Lymphocele Prevention After Pelvic Laparoscopic Lymphadenectomy by a Collagen Patch Coated With...

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Lymphocele Prevention After Pelvic LaparoscopicLymphadenectomy by a Collagen Patch Coated With

Human Coagulation FactorsA Matched Case-Control Study

Andrea Tinelli, MD,* Ospan A. Mynbaev, MD, PhD,Þ Daniel Alberto Tsin, MD, PhD,þGiorgio Giorda, MD,§ Antonio Malvasi, MD,|| Marcello Guido, PhD,¶

and Farr R. Nezhat, MD, PhD#

Objective: LymphocelesAQ1 are among the most common postoperative complications ofpelvic lymphadenectomy (PL), with a reported incidence of 1% to 50%. Symptoms arepelvic pain, leg edema, gastrointestinal obstruction, obstructive uropathy, and deep veinthrombosis, and severe complications such as sepsis and lymphatic fistula formation.After laparoscopic PL, we tested the prevention of lymphoceles using collagen patch coatedwith the human coagulation factors (TachoSil) on 55 patients with endometrial cancer stagesIB to II who had undergone laparoscopy.Materials and Methods: The authors divided the patients into 2 laparoscopy groups:PL plus TachoSil (group 1: 26 patients) and PLwithout TachoSil in a control group (group 2:29 patients), as historical cohort of patients who underwent PL between 2010 and 2012.We collected surgical parameters, and the patients underwent ultrasound examination onpostoperative days 7, 14, and 28. The main outcome measures were the development ofsymptomatic or asymptomatic lymphoceles, the need for further surgical intervention, asadverse effect of surgery, and the drainage volume and duration.Results: The same number of lymph nodes in both groups was removed; group 1 showeda lower drainage volume. Lymphoceles developed in 5 patients in group 1 and in 15 patientsin group 2; of these, only 2 patients were symptomatic in group 1 and 5 patients weresymptomatic in group 2, without statistical difference and no percutaneous drainage request.Conclusions: In this preliminary investigation, the intraoperative laparoscopy applicationof TachoSil seems to reduce the rate of postoperative lymphoceles after PL, providinga useful additional treatment option for reducing drainage volume and preventing Lsdevelopment after PL.

Key Words: Lymphocele, Endometrial cancer, Pelvic lymphadenectomy, TachoSil,Lymph nodes, Radical hysterectomy, Lymphocysts, Drainage, Complications

ORIGINAL STUDY

International Journal of Gynecological Cancer & Volume 00, Number 00, Month 2013 1

Copyeditor: Wilma Q. Sabueto

*Department of Obstetrics and Gynaecology, Vito Fazzi Hospital,Lecce, Italy; †Experimental Researches Modeling Division, MoscowState University of Medicine and Dentistry, Moscow, Russia; ‡Divi-sion of Minimal Invasive Endoscopy, Department of Gynecology,The Mount Sinai Hospital, Queens, NY; §Division of GynecologicOncology, Centro di Riferimento Oncologico, Istituto NazionaleTumori, Aviano, Italy; ||Department of Obstetrics and Gynaecology,Santa Maria Hospital, Bari, Italy; ¶Laboratory of Hygiene, Depart-ment of Biological and Environmental Sciences and Technologies,

Di.S.Te.B.A., Faculty of Sciences, University of Salento, Lecce,Italy; and #Columbia University College of Physicians and Sur-geons, New York, NY; and Division of Gynecologic Oncology andthe Department of Obstetrics and Gynecology, St. Luke’s-RooseveltHospital Center, NY.Address correspondence and reprint requests to Andrea Tinelli, MD,

Department of Obstetrics and Gynecology, Division ofExperimental Endoscopic Surgery, Imaging, Technologyand Minimally Invasive Therapy, Vito Fazzi Hospital,Piazza Muratore, 73100 Lecce, Italy. E-mail:[email protected].

The authors declare no conflicts of interest.

