Minimally Invasive Therapy. 2011;20:290–295

TECHNICAL REPORT

Post-laparoscopic mesh in post-menopausal umbilical hernia repair:A case series

ANDREA TINELLI1, ANTONIO MALVASI2, CORRADO MANCA3,GIOVANNI ALEMANNO3, STEFANO BETTOCCHI4,5, TAHAR BENHIDJEB6

1Department of Obstetrics and Gynaecology, Vito Fazzi Hospital, Lecce, Italy, 2Department of Obstetrics andGynaecology, Santa Maria Hospital, Bari, Italy, 3Department of General Surgery, Vito Fazzi Hospital, Lecce, Italy,4Department of General and Specialist Surgical Sciences, University of Bari, Italy, 5Department of Obstetrics, Gynecologyand Neonatology, II Unit of Obstetrics and Gynaecology, University of Bari, Bari, Italy, and 6Department of General,Visceral and Thoracic Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

AbstractWe evaluated the efficacy and safety of the use of a composite PTFE/polypropylene patch, Ventralex (Davol Inc., C.R. Bard,Inc., RI, USA), to repair, concurrent with laparoscopy, umbilical hernia in 51 postmenopausal women. After laparoscopy,patients were submitted to the hernia repair by a patch intraperitoneally placed behind the hernia. Primary outcomes includedcomplication rates, while hernia recurrence was the secondary outcome. Patient age range was 58 ± 4.3 years, the size ofpatches was small in 17.6% of women, medium in 68.7% and large in 13.7%. Seventy-six percent of patients had an ASAI–II score, the mean operating time for hernia repair was 7 ± 2 minutes with 15 cc of related blood loss, with 1.8 days of hospitalstay. The visual analogue scale was 0–3 for 62.7%, 4–6 for 27.5% and 7–10 for 9.8% of women. All laparoscopic and umbilicalhernia repair terminated without any further intra or postoperative complications, with 36 months of follow-up; none of thepatients showed recurrences. Combining laparoscopy and intraperitoneal mesh repair appears to be indicated for umbilicalhernia treatment in post-menopausal patients undergoing laparoscopy, resulting in a safe and easy procedure, with shorthospital stay and fast dismissal, with no major morbidity or recurrence.

Key words: Umbilical hernia, menopause, laparoscopy, skin aging, prosthetic patch, Ventralex, abdominal access

Introduction

Umbilical hernia is an important complication ofabdominal surgery, it is a common surgical problemmainly encountered in the 5th and 6th decades of life,observed in >90% of elderly patients. It is seen mainlyin obese patients, especially in women, and in patientswith liver cirrhosis (1).Such hernias can cause serious morbidity, such as

incarceration (6–15%) and strangulation (2%), (2,3)and, if the hernia is not reduced promptly, smallbowel that is strangulated in the hernia may becomeischemic and necrotic and perforation may ultimatelyoccur.

Procedures for the repair of these hernias withsutures and with mesh have been reported, but thereis no consensus about which type of procedure is best.Considering umbilical hernia repair, it is important todistinguish the size of the hernia when deciding on thetype of repair (4).For hernias of <1 cm in diameter, most surgeons

still opt for a primary closure (5).The first operative techniques included simple

suture herniorrhaphy, Mayo or keel repair techniques(3), but the primary suture for umbilical herniaresulted in recurrence rates of 19–54% (6,7).A paper of Luijendijk et al. stated a sort of consen-

sus on primary ventral hernias >3 cm in size, for which

Correspondence: A. Tinelli, Department of Obstetrics and Gynaecology, Division of Experimental Endoscopic Surgery, Imaging, and Minimally InvasiveTherapy and Technology, Vito Fazzi Hospital, Piazza Muratore, I-73100 Lecce, Italy. Fax: +39/0832/661511. E-mail: andreatinelli@gmail.com

ISSN 1364-5706 print/ISSN 1365-2931 online � 2011 Informa HealthcareDOI: 10.3109/13645706.2010.542754

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a laparoscopic or open retromuscular mesh repair isrecommended (8).Although many techniques of repair have been

described, the results are often disappointing, espe-cially for the “in between” hernias of 1 to 3 cm in size,for which no consensus on the best repair is available(2,3). Until recently primary suture repair, the vest-over-pants repair and open or laparoscopic meshreinforcement were the most frequently used techni-ques; polypropylene and polyester meshes, as inother types of abdominal wall hernias, are the mostcommonly used materials.In order to evaluate the efficacy and safety of the use

of mesh materials to repair umbilical hernia, duringlaparoscopy, the authors undertook a study based onwell-designed cohort or case-control studies in post-menopausal women.

