Long-Term Follow-Up of Laparoscopic Incisional and Ventral Hernia Repairs

Abstract

Purpose:

Laparoscopic incisional and ventral hernia repair (LIVHR) has been advocated for short hospital stay, rapid ambulation, and low recurrence rates and has gained increasing popularity. We report here the outcomes of long-term follow-up of LIVHR.

Subjects and Methods:

The series comprised 100 LIVHR procedures performed between June 2000 and February 2004. LIVHR was performed with the standard three-trocar configuration. Underlay expanded polytetrafluoroethylene mesh was placed in a tension-free manner and bridged the fascia defect with an adequate overlap of at least 4 cm. Enrolled patients were prospectively followed up at return visits.

Results:

Two conversions due to densely scarred abdomen were inevitable. There were four true recurrences (4%) and three eventrations (loss of prosthetic elasticity) (3%). There was no difference in recurrence rate and eventrations among ventral, incisional, and recurrent incisional hernias. Patients with recurrent incisional hernias reported more seroma formations, and seroma formation was independently associated with adhesiolysis (adjusted odds ratio=4.57).

Conclusions:

Long-term follow-up of LIVHR was satisfactory both in complications and in recurrences. The efficacy of LIVHR was ascertained and reproducible for Taiwanese patients. The concerns with chronic pain necessitate preoperative counseling with patients indicated or planned for LIVHR.

Introduction

Laparoscopic incisional and ventral hernia repair (LIVHR), first introduced by LeBlanc and Booth¹ and Park et al.² almost two decades ago, adopts the principle of Stoppa,³ River et al.,⁴ and Wantz⁵ to perform underlay expanded polytetrafluoroethylene (ePFTE) mesh repairs and has gained increasing popularity in recent years. The tension-free procedure has been advocated for minimal invasiveness, low recurrence rates, short hospital stays, and rapid convalescence. Optimistic results of lower or equal recurrence rate as traditional open incisional hernia repair have also been reported.^6–9 Detrimental factors yielding recurrences and complications, however, have seldom been investigated and remain unresolved for this surgical technique, especially when longer outcomes of this surgical technique are anticipated.

The annual incidence of incisional and ventral hernia repair in Taiwan is around 2500–3000 cases according to national health insurance claim data, most of which are managed with the open approach. The true incidence of incisional hernia may be much higher, considering the usual neglect of patients suffering from this disease entity and the lack of reliable hernia registry. Therefore clinical outcomes of LIVHR deserve meticulous evaluation, and complications associated with laparoscopic technique and prosthetic repair, such as seroma formation and chronic nondisabling pain, should be considered in addition to recurrences when evaluating the performance and efficacy of LIVHR. In this study we reported long-term follow-up of LIVHR in Taiwan, as well as causative factors of recurrences and complications.

Subjects and Methods

Study population

From June 2000 to February 2004, 83 incisional (34 were recurrent) and 17 primary ventral hernia patients received LIVHR at Cathay General Hospital (Taipei, Taiwan) in a consecutive manner. During the period the ePFTE mesh (Dualmesh^®; Gore, Flagstaff, AZ) was not covered by national health insurance, and the cost was at the patients' own expense. The benefits and potential drawbacks of LIVHR were well explained.

Demographic features are summarized in Table 1; there were no difference in sex, age, and body mass index among the three groups, but a lower body weight for the primary incisional hernia group was noted. For 34 patients with recurrent incisional hernia, 43 courses of open repair, including 11 polypropylene (Marlex^®; Chevron Phillips Chemical Co., The Woodlands, TX) mesh repairs in 9 patients, had been conducted. The median time from repair to recurrence was 9.6 months (range, 2–56 months).

Table 1.

Demographic Features

	Ventral hernia	Incisional hernia	Recurrent incisional hernia	P value
Total number	17	49	34
Sex
Male	7	25	15
Female	10	24	19	.72
Age (years)^a	62.3±15.9	67.9±9.1	61.4±13.2	.1
Weight (kg)^a	67.5±12.4	61.3±12.4	65.1±12.5	<.001
BMI (kg/m²)^a	27.7±3.9	25.7±4.6	26.3±3.5	.31
Previous laparotomy^b	4 (2)	69 (49)	78 (34)
Previous open repair^b			43 (34)
Previous Marlex mesh repair^b			11 (9)

Presented as median±standard deviation values.

