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IBRAHIM ABDEL GHAFFAR ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ348 LICHTENSTEIN HERNIOPLASTY USING POLYPROPYLENE-POLIGLECAPRONE 25 COMPOSITE MESH IN BILATERAL INGUINAL HERNIA IBRAHIM ABDEL GHAFFAR Department Of General Surgery, Faculty of Medicine, Al-Azhar University ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ـــــــــــــــــــــــــــــــــــــABSTRACT Objective: To evaluate the lightweight composite mesh of polypropylene- poliglecaprone (Ultrapro®) mesh in bilateral inguinal hernia repair (Lichtenstein technique) as regard outcome and complications. Study design: A prospective, interventional study conducted on 27 patients in Al-Azhar University Hospitals from 2009 to 2012. Materials and Methods: During study period, male patients with primary non complicated bilateral inguinal hernia, between 20 and 65 years of age, and fit for surgery, were selected. Bilateral Lichtenstein procedure using Ultrapro® mesh was done. Patients were followed up for twelve months, on weekly basis for one month then every three months. Intraoperative findings, postoperative complications including pain, recurrence, and patients' satisfaction, were thoroughly assessed. Results: All patients were males with mean age of 57.6 years and median duration of symptoms of 7.4 years. The majority of hernias were of funicular and complete scrotal types and of type III according to the Nyhus classification. Mean operative time was ninety minutes, without significant intraoperative complications. Mean hospital stay was 1.5 days. Postoperative pain was easily controlled with analgesics. Postoperative complications were; urine retention (two patients, 7.4%), mild scrotal edema (four patients, 14.81%), superficial ecchymosis of the wound (two patient, 7.4%), unilateral seroma (three patient, 11.11%), numbness at the upper medial side of the thigh (two patients, 7.4%), and feeling of foreign body (one patient, 3.7%). As regards to postoperative pain; twenty three patients

ibrahim abdel ghaffar

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IBRAHIM ABDEL GHAFFAR

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348

LICHTENSTEIN HERNIOPLASTY USING

POLYPROPYLENE-POLIGLECAPRONE 25 COMPOSITE

MESH IN BILATERAL INGUINAL HERNIA

IBRAHIM ABDEL GHAFFAR

Department Of General Surgery, Faculty of Medicine, Al-Azhar University

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ABSTRACT

Objective: To evaluate the lightweight composite mesh of polypropylene-

poliglecaprone (Ultrapro®) mesh in bilateral inguinal hernia repair

(Lichtenstein technique) as regard outcome and complications. Study design: A

prospective, interventional study conducted on 27 patients in Al-Azhar

University Hospitals from 2009 to 2012. Materials and Methods: During study

period, male patients with primary non complicated bilateral inguinal hernia,

between 20 and 65 years of age, and fit for surgery, were selected. Bilateral

Lichtenstein procedure using Ultrapro® mesh was done. Patients were followed

up for twelve months, on weekly basis for one month then every three months.

Intraoperative findings, postoperative complications including pain, recurrence,

and patients' satisfaction, were thoroughly assessed. Results: All patients were

males with mean age of 57.6 years and median duration of symptoms of 7.4

years. The majority of hernias were of funicular and complete scrotal types and

of type III according to the Nyhus classification. Mean operative time was

ninety minutes, without significant intraoperative complications. Mean hospital

stay was 1.5 days. Postoperative pain was easily controlled with analgesics.

Postoperative complications were; urine retention (two patients, 7.4%), mild

scrotal edema (four patients, 14.81%), superficial ecchymosis of the wound (two

patient, 7.4%), unilateral seroma (three patient, 11.11%), numbness at the

upper medial side of the thigh (two patients, 7.4%), and feeling of foreign body

(one patient, 3.7%). As regards to postoperative pain; twenty three patients

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(85.18%) were pain free after 1 month post operatively, additional two patients

(92.95%) were pain free after 3 months, one patient (3.7%) had intermittent

pain for six months and one (3.7%) for nine months (not interfering with

activities in both). Mean period for return to normal activity was three weeks. In

all patients postoperative complications were disappeared at the end of follow

up period with no recurrence. Conclusion: Bilateral inguinal hernioplasty

using Ultrapro® lightweight mesh is effective and successful with encouraging

results and minimal complications.

