracic (%)
13 (8)
Umbilical (%)
10 (7)
Body mass index Median Range
30 16-57
Follow-up in months Median Range
Range
Liver (%)
8 (5)
Kidney (%)
6 (4)
70
Pancreatic (%)
3 (2)
18-190
Other (%)
8 (5)
Intraoperative size of hernia in cm2 Median
n ¼ 163
Incisional hernia after primary operation in months 119
Median
38
4-900
Range
1-384
Infection (%)
2 (1)
Hematoma (%)
6 (4)
Operation time in minutes Median Range
105 21-353
Abdominal incision Upper midline þ caudal midline (%)
98 (60)
Seroma (%)
3 (2)
Upper midline (%)
24 (14)
Diabetes (%)
23 (14)
Lower midline (%)
16 (10)
Steroid treatment (%)
7 (4)
Umbilical
8 (5)
Pararectus abdominis muscle (%)
6 (4)
Rip arc
6 (4)
Upper abdomen crosswise
4 (2)
Transrectus abdominis muscle (%)
1 (1)
Lumbar (%)
1 (1)
An incisional hernia recurrence after EIOM repair was observed in 6 (3.7%) patients 27 mo (range, 12-41) postoperatively (Table 5; Fig. 4, KaplaneMeier curves). All of the patients had to undergo surgery again. Depending on the intraoperative findings, the mesh was either completely or partially removed. The closure of the hernia was performed again with EIOM repair.
Table 2 e Characteristics Erlangen Inlay Onlay Mesh (EIOM) repair of incisional hernia.
Patients’ satisfaction ranged from very good to satisfied in 133 patients (91%). Thirteen patients (9%) were rather dissatisfied or not satisfied at all (Table 6). The pain sensation at rest decreased continuously postoperatively. In eight patients (5%), chronic pain also occurred 3 y postoperatively (Table 7). Of these, four patients (2.7%) continued to take painkillers. Movement-dependent pain was reported by 24 patients (15.7%), from which 12 patients experienced pain during daily activities (e.g., when tying shoes). Long-term intestinal motility was unremarkable in 133 patients (90%) (Table 8). On average, patients were able to complete their work in 8 wk (range, 1-52) postoperatively.
Tensiometry (n ¼ 86) in kP Median
2.2
Anatomic approximation of the fascia (n ¼ 151) Yes (%)
101 (62)
No (%)
48 (29)
Fascial gap in cm (n ¼ 39) Median Range
5 1-15
Expertise of operator (n ¼ 165) Assistant (%) Consultant (%)
Table 3 e Recurrent hernia and primary repair. Variable
52 (32) 111 (68)
Recurrent hernia (%)
n ¼ 163 44 (27)
Repair with mesh
21 (13)
Repair unknown procedure
16 (10)
Unresorbable suture
4 (2)
Resorbable suture
3 (2)
ayik et al incisional hernia repair
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Table 4 e Postoperative complications of the bowel. Variable
n ¼ 163
No defecation within 3-5 d (%)
2 (1.2)
No defecation > 5 d (%)
1 (0.6)
Bowel fistula
1 (0.6)
Other
1 (0.6)
Discussion The EIOM repair has been used as a standard therapy for incisional hernias at the University Hospital Erlangen-Nu¨rnberg since the 1990s. The technique was developed in domo and was first publicized in 1996.7,8 To achieve optimal tension of the fascial margins with respect to the question of whether to perform anatomical reconstruction or leave a fascial gap, tensiometry was introduced.7-9 The advantages of this technique can be summarized as follows: 1. The fascia margins are prepared to 2-3 cm. Larger ground damage is thereby reduced as compared with the sublay technique. 2. Two meshes are used because this reduces the tearing of the suture fixation of the mesh from the abdominal wall. The U-shaped single-stitched seam is anchored to the mesh, which lays ventrally and dorsally of the abdominal. Therefore, a smaller overlap of the fascia through the mesh is sufficient. 3. Especially, in giant incisional hernias in which the abdominal wall is retracted laterally and where an incision of the fascia of the external transverse abdominal musculature would be necessary, for example, according to the Ramirez technique, is omitted with this technique. 4. The mesh has no contact with the muscle, so that motiondependent pain would be less expected than the sublay mesh supply. These considerations might have to be proven by a randomized clinical trial. The disadvantage of this technique is the large amount of time required for larger hernias because many U-seams have to be stung individually. In addition, many needles are involved. The surgeon has to work very carefully so that he does not hurt himself or his colleague with it.
Table 5 e Rate of recurrence after Inlay Onlay Mesh repairdErlangen procedure. Variable
n ¼ 165
Variable Satisfaction (n ¼ 147)
No (%)
157 (96.3)
Yes (%)
6 (3.7)
Recurrence in months
Range
The aim of this study was to record the long-term outcomes of this technique retrospectively. First of all, any type of incisional hernia can be treated with this method without limitations, regardless of the size or position of the hernia. In addition, recurrent hernias can also be treated with the same technique. A major fear of incisional hernia surgery is the occurrence of an enterocutaneous fistula or intestinal motility disorder. These complications occur particularly if the prosthetic mesh is placed adjacent to the stomach or in contact with the small or large intestine. Therefore, as this type of operation was first introduced, a resorbable polygalactin mesh (Vicryl Ethicon) was regularly fixed to the inlay mesh, with the aid of vicryl sutures, to protect the bowel and therefore minimize potential bowel complications. The dreaded complication of intestinal fistula or obstruction due to intestinal adhesions to the mesh was observed in one patient only (0.6%). This 72-year-old patient had a recurrent hernia of 15 6 cm, which was primarily treated with a composite mesh 3 y earlier. This patient was
Table 6 e Subjective results after EIOM repair of incisional hernia.