Presented as number of events (number of cases).

LIVHR procedures

The surgical technique of LIVHR has been described elsewhere,¹⁰ and a brief summary is given below. Our method was modified from that of LeBlanc.¹¹ One dose of first-generation cephalosporin prophylactic antibiotic was given 30 minutes before the hernia repair. The patient was lying in the reverse Trendelenburg position with the stomach and urinary bladder decompressed. The margins of hernia defects were delineated on the skin after patients were fully paralyzed. Pneumoperitoneum was created and was insufflated to 14 mm Hg through a Veress needle puncture. Three trocars were established around the hernia defect, followed by adhesiolysis and reduction of any incarcerated contents. Adequate mesh overlapping was required for at least 4 cm beyond the fascia defect in all directions. The underlay Dualmesh, which was threaded at four corners before transporting into the abdominal cavity, was positioned well under direct laparoscopic visualization. The prosthesis bridged the defect and was secured well through antecedently placed threads at four corners with a Suture Passer^® (Gore) and crowned with Pro-Tack^® (Auto-Suture Inc., USSC, New London, CT) circumferentially in a tension-free manner.

Outcomes measurement

Enrolled patients were regularly followed up at outpatient department. Complications, recurrences, and any complaints related to LIVHR were prospectively recorded. Any recurrence that involved more than one side of the hernia or larger than 2.5 cm in the greatest diameter was considered a true recurrence; re-LIVHR would be indicated. If no true fascia defect or hernia content was identifiable and the mesh was not dislodged but mesh distortion (winding) was evidenced by a subjective feeling of abdominal inflation, loss of prosthetic elasticity (eventration) was identified. Chronic nondisabling pain was defined as LIVHR-related tenderness that remained unsolved more than 6 months postoperatively in the absence of pain control.

Statistical analysis

Tentative risk factors for recurrences and complications were determined by chi-squared test or Fisher's exact test in the univariate analysis (α level=0.10). Potential factors from univariate analysis were then modeled with logistic regression to obtain the adjusted odds ratio. Continuous variables were converted to dichotomous factors by the median value of the whole study cohort. All tests were two-sided, and values of P<.05 were considered statistically significant.

Results

Perioperative details

Intraoperative findings of fascia defects are listed in Table 2. We observed a trend of smaller defects for ventral hernias, larger defects for incisional hernias, and much larger defects for recurrent incisional hernias. The number of defects, proportion of patients with adhesion and incarceration, operation time, and postoperative hospital stays did not differ significantly among all three groups. Three cases were performed as emergency operations. Most cases with multiple defects could be repaired by a single piece of mesh. Two pieces of Dualmesh were required by 3 patients for extra large defects.

Table 2.

Hernia Defects and Operative Findings

	Ventral hernia	Incisional hernia	Recurrent incisional hernia	P value
Case numbers	17	49	34
Defect numbers^a	1.1 (1–2)	1.6 (1–4)	1.5 (1–3)	.09
Defect size (cm²)^a	17.5 (9–35)	47.9 (9–160)	69.8 (9–290)	.02
Adhesion	6 (35%)	26 (53%)	20 (59%)	.48
Incarceration	6 (35%)	10 (20%)	11 (32%)	.44
Operation time (minutes)^b	102.3±22.1	115.4±31.8	128.5±53.8	.18
Postoperative stay (days)^a	3.5 (2–6)	4.4 (2–7)	4.7 (2–7)	.08
Seroma	1	5	11	.02

Presented as median (range).

Presented as median±standard deviation values.

Two conversions to open repair were inevitable because of densely scarred abdomen (conversion rate, 2%). Immediate complications included fever (n=7), urine retention (n=4), ileus (n=3), wound infection (n=2), and trocar site bleeding (n=1). Seroma formations were found in 17 cases (1 in ventral hernia, 5 in incisional hernias, and another 11 in recurrent incisional hernias), all of which were resolved with serial aspirations (n=5) or observation only (n=12). Patients with previously failed repairs experienced more seroma formations (P=.02 by Fisher's exact test).