Key words: Bilateral inguinal hernia, Lichtenstein hernioplasty, polypropylene-

poliglecaprone (Ultrapro®) mesh.

INTRODUCTION

Inguinal hernia is among the most common problems encountered by

general surgeons and may have significant complications.(1) Globally, inguinal

hernia is the most common type of hernia, comprising of approximately 75% of

all abdominal wall hernias.(1-3) Surgery is indicated to prevent complications. (4)

Fortunately, most inguinal hernias are repaired electively. (5,6) Inguinal hernia

repair accounting for 10 to 15% of all surgical procedures and is the second

most common surgical procedure after appendicectomy. (3,7) It has been

estimated that worldwide over 20 million repairs of inguinal hernia are carried

out each year, the specific operation rates varying between countries from

around 100–300 per 100 000 population per year .(8)

Several methods of inguinal hernia repair have been developed over the

years to improve the outcome, the most important being the Lichtenstein mesh

repair (9,10) and laparoscopic mesh repair. (10,11) Better results are obtained with

Lichtenstein (mesh) repair including rapid return to normal activities (12) and low

recurrence rate (less than 1%). (12,13)

Today, some strong recommendations exist in favor of Lichtenstein repair.

American College of Surgeons choose this technique as "gold standard" (9),

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IBRAHIM ABDEL GHAFFAR

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while National Institute of Clinical Excellence [NICE] from UK (14) and The

National Agency for Accreditation and Evaluation in Health [ANAES] from

France (15) recommended it for inguinal hernia repair. It is easy to learn and

perform. (16) The Lichtenstein Hernia Institute and the British Hernia Centre

reported very low recurrence rates in thousands of cases. (17,18)

Bilateral hernias are another specific issue. The European Hernia Society

(EHS) recommends Lichtenstein and endoscopic repairs. (19) It is widely

believed that the surgical trauma of a one-stage bilateral inguinal hernia repair

results in a greater degree of postoperative pain and an increase in wound

infection, when compared with sequential unilateral repairs. Several authorities

favor sequential repair, and in the past this has been accepted practice.

However, retrospective reviews have indicated that simultaneous repair may be

performed with no greater morbidity than sequential repair. There is no

difference in the long-term recurrence rates after bilateral simultaneous and

unilateral repair. The main advantage of simultaneous over sequential bilateral

hernia repairs is that only one admission, one anaesthesia, one operation and one

period of convalescence are required. This enables a more efficient use of

hospital beds, and as a result there is an economic saving to both the patient and

the hospital. In addition the risk of strangulation on the unoperated side is

eliminated. (20)

Usher first introduced polypropylene prosthetics for inguinal hernia in the

late 1950s, however, the wide acceptance of them took place in 80's following

Lichtenstein's report of very successful results. Meshes have decreased the rate

of recurrence significantly, but some problems related to meshes have been

reported. A hernia mesh has certain features like material, strength, elasticity,

density, pore size. Standard polypropylene (PP) mesh is the most frequently

used one. It is cheap, available in most institutions, non-absorbable, and strong

enough to avoid recurrence. Nevertheless, some actual problems with mesh use

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like foreign body sensation and chronic postoperative pain have created a

conflict about standard polypropylene mesh. Polyester mesh might be an

alternative, but it could not gain popularity. Polyester meshes can degrade by

time especially in infected areas. (21) Newer lighter meshes have been produced

to overcome those problems. (22)

Partially absorbable meshes have two components. Polypropylene non

absorbable part does not lose its strength at all. The other half is absorbed within

12 weeks. (23) Eventually less foreign material is left in situ, while the remaining

mesh can still provide a sufficient mechanical barrier against recurrence. (24)

The use of partially absorbable light weight meshes could be associated with

reduced feeling of a foreign body. (25)