Recurrence
Median
Fig. 4 e KaplaneMeier curves for recurrence of hernia after EIOM repair. The first recurrence incisional hernia was recorded 12 mo and the last after 41 mo after surgery. (Color version of figure is available online.)
27 12-41
Very good (%)
56 (38)
Good (%)
63 (43)
Satisfied (%)
14 (10)
Rather not satisfied (%)
6 (4)
Not satisfied (%)
7 (5)
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Table 7 e Pain after EIOM repair of incisional hernia. Variable
After 1 mo
After 1 y
After 3 y
Pain (n ¼ 147) No (%)
66 (45)
113 (77)
120 (83)
Barely (%)
26 (18)
10 (7)
3 (2)
From time to time (%)
30 (20)
12 (8)
14 (10)
Often (%)
16 (11)
7 (5)
5 (3)
8 (6)
4 (3)
3 (2)
Always (%) Painkiller use (n ¼ 145) No (%)
116 (80)
135 (93)
135 (94)
Barely (%)
17 (12)
7 (5)
5 (3)
Often (%)
8 (6)
1 (0.7)
1 (0.7))
Always (%)
4 (3)
2 (1)
3 (2)
Movement pain
(n ¼ 147)
(n ¼ 147)
(n ¼ 146)
No (%)
91 (62)
113 (78)
Yes, with every movement (%)
20 (14)
7 (5)
6 (4)
7 (5)
6 (4)
5 (3)
Yes, while sitting (%) Yes, while going (%) Yes, when binding shoes (%)
8 (5)
4 (2.7)
20 (14)
reoperated 7 mo after the EIOM repair for a colonic fistula. The exact cause of the fistula, whether it was a technical defect or an obstruction of the intestine due to excessive adhesiolysis of the previous operations, could not be known. The mesh was removed and the intestinal portion was resected. The abdominal wall was then closed with a duplicate Vicryl mesh. The further postoperative course was inconspicuous. The risk of enterocutaneous fistula development after direct contact of the mesh with the intestine is discussed controversially in the literature. Recent studies reported no enterocutaneous fistula, even with high numbers of cases,10-12 which contradicts results of older studies.13-15 In our experience, contact of the mesh with the intestine alone is insufficient to develop an enterocutaneous fistula. Additional factors such as serous or extensive adhesiolysis may play a role in the development of enterocutaneous fistula. It should be noted here that with this method, even very large hernias (30 30 cm) could be safely treated. Surprisingly the hernia size of the six Patient’s developing a recurrent hernia was less than 100 m2. We have no really convincing explanation for this. The operation time was comparatively long, ranging between 21 and 353 min (average ¼ 105 min) and correlated significantly with the size of the defect. EIOM is a feasible procedure that can be performed safely by a surgical trainee under supervision. The clinician experience showed no significant difference in terms of complications or recurrence (P ¼ 0.33) (Table 9). This method also enabled patients with a BMI of up to 57 to undergo surgery. The recurrence rates of the standard sublay technique is given in the literature as follows: (5.2%),15 (4.9%),3 (5%),16 (2.6%),6 and (24%).5 The overall recurrence rate in this study was 3.7%. The recurrence rate increased significantly when the BMI was higher than 32 (P ¼ 0.03). Here, a recurrence rate of 10.5% for patients with BMI> 32 was reported. By contrast,
16 (11)
121 (83)
1 (0.7) 12 (8)
patients with BMI 32 showed a significant decreased recurrence rate of 1.7% (Table 9). However, here it is noteworthy to mention that the longer the observation period of the study, the more relapses can be detected.17 The mean follow-up of 70 mo is significantly longer than that of the aforementioned studies, and the mean BMI (30 kg/m2) and mean hernia size (117 cm2) are also significantly larger. The recurrence rate of the incisional hernia for patients with BMI <32 kg/m2 was 1.7%. In view of the long follow-up, the result is excellent. In regard to patients’ satisfaction, a high number of patients were satisfied with the surgical outcome 133 (91%) (Table 6). Less than 5% of patients developed chronic pain, of which 2.7% still needed pain medication. The pore size and the stiffness of the used mesh were both responsible for the postoperative pain18. In the proposed sublay standard technique, overlap of the fascial margin of at least 5 cm is required. The mesh is implanted in the glenoid-bearing area of the rectus abdominis muscle, which comes inevitably in contact with the muscle. This explains the discomfort of up to 43% reported in some studies using the Marlex mesh.19 Here, two different meshes were used, namely the Marlex mesh (n ¼ 93)
Table 8 e Constipation (bowel movement). Constipation (n ¼ 146) No (%) Barely (%)
112 (77) 13 (9)
From time to time (%)
7 (5)
Often (%)
8 (6)
Always (%)
6 (4)
ayik et al incisional hernia repair
Table 9 e Cross-table showing the number of patients with recurrent hernia in relation to BMI, hernia size, and expertise of operator. Variable
Recurrent hernia
Total
c2-test
P ¼ 0.03
Yes
No
BMI ¼ 0-32
2
118
120
BMI >32
4
34
38
Assistant
3
49
523
Consultant
3
108
111
Hernia size < 100 cm2
6
88
94
2
0
61
61
Hernia size 100 cm
P ¼ 0.339 P ¼ 0.047
and Prolene mesh (n ¼ 68). These belong to the so-called heavy and small pore meshes. A difference in satisfaction or recurrence rate could not be determined according to the meshes used. The goal with the EIOM repair was to minimize the overlap of the fascia (2 cm) as much as possible to minimize the feeling of a foreign body. Thus, 84% of patients did not report any complaints after 3 y (Table 7). In the case of movementrelated pain, the patients (8%) found tying shoelaces the most stressful. The size of the mesh did not correlate with the degree of pain reported by the patient. The authors of this study are aware that this work was a retrospective study obtained only through a standardized interview of patients or their relatives without their personal examination. This does not mean that the results are irrelevant, rather the results show that it is worth further refining this technique of surgery and; for example, to investigate the EIOM technique as part of a randomized study with the recommended standard surgery technique (sublay technique).
