|Year : 2020 | Volume
| Issue : 3 | Page : 764-773
Short-term outcomes of laparoscopic intraperitoneal onlay mesh with facial repair (ipom-plus) for ventral hernia: a randomized controlled trial
Bassem M Sieda, Osama H Khalil
Department of General Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt
|Date of Submission||22-Mar-2020|
|Date of Decision||31-Mar-2020|
|Date of Acceptance||05-Apr-2020|
|Date of Web Publication||28-Aug-2020|
MBBS, MSc, PhD Osama H Khalil
Department of General Surgery, Faculty of Medicine, Zagazig University, Zagazig, 44519
Source of Support: None, Conflict of Interest: None
Background Laparoscopic ventral hernia repair has become a widely used technique.
Objective This study evaluates the outcomes of laparoscopic ventral hernia repair with and without fascial repair, with particular reference to complications, seromas, and early recurrence.
Patients and methods A total of 177 patients were divided into three groups. Group I underwent laparoscopic [intraperitoneal onlay mesh (IPOM)] hernioplasty without repair. Group II underwent laparoscopic IPOM hernioplasty with intracorporeal repair. Group III underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS loop. Patients were followed for 6 months for early postoperative morbidity, including seroma formation, whereas the secondary end points were the adequacy of transfacial repair and its effect on early hernia recurrence.
Conclusion Transfacial suture closure of hernia defect is the simplest method of the hernia repair and effective with less incidence of seroma and early recurrence as compared with nonfascial repair technique. Defect closure strengthens the abdominal wall by regaining its whole function and gives more space for mesh insertion. Whatever technique used for ventral hernia repair, obesity is still the most important risk factor for seroma and hernia recurrence.
Keywords: laparoscopic ventral hernia repair-transfacial repair, onlay mesh, ventral hernia
|How to cite this article:|
Sieda BM, Khalil OH. Short-term outcomes of laparoscopic intraperitoneal onlay mesh with facial repair (ipom-plus) for ventral hernia: a randomized controlled trial. Egypt J Surg 2020;39:764-73
|How to cite this URL:|
Sieda BM, Khalil OH. Short-term outcomes of laparoscopic intraperitoneal onlay mesh with facial repair (ipom-plus) for ventral hernia: a randomized controlled trial. Egypt J Surg [serial online] 2020 [cited 2020 Oct 1];39:764-73. Available from: http://www.ejs.eg.net/text.asp?2020/39/3/764/293688
| Introduction|| |
Ventral hernia is a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5% in the literature, and ventral incisional hernia rates vary from 35 to 60% within 5 years after laparotomy ,. After laparoscopy, this rate is estimated to decline from 5 to 15% even after two decades. Laparoscopic ventral hernia repair (LVHR) or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position ,. The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with intraperitoneal onlay mesh (IPOM) reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes ,,,,,,,. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established .
| Patients and methods|| |
After obtaining Institutional Review Board approval in Zagazig University Hospitals, a prospective randomized controlled trial was conducted on 177 consecutive patients who underwent LVHR with IPOM. The study was performed in two institutions, Zagazig University Hospitals and Tertiary Hospital in Riyadh, Saudi Arabia, from October 2016 to October 2019. All patients signed informed consent after detailed procedure was explained to them ([Figure 1]).
Group assignment: patients were divided by random allocation into three groups:
- Group I (control group): it included 69 patients who underwent laparoscopic IPOM hernioplasty without repair.
- Group II: it included 50 patients who underwent laparoscopic IPOM hernioplasty with intracorporeal repair using prolene 0 or stratifix PDS.
- Group III: it included 58 patients who underwent laparoscopic IPOM hernioplasty with transfacial closure using PDS loop 0.
The primary end point was the early postoperative morbidity, including hematoma, seroma formation, surgical site infection (SSI), and pain, whereas the secondary end point was the adequacy of transfacial repair and its effect on early hernia recurrence.
Preoperative data and selection criteria
Patients older than 18 years undergoing surgery for primary or incisional ventral hernia and having defect whose width did not exceed 10 cm were enrolled after informed consent.
Patients undergoing revision or emergency surgery were excluded from study. Parastomal or recurrent hernias were not included. Patients not candidate for laparoscopy were excluded, including patients with cardiac disorders and those with COPD.