Material and methods

From January 2005 to December 2009, a total of63 postmenopausal women had a symptomaticumbilical hernia of 1–3 cm and were concurrentlyscheduled to undergo laparoscopy for gynecologicaland surgical disease.The inclusive criteria were: Large abdominal-

pelvic mass of ‡9 cm in diameter, post-menopausalstatus (assessed by FSH and 17-beta-estradiol hema-tochemical assay or amenorrheic for at least12 months), no history of open abdominal surgeryor no previous intra/peri umbilical surgery, a bodymass index (BMI) between 20 and 28 kg/m2, no use ofhormonal replacement therapy (HRT) for at leastone year.Fifty-one of the scheduled patients accepted the

study and signed informed consent prior to laparo-scopic surgery and hernia repair.All laparoscopic procedures were performed under

general anesthesia by endotracheal intubation andall women received a prophylactic dose of 2 gcefazoline I.V.Laparoscopic entry was by the direct optical access

technique (9–11) and was performed as follows: First,a 10-mm intra- umbilical incision was made, and theabdominal wall lifted;then, an optical bladeless trocar(“Endopath” Trocars, Ethicon, Johnson & Johnson,Somerville, NJ, USA) with a laparoscope was intro-duced directly into the abdominal cavity by applying aconstant axial penetrating force under direct visualidentification of abdominal wall layers, starting fromsubcutaneous fat tissue to the rectus sheath and theperitoneum and, finally, examining the intra-abdominal contents. This was followed by secondarycreation of a pneumoperitoneum.

After removal of the intraumbilical laparoscopictrocar, all umbilical hernias were repaired by theintraperitoneal Ventralex (Davol Inc., C.R. Bard,Inc., RI, USA) hernia patch; this hernia patch wasintroduced with promising preliminary short-term results (12,13), and it consists of a polypropylenelayer attached to an ePTFE layer incorporating arecoil PET memory ring.Umbilical hernia repair by Ventralex begins with

the subcutaneous fat dissection away from the herniasac: The sac is dissected out and opened to check forabdominal content. Then, a finger is inserted into thedefect to clear the surrounding peritoneum. TheVentralex hernia patch is then inserted into the peri-toneal cavity by grasping the outer borders in a forcepsor blunt clamp with a size ensuring at least 2-3cmoverlap on all sides. The mesh is composed of a roundpatch of 4.3 cm (small size), 6.4 cm (medium size) or8cm diameter (large size), with a long tail or strap,which should facilitate placement, positioning andsuturing of the device in place. The side of the patchtowards the abddominal wall is a polypropylene mesh,which encourages tissue in-growth into the abdominalmuscle, while at the inner side an ePTFE layer shouldminimize adhesions to the prosthesis. It also features amemory recoil ring consisting of non-resorbable poly-ethylen terephtalate (PET) that allows the patch to lieflat against the abdominal wall in the intraabdominalcavity (Figure 1).After introduction, we pull up on the positioning

straps gently, to flatten the patch against the abdom-inal wall. While pulling up on the positioning straps,we insert a finger or peanut sponge into the defect andin between the anterior portion of the patch and theperitoneum.We sweep circumferentially around the patch to be

as sure as possible that the patch is laying flat andnothing (bowel/omentum) can be caught between thepatch and the abdominal wall.To fix the mesh against the abdominal wall we have

to suture the positioning straps to the margins of thefascia defect with 1 U-suture on each side, while theremaining excess of the straps can be cut. Althoughnot specifically recommended, the anterior fascia isclosed over the mesh in all cases using slowly resorb-able material to minimize the risks for mesh infection.Closure of both subcutaneous tissue and skin occursusing resorbable sutures.Finally, the intra-abdominal side of the Ventralex

mesh is localized by a laparoscope inserted in theancillary trocar (Figure 2).Primary outcomes included complication rates,

while hernia recurrence is the secondary outcome.Since this combined operation (laparoscopy plusumbilical repair) constitutes a new option of

Short umbilical hernia repair by a composite patch 291

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laparoscopic access in the abdomen plus combiningminimally invasive hernia repair, all patients treatedby laparoscopic procedure were discharged after24–36 hours in order to observe accurately anypossible complications in the early postoperativeperiod. On the days following dismissal, no restrictionsin activity were recommended. Data parameters forVentralex hernia patch were collected and analyzed.