Conclusion The EIOM procedure is a safe surgical technique that can be performed safely by a surgical trainee under supervision. All types of incisional hernias can be treated with this technique. Cases with larger abdominal wall defects can be safely treated with EIOM without causing additional symptoms to the patients. BMI play a significant role in recurrence. Complications such as the occurrence of an enterocutaneous fistula due to direct contact between the prosthetic mesh and intestines are negligible. Therefore, EIOM repair can be considered as a safe alternative method to the recommended sublay technique.
Acknowledgment The present work was performed in the fulfillment of the requirements for obtaining the degree ‘‘Dr. med.’’ We thank all patients and their relatives.
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Disclosure The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in this article. The authors declare that they have no conflict of interest.
references
1. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240:578e583 [discussion 583-585]. 2. Schumpelick V, Arlt G, Klinge U. Hernienchirurgie: versorgung von Nabelhernie und Narbenhernie. Dtsch Arztebl Int. 1997;94:3471. 3. Schumpelick V, Klinge U, Junge K, Stumpf M. Incisional abdominal hernia: the open mesh repair. Langenbecks Arch Surg. 2004;389:1e5. 4. Strambu V, Radu P, Bratucu M, et al. Rives technique, a gold standard for incisional hernias – our experience. Chirurgia (Bucur). 2013;108:46e50. 5. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343:392e398. 6. Toniato A, Pagetta C, Bernante P, Piotto A, Pelizzo MR. Incisional hernia treatment with progressive pneumoperitoneum and retromuscular prosthetic hernioplasty. Langenbecks Arch Surg. 2002;387:246e248. 7. Klein P1, Konzen G, Schmidt O, Hohenberger W. [Reconstruction of scar hernias–intraoperative tensiometry for objective determination of procedure of choice]. Chirurg. 1996;67:1020e1027. 8. Klein P, Schmidt O, Reingruber B, Hohenberger W. [Reconstruction of incisional hernias with defined tensiometrically controlled tension–a possibility for anatomically correct reconstruction of the abdominal wall]. Langenbecks Arch Chir Suppl Kongressband. 1998;115:1027e1030. 9. Reingruber B, Kastl S, Stremmel C, Klein PD. Incisional hernia repair: tensiometry for the selection of the appropriate procedure. Eur J Surg. 2001;167:903e908. 10. Brandi CD, Roche S, Bertone S, Fratantoni ME. No enterocutaneous fistula development in a cohort of 695 patients after incisional hernia repair using intraperitoneal uncoated polyproylene mesh. Hernia. 2017;21:101e106. 11. Duzgun SA, Bayhan Z, Zeren S, Zengin A. Comment to: "No enterocutaneous fistula development in a cohort of 695 patients after incisional hernia repair using intraperitoneal uncoated polypropylene mesh" by Brandi, C.D., Roche, S., Bertone, S. et al. Hernia (2017) 21: 101. Hernia. 2017;21(5):825e826. 12. Vrijland WW, Jeekel J, Steyerberg EW, Den Hoed PT, Bonjer HJ. Intraperitoneal polypropylene mesh repair of incisional hernia is not associated with enterocutaneous fistula. Br J Surg. 2000;87:348e352. 13. Basoglu M, Yildirgan MI, Yilmaz I, et al. Late complications of incisional hernias following prosthetic mesh repair. Acta Chir Belg. 2004;104:425e428. 14. Kaufman Z, Engelberg M, Zager M. Fecal fistula: a late complication of Marlex mesh repair. Dis Colon Rectum. 1981;24:543e544. 15. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998;133:378e382.
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16. McLanahan D, King LT, Weems C, Novotney M, Gibson K. Retrorectus prosthetic mesh repair of midline abdominal hernia. Am J Surg. 1997;173:445e449. 17. Fink C, Baumann P, Wente MN, et al. Incisional hernia rate 3 years after midline laparotomy. Br J Surg. 2014;101:51e54. 18. Langer I, Herzog U, Schuppisser JP, Ackermann C, Tondelli P. [Preperitoneal prosthesis implantation in
surgical management of recurrent inguinal hernia. Retrospective evaluation of our results 1989-1994]. Chirurg. 1996;67:394e402. 19. Welty G, Klinge U, Klosterhalfen B, Kasperk R, Schumpelick V. Functional impairment and complaints following incisional hernia repair with different polypropylene meshes. Hernia. 2001;5:142e147.
Available online at www.sciencedirect.com
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Long-term Outcome of Incisional Hernia Repairs Using the Erlangen Inlay Onlay Mesh (EIOM) Technique Nizameddin Ayik, MD,a,b Peter Klein, MD,b Robert Gru¨tzmann, MD,b and Resit Demir, MDa,b,* a b
Medical Care Center; MVZ PD Dr. Demir & Colleagues, Nu¨rnberg Department of Surgery, Friedrich-Alexander University Hospital Erlangen-Nu¨rnberg, Erlangen, Germany
article info
abstract
Article history:
Background: The objective of this study was to investigate the long-term outcome of inci-
Received 4 December 2018
sional hernias treated with the Erlangen Inlay Onlay Mesh (EIOM) repair technique, taking
Received in revised form
into account recurrence, complications, and patient satisfaction.