Lightweight meshes are designed to mimic the physiology of the

abdominal wall and the inguinal region. (26,27) Meshes in this group are produced

with small polymer fibers, large pores (>1 mm) and a high flexibility. The

tensile strength is adapted to that of local tissues and the surface area in contact

with the host tissues is low. A welcome and major side effect of the sensitive

mechanical adoption of these meshes to the abdominal wall is a significant

reduction of scar tissue formation resulting in a long-term flexible repair. (27,28)

Flexible lightweight mesh constructions with similar elasticity to the anterior

abdominal wall demonstrate their superiority with respect to a physiologic

abdominal wall repair. (29)

Monocryl (poliglecaprone 25) is a monofilament derived from a segmented

copolymer of caprolactone and glycolide. This complex polymeric system

contains soft segments of polyglycolide that provide high strength. Both hard

and soft segments are combined in the same polymeric chain. Evaluating the

toxicity potential of Monocryl suture, no genotoxic, cytotoxic, teratogenic,

irritating or allergic effects were found. As suture material it was introduced in

1995 and since then it demonstrated many preferable qualities including a

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IBRAHIM ABDEL GHAFFAR

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352

significantly lowered tissue reaction in the early phases of wound healing

compared with polyglactine 910 (vicryl). Monocryl is essentially absorbed

without increased cellularity, inflammatory and fibrotic reaction within 84-140

days. (30)

The monocryl poylpropylene composite mesh is currently the member of

the lightweight large porous mesh family with the lowest foreign body reaction

and optimized handling. The clinical studies produced encouraging results to

move forward with this mesh concept. (31)

MATERIALS AND METHODS

Population

This was a prospective, interventional study performed at the department

of surgery, Al-Azhar university hospitals from 2009 to 2012. Twenty seven

patients with bilateral inguinal hernias were eligible for the study. All patients

were males with mean age of 57.6 years.

Inclusion criteria: Clinical diagnosis of bilateral inguinal hernia, any

grade, both types (direct, indirect), primary, not complicated in fit males, age

between 20 and 65 years.

Exclusion criteria: Abnormal laboratory tests; increased intra-abdominal

pressure, patients declared unfit for general or spinal anesthesia and surgery due

to other co-morbid factors.

Study protocol

All patients were interviewed with a standardized questionnaire, and had a

physical examination. The questionnaire inquired about the hernia history as

regard causes, onset, previous complications or repair and history of diseases

that cause increased intra-abdominal pressure.

Complete physical examination (general and local) including PR

examination was done to all patients. Complete laboratory tests, ECG, chest X

ray and abdominopelvic ultrasound were done for all patients.

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Lichtenstein hernioplasty using monocryl polypropylene composite mesh

for bilateral inguinal hernia was planned for all cases. Patients were completely

counseled regarding the procedure, outcome and possible complications. A

written consent was taken.

The procedure

Patients were admitted a day prior to surgery. Assessment for

general/spinal anesthesia was done. Preoperative preparations as (shaving of

pubic hair, fasting 8 hours before surgery) were done. Intravenous Antibiotic

(third generation cephalosporin) was given at the induction of anesthesia as

prophylaxis. The operations were carried out under general/spinal anesthesia.

Standard 6x11cm mesh was inserted on both sides. Fixation of the mesh was

done by prolene 2/0. Drain was inserted on demand (according to size of the

hernia, dissection and hemostasis).

During surgery the procedure followed was meticulous and precise. It was

ensured that all the recommended precautions are taken. Effective postoperative

analgesia was ensured. Scrotal elevator was prescribed for one week to decrease

scrotal oedema. After their discharge from hospital, patients were followed up

on weekly basis for four weeks, then every three months for one year. They

were also advised to avoid any predisposing factors that increase intra-

abdominal pressure; straining (cough, constipation), lifting heavy objects and

hard working for at least three months. Mild laxative and systemic antibiotic

were prescribed.

At follow-up, patients were interviewed with the same standardized

questionnaire used before, which included additional items related to surgery

satisfaction and complications. During every visit the patients were physically

examined for the outcome of the procedure including early, late complications,

pain assessment (based on Inguinal Pain Questionnaire, IPQ) (32) and recurrence.