Follow-up events

Median follow-up time was 104.5 months (range, 28–144 months) or 8.7 years. The cutoff date of follow-up was set as June 30, 2012. A patient who died because of competing causes not attributed to LIVHR or who was recurrence-free at the last visit before June 30, 2012 was considered censored. Table 3 summarized relevant events during the follow-up period up to 12 years. Four true recurrences were found 8, 12, 16, and 24 months postoperatively during the early period of LIVHR at our institute. Redo LIVHR was performed for 3 cases; inadequate mesh size with undue tension should be blamed for recurrences. Eventrations occurred in 3 cases, all with incisional or recurrent incisional hernias; sliding or winded mesh opposed to fascia defect edges was found, and loss of elasticity of the prosthetic part of abdominal wall was experienced by these 3 patients, who reported the sense of bulging out, but there was no actual herniated content. For ventral hernias, no patients reported true recurrences or eventrations, and borderline more recurrences were observed in recurrent incisional hernias (P=.07 by Fisher's exact test). Eleven (11%) patients experienced chronic nondisabling pain persisting more than 6 months after LIVHR with decreased life quality, especially for recurrent incisional hernias.

Table 3.

Follow-Up Events

	Ventral hernia	Incisional hernia	Recurrent incisional hernia	P value
True recurrences^a		1 (12)	3 (8, 16, 24)	.07
Eventrations^a		1 (7)	2 (18, 26)	.17
Chronic pain	1	3	7	.1

Presented as number of cases (postoperative interval in months).

Causative factors for adverse events

Potential causative factors for seroma formation, chronic pain, eventrations, and recurrences were evaluated (Table 4). Candidates predictive of seroma formation included adhesiolysis, operation time more than 110 minutes, and postoperative stays of more than 4 days. For eventration, potential risk factors were more than one fascia defect, defect larger than 30 cm², and operation time longer than 110 minutes. Adhesiolysis seemed to have a protective effect with eventration (odds ratio=0.13, P<.1). The causality of adhesiolysis on seroma formation remained borderline significant with an adjusted odds ratio of 4.57 (P=.07) in multivariate analysis after adjustment for all potential predictive confounders.

Table 4.

Causative Factors for Adverse Events

	Eventrations	Seroma
Sex (male)
Age (≥60 years)
Weight (≥60 kg)
BMI (≥25 kg/m²)
Adhesiolysis	0.13^a	5.58^b
Incarceration
Defect number (>1)	13.2^b
Defect size (30 cm²)	7.44^a
Operative time (≥110 minutes)	7.44^a	5.58^b
Postoperative stay (>4 days)		3.15^a

P<.1, ^bP<.05.

BMI, body mass index.

Discussion

Our long-term follow-up ascertained the efficacy of LIVHR for Taiwanese patients. LIVHR is satisfactory both in low recurrence rates and in low complication rates. The burden of incisional hernia may be as long as the history of surgery. Simple fascia closure may bring about a recurrence rate as high as 30%, and mesh repair with a prosthesis incorporated into the fascia defect could lower the rate to 21%.¹⁰ It should be noted that extensive tissue dissection from any surgical repairs could lead to wound complications and further recurrences. The Stoppa/Wantz's law introduced the concept of a large prosthesis with adequate overlap, and the bisurface design of the ePTFE Dualmesh facilitated the intraperitoneal underlay placement of the prosthetic mesh with adequate biocompatibility.^1–5 Laparoscopic surgery eliminated the large incisional wound required by traditional open repair, avoiding cutting through distorted anatomical structure, dense fibrous scar, and further abdominal wall trauma.

The outcomes of LIVHR were interpreted as having equal or lower recurrences than open repairs with the benefits of laparoscopy (i.e., early ambulation, less pain, minimal invasiveness, and delineation and repair of multiple fascia defects via an intra-abdominal view). Heniford et al.⁷ reported by far the largest series of LIVHR from four institutes with 819 cases and a mean follow-up of 20.2 months. The recurrence rate was 4.7%, and recurrence was associated with large defects, obesity, previous open repair, and complications. Various recurrence rates from 2% to 7% were reported from other studies,^6,8–12 reflecting heterogeneity in the study population and, more importantly, the ambiguous definition of a failed LIVHR. In our series, we classified failure events into true recurrence (re-LIVHR needed) and eventrations (loss of prosthetic elasticity); the latter was defined as a situation in which patients felt a sense of inflation, and the mesh might get curved but not dislodged and without evidence of true hernia recurrence. Increased abdominal pressure, brittle fascia strength, and no anatomical abdominal wall repair all resulted in eventrations. Underlay Dualmesh successfully blocked the bulge of intra-abdominal viscera with the cost of distorted mesh configuration and a distended anterior wall. More than one fascia defect, a defect larger than 30 cm², and prolonged operation time (more than 110 minutes) were causative for eventrations in the current study.