8 April 2019
Methods: A total of 163 patients treated in the surgical department of Erlangen university
Accepted 10 April 2019
hospital with the EIOM repair between the years 1996 and 2009 were evaluated
Available online 27 May 2019
retrospectively. Results: The collected data revealed a mean follow-up period of 70 (18-190) months. Inci-
Keywords:
sional hernia recurrence after EIOM repair was observed in 6 (3.7%) patients after a mean
Abdominal incisional hernia
observation period of 70 mo (18-190) postoperatively. The recurrence rate increased
Open mesh repair
significantly when the body mass index (BMI) was higher than 32 kg/m2. Here, a recurrence
Sublay Erlangen
rate of 10.5% for BMI> 32 versus 1.7% with BMI 32 was reported. There were no significant
Long-term
differences in hernia recurrence if haven been operated by an assistant under supervision
Inlay onlay
or by a consultant. In regard to patient satisfaction, 91% of patients included in this study were satisfied with the surgical outcome. Conclusions: The EIOM procedure is a safe surgical technique that can be used for the treatment of all, also for giant incisional abdominal wall hernias regardless of the size, BMI, or position of the incisional hernia. ª 2019 Elsevier Inc. All rights reserved.
Introduction The development of an incisional hernia after an abdominal surgery remains an unsolved problem worldwide. An incidence of up to 20% has been reported.1 Several surgical techniques to repair incisional hernias have been described in the literature. Suture repair of incisional hernia reported recurrence rates of 24%-46% after an observation period of 8.512 years.2 On the other hand, mesh repair results in
recurrence rates of 3 to 24%.3 The open mesh repair using the sublay technique is considered the gold standard for incisional hernias.4 Here, a mesh is placed in the posterior rectus sheath after dissecting the subcutaneous tissues and approximating the fascial margins. With this technique, the greater the overlapping of the defect walls, the lower the recurrence rate. For example, a 2 cm overlap reported 24% recurrence rate5; whereas 6 cm overlap resulted in a recurrence rate of 2.6%.6 However, the extended preparation of the
* Corresponding author. Medical Care Center; MVZ PD Dr. Demir & Colleagues, Nu¨rnberg, Erlangen, Germany. Tel.: þ49 911966170; fax: þ49 9119661735. E-mail address: [email protected] (R. Demir). 0022-4804/$ e see front matter ª 2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jss.2019.04.045
ayik et al incisional hernia repair
abdominal wall required in this technique as well as the oversized foreign material used, are mainly responsible for complications such as chronic pain, hematoma, seroma, etc.7 In addition, in case of large incisional hernias, the fascial margins are lateralized and contracted to the extent that an approximation of the fascial margins is almost impossible without substantial increase in abdominal pressure. To overcome these complications, and to improve the results of fascial closure by minimizing tension on the repair site, the University of Erlangen-Nu¨rnberg developed in the early 90s the so-called “Erlangen Inlay Onlay Mesh Repair” (EIOM repair). The EIOM repair tolerates the highest tension, up to 3.5 kp. With this method and a maximum tension of 3.5 kp, we achieved a complete functional reconstruction in 65% of cases and our rate of recurrence amounted to 2.3% in an early study.7 Here, an overlap of 2 cm fascia is required and suitable for all forms of incisional hernia. However, information about the long-term outcome of this technique is lacking. Therefore, the aim of the following study was to investigate the longterm outcome of incisional hernias treated with the EIOM repair technique, taking into account recurrence, complications, and patient satisfaction.
Materials and methods Design of the study Medical records of 443 patients treated in the surgical department of Erlangen university hospital between 1996 and 2009 were collected. A total number of 410 patient data were determined via the digital database of the clinic, and the remaining 33 were collected via patient records. Only patients treated by means of the EIOM repair were included in the study (219 patients [49.4%]). No follow-up results could be obtained in 54 patients (24%) for various reasons. Forty-eight patients (22%) could neither be reached by telephone, nor could relatives be found. In addition, attempts to reach the patients through contacting the family physician or relatives were unsuccessful. Two patients suffered from dementia, one patient suffered from Down syndrome, and another patient refused to participate in the study. Two patients had moved abroad and therefore no follow-up could be carried out. Another two patients were excluded because of the short follow-up (<12 mo). Ultimately, 163 patients were included for statistical analyses. This corresponds to a response rate of 74%. The data were collected by means of standardized questions from the questionnaire designed specifically for this study. The patients were questioned exclusively via a telephone interview, which was always performed by the same interviewer. A number of 145 patients (88%) answered the questions themselves, whereas the other 20 patients (12%) had already passed away at the time of data collection. In these cases, the required information was successfully collected from the life partner or from family doctor. The obtained data were transferred directly from the interviewer to the questionnaire during the interview. Subsequently, the data were incorporated into the IBM SPSS statistics program version 19. The level of significance was determined by the chi-square test and set at P 0.05. The primary outcome was
15
to evaluate the recurrence rate of this technique. The secondary outcomes were fistula formation for the bowel, subjective complaints, and patient satisfaction.
Ethical approval Institutional approval was obtained for this study. Informed consent was also obtained for enrollment into the study from patients or, when this was not possible, from their relatives.
Erlangen Inlay Onlay Mesh repair technique Figures 1e3 shows the EIOM repair technique also described in the study by Reingruber et al. 9 The sac and the healthy fascia at the margins of the hernia are dissected at least 2 cm free of adherent tissue. The hernia sac was resected and the peritoneum was mechanically freed as far as possible with scissors and scalpel of fat and placed in a physiological solution, for later on suturing to the inlay mesh with resorbable sutures. During maximal muscular relaxation by the anesthetist (defined by simultaneous radial nerve conduction measurements), the abdominal wall is forcefully stretched by hand (“stretching”). Then clamps are applied to the opposing margins of the fascia, and tensiometers are hooked on to their handles. The tension required to approximate the edges is measured. This maneuver is repeated at several points along the defect, and the highest value establishes the procedure to be followed.