Copyright * 2013 by IGCS and ESGOISSN: 1048-891XDOI: 10.1097/IGC.0b013e31828eeea4

Received January 31, 2013, and in revised form February 22, 2013.Accepted for publication February 24, 2013.

(Int J Gynecol Cancer 2013;00: 00Y00)

Pelvic lymphadenectomy is a routine step during surgicalstaging and treatment of endometrial cancer, which is a

common cancer occurring predominately in postmenopausalwomen and having as main risk factor unopposed estrogen.1

Most patients with endometrial cancer present with early dis-ease (International Federation of Gynecology and Obstetrics[FIGO] stage I), where the disease is confined to the uterus.2

The lymphatic drainage of the uterine corpus is complex,with a bilateral and a bipartite lymphatic pathway. The loweruterine segment drains to the pelvic lymph nodes via thebroad ligaments, parametria, and paracervical pathway; theupper segment of the uterine corpus drains into the para-aortic lymph nodes via the infundibulopelvic ligaments.3

More recently, Abu-Rustum et al4 evaluated the role ofsentinel lymph nodes evaluation in patients with early-stageendometrial cancer, studying the pelvic lymphatic pathway.That study provided precise anatomical mapping of the sen-tinel lymph nodes found. Most of the detected sentinel lymphnodes (90%) were located in the pelvis (external iliac, hy-pogastric, and obturator lymph nodes). However, 4% werelocated in the para-aortic region and 6% were located in thecommon iliac region.4

Endometrial cancer spreads directly into surroundingtissues, such as corpus uteri and cervix, but disease spreadalso occurs via lymphatic vessels. Standard treatment for en-dometrial cancer is the surgical removal of the uterus, tubes,and ovaries, that is, hysterectomy and bilateral salpingo-oophorectomy and washings.5

In 1987, the Gynecologic Oncology Group trial reportedby Creasman et alAQ2 6 stressed the importance of surgical stagingin providing prognostic information for patients with endo-metrial carcinoma. Results of histopathological studies dem-onstrated spread to pelvic and para-aortic lymph nodes in upto 10% of the cases of early-stage disease, whereas metastasisto more distant organs is via the blood stream (hematologicalspread).6

In 2009, the new FIGO staging emphasized the im-portance of evaluation of the status of lymph node involve-ment in patients with endometrial carcinoma. Most patientswith stage I disease (90%) will not have any metastasis andwill be subjected to the adverse effects of lymphadenec-tomy, including increased operative time, surgical complica-tions, lymphedema, and lymphocyst formation.7 In addition,the results of 2 recent large randomized trials did notfind any survival benefit for systematic lymphadenectomy inearly endometrial cancer.8,9 Both of these studies found thatlymphadenectomy did not confer a survival advantage in alow-risk group of patients with endometrial cancer but thatlymphadenectomy did allow for more accurate staging witha significant number of patients upstaged.8 Surgical stagingby pelvic lymphadenectomy not only identifies most pa-tients with extrauterine disease but also identifies patients

with uterine risk factors for recurrence. Hence, the lymphnode metastasis detection by pelvic lymphadenectomy mustbe weighed against the additional morbidity and costs asso-ciated to surgery.

Anyway, the most frequent postoperative complicationassociated to lymph node dissection is the lymphocele orlymphocyst, a collection of lymphatic fluid along the lym-phatic vessels, as a consequence of surgical dissection withno closure of afferent lymphatic vessels. Authors have pre-viously addressed the issue of the prevention of lymphoceleor lymphocyst after pelvic lymphadenectomy in endome-trial cancer after laparotomy through the use of a collagenpatch coated with the human coagulation factors, namedTachoSil (Nycomed InternationalManagementGmbH, Zurich,Switzerland), at the end of pelvic lymphadenectomies.10