All patients underwent routine laboratory investigations, ultrasound soft tissue for establishing diagnosis, detection size of defect, and chest radiography. Prophylactic first generation cephalosporin was given for patients before operation.
Intraoperative data and surgical procedure
Under general anesthesia, with the patient in supine position, lateral visiport 12 mm was inserted in the left anterior axillary line ([Figure 2]). Other two 5 mm ports were inserted under vision with more ‘as necessary’; ‘as laterally as possible from the hernial defect’, usually all ports on the left side. A 30° optic was used. Adhesiolysis was done ([Figure 3]). The contents of hernia were reduced ([Figure 4]). The borders of the defect were illuminated and outlined. The abdominal wall was marked from outside for measurement of defect size and for corners fixation of mesh with 5 cm away from defect edge. Small defects are less than 4 cm width, moderate defects are 4–7 cm width, and large defects are 9–10 cm width.
Prolene 1 sutures were applied at the corners of the mesh introduced into the peritoneal cavity. Endoclose was passed at the marked site from abdominal wall, sutures were hanged and tied subcutaneously, and completion of mesh fixation was done using a secure strap ([Figure 5]).
PDS 0, a stratifix suture (STRATIFIX Symmetric PDS Plus Knotless Tissue Control Device, Ethicon, Somerville, New Jersey USA) ([Figure 6]), or prolene 1 ([Figure 7]), was used to repair and plicate the defect, and then mesh fixation was done. We aimed to compare the two types of sutures that could be used for repair. Stratifix knotless sutures has many advantages, starting from more efficiency and consistency and antibacterial protection compared with the continuous prolene suture used in the other group (reviewer 4).
The PDS loop sutures were prepared by cutting the needles, keeping two detached ends and one blind end. A small curved supraumbilical incision was done. The endoclose was passed through upper border of incision penetrating the abdominal wall above the defect, hanging the blind end of the PDS loop to outside ([Figure 8]). It was passed through the lower border of the wound crossing the defect. It hanged one detached end of the PDS ([Figure 9]) loop suture to outside and passed again through lower border of incision to catch the other detached end. The two ends were hanged and not tied to avoid incision closure. The process is repeated by passing 1–2 cm lateral or medial to the previous sutures, and then blind ends were divided. Lastly, all sutures are tied. Mesh was fixed as before.
Postoperative data and follow-up
Abdominal binder was applied postoperatively. Patients were advised for early ambulation. Patients were discharged on the second day and followed up in outpatient clinic, scheduled after 4–5 days for dressing. Patients were followed weekly in the first month, then monthly till the end of 6-month postoperatively for early detection of the hernia recurrence.
| Results|| |
There were 98 females and 79 males. In males, the age range was 34–49 years, and in females, 24–47 years. Obesity is defined as a BMI greater than or equal to 30 kg/m2 and morbid obesity also termed class III obesity as BMI greater than or equal to 40 kg/m2. BMI ranged from 27 to 43 kg/m2 ([Table 1] and [Table 2]).
Mesh fixation was always ensured with four corners transfascial nonabsorbable sutures and completion of fixation using intraperitoneal fixation devices. Repair was done with intracorporeal sutures or transfacial closure in vertical direction even in large size defects.
There were three conversions in group I (4.3%) owing to large nonreducible hernia containing the small bowel. They were converted to midline incision, adhesiolysis, reduction of content, and application of onlay prolene mesh. There was no conversion in group II and group III, even though previous surgery existed.
The intraoperative complications were three cases: one case in group I (1.4%) owing to small bowel injury during content dissection. Laparoscopic repair was done in one layer using PDS 3/0, as the tear did not exceed more than 30% of wall circumference. Other two cases in group II (4%) represented bleeding owing to omental excessive bleeding and epigastric artery injury during mesh fixation. Both were treated by means of coagulation and ligation. There was no significant difference between the groups ([Table 3]).
Postoperative pain (acute phase)
It was evaluated using a visual analog scale. It was 3-2-1/10 for group I, 4-3/10 for group II and 7-6-5/10 for group III on first, second, and third postoperative day (POD), respectively. Pain decreased on POD 4 to 2/10 for group I, 3/10 for group II, and 6/10 for group 3. After one week, the pain score became 1/10 for group 1, 2/10 for group 2, and 4/10 for group 3.