Complete anatomical reconstruction (tension 1.5 to 3.5 kP) We use two layers of polypropylene (Marlex, C.R. Bard, Inc., Covington, GA) or Prolene (Ethicon Germany, Johnson & Johnson Medical GmbH, Norderstedt) mesh, the posterior one as an inlay (underlay) graft sometimes if possible the hernial sac or Vicryl mesh sutured to its visceral surface to avoid bowel adhesions and fistulas with a resorbable vicryl (Ethicon Germany, Johnson & Johnson Medical GmbH, Norderstedt) suture (Fig. 1). Untied double-armed, nonabsorbable, monofilament U-sutures (Seralene 1 (Serag-Wiessner GmbH & Co KG, Naila, Germany)), placed 1 cm from the edges of the fascia, hold the inlay (underlay) in position until the second layer is placed over the approximated fascia. In the next step, the double-armed U-sutures were pulled through the fascia. Subsequently, the fascia was sewn continuously with nonabsorbable, monofilament. The U-suture were then pulled through the onlay mesh and knotted (Fig. 3E). This technique results in an equal distribution of tension through the mesh to the fascia and so keeps the sutures from cutting through the tissue. To avoid seromas, the subcutaneous tissue is sutured to the underlying onlay mesh, drainage catheters are used, and suction is applied for the first 2 to 5 postoperative days.
Inlay/onlay prosthetic implant (max. tension ¼ 3.5 kP) In the same fashion as aforementioned, two layers of polypropylene mesh were used to bridge the defect in a sandwich
16
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Fig. 1 e Closure of the abdominal wall without fascia gap (anatomical reconstruction): After preparation of the fascia margins of at least 2 cm, the size of the hernia in cm and the force (tensiometer) needed to bring the fascia margins together were measured. When the tensiometry <3.5 kp became true, anatomical reconstruction was performed. With 2 cm supernatant to the fascia margin two meshes were cut out. To the visceral surface of the inlay mesh (dorsal to the peritoneum), Vicryl resorbable mesh was sutured with resorbable Vicryl suture to avoid visceral surface to avoid bowel adhesions and fistulas. Further double-armed U-sutures were placed first at a distance of 1 cm from the fascia edge and at 1 cm at the ends of the next suture. In the next step, the double-armed U-sutures were pulled through the fascia. Subsequently, the fascia was sewn continuously. The U-suture were then pulled through the onlay mesh and knotted. Over Redon drainage then the subcutaneous tissue and the skin was closed. (Color version of figure is available online.)
fashion (Fig. 2). The fascia margins were tightened with the tensiometer to 3.5 kP. If the fascia edges did not come together with this pulling force exactly, this gap was left and the EIOM repair was carried out without anatomical reconstruction of the fascia via continuous suture.
Results A total of 163 patients with incisional hernias and treated between 1996 and 2009 with the EIOM repair were reached. Table 1 shows an overview of the data of the patients included in the study. One-third of the patients were operated by assistant doctors under guidance (Table 2). An anatomical reconstruction of the fascia was omitted in 48 (29%) patients to
avoid excessive tension on the fascia. The mean fascia gap was 5 cm (range 1-15 cm) with a median tensiometry of 2.2 kP. The mean follow-up period was 70 mo (range 18-190). The average age of the included patients was 60 y, including slightly more male (53% [n ¼ 87]) than female patients (47% [n ¼ 76]). The average body mass index (BMI) was 30 (range 16-57). In the primary surgery, median upper and lower abdominal laparotomies were performed in 84% of the patients (n ¼ 138). Twenty-four of them received only one upper abdominal incision, whereas in 16 patients, only one lower abdominal laparotomy was performed. The incisional hernia occurred on average after 38 mo (range 1-384) after the primary procedure (Table 1). In 44 patients, it was a recurrent incisional hernia (Table 3), whereby at least nine patients were treated with a nonresorbable mesh of another technique.
Fig. 2 e Closure of the abdominal wall with fascia gap: The fascia margins were tightened with the tensiometer to 3.5 kP. If the fascia edges did not come together with this pulling force, this gap was left and the EIOM repair was carried out. (Color version of figure is available online.)
ayik et al incisional hernia repair
17
Fig. 3 e Implantation of the EIOM. First step 1 (A): After the free preparation of the fascia margins, the hernia size is measured. An appropriate Prolene or Marlex mesh cut out as an inlay. The double-armed suture (nonresorbable Prolene 1) is threaded in 1-cm intervals in a U-shape and hung with clamps (1a). Dorsal of the mesh is sewn either a Vicryl net or the peritoneum of the hernial sack. Second step 1 (B, C): The double-armored threads are now stabbed carefully from dorsal to the fascia to the ventral and fixed again with a clamp. Third step 1 (D): The onlay mesh is stabbed through by the U-seams. Forth step 1E: After cutting the needle, threads are now knotted and drainages are inserted. (Color version of figure is available online.)
Thirteen patients were a second recurrence. The average size of the abdominal defect was 119 cm2 (range, 4-900 cm2) (Table 1). The duration of the surgery was 105 min (range, 21-353). General complications included pulmonary complications (two patients), cardiovascular complications (four patients), and neurological problems (one patient), which were grade I complications to Clavien Dindo scale. One patient developed superficial redness and another had a serous
drainage from the incision that ceased over time without specific treatment. Both patients were treated conservatively. In six patients, a hematoma was observed postoperatively. In one of these, the hematoma had to be removed. With regard to the postoperative intestinal activity, a subileus was observed in one patient and was treated conservatively. Only one patient had a small bowel fistula 9 mo after the incisional hernia, which had to be restored surgically (Table 4).