TachoSil is a sterile ready-to-use absorbable patch for intra-operative topical application, which works by mimicking thefinal steps of the natural blood clotting process, creatinga robust fibrin clot at the surgical wound site to achievehemostasis and sealing in 3 to 5 minutes. TachoSil providesquick, reliable hemostasis by creating a robust fibrin clotadherent to the tissue surface, and it is involved in the sealingof lymphatic capillaries. During this process, thrombin con-verts fibrinogen into fibrin monomers, which spontaneouslypolymerize; and endogenous factor XIII catalyses the cross-linking of fibrin, creating a firm, mechanically stable net-work. The resulting fibrin clot ensures effective hemostasisand sealing, thus preventing leaks. The cross-linking of fibrincreates a robust matrix with the collagen carrier, provid-ing sealing and giving mechanical support to the tissue.11

TachoSil is currently approved in Europe for supportive he-mostatic treatment in surgery; it has a large patch of 9.5 �4.8 � 0.5 cm, a medium patch of 4.8 � 4.8 � 0.5 cm, and asmall patch of 3.0 � 2.5 � 0.5 cm. In this study, we addressthis issue through the use of laparoscopy adding TachoSil atthe end of laparoscopic lymphadenectomies by a prospectiveinvestigation.

MATERIALS AND METHODSIn a University-affiliated hospital, with the collabora-

tion between the department of gynecology and obstetricsand the department of pathology, the authors performed anopen randomized prospective study approved by a local ethicscommittee. Fifty-five consecutive patients with endometrialcancer were treated surgically from 2010 to 2012. All womeninvestigated had an early endometrioid cancer preoperativelyevaluated by pelvic magnetic resonance imaging plus pelviccomputed tomography.

The procedures used in the present study were in ac-cordance with the guidelines of the Helsinki Declaration onhuman experimentation. The protocol purpose was carefully

Tinelli et al International Journal of Gynecological Cancer & Volume 00, Number 00, Month 2013

2 * 2013 IGCS and ESGO

explained to the patients before they entered the study, andtheir written consent was obtained.

The only exclusion criterion was any evidence of coag-ulation disorders, and such cases were excluded from the study.The authors used the most common tests to assess coagula-tion functions including activated partial thromboplastin time,prothrombin time (also used to determine international nor-malized ratio), fibrinogen, and D-dimer. Preoperative screen-ing took place within 7 days before the planned date ofsurgery and included full assessment of exclusion criteria,physical examination, and a full medical history.

Randomization allocating patients proportionally foreach center was performed. The method of randomization,decided at the beginning of the study, was in parallel assign-ment, at a randomization ratio of 1:1: standard technique plusTachoSil device in 26 patients (group 1) and standard techniqueonly in 29 women (group 2). All patients received a once-daily dose of 4000 units of subcutaneous low molecularYweight heparin into the upper arm starting from the day beforesurgery and continuing up to 4 weeks postoperatively, as re-ferred in the authors’ protocol.

The study setup was accordingly by a team with exten-sive background in gynecologic oncologic diagnosis, surgeryand management; the team of examining pathologists re-mained the same over the study period, and a standardizedapproach to identify lymph nodes was used. All procedureswere laparoscopic and executed by 4 well-trained surgeons,so as resident gynecologists blinded to surgery followed pa-tients in the surgical early and late follow-up.

The first step of the surgery was abdominopelvicwashing, followed by pelvic lymphadenectomies, performedby level 2 in the Querleu and Morrow classification of pelviclymphadenectomy of 2008. It started along the external iliacvein, and the lymphatic overlying the external iliac artery wasalso removed. Dissection then proceeded inferiorly to theobturator fossa, to isolate and preserve the obturator nerve, theobturator artery, and vein and to remove the obturator lymphnodes. The circumflex nodes were identified and preserved.Dissection further proceeded proximally to the bifurcation ofthe common iliac artery, where the lymph nodes in the anglebetween the external iliac and hypogastric arteries were re-moved, without closure of peritoneum over vessels after pel-vic lymphadenectomy (F1 Fig. 1).

Pelvic lymphadenectomy (PL) was always standard-ized by 2 devices: the Enseal vessel-sealing system (EthiconEndo-Surgery, Cincinnati, OH), and the Gyrus PK bipolarplasmakinetic vessel sealing (PlamaKinteticTM; Gyrus Medi-cal, Maple Grove, MN), 2 precise cutting and simultaneouscoagulation in laparoscopic surgery.

