A prospective randomized trial:The influence of intraoperative application of
fibrin glue after radical inguinal/iliacal lymph node disction on
postoperative morbidity
H.Neuss a ,W.Raue a ,G.Koplin a ,W.Schwenk a ,C.Reetz b ,J.W.Mall b ,*
a
Department of General,Visceral,Thoracic and Vascular Surgery,Head:Professor J.M.Mu ¨ller,MD,Charite ´,Universitaetsmedizin Berlin,
Charite ´,Campus Mitte,Charite ´platz 1,10117Berlin,Germany
b
Departments of General and Visceral Surgery,Krankenhaus Oststadt/Heidehaus und Großburgwedel,Klinikum Region Hannover GmbH,
Podbielskistras 380,30659Hannover,Germany
Accepted 30September 2008Available online 17November 2008
Abstract
Background :Effects of intraoperative application of fibrin glue following combined radical inguinal and iliacal lymph node disction (RILND)on the amount of postoperative lymphatic cretion are discusd controversially.To detect whether fibrin glue application results in a decread lymphatic cretion following RILND a randomized patient blinded clinical trial was conducted.
Method :Between September 2003and September 200658patients with stage IV melanoma underwent therapeutic RILND and were randomized into two groups.29Patients received 4cc fibrin glue after RILND whereas 29patients were only irrigated with saline 0.9per-cent.Postoperatively all patients received two inguinal and one iliacal clod suction drain.The main outcome criteria were the duration of drain placement in the wound.Minor criteria were the total amount of cretion and the length of hospital stay.
Results :There was no difference between the treatment and the control group in the duration of drain placement (fibrin group:4days (1e 27);control group 5days (1e 26);p ¼0.64).The total amount of fluid was 310cc (30e 6005)in the fibrin group vs.365cc (30e 3945cc)in the control group (p ¼0.9)a
nd the length of hospital stay 10days (3e 41)(group 1)compared to 11days (3e 41)(p ¼0.99)were not different between both groups either.
Conclusion :Intraoperative application of 4cc fibrin glue does not reduce the length of drain placement,drain output or hospitalisation of patients undergoing RILND with melanoma metastasis to the lymph node basin.Ó2008Elvier Ltd.All rights rerved.
Keywords:Melanoma;Lymph node disction;Fibrin glue;Drain placement;Groin
Introduction
The incidence of malignant melanoma is increasing in western countries.In caucasian population the yearly increa of new diagnod melanomas is 3e 7%.1In Europe there are 10e 12/100,000newly diagnod malignant melanomas and up to 82/100,000in Queensland/Australia each year.2
An increa of thickness of the primary tumor (Breslow)leads to an increa of metastas in the regional lymph node basin.The number of lymph node metastas corre-lates with outcome and prognosis.3About 25%of patients with a depth of primary melanoma between 0.76and
1.5mm develop metastas to the regional basin within three years.4At a tumor depth of 1.5e 4mm,i
n 60%of the patients metastas will be found.5,6Approximately 70%of first detected metastas after diagnosis of a mela-noma are in the regional lymph node basin.
Surgical radical lymph node disction with either curative or palliative intent may be a treatment option in melanoma patients with regional metastas to the inguinal or combined inguinal/iliacal region.Therapeutical regional lymph node disction (LND)is indicated with proven regional lymph node metastas.The ntinel node biopsy or fine needle aspiration cytology (FNAC)provides a lec-tive surgical approach.7,8
The surgical procedure of the radical inguinal/iliacal lymph node disction (RILND)is responsible for
*Corresponding author.Tel.:þ495119063332;fax:þ495119063460.E-mail address:julian.mall@krh.eu (J.W.Mall).0748-7983/$-e front matter Ó2008Elvier Ltd.All rights rerved.
doi:10.1016/j.ejso.2008.09.016
Available online at
EJSO 35(2009)884e 889
morbidity such as postoperative lymphedema,prolonged lymphatic wound cretion,wound necrosis and nsoric or motoric neurological deficit.
The Department of General,Visceral,Thoracic and Vascular Surgery and Department of Dermatology,Univer-sity Medicine Berlin,Charite´developed a standard protocol for treatment of patients with inguinal metastasis of a mel-anoma,orientated towards the guidelines of a combined therapeutic radical inguinal/iliacal LND after a positive SLN biopsy.7,8
Considering postoperative morbidity,it has been advo-cated that the u offibrin glue may reduce the incidence of postoperative lymphatic cretion.9Many technical variations exist in an attempt to reduce postoperative morbid-ity rates after RILND.However,the different techniques and the resulting complication rates are difficult to compare due to different study designs,patient populations and lection criteria.To investigate the effect of intraoperatively applied fibrin glue after RILND on the amount of lymphatic cretion and the incidence of lymphaticfistulas,indirectly shown by the duration of drain placement and drain output,this prospective randomized study was carried out.