Results

Patient data and results are listed in Table I. Allpatients were mostly Caucasian (88%), with the fol-lowing characteristics: A mean age of 58 years, a meanBMI of 26.2, and the time from menopause wasmore than one year (94%). Anamnesis characteristicswere: Fourteen smokers, six diabetics, and threepatients were non steroid anti-inflammatory drugs(NSAID) users. Most women were on pension andhousewives (76%); of these 25% were ex-workersin hard jobs, 19% ex- shop-assistant/shop-girls,24% ex-office-workers, 23% ex- clerks, 9% were

ex-employees. Twenty-four percent of women wereworkers, as practitioners. The laparoscopic operationswere: Diagnostic laparoscopy in 12 women, appen-dectomy for six patients, ten cholecystectomies, twosigmoid diverticulectomies, 13 ovarian cyst removalsand eight myomectomies.The size of patches used for hernia repair were:

small in nine women (17.6%), medium in35 (68.7%), and large in seven (13.7%).The analyzed surgical parameters were the follow-

ing: The majority of women was ASA I–II score(74.6%), the mean operating time for hernia repairwas seven minutes, the blood loss was, on average,15 cc (by weight of swabs in millilitre), and theaverage hospital stay was 1.8 days.The visual analogue scale (VAS) scale was 0–3 for

32 women (62.7%), 4–6 for 14 patients (27.5%), 7–10 for five patients (9.8%). Most of these data arereported in Table I.None of the patients had hernia-related postoper-

ative complications, without wound infections orabscess requiring surgery or removal of the mesh,with no occurrence of the minor vascular and visceralinjuries in patch positioning.All laparoscopic and umbilical hernia repairs

were terminated without any further intra- or post-operative complications. The long-term follow upof 36 months did not show any recurrence rate.Eventual postoperative pain management was suc-

cessfully standardized for the first three days afterdischarge and at the patient’s preference thereafter:A scheme of paracetamol, four times 1g per day, wasalternated with the NSAID, 500 mg three timesper day.The early postoperative four to six weeks follow-

up did not show any early complications in postop-erative umbilical wound-healing, neither did thelong-term follow-up of 36 months.

Positioning strap

Monofilament polypropylene

ePTFE barrier

Memory recoil ring

Protective ePTFE overlap

Figure 1. The Ventralex Hernia Patch: The long tail or strap, the polypropylene mesh, the inner side an ePTFE layer, and a memory recoil ringconsisting of non-resorbable polyethyleen terephtalate (PET).

Ventralex

Diaphragm

Anteriorabdominal

wall

Figure 2. Intra-abdominal laparoscopic vision of the Ventralexmesh adherent to the anterior abdominal wall, detected by laparo-scope inserted in ancillary trocar.

292 A. Tinelli et al.

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Discussion

This investigation concerns a simplified intra-abdominal hernia repair technology characterizedby minimal suturing, a small incision and potentiallyfast recovery times, to apply concurrently duringlaparoscopy.The 36 months follow-up of our patients did not

show any recurrence or hernia repair-related compli-cation. The problem of umbilical hernia after primaryrepair is the recurrence rate that ranged from 19 (seeabove) to 54% (5,14), and repairs that included theuse of mesh to close the defect have better but stillhigh recurrence rates, up to 34% (15,16).These studies of suture repairs and mesh repairs,

however, were either uncontrolled or nonrando-mized, and it remains uncertain whether mesh repairis superior to suture repair.Lau et al. affirmed that the use of different kinds of

meshes for hernia repair reduced the general rate ofrecurrence (17), while Balique et al. affirmed that therecurrence rate when using prosthetic materials isreduced to 15–20% (18).On the other hand, there are some risk factors,

which can increase the risk of umbilical herniarecurrence.Many retrospective studies have analyzed and

assessed independent risk factors for umbilicalhernia recurrence (19), even if there are only a few

randomized clinical trials, which proved risk factorsfor recurrence. Arroyo et al. in their randomizedprospective trial of 200 patients compared two differ-ent surgery techniques: Suture and mesh repair tech-niques. The recurrence rate was significantly higher inthe suture repair group than in the mesh repair group(11% vs 1%, P = 0.0015). Nevertheless, they did notfind any significant relationship between recurrencerate and hernia size. The recurrence rates were similarfor defects greater or smaller than 3 cm. The patient’sBMI of >30 kg/m2 was a risk factor for umbilicalhernia recurrence (4).The size of the hernia was an independent risk

factor for recurrence in two retrospective studies byour group, in which “approximating” (edge-to-edge)fascial repairs and “overlapping” repairs were evalu-ated, but not in another study (20,21).In medical records, however, the size of the defect is