McKinlay and Park⁹ compared 69 recurrent with 101 primary incisional hernias and reported higher complications in the recurrent group, but the recurrence rate of the two groups showed no difference. Our series adopted a more precise definition of LIVHR failure; the recurrence rate of the three groups (ventral, incisional, and recurrent incisional hernias) showed no difference (P=.07). It should be noted that primary ventral hernias had a 100% successful rate of LIVHR in our series without any failure.

Chronic pain is another important outcome in LIVHR, yet seldom has this been reported. Weiss and Park⁸ used the same time interval of 6 months after LIVHR as the criterion for chronic pain. Their incidence was 2% of 152 patients. Under the clinical scenario of no recurrence, chronic nondisabling pain is distressing. Our study highlighted the existence and long-term neglect of this complication. Recurrent incisional hernias may be associated with chronic pain (P=.1 by Fisher's exact test). Other possible causes include transabdominal sutures and spiral tacks for mesh fixation, thin abdominal adipose tissue, severe tissue trauma, and entrapped neuralgia. An alternative mesh fixation device to avoid chronic pain is now available¹³; a further comparative study considering chronic pain should be launched. Good communication to patients undergoing LIVHR is a required action before more details are elucidated for this issue. During the enrollment period of our study, the Suture Passer and Pro-Tack were routinely used; their unabsorbable nature and transfascial piercing threads inevitably resulted in chronic pain to a certain extent, depending on the number and locations of permanent fixations. For those who did suffer from chronic pain without hernia recurrences, reassurance and symptomatic relief by oral or local injection of non-steroidal anti-inflammatory drug could effectively end the pain, and preoperative counseling was highly recommended even when the latest absorbable fixing device was adopted.

The last outcome in the current study was seroma. Susmallian et al.¹⁴ demonstrated that virtually all LIVHRs with ePTFE were encroached with seroma, either clinically or subclinically. The fascia defects were usually not closed but “bridged” by prosthetic mesh in LIVHR, and more fluid accumulation or hematoma formation inside this dead space contributed to postoperative seromas. Unless complicated with infection, sterile seroma was usually self-limited and would be solved with time. Our experiences showed that potential risk factors for seroma formation included adhesiolysis, prolonged operation time (both P<.05), and more than 4 days of postoperative stay. The adjusted odds ratio for adhesiolysis was 4.57 with borderline significance (P=.07). Seventeen cases (17%) in our series suffered from this complication, and this rate was strikingly similar to that reported by Toy et al.¹⁵ It should be noted that more than half of the patients with seroma formation had recurrent incisional hernias. In our series larger fascia defects and more than one defect were associated with eventrations but not seromas, indicating the mechanism of seroma formation might be quite different from that of eventration. Adhesiolysis was performed for the densely adhered viscera and parietal peritoneum and for the restoration of distorted abdominal wall anatomy resulted from previous surgeries or repairs. Pathophysiology of seroma formation might be interrelated with ePTFE propensity, especially for rough parietal surface host–mesh interaction. Some surgeons suggested simple observation without manipulation for the fear of mesh infection unless symptomatic or persisting more than 6 weeks.⁸

Conclusions

Most ventral and incisional hernia populations are characterized by old age, more co-morbidities, and underlying disease related to the intra-abdominal pathology and laparotomy. Our results showed that patients with recurrent incisional hernias may enjoy similar outcomes and life quality despite their previous failed repairs. Higher incidence of seroma formation was associated with recurrent incisional hernias as well as extensive adhesiolysis. Chronic pain after a successful LIVHR necessitates long-term follow-up and further understanding of bioprosthetic physiology of abdominal wall hernia repairs with an emphasis on patients' subjective well-being. The durability of LIVHR with low recurrences was ascertained in the current study, and we also highlighted the importance of preoperative counseling and quality of life assessment as part of outcomes evaluation of this surgical technique.

Footnotes

Disclosure Statement

No competing financial interests exist.

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