RESULTS

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A total of 27 consecutive patients scheduled for Lichtenstein hernioplasty

using monocryl polypropylene composite mesh for bilateral inguinal hernia.

They were between 20 and 65 years of age with a mean age of 57.6 years. The

commonest age group in this study was from 50 to 60 years [16 patients

(59.25%)]. All patients were males with symptomatic hernias. The median

duration of symptoms was 7.4 years. The majority of hernias were of funicular

and complete scrotal types and of type III according to the Nyhus classification.

Seven patients (25.9%) presented with scrotal type on both sides, six patients

(22.22%) with scrotal type on one side and funicular on the contralateral side,

six patients (22.22%) with funicular type on both sides, four patients (14.81%)

with scrotal type on one side and bubonocele on the contralateral side, two

patients (7.4%) with funicular type on one side and bubonocele on the

contralateral side and two patients (7.4%) with bubonocele bilaterally. Three

patients (11.11%) presented with associated unilateral vaginal hydrocele and

two patients (7.4%) with bilateral vaginal hydrocele (Table 1).

Table (1): Patient demographics

No. (%) Parameter

57.6 years Mean age

16 patients (59.25%) Commonest age group (50-60 Y)

7.4 years Median duration of symptoms

Seven patients (25.9%)

Six patients (22.22%)

Four patients (14.81%)

Six patients (22.22%

Two patients (7.4%)

Two patients (7.4%)

Type of hernia;

Bilateral Scrotal

Scrotal- funicular

Scrotal-bubonocele

Bilateral Funicular

Funicular-bubonocele

Bilateral bubonocele

Two patients (7.4%)

Three patients (11.11%)

Associated vaginal hydrocele;

Bilateral

Unilateral

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The analysis of the results was based on:

1- The operative and early postoperative finding.

The median duration of surgery was 90 minutes (range, 80–100 minutes).

Intraoperative hernias were of direct, indirect and combined types. In nine

patients (33.33%) the hernia was direct on both sides, In eight patients (29.62%)

it was indirect on both sides, In three patients (11.11%) it was direct on one side

and indirect on the contralateral side, In three patients (11.11%) it was

combined on one side and indirect on the contralateral side, In two patients

(7.4%) it was combined on one side and direct on the contralateral side, In two

patients (7.4%) it was combined on both sides. Postoperative pain was mild in

ten patients (37.03%), moderate in fifteen (55.55%), severe in two patients

(7.4%) and was controlled in all patients by non-steroidal anti-inflammatory

drugs (diclofenac sodium 75 mg i. m. injection). The mean hospital stay after

surgery was 1.5 days (Table 2).

Table (2): Operative findings and outcome

Mean time / No. (%) Parameter

90 minutes Operative time

1.5 days Hospital stay

Nine patients (33.33%)

Eight patients (29.62%)

Two patients (7.4%)

Three patients (11.11%)

Two patients (7.4%)

Three patients (11.11%)

Type of hernia;

Bilateral direct

Bilateral indirect

Bilateral combined

Direct-indirect

Direct-combined

Indirect-combined

Three weeks Return to normal activity

There was no mortality, intraoperative or postoperative significant

bleeding, two patients (7.4%) developed urine retention and treated with

catheterization, two patients (7.4%) developed superficial ecchymosis in the

wound and were treated conservatively and four patients (14.81%) developed

mild scrotal edema (resolved spontaneously).

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2- The development of complications.

The average time for return to normal daily activity was three weeks.

Complications like hematoma, secondary hydrocele, ischemic orchitis, testicular

atrophy, dysejaculation syndrome, wound sepsis, mesh migration, rejection,

erosion and fistula formation were not observed. Three patients (11.11%)

developed unilateral seroma. Two patients (7.4%) developed numbness at the

upper medial side of the thigh. One patient (3.7%) experienced a feeling of

foreign body by the third month (Table 3).