After PL, the surgeons used the TachoSil in 26 patientsof group 1 at the end of procedure.

The TachoSil rolling was necessary, made by surgeonsduring surgery and after using a gauze to dry and clean theaffected area (F2 Fig. 2), in the absence of the specific device thatthe company is developing. Surgeons shaped a medium patchof TachoSil of 9.5 � 4.8 � 0.5 cm, subdivided into 2 equalpatches to place both into the obturator fosse to provide quick,reliable hemostasis by creating a robust fibrin clot, whichadheres to the tissue surface into the obturator fosse (F3 Fig. 3).

Therefore, only 1 package of TachoSil was required forbilateral pelvic lymphadenectomy.

After PL, the surgeons completed operations with anA type radical hysterectomy (by Querleu and Morrow clas-sification of extended hysterectomy of 2008) and bilateralsalpingo-oophorectomy.

Once surgery was completed, a 15-Fr drain was rou-tinely placed in the Douglas pouch to collect potential on-going bleeding or washings after pelvic lymphadenectomies.The pelvic drainage was removed when the drainage volumedecreased to less than 30 mL per day; and it was, in any case,held in place for up to a maximum of 3 days, as decided by theteam at the study setup.

The main outcome measures of this study were thedevelopment of symptomatic or asymptomatic lymphoceles,the need for further surgical intervention as adverse effectof surgery, and the drainage volume and duration.

The physicians AQ4considered symptomatic any patient whopresented with some pelvic symptoms such as pelvic full-ness, fever, chills, or lower abdominal pain, even if slight, withultrasound feedback showing a lymphocele. The authors usedultrasound as the most feasible and reliable cheapest imagingtechnique in lymphocele diagnosis.12 The ultrasound criteriato define a lymphocele were the following: cystic but internalechoes and septations may present or a low echogenicity col-lection, which may have thickened septa and internal debris.12

All patients underwent a standardized ultrasound examinationperformed by the same physicians blinded to treatment, onpostoperative days 7, 14, and 28 to test for the presence of

Fig

14/C

FIGURE 1. Dissection of the obturator fossa withisolation and preservation of the obturator nerve,exposing the arcus tendineus, of the external iliac arteryand vein, and of hypogastric arteries after pelviclymphadenectomy.

International Journal of Gynecological Cancer & Volume 00, Number 00, Month 2013 Use of TachoSil as Adjunct Treatment AQ3

* 2013 IGCS and ESGO 3

any lymphoceles as recommended by literature.13,14 In fact,lymphoceles usually appear 7 to 15 days after pelvic nodedissection, and most of them represent incidental findingswithout clinical significance, usually resolving spontaneouslywhen lymph reabsorbs and new lymphatic vessels develop.14

Successive scheduled institutional follow-up consisting of pel-vic examination (vaginal and rectal) and pelvic transvaginaland transabdominal ultrasound scan to detect the presence ofpelvic masses and the presence of lymphoceles and lymphor-rhea were scheduled monthly for the first 3 months, then every3 months for the first 2 years, and every 6 months thereafter.All intraoperative and early postoperative complications at-tributable to PLwere documented. Another considered surgicalparameter was the need for further surgical intervention, de-fined as any invasive procedure, including percutaneous andopen surgical procedures, required to control complications.The secondary end points included drainage volume and du-ration. Data were collected by blinded physicians and evalu-ated by an independent reviewer.

One goal of the proposed study is to test the null hy-pothesis that the positive proportion is identical in the 2populations. The criterion for significance (alpha) has beenset at 0.050. The test is 2-tailed, which means that an effectin either direction will be interpreted. With the proposedsample of at least 26 subjects required in each group, the studywill have the power of 80.0% to yield a statistically signifi-cant result. This computation assumes that the difference in

Fig

34/C

FIGURE 3. TachoSil positioning into the obturatorfossa under the obturator nerve.