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Table 1 e Baseline characteristics of the patients with incisional hernia, according to the study group (1996-2009). Variable Gender, M/F
n ¼ 163
Variable
87/76
Main reason for laparotomy before repair
Age in years Median Range
Gastrointestinal operation (%)
83 (51)
60
Cholecystectomy (%)
15 (9)
6-86
Gynecology (%)
16 (10)
Thoracic (%)
13 (8)
Umbilical (%)
10 (7)
Body mass index Median Range
30 16-57
Follow-up in months Median Range
Range
Liver (%)
8 (5)
Kidney (%)
6 (4)
70
Pancreatic (%)
3 (2)
18-190
Other (%)
8 (5)
Intraoperative size of hernia in cm2 Median
n ¼ 163
Incisional hernia after primary operation in months 119
Median
38
4-900
Range
1-384
Infection (%)
2 (1)
Hematoma (%)
6 (4)
Operation time in minutes Median Range
105 21-353
Abdominal incision Upper midline þ caudal midline (%)
98 (60)
Seroma (%)
3 (2)
Upper midline (%)
24 (14)
Diabetes (%)
23 (14)
Lower midline (%)
16 (10)
Steroid treatment (%)
7 (4)
Umbilical
8 (5)
Pararectus abdominis muscle (%)
6 (4)
Rip arc
6 (4)
Upper abdomen crosswise
4 (2)
Transrectus abdominis muscle (%)
1 (1)
Lumbar (%)
1 (1)
An incisional hernia recurrence after EIOM repair was observed in 6 (3.7%) patients 27 mo (range, 12-41) postoperatively (Table 5; Fig. 4, KaplaneMeier curves). All of the patients had to undergo surgery again. Depending on the intraoperative findings, the mesh was either completely or partially removed. The closure of the hernia was performed again with EIOM repair.
Table 2 e Characteristics Erlangen Inlay Onlay Mesh (EIOM) repair of incisional hernia.
Patients’ satisfaction ranged from very good to satisfied in 133 patients (91%). Thirteen patients (9%) were rather dissatisfied or not satisfied at all (Table 6). The pain sensation at rest decreased continuously postoperatively. In eight patients (5%), chronic pain also occurred 3 y postoperatively (Table 7). Of these, four patients (2.7%) continued to take painkillers. Movement-dependent pain was reported by 24 patients (15.7%), from which 12 patients experienced pain during daily activities (e.g., when tying shoes). Long-term intestinal motility was unremarkable in 133 patients (90%) (Table 8). On average, patients were able to complete their work in 8 wk (range, 1-52) postoperatively.
Tensiometry (n ¼ 86) in kP Median
2.2
Anatomic approximation of the fascia (n ¼ 151) Yes (%)
101 (62)
No (%)
48 (29)
Fascial gap in cm (n ¼ 39) Median Range
5 1-15
Expertise of operator (n ¼ 165) Assistant (%) Consultant (%)
Table 3 e Recurrent hernia and primary repair. Variable
52 (32) 111 (68)
Recurrent hernia (%)
n ¼ 163 44 (27)
Repair with mesh
21 (13)
Repair unknown procedure
16 (10)
Unresorbable suture
4 (2)
Resorbable suture
3 (2)
ayik et al incisional hernia repair
19
Table 4 e Postoperative complications of the bowel. Variable
n ¼ 163
No defecation within 3-5 d (%)
2 (1.2)
No defecation > 5 d (%)
1 (0.6)
Bowel fistula
1 (0.6)
Other
1 (0.6)
Discussion The EIOM repair has been used as a standard therapy for incisional hernias at the University Hospital Erlangen-Nu¨rnberg since the 1990s. The technique was developed in domo and was first publicized in 1996.7,8 To achieve optimal tension of the fascial margins with respect to the question of whether to perform anatomical reconstruction or leave a fascial gap, tensiometry was introduced.7-9 The advantages of this technique can be summarized as follows: 1. The fascia margins are prepared to 2-3 cm. Larger ground damage is thereby reduced as compared with the sublay technique. 2. Two meshes are used because this reduces the tearing of the suture fixation of the mesh from the abdominal wall. The U-shaped single-stitched seam is anchored to the mesh, which lays ventrally and dorsally of the abdominal. Therefore, a smaller overlap of the fascia through the mesh is sufficient. 3. Especially, in giant incisional hernias in which the abdominal wall is retracted laterally and where an incision of the fascia of the external transverse abdominal musculature would be necessary, for example, according to the Ramirez technique, is omitted with this technique. 4. The mesh has no contact with the muscle, so that motiondependent pain would be less expected than the sublay mesh supply. These considerations might have to be proven by a randomized clinical trial. The disadvantage of this technique is the large amount of time required for larger hernias because many U-seams have to be stung individually. In addition, many needles are involved. The surgeon has to work very carefully so that he does not hurt himself or his colleague with it.