Table (3): Complications of the procedure

No. (%) Parameter

2 (7.4%) Urine retention

4 (14.81%) Mild scrotal edema

2 (7.4%) Superficial ecchymosis of the wound

3 (11.11%) Unilateral seroma

2 (7.4%) Numbness at the upper medial side of the thigh

1 (3.7) Feeling of foreign body

0 (0%)

Hematoma, secondary hydrocele, ischemic

orchitis, testicular atrophy, dysejaculation

syndrome, wound sepsis and Mesh migration,

rejection, erosion and fistula formation.

0 (0%) Recurrence

As regards to post-operative pain; twenty three patients (85.18%) were

pain free at 1 month post operatively, additional two patients (92.95%) were

pain free at 3 months, one patient (3.7%) had intermittent pain that lasted for six

months (not interfering with activities) and one patient (3.7%) experienced pain

for up to nine months (not interfering with activities) (Figure 1).

Figure (1): Resolution of pain post operatively

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At the end of the follow up period all patients showed complete cure, no

residual pain, were satisfied by surgery and no recurrence was reported.

DISCUSSION

Inguinal hernia repairs consume an important part of health care resources

because of the high incidence of the problem. (33) Every recurrence after a

primary repair will add an extra cost to health care economics. Moreover,

secondary or tertiary operations after previous repairs carry higher risk of re-

recurrence and specific complications like testicular atrophy. Therefore, every

surgeon should know and perform a current repair method successfully in his

daily practice. (24)

Since Bassini published his original description of inguinal hernia repair in

1887, many techniques for hernia repair such as Shouldice, Darning, modified

Bassini, Lichtenstein and laparoscopic repair have been published. (5,7,8,34-36)

Laparoscopic and Lichtenstein mesh repair are becoming popular in recent days

(36) as they are associated with rapid return to normal activities with low

recurrence rates. (12)

Most studies of postoperative complications after bilateral hernia repair

have been retrospective. These are likely to be inaccurate because of incomplete

recording. Only a prospective comparison can answer the question whether

there is greater morbidity after simultaneous or sequential repair. The study of

Jarrett et al. (20) is the first to describe such a prospective assessment. They have

compared bilateral simultaneous repair with bilateral sequential repairs, and also

with unilateral repair. They conclude that patients undergoing bilateral

simultaneous inguinal hernia repair are not subject to an increased postoperative

morbidity as a consequence of the bilateral repair.

Miller and colleagues (37) demonstrated that the simultaneous repair of

bilateral inguinal hernias is safe and does not result in an increased recurrence

rate. In the present study neither significant increase in operative time (median

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90 minutes), hospital stay (median 1.5 days) nor increased intraoperative and

postoperative morbidity related to the simultaneous repair were recorded.

Postoperative pain and recovery period of the bilateral open tension-free

hernioplasty are equally comparable with those of laparoscopic repair. (38) In

patients presenting with large chronic or recurrent hernias, laparoscopy is often

technically challenging because the difficulties associated with reduction of the

hernia or adhesions. Prior abdominal interventions (e.g. appendectomy) often

complicate laparoscopic dissection. (39)

Additionally, the long-term recurrence rate of 0.1% for tension-free repair

is significantly lower than the 1% to 4% short-term recurrence rate of the

laparoscopic technique. (40-42) More importantly, the tension-free procedure is not

associated with the reported complications of laparoscopic hernia repair, such as

massive bleeding, intestinal perforation, bladder perforation, small bowel

obstruction, trocar site herniation, seroma formation, nerve injuries (as high as

15%), and even death. (42) These complications, which are continuously reported

in the literature, are extremely rare, or even unheard of, with the open hernia

repair. (38) In the present study postoperative pain was tolerable and easily

controlled by simple analgesics, no major intraoperative complication such

related to laparoscopic repair were reported.

The lightweight large porous meshes have less surface area than the

heavyweight group, consequently, the foreign body reaction (FBR) in

lightweight mesh is significantly reduced. In addition to this significantly

decrease typical chronic inflammatory reaction, the fibrotic reaction around the

mesh in total as well as around each mesh fiber is greatly reduced. The fibrotic

reaction as a result of the inflammatory response, however, considerably

influences the long term quality of the hernia repair. (30)

Ultrapro® represents a new member of the lightweight large porous mesh

group. The mesh is constructed of a monofilament lightweight large porous PP

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mesh with pores of more than 3 mm. An absorbable monocryl (poliglecaprone

25) component is added to improve handling characteristics and to optimize

implantation and increased tensile strength in the first week of repair.