Fig

24/C

FIGURE 2. A, Gauze application to dry and clean the selected area. B, TachoSil rolling by surgeons. C, TachoSilapplication over the lymphadenectomy. D, Application of a gauze on TachoSil to permit the device adhesionto the obturator fossa.



proportions is 0.37 (specifically, 0.82 vs 0.45). This effect wasselected as the smallest effect that would be important todetect in the sense that any smaller effect would not be ofclinical or substantive significance. It is also assumed that thiseffect size is reasonable in the sense that an effect of thismagnitude could be anticipated in this field of research.

The data collected were analyzed using the StatViewversion 5.1 forMacintosh (Abacus Concepts, Inc, Berkeley, CA,1992). Continuous variables were expressed as mean T SD,whereas categorical variables were expressed in absolute. Forcategorical variables, the Fisher exact test was used, whereascomparisons between 2 groups with normality and homoge-neity of variances were performed by 2-tailed unpaired Stu-dent t test. Alternatively, comparisons between groups withabnormality and heterogeneity of variances were performedby Welch t test. P G 0.05 was considered significant.

This study did not include an evaluation of costs butonly a collection of surgical parameters.

RESULTSThe patients with endometrioid cancer were all white,

and the characteristics of the 2 groups, shown inT1 Table 1,were homogeneous and equally distributed, with no statisticaldifference. The same pathologist evaluated all specimens, di-agnosing the FIGO stage (classification of 2009) equally dis-tributed in both groups: in group 1, we operated on 16 womenin stage II, 7 women in stage IB, and 3 women in stage IA;whereas in group 2, we had 18 patients in stage II, 7 patientsin stage IB, and 4 patients in stage IA.

All cancer data on uterine risk factors for recurrence,including stage, histological grade, deep myometrial invasion,lymphovascular space involvement, and lymph nodes involve-ment, are incorporated inT2 Table 2.

There were no differences in operative times and inestimated blood loss between the 2 groups and no intraopera-tive or early postoperative general complications during sur-gery like hemorrhage, hematoma, and postoperative ileus.

No women were reoperated on after a follow-up of90 days, and the compliance rate of women undergoing ultra-sound evaluation was optimal (55/55), with nearly no dropout.

We removed 16.5 T 1.5 lymph nodes (range, 15Y20 lymphnodes) in patients in group 1 and 17.0 T 1.5 lymph nodes(range, 15Y20 lymph nodes) in patients in group 2, with nostatistically relevant difference.

Patients in group 1 showed a lower drainage volume,and the drainage tube was kept in place for at least 3 days butwas removed sooner from patients in group 1, with statisticalsignificance.

Lymphoceles developed only in 5 patients in group 1versus 15 patients in group 2, with significant difference;of these, only 2 patients were symptomatic (pelvic pain andweight, and gastrointestinal heaviness) in group 1 and 5 pa-tients in group 2, without statistical difference. All these dataare shown in T3Table 3.

When a symptomatic large (95 cm) lymphocele wasfound, it was treated, in both groups, with ultrasound-guideddrainage and sclerotherapy with a 0.45% lactic acid solution.Symptoms referred by patients were the following: lowerabdominal pain, fever, sciatic compression neuropathy, chills,and palpable pelvic mass. However, percutaneous drainageproved necessary in 4 cases: one in group 1 and 3 cases ingroup 2, without statistical difference.

DISCUSSIONThe present study suggests that the incidence of lym-

phocele is considerably lower when endometrial cancer stagingis performed laparoscopically, as confirmed by Ghezzi et al15

and Acholonu et al,16 rather than by open surgery.10

TABLE 1.AQ5 Baseline homogeneous characteristics ofthe study participants

CharacteristicGroup 1(n = 26)

Group 2(n = 29) P

Age, mean T SD, yrs 55.6 T 4.5 57.3 T 2.3 NS*BMI, mean T SD, kg/m2 26.5 T 2.6 28.4 T 3.2 NS†Parity, mean T SD 1.4 T 1.3 1.7 T 0.5 NS*Removed lymph nodes,mean T SD

16.5 T 1.5 17.0 T 1.5 NS†

Data are expressed as mean T SD.*Statistical analysis was performed by unpaired t test with Welch

correction.†Statistical analysis was performed by an unpaired Student t test.