Table 5 e Rate of recurrence after Inlay Onlay Mesh repairdErlangen procedure. Variable
n ¼ 165
Variable Satisfaction (n ¼ 147)
No (%)
157 (96.3)
Yes (%)
6 (3.7)
Recurrence in months
Range
The aim of this study was to record the long-term outcomes of this technique retrospectively. First of all, any type of incisional hernia can be treated with this method without limitations, regardless of the size or position of the hernia. In addition, recurrent hernias can also be treated with the same technique. A major fear of incisional hernia surgery is the occurrence of an enterocutaneous fistula or intestinal motility disorder. These complications occur particularly if the prosthetic mesh is placed adjacent to the stomach or in contact with the small or large intestine. Therefore, as this type of operation was first introduced, a resorbable polygalactin mesh (Vicryl Ethicon) was regularly fixed to the inlay mesh, with the aid of vicryl sutures, to protect the bowel and therefore minimize potential bowel complications. The dreaded complication of intestinal fistula or obstruction due to intestinal adhesions to the mesh was observed in one patient only (0.6%). This 72-year-old patient had a recurrent hernia of 15 6 cm, which was primarily treated with a composite mesh 3 y earlier. This patient was
Table 6 e Subjective results after EIOM repair of incisional hernia.
Recurrence
Median
Fig. 4 e KaplaneMeier curves for recurrence of hernia after EIOM repair. The first recurrence incisional hernia was recorded 12 mo and the last after 41 mo after surgery. (Color version of figure is available online.)
27 12-41
Very good (%)
56 (38)
Good (%)
63 (43)
Satisfied (%)
14 (10)
Rather not satisfied (%)
6 (4)
Not satisfied (%)
7 (5)
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Table 7 e Pain after EIOM repair of incisional hernia. Variable
After 1 mo
After 1 y
After 3 y
Pain (n ¼ 147) No (%)
66 (45)
113 (77)
120 (83)
Barely (%)
26 (18)
10 (7)
3 (2)
From time to time (%)
30 (20)
12 (8)
14 (10)
Often (%)
16 (11)
7 (5)
5 (3)
8 (6)
4 (3)
3 (2)
Always (%) Painkiller use (n ¼ 145) No (%)
116 (80)
135 (93)
135 (94)
Barely (%)
17 (12)
7 (5)
5 (3)
Often (%)
8 (6)
1 (0.7)
1 (0.7))
Always (%)
4 (3)
2 (1)
3 (2)
Movement pain
(n ¼ 147)
(n ¼ 147)
(n ¼ 146)
No (%)
91 (62)
113 (78)
Yes, with every movement (%)
20 (14)
7 (5)
6 (4)
7 (5)
6 (4)
5 (3)
Yes, while sitting (%) Yes, while going (%) Yes, when binding shoes (%)
8 (5)
4 (2.7)
20 (14)
reoperated 7 mo after the EIOM repair for a colonic fistula. The exact cause of the fistula, whether it was a technical defect or an obstruction of the intestine due to excessive adhesiolysis of the previous operations, could not be known. The mesh was removed and the intestinal portion was resected. The abdominal wall was then closed with a duplicate Vicryl mesh. The further postoperative course was inconspicuous. The risk of enterocutaneous fistula development after direct contact of the mesh with the intestine is discussed controversially in the literature. Recent studies reported no enterocutaneous fistula, even with high numbers of cases,10-12 which contradicts results of older studies.13-15 In our experience, contact of the mesh with the intestine alone is insufficient to develop an enterocutaneous fistula. Additional factors such as serous or extensive adhesiolysis may play a role in the development of enterocutaneous fistula. It should be noted here that with this method, even very large hernias (30 30 cm) could be safely treated. Surprisingly the hernia size of the six Patient’s developing a recurrent hernia was less than 100 m2. We have no really convincing explanation for this. The operation time was comparatively long, ranging between 21 and 353 min (average ¼ 105 min) and correlated significantly with the size of the defect. EIOM is a feasible procedure that can be performed safely by a surgical trainee under supervision. The clinician experience showed no significant difference in terms of complications or recurrence (P ¼ 0.33) (Table 9). This method also enabled patients with a BMI of up to 57 to undergo surgery. The recurrence rates of the standard sublay technique is given in the literature as follows: (5.2%),15 (4.9%),3 (5%),16 (2.6%),6 and (24%).5 The overall recurrence rate in this study was 3.7%. The recurrence rate increased significantly when the BMI was higher than 32 (P ¼ 0.03). Here, a recurrence rate of 10.5% for patients with BMI> 32 was reported. By contrast,
16 (11)
121 (83)
1 (0.7) 12 (8)
patients with BMI 32 showed a significant decreased recurrence rate of 1.7% (Table 9). However, here it is noteworthy to mention that the longer the observation period of the study, the more relapses can be detected.17 The mean follow-up of 70 mo is significantly longer than that of the aforementioned studies, and the mean BMI (30 kg/m2) and mean hernia size (117 cm2) are also significantly larger. The recurrence rate of the incisional hernia for patients with BMI <32 kg/m2 was 1.7%. In view of the long follow-up, the result is excellent. In regard to patients’ satisfaction, a high number of patients were satisfied with the surgical outcome 133 (91%) (Table 6). Less than 5% of patients developed chronic pain, of which 2.7% still needed pain medication. The pore size and the stiffness of the used mesh were both responsible for the postoperative pain18. In the proposed sublay standard technique, overlap of the fascial margin of at least 5 cm is required. The mesh is implanted in the glenoid-bearing area of the rectus abdominis muscle, which comes inevitably in contact with the muscle. This explains the discomfort of up to 43% reported in some studies using the Marlex mesh.19 Here, two different meshes were used, namely the Marlex mesh (n ¼ 93)
Table 8 e Constipation (bowel movement). Constipation (n ¼ 146) No (%) Barely (%)
112 (77) 13 (9)
From time to time (%)
7 (5)
Often (%)
8 (6)
Always (%)
6 (4)
ayik et al incisional hernia repair
Table 9 e Cross-table showing the number of patients with recurrent hernia in relation to BMI, hernia size, and expertise of operator. Variable
Recurrent hernia
Total
c2-test
P ¼ 0.03
Yes
No
BMI ¼ 0-32
2
118
120
BMI >32
4
34
38
Assistant
3
49
523
Consultant
3
108
111
Hernia size < 100 cm2
6
88
94
2
0
61
61
Hernia size 100 cm
P ¼ 0.339 P ¼ 0.047
and Prolene mesh (n ¼ 68). These belong to the so-called heavy and small pore meshes. A difference in satisfaction or recurrence rate could not be determined according to the meshes used. The goal with the EIOM repair was to minimize the overlap of the fascia (2 cm) as much as possible to minimize the feeling of a foreign body. Thus, 84% of patients did not report any complaints after 3 y (Table 7). In the case of movementrelated pain, the patients (8%) found tying shoelaces the most stressful. The size of the mesh did not correlate with the degree of pain reported by the patient. The authors of this study are aware that this work was a retrospective study obtained only through a standardized interview of patients or their relatives without their personal examination. This does not mean that the results are irrelevant, rather the results show that it is worth further refining this technique of surgery and; for example, to investigate the EIOM technique as part of a randomized study with the recommended standard surgery technique (sublay technique).