The analysis showed increase in the incidence of pain on POD 1. group III patients experienced more pain. Less pain was also encountered in less bulky abdominal wall in thin individuals. The tacks may be anchored subcutaneously, causing little pain. High BMI individuals had more postoperative pain, especially in group III. There is a significant difference among the three groups ([Figure 10]).
|Figure 10 A line graph shows comparison between the studied groups regarding visual analog scale of pain; markers represent mean, Y-error bar represent 95% confidence interval of mean. *Significant difference as P<0.05.|
Click here to view
SSIs accounted for 10 (5.6%) cases among the total patients. They comprised nine (5%) patients with superficial site infection at trocar site (four in group I, three in group II, and two in group III). There was no postoperative peritonitis infection (0.0%) but one mesh infection (0.5%) in group I. The case of mesh infection was marked by postoperative cellulitis and skin necrosis, resulting in chronic suppurative abdominal wall infection and early hernia recurrence. At first, ultrasound-guided drainage was done under broad-spectrum antibiotic coverage. Several months later, the patient was re-operated on for a two-stage strategy: the first stage was for mesh removal, and the second stage was new mesh repair using large prolene mesh onlay. There was no significant difference between groups regarding SSI, whereas high BMI is a significant risk factor for postoperative SSI. Moreover, there is no significant difference between stratifix knotless sutures and prolene regarding SSI on statistical analysis ([Table 4]).
Overall, six patients had abdominal wall localized hematomas (four in group I, one in group II, and one in group III), especially in obese patients with BMI 35. All patients underwent conservative measures, and no one required intervention, either radiological or surgical. High BMI is a significant risk factor for postoperative hematoma. There was no significant difference among the three groups.
Overall seroma rate was 15.8% (28 patients). Group I had 17 (24.6%) patients with seroma (15 patients with BMI more than 37, comprising four patients with SSI and four patients with hematoma). Group II had seven (14%) patients with seroma (three patients with SSI, four with large sized defect, and two patients with high BMI). Moreover, four (6.8%) patients in group III has seroma (seroma was attributed to such patients owing to excessive use of cautery, high BMI, and SSI). A total of 15 patients required repeated wound care with antibiotics and lastly resolved. Moreover, 13 (7.4%) patients had a large persistent seroma which lasted more than 3–6 months (type III) and required ultrasound-guided drainage. Persistent unresolved seroma rate requiring invasive treatment and open drainage was 1.7% (three patients). Three patients required local punctures with diluted povidone iodine injection–suction.
The predictive risk factors for seroma are BMI (obesity), previous surgery, number of previous procedures, previous hernia repair, SSI, size of defect, and excessive use of cauterization. There is a statistical difference among the three groups, with least seroma formation in group III, with P value of 0.007.
Neurological pain (chronic phase)
A total of 14 patients complained of some sort of lower abdominal wall pain and numbness (seven in group I, three in group II, and four patients in group 3). Gabapentin tablets were prescribed for all 14 patients; 10 patients improved and four patients are still under treatment after 6 months. There was no statistical difference among the three groups.
Early recurrence is described as recurrence within the first 6 months postoperatively. A total of 13 (7.3%) patients showed early recurrence, including 10 patients in group I (eight patients with BMI more than 32, four patients with SSI, and two patients with large sized defect); two patients in group II, who developed port site hernia preceded with SSI and with high BMI; and only one patient in group III, who already had early postoperative hematoma and SSI. There was a significant difference among groups, with group III with least recurrence, with P value 0.008. Obesity, postoperative complication, and large sized hernia were independent factors for early hernia recurrence in the three groups.
A total of four (2.2%) patients developed ileus, with mean time of 2 days: two patients already underwent conventional open repair and two patients were in group I underwent LVHR (due to delayed mobilization postoperatively). There was no significant difference among the three groups. The range of ileus duration was 2–7 days.
Length of stay
Most of patients with postoperative complication stayed more than 2 days, but most cases stayed from 1 to 2 days. There was no significant difference among the three group ([Table 5]).
Continuous data are expressed as the mean±SD and median (range), and the categorical data are expressed as a number (percentage). Continuous variables were checked for normality by using Shapiro–Wilk test. Kruskal–Wallis H test was used to compare more than two groups of non-normally distributed data. Categorical data were compared using χ2-test. All tests were two tailed. P less than 0.05 was considered statistically significant. All data were collected, tabulated, and statistically analyzed using SPSS 22.0 for windows (SPSS Inc., Chicago, Illinois, USA) and MedCalc 13 for windows (MedCalc Software bvba, Ostend, Belgium).
| Discussion|| |
Many surgical procedures exist for LVHR. There is controversy regarding the type of mesh, how to fix it, the closure of hernia defect, and the mesh position. However, all surgeons still follow the universal principles that apply to LVHR .