TABLE 2. Cancer data on uterine risk factors forrecurrence, including stage, histological grade,deep myometrial invasion, lymphovascular spaceinvolvement, and lymph nodes involvement

CharacteristicGroup 1(n = 26)

Group 2(n = 29)

Stage, n (%)IA 3 (11.5) 4 (13.7)IB 7 (26.9) 7 (24.1)II 16 (61.6) 18 (62.2)

Histologic grade, n (%)1 5 (19.2) 4 (13.7)2 9 (34.6) 10 (34.4)3 12 (46.2) 15 (51.9)

Depth of myometrial invasion, n (%)e 12 (46.1) 14 (48.2)Q 14 (53.9) 15 (51.8)

Lymphovascular space involvement,n (%)+ 5 (19.2) 8 (27.5)j 11 (80.8) 21 (72.5)

Patients’ with lymph nodesinvolvement, n (%)

3 (11.5) 5 (17.2)

AQ5

International Journal of Gynecological Cancer & Volume 00, Number 00, Month 2013 Use of TachoSil as Adjunct Treatment


The advantages of laparoscopic surgery are intrin-sically linked to greater surgical precision, reduced peri-toneum handling and tissue bleeding, as well as decreasedcontamination with foreign bodies (pulverization, dust, etc).As a consequence, laparoscopy is associated with less post-operative adhesions compared to open surgery.15

Reported incidence rates of lymphocele after surgeryfor gynecological cancer range from 1% to approximately50%. This wide variation is mainly due to the large variabil-ity in the modality of diagnosis. Lymphoceles usually appear7 to 15 days after pelvic node dissection, and most of themrepresent incidental findings without clinical significance, usu-ally resolving spontaneously when lymph reabsorbs and newlymphatic vessels develop.15

Most lymphocysts are asymptomatic and are identifiedonly fortuitously on routine postoperative imaging studies.Although lymphocysts may seem of little clinical significancegiven the seriousness of the underlying malignancy, they cancause additional morbidity and they occasionally delay theinitiation of adjuvant treatments. When symptoms do occur,they are typically related to compression of surrounding struc-tures, resulting in pelvic pain, leg edema, gastrointestinalobstruction, obstructive uropathy, and deep vein thrombosis.Furthermore, severe and potentially life-threatening compli-cations can arise including sepsis, chylous ascites, lymphaticfistula formation, and pulmonary embolism. Moreover, whenserious later sequelae supervene, adjuvant radiotherapy mustbe delayed or is even contraindicated.17Y19

The role of lymphadenectomy in endometrial cancerstaging is still under debate, as pelvic and para-aorticlymphadenectomy can be associated with intraoperative andpostoperative complications including bleeding and injury tosurrounding structures. In addition, lymphocysts and lymph-edema may develop.

Nezhat et al,20 in a recent review on lymphadenectomyfor treatment of endometrial carcinoma, suggested that acomprehensive surgical staging including pelvic and para-aortic lymphadenectomy remains the single best method for

assessment of lymph node status in patients with intermediate-and high-risk endometrial carcinoma. They stated that a com-prehensive pelvic and para-aortic lymphadenectomy shouldbe performed in patients with intermediate- and high-risk(grade 3, invasion 950%, and nonendometrioid types) endo-metrial cancers.

However, once established that laparoscopy is better thanlaparotomy in the prevention of complications and ‘‘restitu-tion to integrum AQ6,’’ the best way to reduce the percentage oflymphocele after pelvic lymphadenectomy can be figured out AQ7.

A recent review21 suggested that the use of new energysources for the surgical management of gynecological malig-nancies and more specifically for performing pelvic and/orlumboaortic lymphadenectomy may decrease the incidenceof lymphocysts when used in combination.

In 2005, Nezhat et al22 reported their findings from apilot study of ultrasonic shears for the management of gyne-cological malignancies.

