Reduction of Groin Lymphatic Complications by Application of Fibrin Glue: Preliminary Results of a Randomized Study

Reduction of Groin Lymphatic Complications by Application of Fibrin Glue: Preliminary Results of a Randomized Study

Reduction of Groin Lymphatic Complications by Application of Fibrin Glue: Preliminary Results of a Randomized Study Luca Giovannacci, MD,1 Jean-Claude...

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Reduction of Groin Lymphatic Complications by Application of Fibrin Glue: Preliminary Results of a Randomized Study Luca Giovannacci, MD,1 Jean-Claude Renggli, MD,1 Thomas Eugster, MD,2 Peter Stierli, MD,2 Peter Hess, MD,1 and Lorenz Gu¨rke, MD,1 Solothurn, Switzerland

Lymphoceles and lymph fistulas are common complications after exposure of the common femoral artery in the Scarpa triangle because of operative transsection of overlying lymphatics. The purpose of this prospective randomized study was to determine the incidence of groin lymphatic complications and to assess the impact of routine application of fibrin glue on lymphatic structures and subcutaneous tissue prior to closure. All patients undergoing exposure of the common femoral artery in the Scarpa triangle were included in this study. They were divided into two groups according to closure technique. In group A, closure was performed without fibrin glue. In Group B, fibrin glue was applied to lymphatic structures prior to closure. The efficacy of fibrin glue application was estimated on the basis of two criteria: incidence of local complications and amount of lymphatic fluid in the Redon drain. The preliminary findings suggest that application of fibrin glue leads to a significant reduction in the incidence of lymphatic complications after femoral artery exposure in the Scarpa triangle.

INTRODUCTION Although exposure of the femoral artery in the Scarpa triangle is a simple procedure, it often engenders potentially serious local complications. Lymphorrhea, operative wound dehiscence, and superficial skin necrosis lead to superficial and deep infection in up to 18% of cases.1,2 Local complications also lengthen the duration of hospitalization.3 1

Vascular Surgical Unit, University Hospital Basel, Basel, Switzerland. 2 Vascular Surgical Unit, Nantoonsspital Aarau, Aarau, Switzerland. Presented at the Annual Meeting of the French Society for Vascular Surgery, Marseille, France, May 31-June 3, 2000.

Correspondence to: L. Giovannacci, MD, Service de Chirurgie, Bu¨rgerspital Solothurn, 4500 Solothurn, Switzerland. Ann Vasc Surg 2001; 15: 182-185 DOI: 10.1007/s100160010049 © Annals of Vascular Surgery Inc. Published online: March 1, 2001 182

The purpose of this study was to estimate the incidence of groin lymphatic complications after femoral artery exposure in the Scarpa triangle and to determine if application of fibrin glue (Tissucol®) could reduce the incidence of postoperative lymphoceles and lymphorrhea.

PATIENTS AND METHODS The patient population of this randomized prospective study includes all patients over the age of 20 years who underwent exposure of the femoral artery in the Scarpa triangle in our department between August 1998 and November 1999. A total of 103 patients with a mean age of 68 years (range, 32-97) were enrolled. Operative indications are listed in Table I. The femoral artery was exposed by vertical incision in the Scarpa triangle. This incision was placed 2 cm lateral of the femoral artery to minimize lymphatic injury.

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Use of fibrin glue in groin lymphatic complications 183

Table I. Operative indications Indication

n

Chronic occlusive arterial disease Aneurysm Acute arterial ischemia Post-traumatic arterioveinous fistula

66 15 20 2

The strip containing lymph tissue was retracted medially to allow exposure of the femoral artery. Lymphostasis was achieved by electrocoagulation of small lymphatic vessels and ligature of larger ones. Superficial fascia was then incised longitudinally to the femoral artery. Patients were randomized at the end of revascularization. In group A, the wound was closed without application of fibrin glue. In group B, 1 to 2 mL of fibrin glue (Tissucol®) was applied to lymphatic structures and subcutaneous tissue prior to closure in order to seal lymphatic vessels and prevent formation of a cavity between dissection layers. In both groups closure was performed layer by layer using an interrupted suture line with absorbable material after placement of a subcutaneous suction drain. In the postoperative period, the wound was examined daily to detect dehiscence, skin necrosis, lymphocele, and lymphorrhea. The amount and gross appearance of fluid in the suction drain was noted. One month after the procedure, the wound was reexamined and ultrasound was performed if fluid accumulation was suspected. Lymphorrhea was defined as perfusion of clear lymphatic fluid at the operative wound site.4,5 For lack of standardized criteria in the literature, diagnosis was based on either significant fluid production, i.e., >30 mL/day more than 3 days after the procedure, or persistent lymphatic leakage regardless of amount more than 5 days after the procedure. Lymphoceles were defined as a subcutaneous collection of clear lymphatic fluid without infection or hematoma.5,6 Initial treatment of groin lymphatic complications was conservative, including bed rest, elevation of the lower extremities, regular wound cleaning, and compression in case of lymph fistula. Bacteriologic examination of lymphatic fluid was performed in all cases. If conservative treatment failed, surgical lymphostasis was performed in the Scarpa triangle. In case of reoperation, fibrin glue was applied to dissected surfaces prior to closure. Statistical analysis was achieved using the Fisher’s exact test. Probability values <0.05 were con-