The conversion of laparoscopic repair to open repair was 1.6% in the total patients. The intraoperative complication rate was 1.6%, with only one case of perforated intestine (0.5%). These results are comparable to the studied group of Qadri and colleagues, where major complication of enterotomy was seen in one (2.5%) patient andone1 (2.5%) patient had conversion in laparoscopic repair group .
The incidence of SSI was 5.6% with no significant difference between groups and between patients who underwent repair with stratifix or prolene sutures. We reviewed the literature on IPOM-Plus in the PubMed database and identified 5 reports in which the SSI rate was less than 3% ,,,,. Other studies of Itani and colleagues and Kurmann and colleagues matched our results regarding the incidence of SSI ,.
In this study, the seroma rate was 15.8%. Most of the patients responded to conservative measures and minimal invasive approach. Only 1.7% of seroma cases needed open drainage. These results partly match with other studies, which confirms that the seroma is the most common complication after hernia repair, in ∼30% of cases, although it can resolve spontaneously ,,. Other studies like that of Palanievelu  showed low rate of postoperative seroma, in 7.6% of cases. Group III showed the least incidence of seroma, like some evidence that closure of the fascial defect may decrease the seroma rate, but this remains disputed in the literature ,.
There are no postoperative peritonitis infections and one mesh infections (0.05%). Patel et al.  operated 733 patients with LVHR. The average age was 56.5 years, BMI 33.9 kg/m2, and hernia size 11.5 cm. After a mean follow-up of 19.4 months, the overall hernia recurrence rate was 8.4%, which is close to our recurrence (7.3%). Overall rate of SSI after reoperation was 5.6%. Our rate of mesh infection was 0.5%. This compares favorably with the 5.5% rate of mesh infection experienced after index LVHR by Puraj and colleagues, who documented that reoperating a patient with prior intraperitoneal mesh is safe, without any increased risk of having the mesh to become secondarily infected, despite performing a contaminated field surgical procedure.
Postoperative seroma can naturally evolve in different ways, namely, resorption, persistence, or complication. Because of the high incidence of seroma, we considered a persistent symptomatic seroma that needed intervention as a complication. The risk factors for seroma were BMI (obesity), previous surgery, SSI, number of previous procedures, previous hernia repair, size of defect, and excessive use of cauterization. Colon et al. , with the data based on the Morales–Conde classification (type III and IV), showed the persistence of seroma would, in turn, relate to the size of the mesh, which could delay its resorption.
In a recent study done by Dimitrios Prassas et al. , laparoscopic IPOM combined with electric cauterization of the hernia sac significantly reduces the rate of postoperative seroma compared with the IPOM technique in patients with ventral and incisional hernias, and this is not compatible with our study.
Postoperative pain was not significantly different among the three groups. It was attributed to application of secure strap, and the mesh was fixed by staples in all patients. In this study, fixation devices influence neither PO complications nor the recurrence rate. However, the group of patients with metal tacks experienced a higher PO pain and 10 of them improved with medical treatment. A recent Danish study showed more recurrence after the use of absorbable tacks versus metal tacks . A systematic review concluded the same results for PO pain and also for recurrence, ranging from 0 to 9% .
The recurrence rate in this series was 7.3%, with significant difference between the groups and lowest rate of incidence in group III. The researchers identified three main causes of early recurrence (obesity, postoperative complications, and large defect). These results are supported by the study of Chlaes et al. .
There is paucity of data regarding comparative outcomes of abdominal wall hernia repair in obese and nonobese patients. The limited data available have significant heterogeneity within patient groups, the hernia defect size and location, follow-up, and the population .