Methods
Study design
58Patients suffering from malignant melanoma with proven lymph node metastasis of the groin were random-ized into two groups concutively between September 2003and September2006following approval of the Insti-tutional Ethic Committee.
Signed informed connt was obtained from all patients prior to enrolment in the study and the rearch respected the rules of the declaration of Helsinki.
Inclusion criteria were a stage III or IV of melanoma dis-ea with lymph node metastasis of the groin proven by a positive ntinel node biopsy(SLNB)or a positive cytol-ogy result afterfine needle aspiration(FNAC)prior to sur-gery.10,11Exclusion criteria from the study were known allergy to bovine proteins,ASA(American Society of Anaesthesiology)class5and mental disorders and loss to follow-up within thefirst three postoperative months.All patients underwent RILND by a single surgeon(JWM) for therapeutic indication.
Surgical procedure
The operation was carried out in an identical fashion ac-cording to the accepted standard of surgical oncologic prac-tice.The site of the primary melanoma,already removed, was either at the lower extremity or the trunk.Low molec-ular weight heparin was given at the evening before the op-eration.
At the beginning of the operation patients received a single shot antibiotic treatment(Cefuroxime).Following a longitudinal incision just from the lateral sartorius muscle to the medial adductor muscles2cm caudal the inguinal ligament.The scar of the previous performed ntinel node biopsy was completely excid.The disction included an en-bloc rection of the superficial and deep lymph node basin of the groin.
First the superficial and the deep-ated lymph nodes were removed from the lateral edge of the sartorius muscle to the adductor muscle.The rection was continued to 15cm below the confluence of the great saphenous vein, which was discted on its complete cour and ligated at the confluence to the femoral vein.The superior margin of the superficial inguinal LAD was the inguinal ligament. After dividing the fascia lata,the deep-ated inguinal lymph nodes between the femoral vesls and the fascia of the M.vastus intermedius and lateralis of the femoral muscle were removed.The inguinal ligament confined the rection of deep-ated inguinal lymph nodes,which were completely excid along the cour of the common femoral artery and vein.
The iliac LAD was performed through a cond incision approximately7cm in length,t pararectally.Using this approach in combination with a retroperitoneal disction of the iliac vesls from the inguinal ligament up to the bi-furcation of the aorta,all accompanying iliac and obturator lym
ph nodes were accessible.The ureter in the operating field was expod for safety reasons.
Fibrin application
Following completion of the disction three drains were placed:two inguinal(clod suction drain,12Ch),and one (Robinson,16Ch)along the iliac vesls before wound clo-sure.The wounds were irrigated with Ringer’s solution and after closure of the iliacal wound,according to randomiza-tion,29patients received4ccfibrin glue(TissuecolÒ, BaxterÒ,Germany)via spray applicator(TissomatÒ, BaxterÒ,Germany)to the inguinal region.The glue was sprayed from a distance of20cm caudal to cranial with 2e3bar of pressure.We placed two layers of sutures (vicryl2e0and3e0)in the wound before thefibrin appli-cation and tied them after application of thefibrin.For 2min afirm pressure was applied by the surgeon.The skin was clod with staples.After wound closure the suc-tion drains were opened.
Postoperative care
Fromfirst postoperative day the patients wore afitted surgical support ho.Mobilisation was limited until post-operative day two.Amount and quality of the drainedfluids were recorded every24h,and they were removed when the amount was less than50cc/die.More than50cc/die for more than6days
was considered as lymphaticfistula.12 The Robinson drain was removed when the collectedfluid was less than30cc/die.The drains were kept under suction at all times.
885
H.Neuss et al./EJSO35(2009)884e889
All patients were assd twice daily including general inspection of the patient,wound inspection and measuring of the leg circumferences15cm above and under the knee joint to detect lymphedema.We considered a relevant lym-phedema when the difference between the operated and the healthy leg side was 2cm.13In ca of wound swelling an ultrasound control of the groin was performed and puncture of the cretion was performed.
According to the study protocol patients were dis-charged when all three drains were removed and no clinical signs of wound swelling or infection were detected. Patients were en on an outpatient basis routinely at the Department of Dermatology and Allergology,University medicine Berlin Charite´on a three monthly term.
Statistical analysis
Statistical analysis was performed using the SPSS15.0G System for Windows professionalÒ.The sample size was cal-culated before the beginning of the study.In the main outcome criteria a difference in the duration of drain placement of1.5 days between study and control group was considered as clin-ically relevant.The duration of drain placement in the control group was estimated to be3(0.5)days.Using a two tailed-test, a¼0.05and b¼0.2,a difference of1.5days between the groups could be detected with29patients in each group. Values were tested for normal distribution by Spearman’s
log rank correlation test.