No symptomatic lymphocysts were diagnosed in thecohort of 100 patients managed with laparoscopic pelvicand/or para-aortic lymphadenectomy using the ultrasonicshears. Follow-up duration is not reported, and the studyfocuses on the intraoperative complications. Underestima-tion of the incidence of lymphocyst due to a short follow-upduration is a possibility.

In 2010, Gallotta et al23 described a prospective ran-domized trial of the Ligaclip (Ethicon Endo-Surgery) andof bipolar coagulation in 30 patients who underwent lapa-roscopic pelvic lymphadenectomy. The incidence of post-operative lymphocysts was 10 times lower in the Ligaclipgroup (1/15 patients) than in the bipolar coagulation group(9/15 patients) (P = 0.006). The authors suggest that theLigaclip may selectively close the lymphatic vessels, thuspreventing lymphorrhea. Selective lymphatic vessel closureis possible by virtue of recent advances in laparoscopic vi-sualization technology.

It still is not clear in the literature whether the use ofdevices or drugs after lymphadenectomy can be of help in

TABLEAQ5 3. Difference and complications after pelvic lymphadenectomy among the 2 groups

Variable Group 1 (n = 26) Group 2 (n = 29) P

Drainage volume, mL 65 T 15 150 T 40 G0.01*Drainage removal, days 2 T 0.5 3 T 0.5 G0.01†Lymphoceles development, n (%) 5 (19.2) 15 (51.7) 0.023575

G0.05‡Symptomatic lymphocele in patients with fever,pelvic pain, leg edema, n (%)

2 (7.6) 5 (17.2) 0.4264NS‡

Percutaneous drainage, n (%) 1 (3.8) 3 (10.3) 0.613112NS‡

For statistical analysis, the following were used:*Unpaired Student t test.†Unpaired t test with Welch correction.‡Fisher exact test.



preventing the formation of lymphoceles. Postoperative octre-otide therapy seems beneficial, but the role of this drug inpelvic oncological surgery remains to be determined.22

We have recently reported our experiences on the effec-tiveness of TachoSil in a patient’s undergoing laparotomy,10

for which we have validated its efficacy in laparoscopy.About the efficacy and safety of TachoSil, it was al-

ready demonstrated in many surgeries.24Y27 Moreover, otherstudies28Y30 showed lymphocele prevention by using TachoSilafter pelvic lymphadenectomy.

We examined our data and the preventive strategiesproposed to reduce lymphocele development, such as fibrinapplication, omentoplasty, omission of peritoneal closure,avoidance of preoperative heparin use and, finally, the un-necessary placement of retroperitoneal drainage at the endof surgery.30 TAQ8 he possible weaknesses of this study were thelimited number of patients, the routine use of pelvic drain-ages (traditionally recommended to reduce the incidence oflymphocysts), and the limitation of first-month serial sono-grams (to record the timing of lymphocele development)and of low FIGO stage endometrial cancers. Moreover, ourstudy lacks extensive valuable information on the incidenceand clinical relevance of asymptomatic lymphocele devel-opment after pelvic lymphadenectomy.

CONCLUSIONIn the authors’ experiences, the collagen patch coated

with the human coagulation factors used after pelviclymphadenectomy in preventing asymptomatic lymphoceledevelopment demonstrated efficacy in preventing the asymp-tomatic lymphocele development. Not the same can be sta-tistically proved, on the contrary, for the evident differencebetween the 2 groups with regard to symptomatic lymph-oceles. Even if TachoSil seems to provide a useful additionaltreatment option in preventing symptomatic and asymptom-atic lymphoceles and in reducing pelvic lymph drainagevolume, our investigation is a preliminary evaluation on asmall number of women treated by pelvic lymphadenec-tomy. A multicenter randomized clinical trial, possibly in-cluding also lumboaortic lymphadenectomy, with a largernumber of patients and longer follow-up is necessary toevaluate the overall outcomes of the combination of laparo-scopic lymphadenectomy plus TachoSil application.

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International Journal of Gynecological Cancer & Volume 00, Number 00, Month 2013 Use of TachoSil as Adjunct Treatment


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