Conclusion The EIOM procedure is a safe surgical technique that can be performed safely by a surgical trainee under supervision. All types of incisional hernias can be treated with this technique. Cases with larger abdominal wall defects can be safely treated with EIOM without causing additional symptoms to the patients. BMI play a significant role in recurrence. Complications such as the occurrence of an enterocutaneous fistula due to direct contact between the prosthetic mesh and intestines are negligible. Therefore, EIOM repair can be considered as a safe alternative method to the recommended sublay technique.
Acknowledgment The present work was performed in the fulfillment of the requirements for obtaining the degree ‘‘Dr. med.’’ We thank all patients and their relatives.
21
Disclosure The authors reported no proprietary or commercial interest in any product mentioned or concept discussed in this article. The authors declare that they have no conflict of interest.
references
1. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240:578e583 [discussion 583-585]. 2. Schumpelick V, Arlt G, Klinge U. Hernienchirurgie: versorgung von Nabelhernie und Narbenhernie. Dtsch Arztebl Int. 1997;94:3471. 3. Schumpelick V, Klinge U, Junge K, Stumpf M. Incisional abdominal hernia: the open mesh repair. Langenbecks Arch Surg. 2004;389:1e5. 4. Strambu V, Radu P, Bratucu M, et al. Rives technique, a gold standard for incisional hernias – our experience. Chirurgia (Bucur). 2013;108:46e50. 5. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343:392e398. 6. Toniato A, Pagetta C, Bernante P, Piotto A, Pelizzo MR. Incisional hernia treatment with progressive pneumoperitoneum and retromuscular prosthetic hernioplasty. Langenbecks Arch Surg. 2002;387:246e248. 7. Klein P1, Konzen G, Schmidt O, Hohenberger W. [Reconstruction of scar hernias–intraoperative tensiometry for objective determination of procedure of choice]. Chirurg. 1996;67:1020e1027. 8. Klein P, Schmidt O, Reingruber B, Hohenberger W. [Reconstruction of incisional hernias with defined tensiometrically controlled tension–a possibility for anatomically correct reconstruction of the abdominal wall]. Langenbecks Arch Chir Suppl Kongressband. 1998;115:1027e1030. 9. Reingruber B, Kastl S, Stremmel C, Klein PD. Incisional hernia repair: tensiometry for the selection of the appropriate procedure. Eur J Surg. 2001;167:903e908. 10. Brandi CD, Roche S, Bertone S, Fratantoni ME. No enterocutaneous fistula development in a cohort of 695 patients after incisional hernia repair using intraperitoneal uncoated polyproylene mesh. Hernia. 2017;21:101e106. 11. Duzgun SA, Bayhan Z, Zeren S, Zengin A. Comment to: "No enterocutaneous fistula development in a cohort of 695 patients after incisional hernia repair using intraperitoneal uncoated polypropylene mesh" by Brandi, C.D., Roche, S., Bertone, S. et al. Hernia (2017) 21: 101. Hernia. 2017;21(5):825e826. 12. Vrijland WW, Jeekel J, Steyerberg EW, Den Hoed PT, Bonjer HJ. Intraperitoneal polypropylene mesh repair of incisional hernia is not associated with enterocutaneous fistula. Br J Surg. 2000;87:348e352. 13. Basoglu M, Yildirgan MI, Yilmaz I, et al. Late complications of incisional hernias following prosthetic mesh repair. Acta Chir Belg. 2004;104:425e428. 14. Kaufman Z, Engelberg M, Zager M. Fecal fistula: a late complication of Marlex mesh repair. Dis Colon Rectum. 1981;24:543e544. 15. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998;133:378e382.
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16. McLanahan D, King LT, Weems C, Novotney M, Gibson K. Retrorectus prosthetic mesh repair of midline abdominal hernia. Am J Surg. 1997;173:445e449. 17. Fink C, Baumann P, Wente MN, et al. Incisional hernia rate 3 years after midline laparotomy. Br J Surg. 2014;101:51e54. 18. Langer I, Herzog U, Schuppisser JP, Ackermann C, Tondelli P. [Preperitoneal prosthesis implantation in
surgical management of recurrent inguinal hernia. Retrospective evaluation of our results 1989-1994]. Chirurg. 1996;67:394e402. 19. Welty G, Klinge U, Klosterhalfen B, Kasperk R, Schumpelick V. Functional impairment and complaints following incisional hernia repair with different polypropylene meshes. Hernia. 2001;5:142e147.