Patients and treating physicians at the ward were blinded for the randomization.Randomization was carried with a randomization program(RandomaÒ,Martin Kracht AG Rostock,Germany)at the day before operation.Stratifica-tion criteria were x,age and body mass index.
Differences between the groups were assd using the Mann Whitney U test for continuous data.Parametric data were analyzed with Fisher’s exact test.Values of normally distributed parameters in the text are given as median (range).p Values less than0.05were considered as signifi-cant.Graphical data are prented as Box and Whisker plots.
Results
Patient characteristics
Between September2003and September200664mela-noma patients underwent a RLND of the groin.Four pa-tients did not meet all inclusion criteria and were excluded.Two patients refud to take part in the study. 58patients were randomized into two groups,the treatment and the control group.
Both groups were comparable regarding age,x and body mass index(BMI)(Table1).The median age of the patients was59years(35e77)in group1(withfibrin glue)and62years(26e86)in group2(nofibrin glue) (p¼0.72).The BMI was26in both groups(p¼0.36). An86-year-old woman of the control group died21days after surgery becau of vere pulmonal artery embolism and an apoplex20days postoperatively.
No allergic reaction to bovinefibrin glue was obrved in the treatment group.According to CDC classification there occurred two deep infections with the necessity of wound revision(one in each group;p¼1.0).14Erythema-tous inflammations(n¼10(group1)vs.n¼11(group2); p¼1.0)treated with oral antibiotics(Clindamycin)over5 days and local cooling leading to complete regression of the infla
mmation and uneventful further hospital cour.The documented skin necros at the edges of the wound were without clinical relevance.Early lymphedema during the postoperative cour on the ward was diagnod in4pa-tients(group1)and5of group2(p¼0.1).There was one persistent clinical relevant lymphedema en in the three month interval during the follow-up consultations in each group(Table2).
Duration of drain placement
The duration of drain placement in the wound in both groups is shown in Fig.1.The drains in group1(fibrin glue)were in place for a median of4days(1e27)(drain1) and1day(1e12)for drain2whereas the drains in group2 (nofibrin glue)were left in place for a median of5days (1e26)for drain1and2days(1e8)for drain2.There were no significant differences between the treatment and control groups(drain1:p¼0.64;drain2:p¼0.35).We detected a slightly shorter duration of drain placement in Table1
Characteristics of58study patients.
Fibrin group
(n¼29)
Control group
(n¼29)
p
Sex(W/M)14/1514/15 1.0 Age(yrs)59(35e77)62(26e86)0.72 Weight(kg)80(69e94)76(66e89)0.36 BMI(kg/m2)26(19e46)26(19e35)0.36 ASA(n)
IþII2424 1.0 IIIþIV55 1.0 Primary of unknown
localisation(n)
10 1.0 Clark level determined(n)2525 1.0 III54
IV1515
V56
Breslow determined(n)25230.33 <1.5mm83
>1.5<4.5mm910
>4.5mm810
Lymph nodes inguinal(n)
Total number7(1e20)9(1e32)0.94 Positive0(0e13)0(0e14)0.34 Lymph nodes Iliacal(n)
Total number4(0e18)5(0e18)0.59 Positive0(0e15)0(0e17)0.31 Data given as median and(range);BMI¼body mass index;ASA¼American Society of Anaesthesiologists Physical Status Score.
886H.Neuss et al./EJSO35(2009)884e889
the treatment group for 1day although this difference did not reach statistical significance (p ¼0.64).Amount of postoperative fluid
The amount of collected fluid did not differ between the treatment and the control group.The total collected fluid of drains 1and 2of the groin was 310cc (30e 6005cc)(group 1)compared to 365cc (30e 3945cc)in group 2(p ¼0.9)(Fig.2).Analysing the duration of drains 1and 2,there were no differences between the fibrin and the control group either (drain 1:p ¼0.85;drain 2:p ¼0.15).There
was no difference in the quality of the cretion with re-spect to sanguis or rosanguis cretion.The amount of fluid did not differ between both groups.Though we rec-ognized less volume in the treatment group,this differ-ence did not reach statistical significance either.Length of hospital stay
The median of postoperative hospitalisation of patients was 10days (3e 41)without any differences between treat-ment (10days (4e 36))and control group (11days (3e 41);p ¼0.99).The fibrin alant had no influence on the dura-tion of the hospital stay of the patients after RILND (Fig.3).