Moreno-Egea et al.  evaluated the size of the defect in 315 patients operated on for hernias between 5 and 15 cm in size. The size of the defect was an independent prognostic factor for recurrence with a threshold of 10 cm. In a study done from 2005 to 2014 by Mercoli et al. , 417 patients underwent LVHR. Mean age and BMI were 54 years and 31 kg/m2, respectively. The overall recurrence rate was 9.8%. In a multivariate analysis, previous interventions [odds ratio (OR): 1.44; confidence interval (CI): 1.15–1.79; P=0.01], postoperative complications (OR: 2.57; CI: 1.09–6.03; P=0.03), and Clavien–Dindo score greater than 2 (OR: 1.43; CI: 1.031–1.876; P=0.02) appeared as independent prognostic factors of recurrence. Minor complications were associated with 14.7% of recurrence and major complications with 30% of recurrence. Overall seroma rate was 18.7%, with 1.4% of persisting or complicated seroma. BMI (OR: 1.05; CI: 1.01–1.08; P=0.026) and vascular surgery history (OR: 5.74; CI: 2.11–15.58; P<0.001) were independent predictive factors for seroma. Recurrence did not appear to be related to seroma.
Several factors were studied for their effect on seroma or recurrence. Age has no effect on seroma nor recurrence in the study of Muysoms et al.  comparable results, but got a longer length of hospital stay in patients over 65 years. Age was another factor for longer length of stay, which can be explained by several factors, namely, co-morbidities and complex and bulky hernias, requiring larger dissections.
One of the most serious complications is the incidence of postoperative hematomas. In our series, we observed six hematoma cases (3.3%), two of which were significant. Both patients were obese. One patient was successfully managed by cauterization and the other one was managed by intracorporeal ligation, which can be related to the accidental injury of the epigastric artery during mesh fixation. Hematoma prevalence is estimated to be between 0.4 and 4% in the literature ,. This can be related to transfascial suturing or to mesh fixation devices (tackers).
In this study, the postoperative ileus incidence was 2.2% owing to conversion of two cases to open technique and delayed patients’ mobilization. The mean of ileus duration was 2 days with range of 2–7 days. A retrospective study demonstrated a 1.3% incidence of postoperative ileus with a duration greater than 7 days . A prospective trial of 144 patients undergoing LVHR reported a mean time of 1.8 days to return of bowel function with a range of 0–8 days . A study of 819 laparoscopic hernia repairs reported a 3% incidence of prolonged ileus, although the duration of the ileus was not defined. In each of these studies, postoperative ileus resolved uneventfully .
From 2005 to 2014, Mercoli et al.  operated 417 patients by LVHR. Intraoperative complications occurred in three patients. The overall recurrence rate was 9.8%. Median time for recurrence was 15.3 months (3–72). In a multivariate analysis, previous surgery (OR: 1.44; CI: 1.15–1.79; P=0.01), postoperative complications (OR: 2.57; CI: 1.09–6.03; P=0.03), and Clavien–Dindo score 2 (OR: 1.43; CI: 1.031–1.876; P=0.02) appeared as independent prognostic factors of recurrence. Minor complications were associated with 14.7% of recurrence and major complications with 30% of recurrence. Emergency LVHR (6%) did not increase the rate of complications. Overall seroma rate was 18.7%, with 1.4% of persisting or complicated seroma. BMI (OR: 1.05; CI: 1.01–1.08; P=0.026) and vascular surgery history (OR: 5.74; CI: 2.11–15.58; P=0.001) were independent predictive factors for seroma. Recurrence did not appear to be related to seroma, superficial abscesses, PO peritonitis, and mesh infections up to 1 year after the procedure. The overall SSI rate was 2.15%. Long postoperative follow-up of at least 12 months is needed for more evaluation.For chronic neurological pain at the later stages, after 3–6 months, Gabapentin was used as a main line of the treatment, and there was no significant difference among groups. Gabapentin was recommended as one of the first line of treatment of chronic pain in the study of Bjurstrom et al. . This did not match with a Cochrane review including 40 randomized clinical trials, which concluded, cautiously, that preoperatively administered ketamine may reduce the risk of chronic pain, but that there is no evidence for recommending gabapentinoids, pregabalin, or other drugs for prevention of chronic postoperative pain .
| Conclusion|| |
LVHR is a favored procedure for correction of abdominal wall defects. Many techniques can be used for LVHR according to the experience of the surgeon and available resources. Closure of fascial defect appears to decrease postoperative morbidity and give chance for good fixation of the mesh. Seroma and recurrence are the main postoperative complications, which are related to obesity. Other complications like chronic pain, ileus, and hematoma are limited and can be avoided by following the guidelines of LVHR.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]