Table II. Types of arterial revascularization procedures performed in the two study groups

Procedure

Embolectomy Thrombo-endarteriectomy Arterial suture Aorto- or iliofemoral bypass Femoropopliteal bypass Two-stage revascularization procedure

Group A without fibrin glue (n = 60)

Group B with fibrin glue (n = 61)

p

7 7 3 24 15

10 9 3 20 14

NS NS NS NS NS

4

5

NS

NS, not significant.

sidered significant. Relative risk and 95% confidence interval (CI 95%) were also computed.

RESULTS Of the 103 patients randomized, four were excluded because of early death. A total of 121 femoral artery exposures were studied. Exposure was unilateral in 77 patients and bilateral in 22. Closure was performed without application of fibrin glue in 60 cases (group A) and with prior application of fibrin glue in 61 cases (group B). These groups were comparable with regard to the type of procedure (Table II) and risk factors (Table III). The incidence of nonlymphatic local complications was low, including one superficial infection in each group, two skin necroses in group B, and one delayed healing in each group (Table IV). Lymphatic complications were more common in group A, including patients in whom closure was performed without fibrin glue (n = 13, i.e., 21.6%) than in group B, including patients in whom fibrin glue was applied prior to closure (n = 4, i.e., 6.6%). This difference was significant (p = 0.019) with a relative risk of 1.69 for group A versus group B (95% CI, 1.2 to 2.3). A detailed list of complications is given in Table V. Reoperation was required in three patients in whom closure was performed without fibrin glue (group A). One patient was treated for persistent lymphoceles on postoperative day 12. Another patient with lymphorrhea required leg amputation due to worsening leg arteriopathy and infection of a femoral prosthesis, which was removed 10 days after amputation. The third patient was treated for infected lymphorrhea on postoperative day 12. In

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Table III. Risk factors for patients in the two study groups

Table V. Lymphatic complications in the two study groupsa

Risk factor

Group A without fibrin glue (n = 60)

Group B with fibrin glue (n = 61)

p

Obesity Diabetes Kidney insufficiency Venous insufficiency Cardiac insufficiency

12 14 9 5 24

11 10 6 3 23

NS NS NS NS NS

NS, not significant.

Group A without fibrin glue (n = 60)

Group B with fibrin glue (n = 61)

Complication

[n

(%)]

[n

(%)]

Fistula Fistula with superficial infection Fistula with deep infection Lymphoceles

6

(10)

2

(3.3)

1 2 4

(1.7) (3.3) (6.6)

1 0 1

(1.6) (1.6)

a

Table IV. Nonlymphatic complications in the two study groups Group A without fibrin glue (n = 60)

Group B with fibrin glue (n = 61)

Complication

[n

(%)]

[n

(%)]

p

Superficial infection Skin necrosis Delayed healing

1 2 1

(1.7) (3.4) (1.7)

1 0 1

(1.6)

NS NS NS

(1.6)

NS, not significant.

the fibrin glue group (group B), reoperation was required in only one patient for persistent lymph fistula on postoperative day 15. The amount of lymphatic fluid removed by the suction drain was 57 mL (range, 26-87) in the fibrin-glue group in contrast to 72 mL (range, 26117) in the group with no fibrin glue. This difference was not significant.