Number of lymph nodes on histological examination There were no differences in the number of excid in-guinal lymph nodes between both groups (p ¼0.94).In the treatment group 7lymph nodes (1e 20)and in the con-trol group 9(1e 32)lymph nodes were analyzed from the groin.Iliacal were 4(0e 18)(group 1)and 5(1e 18)lymph nodes analyzed (p ¼0.59).The number of metastatic lymph nodes did not differ between both groups either (groin:p ¼0.34;ilical:p ¼0.31)(Table 1).Discussion
A positive ntinel node of the inguinal region is the classical indication for the LND in patients with a primary melanoma reprenting the first regional lymph node basin.Other indications are a palliative inguinal lymph
node
Figure 1.Day of removing groin
drains.
Figure 2.Collected volume of the groin drains.
Table 2
Postoperative complications after RILND.
Fibrin group (n ¼29)
Control group (n ¼29)p Lymphatic fistula (>50ml >3d)14170.6Lymphedema
450.1Postoperative bleeding 00 1.0Hematoma 120.5Seroma
12100.79Wound erythema 1011 1.0Skin necrosis 34 1.0Wound revision
11 1.0Sensible neurologic deficit 67 1.0Motoric neurologic deficit 00 1.0Other complications
00 1.0Intraoperative complications 00 1.0Died
1
1.0
887
H.Neuss et al./EJSO 35(2009)884e 889
disction or e to a lesr extent e the preventive LND.15The surgical technique and the extent of the operation are discusd controversially in the literature and to date no surgical standard of RILND is generally accepted.Morbidity
One major problem is the high morbidity after RILND.Lymphatic fistulas and romas are the most frequently rec-ognized postoperative complications.Prolonged lymphatic cretion due to open lymphatic ducts in the groin may lead to prolonged drainage of wound cretion,swelling and finally infection of the wound.Incidences reach up to 40%(6e 40%)and reprent the most common reason for a prolonged stay in hospital or frequent visits of outpatients in hospitals.16e 19Several attempts have been made to over-come postoperative lymphorrhea.Some authors investi-gated tetracycline sclerotherapy,others instilled talcum poudrage,or ud a fibrin coated collagen patch or a sarto-rius muscle transposition following RILND.20Fibrin glue and fistula
The aim of our study was to prevent lymphatic fistulas,indicated by the duration of drain placement in the wound (main outcome criteria),by administration of fibrin glue in-traoperatively and shorten the postoperative hospital stay.Furrer ported 1993a ries of 30patients with in-guinal/iliacal or axillary RLND without an effect of fibrin glue.21Other studies describe a positive effect of the fibrin glue application after axillary LND.22,23As we have re-cently shown fibrin glue has no effect on reduction of lym-phatic cretion following radical axillary disction in melanoma patients.24Nevertheless the studies are difficult
to compare concerning the different amounts (1e 4cc per do)and application techniques (spraying technique vs.u of a syringe)of fibrin glue ud intraoperatively.They ud different technique of wound closure (immediate vs.delayed wound closure).25A reason for our result could be the limited number of patients,which was calculated to examine the influence of fibrin to drain placement.Extent of LND
The necessary attempt of radical inguinal or combined inguinal/iliacal lymph node disction is not well defined.Investigators describe a disction of superficial or superfi-cial and deep groin lymph nodes.Others describe the necessity of discting the iliacal/obturatory lymph nodes as well.Concomitantly there is no definitive answer of the influence on morbidity or long term outcome o
f patients after different extent of surgical procedure.18,26,27
In patients with skin cancer undergoing radical axillary or inguinal lymphadenectomy the results of fibrin glue ap-plication are also controversial.We could not reproduce the results reported after an LND in breast cancer patients in comparison to melanoma patients becau of the more extended rection of therapeutical lymphadenectomy as limited extend in staging lymphadenectomy for breast can-cer.28The aim of LND in breast cancer is staging and in melanoma surgery therapeutically and mostly much more radical.
At our department (Department of General,Visceral,
Thoracic and Vascular Surgery of the Charite
´,Berlin)a standardized procedure has been established in coopera-tion with the Department of Dermatology.After a positive SLNB or FNAC of the groin we routinely performed a com-bined radical inguinal/ilical LND.Other rearch groups report a better prognosis of patients and lower local recur-rence rates after combined RILND.29,30However,the level of evidence or grade of recommendation is poor.Until other randomized studies show an advantage of limited LND,we prefer the most radical procedure to minimize tumor load and local recurrence rate.Conclusion
We were able to operate all 58melanoma patients with the same indication for advanced surgery only by a single surgeon (JWM)in a standardized surgical technique.In contradiction to Waclawizeck et al.the application of fibrin glue did neither shorten the length of clod suction drain-age nor the amount of drained cretion or the incidence of complications.9Therefore the u of fibrin glue during combined radical inguinal/iliacal LND cannot be recommended.Conflict of interest None
declared.
Figure 3.Postoperative hospital stay.
888H.Neuss et al./EJSO 35(2009)884e 889
Funding
This work was funded by BaxterÒrearch department, BaxterÒ,Germany,Dr.Udo Berg.
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