often described insufficiently, so analyses of retro-spective data are less reliable. Also, the extent ofthe decrease in laxity of the tissue surrounding thehernia, which is influenced by retraction of muscleand scarifice of tissues, may be more important thanthe actual size of the fascial defect. In this prospectivestudy, the size of the defect was not a risk factor forrecurrence. Mainly for the hernia defects between1 and 3 cm there is still debate going on whetherto use prosthetic mesh reinforcement in these cases orto perform any type of suture repair. The only existingprospective randomized trial by Arroyo and collea-gues showed an 11% versus 1% recurrence rate afterprimary suture and mesh repair respectively (4).According to their findings and also retrospectively

shown by Sanjay et al. (22), the conclusion might bethat the use of mesh is mandatory, regardless of thediameter of the defect. One of the major concernsregarding mesh repair for these small defects is themore extensive dissection necessary for mesh place-ment with adequate overlap and the risks for subse-quent wound pain and infection.With the classical laparoscopy by intraumbilical

trocar (as described above), the 10 mm intra umbil-ical incision was made with a 15 blade scalpelthrough the skin and extended to the fascia, tominimize the umbilical surgical trauma. So, to applythe Ventralex mesh, only a limited dissection area isnecessary to introduce the patch intraperitoneally,and this might limit the risks for infectious complica-tions. Moreover, the postmenopausal dermalchanges cause the skin to lose its tone and elasticity,resulting in sagging and wrinkling, with dermalfunctional alterations (10).This method should be proposed as a safe and

feasible umbilical hernia repair, also associated witha minimally laparoscopic access (9–11), that will

Table I. Characteristics of operated patients and results (n = 51)

Age in years 58 (±4.3)

Body massindex (BMI)

26.2 (±2.5)

ASA score

I–II 38 patients(74.6%)

III–IV 13 patients(25.4%)

Umbilical herniadiameter

Size of patches(in diameter)

<1cm small (4.3 cm) 9 (17.6%)

1–3 cm medium (6.4 cm) 35 (68.7%)

>3 cm large (8 cm) 7 (13.7%)

Intraoperative time (min) 7 minutes (±2)

Hernia-related blood loss repair (cc) 15

Hospital stay (days) 1.8

Postoperative pain (Visual Analogue Scale)

0–3 32 (62.7%)

4–6 14 (27.5%)

7–10 5 (9.8%)

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minimize any complications related to the skin agingprocess. As for the surgical technique described, a fewremarks should be taken into account. The first del-icate or insecure step during the procedure is themoment at which the surgeon checks for intraperito-neal adhesions. Despite the fact that the surgeon doesnot feel any fat remaining at the abdominal wall, inquite some cases there still might be some adhesions,e.g. at the level where the border of the Ventralex willbe positioned. Another issue is the presence of aprominent fatty ligament. It is very difficult to esti-mate during finger exploration whether this ligamentwill cause “cupping” of the prosthesis or not. Theligament can certainly affect flat mesh placement. Thecorrect positioning of Ventralex mesh should be moreeasily detected by a laparoscope inserted in an ancil-lary trocar; in fact, once the surgeon is convincedabout the correct deployment of the patch and the flatpositioning of the patch against the abdominal wall,the straps can be fixed to the fascial borders. Whetherresorbable or non-resorbable sutures should be usedis still not clear.

Conclusion

In conclusion, the rationale behind the concept ofthe umbilical hernia repair by prosthetic mesh, i.e.small incision, minimal dissection and repairingdefects of any size without tension, is very elegantand leads certainly to a quick procedure.Mesh handling and cost-effectiveness is important

in every health-care system nowadays, but it is ourduty to carefully evaluate both the technique andthe materials we treat our patients with, beforedrawing major conclusions about the use of alldifferent types of devices, especially in abdominalwall surgery. For small umbilical hernia repairthe tension-free Ventralex hernia repair usingexpanded polytetrafluoroethylene mesh is a veryelegant and quick-to-use mesh device in post-menopausal women, contemporary to laparoscopicsurgery.

Declaration of interest: Authors certify that there isno actual or potential conflict of interest in relation tothis article and they reveal any financial interests orconnections, direct or indirect, or other situationsthat might raise the question of bias in the workreported or the conclusions, implications, or opi-nions stated – including pertinent commercial orother sources of funding for the individual author(s) or for the associated department(s) or organiza-tion(s), personal relationships, or direct academiccompetition.

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