Interestingly, the supplement of PP with Monocryl leads to significantly

decreased FBR compared with simple lightweight large porous PP meshes with

identical textile structure; an effect still under investigation. (30)

Two randomized studies (43,44) reported that use of a partially absorbable

lightweight mesh was associated with less chronic pain than a nonabsorbable

heavy mesh after 1 and 3 years. The frequency of recurrence was similar for the

two meshes. Mike and his colleagues (45) concluded that patients with inguinal

hernia who undergo Ultrpro repair have fewer recurrence and less chronic

inguinal pain than those who undergo conventional open repair by conventional

polypropylene mesh.

In the present study a technique of Lichtenstein hernioplasty using ultrapro

mesh was done for 27 patients with bilateral inguinal hernia. Intra-operative

finding, early postoperative and late complications were evaluated over a follow

up period of one year.

As regard operative time, intra-operative complications, hospital stay and

return to normal activity all were satisfactory. Postoperative complications

were insignificant; urine retention (two patients), mild scrotal oedema (four

patients), superficial ecchymosis in the wound (two patients), unilateral seroma

(three patients), numbness at the upper medial side of the thigh (two patients)

and feeling of foreign body (one patient). Postoperative pain was mild to

moderate except in two patients (severe pain). The resolution of postoperative

pain was encouraging; twenty three patients were pain free at one month, twenty

five patients at 3 months, one of the remaining two patients was free from pain

by the sixth month, the other by the ninth month and in both the pain was not

interfering with activities.

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At the end of follow up time all operated patients were satisfied and

showed complete improvement with no recurrence reported.

CONCLUSION

Bilateral inguinal hernioplasty using Ultrapro® lightweight mesh is

effective and successful with encouraging results and minimal complications.

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25بوليجليكابرون –بين باستخدام شبكة بوليبروبيلين اصالح الفتق االربى على الجان

ابراهين عبد الغفار

جايعت االسز -كهيت انطب -قسى انجزاحت انعايت

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يعذ انفخق االرب ي أ كزز انعهياث انجزاحيت شيعا حيذ يجز سيا حان عشزي يهي

يا يؤد ان اسخالك كبيز ف انارد يشداد ذا . جزاحت الصالح انفخق االرب عه يسخ انعانى

ة نهشبك انخ حعذ اكزز يا ف األسخالك بحذد انضاعفاث ي ذ انضاعفاث يا يحذد خيج

.انشبك رقيهت انس عا ف انشبكت خفيفت انس

( 65-20) 57.6يعذل اعارى -قذ اجزيج ذ انذراست عه سبعت عشزي يزيضا ي انذكر

ة نيخخيشخاي باسخخذاو شبكت حى اصالح انفخق بطزيق -يعا ي انفخق االرب عه انجابي -عاو

.انزكبت خفيفت انس 25بنيجهيكابز –بنيبزبيهي

حى حقييى انجزاحت خالل س حبي حذد ححس كايم نهزض يع ححس حذريج ف سبت

حذد األنى بعذ انجزاح حيذ اخخف األنى ي رالد عشزي حان بعذ شز ي حانخي بعذ رالرت شر

حى رصذ اربعت حاالث ي انخرو . حان بعذ سخت شر ي انحان األخيز بعذ حسعت شري

انخفيف بكيس انصف رالد حاالث ي انخجع انصه عه احي احذ حانخي ي انخيم بأعه

.نفخقانفخذ حان احذ ي عذو االرحياح ف انطقت االربيت نى يخى رصذ حذد حاالث ارحجاع ل

انزكبت خفيفت انس فعانت اجحت ف اصالح انفخق 25بنيجهيكابز –ا شبكت بنيبزبيهي

االرب عه اناحيخي كا ا يضاعفاحا قهيه غيز يؤرز