DISCUSSION Exposure of the femoral artery in the Scarpa triangle results in transsection of small lymphatic vessels in the lower extremity.7 In most cases, transsected vessels close within 2 to 3 days after the procedure without ligation or coagulation. Placement of a suction drain during this period can prevent accumulation of lymphatic fluid and subsequent formation of lymphoceles, which can impair healing or lead to skin necrosis.3,7-9 Although the causes of lymphorrhea and lymphoceles are probably multiple, surgical technique is an important factor. Vertical incision of the Scarpa triangle on the lateral side of the lymphatic chain, as practiced in all patients in this series, has

There were 13 complications (26.6%) in group A in which closure was performed without fibrin glue and 4 complications (6.6%) in group B in which closure was performed with fibrin glue. This difference was significant (Fisher’s exact test, p = 0.019). The relative risk of lymphatic complication was 1.69 for group A versus group B (CI 95%: 1.2 to 2.3).

been shown to lower the incidence of lymphatic complications.2,7,8,10 Risk factors for development of lymphatic complications were evenly distributed between the two study groups. The overall rates of infection, skin necrosis, and delayed healing in the present study, i.e., 4.5, 1.6, and 1.6%, respectively, were similar to those reported elsewhere, ranging from 1 to 25%, 1 to 6%, and up to 5%, respectively.3,4,6,8,11,12 The incidence of lymphatic complications in the no-fibrin-glue group was 21.6%. This figure is higher than those reported elsewhere, ranging from 1.5 to 16%.11-15 The most likely explanation for this discrepancy is our technique of wound examination and diagnostic criteria for lymphatic complications. Unlike in previous reports, persistent oozing regardless of the volume was considered to be a lymph fistula even if it involved only the tube tract after removal of the suction drain. Various criteria have been used previously,3,8 but in most cases lymph fistula was diagnosed only if the patient required redressing several times a day. The incidence of reoperation in this study was low (3.3%). This figure is in agreement with those reported in the literature. Conservative treatment has usually been successful, thus eliminating the need for reoperation in most cases.10,13,16 Several previous studies have demonstrated the efficacy of fibrin glue application in preventing lymphatic complications.7,17 Application of fibrin glue has been performed after lymph node resection for curative tumor treatment. Waclawiczek and Pimpl7 reported a significant reduction of lymphatic com-

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plications by application of fibrin glue after inguinal and axillary lymphadenectomy. These results were confirmed by Furrer et al.9 for inguinal lymphadenectomy and by Gilly et al.18 for axillary lymphadenectomy.

CONCLUSION The preliminary findings of this randomized study show that application of fibrin glue during closure after exposure of the femoral artery in the Scarpa triangle leads to a significant reduction in the incidence of lymphorrhea and lymphoceles. Funding for this study was provided by Baxter AG of Volketswil, Switzerland.

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6. Tyndall SH, Shepard AD, Wilczewski JM, et al. Groin lymphatic complications after arterial reconstruction. J Vasc Surg 1994;19:858-863. 7. Waclawiczek HW, Pimpl W. Lymph fistulae following lymph node dissections—prevention and treatment using fibrin glue. Chirurg 1986;57:330-331. 8. Gordon IL, Pousti TJ, Stemmer EA, et al. Inguinal wound fluid collections after vascular surgery: management by early reoperation. South Med J 1995;88:433-436. 9. Furrer M, Inderbitzi R, Nachbur B. Does administration of fibrin glue prevent development of lymphoceles after radical lymphadenectomy? Chirurg 1993;64:1044-1049. 10. Lewis P, Wolfe JH. Lymphatic fistula and perigraft seroma [editorial]. Br J Surg 1993;80:410-411. 11. Campbell WB, Tambeur LJ, Geens VR. Local complications after arterial bypass grafting. Ann R Coll Surg Engl 1994;76: 127-131. 12. Kwaan JH, Bernstein JM, Connolly JE. Management of lymph fistula in the groin after arterial reconstruction. Arch Surg 1979;114:1416-1418. 13. al Salman MM, Rabee H, Shibli S. Groin lymphorrhea postoperative nuisance. Int Surg 1997;82:60-62. 14. Johnson JA, Cogbill TH, Strutt PJ, et al. Wound complications after infrainguinal bypass. Classification, predisposing factors, and management. Arch Surg 1988;123:859-862. 15. Skudder Jr PA, Geary J. Lymphatic drainage from the groin following surgery of the femoral artery. J Cardiovasc Surg (Torino) 1987;28:460-463. 16. Wolfe, JHN. Treatment of lymphedema. In: Rutherford, RB, ed. Vascular Surgery, 3rd. ed. Philadelphia: WB Saunders, 1989, pp 1668-1778. 17. Ludtke-Handjery A. Der Fibrinkleber in der Behandlung postoperativer Lymphfisteln nach gefa¨sschirurgischen Eingriffen. Z Herz Thorax Gefa¨sschir 1991;5:135-138. 18. Gilly FN, Francois Y, Sayag-Beaujard AC, et al. Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial. Eur Surg Res 1998;30:439-443.