Vulvar Cancer Surgical Treatment Complications Management; 5 Years Experience, SECI

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1 Med. J. Cairo Univ., Vol. 84, No. 2, March: , Vulvar Cancer Surgical Treatment Complications Management; 5 Years Experience, SECI MAHMOUD H. ESHOIEBY, M.D. and BADAWY M. AHMED, M.D. The Department of Surgical Oncology, South Egypt Cancer Institute, Assiut University Abstract Background and Objectives: Vulvar cancer is a rare tumor accounts for approximately 3-5% of all gynaecological malignancies and 1% of all cancers in women, with incidence rate of 1-2/100,000. Typically these cancers occur in the seventh decade when comorbidity is common. The most prominent presenting symptom of vulvar cancer is localized pruritus. Vulvar cancer surgical treatment may has a number of short and long term complications. In our series which include twenty five patients; we will discuss the most common complications and how to avoid and treat them. In this series we will review our most common complications after surgical treatment of cancer vulva and how to avoid and treat them specially in the inguinal region. Patient and Methodes: This is retrospective study was conducted in Surgical Oncology Department, South Egypt cancer institute, Assiut University, from Twenty five patients with proved vulvar cancer to whom surgical treatment was performed were included in our study and their data were retrospectively collected. Result: All patients in our series have squamous cell carcinoma as it is the commonest neoplasm that affects vulva. There is no operative related mortality. All complications are estimated per patient. Patients and tumor characteristics are reviewed. There are only significant difference in seroma formation (15.4% vs 66.7% respectively) p-value 0.01 and lymphedema (23.1% vs 75% respectively) p-value0.01. And there is significant difference in the incidence of wound breakdown (58.3% vs 15.4% respectively) p-value <0.05. Conclusion: Inguino-femoral dissection is an important step in surgical treatment of vulvar cancer but has many postoperative complications as wound dehiscence, seroma, cellulitis and lympedma which affect patient socio-psychological state and increase hospital stay. Key Words: Vulvar Cancer SECI. Correspondence to: Dr. Mahmoud H. Eshoieby, The Department of Surgical Oncology, South Egypt Cancer Institute, Assiut University Introduction EPIDEMIOLOGY Vulvar cancer accounts for approximately 3-5% of all gynaecological malignancies and 1% of all cancers in women, with in incidence rate of 1-2/100,000 [1]. In the Netherlands (16 million inhabitants) about 230 new patients with vulvar cancer are diagnosed [2]. Typically these cancers occur in the seventh decade when comorbidity is common [3]. A rise in absolute numbers of vulvar cancer is expected because of the proportional increase in the average age of the population. The most prominent presenting symptom of vulvar cancer is localized pruritus. Other common symptoms are a vulvar mass, bleeding, pain, discharge or urinary tract symptoms [4,5]. Vulvar complaints are often noted many years before malignant changes are documented and often investigated only after trials of various medical regimens have been unsuccessful. In more than 50% of patients there is a (patient s and doctor s) delay of more than a year before the diagnosis is established [4,6]. About 90% of vulvar cancers are Squamous Cell Carcinomas (SCC) and the remaining 10% comprise an interesting variety of tumours ranging from malignant melanoma to adenocarcinoma of Bartholin s gland and Paget s disease [7]. The pattern of dissemination of SCC of the vulva is predominantly lymphogenic, while spread by direct extension may occur but is less frequent compared to inguinofemoral lymph node metastases. Hematogenous spread is very rare, especially in absence of lymph node metastases [1]. The most important prognostic factor is the inguinofemoral lymph node status. Therefore, the lymph node status is an important factor in the surgicopathological staging according to the international Federation of Gynecology and Obstetrics (FIGO), which has been introduced in 1995 [8]. 343

2 344 Vulvar Cancer Surgical Treatment Complications Management Patients with SCC of the vulva. Five-year survival decreases from 90% with uninvolved lymph nodes to 75% with one or two lymph node metastases to 24% when five or six lymph nodes are involved [9]. The mainstay of treatment for most vulvar malignancies is surgery to the vulva with lymphadenectomy to the inguino-femoral areas, plus radiotherapy or/and chemotherapy for locally advanced, or recurrent disease [10]. Despite technical advances, complications following surgical treatment for vulva cancer remain high [10]. Patients and Methods This retrospective study was conducted in Surgical Oncology Department, South Egypt Cancer Institute, Assiut University, from Twenty five patients with proved vulvar cancer to whom surgical treatment was performed were included in our study and their data were retrospectively collected. In this study we concentrated on the most common operative morbidity in the inguinofemoral region as wound infection, seroma, wound breakdown and lymphedema and the associated causes from our point of view as type of incision (subinguinal or inguinal crease), time of suction removal, sartorius muscle transposition and saphinous vein preservation. Study parameters include; patient's age, Body Mass Index (BMI), length of hospital stay (LOS), laterality of lymphatic dissection, tumor characteristics and post operative morbidity and mortality. All the procedures were performed after obtaining informed consent following the explanation of the surgical and the oncological risks. All patients underwent modified vulvectomies by wide local excision of the vulvar lesion and separate inguinal incision for inguinal lymphadenectomy. Two separate incisions were performed if the tumor was unilateral and less than 2 cm in diameter, one for inguinofemoral lymphadenectomy, and one for vulvectomy with 1-2 cm free margins. Bilateral lymphadenectomy and vulvectomy (three separate incisions) were performed in centrally located or bilateral and large (>2cm) tumors. Resection of the vagina, urethra or anus was performed if needed for radical removal of the tumor. Vulvar region usually not in need for drainage but groin regions were drained for the days by suction drain. All patients received antimicrobial and anticoagulant prophylaxis. All the patients have abdomino-pelvic Computed Tomography (CT) as a routine, full lab, chest x-ray and surgical fittness. Inclusion criteria were as follows: Histologically confirmed, clinically stage-1 to stage-3 vulvar carcinoma and medically fit patients. Exclusion criteria metastatic and locally advanced tumor. Operative mortality was defined as death that occurred during the same hospital stay or within 30 days following the primary operation. Operative morbidities were defined as complications that result in prolonged hospital stay or additional interventions or procedures. Data collection and statistical analysis: Data on the patient's demographics, location of the tumor, postoperative outcomes, and followup status were collected retrospectively and entered into a data base. Data were analyzed using Statistical Package for the Social Sciences version 21.0 (SPSS Inc., Chica-go, IL, USA) with two-tailed significance levels of less than Chi-squared test was used for categorical variables and Fisher s exact test was used where expected cell sizes were less than five. Numerical data were expressed as number and percentage. Statistical analysis: Data were analyzed using Statistical Package for the Social Sciences version 21.0 (SPSS Inc., Chica-go, IL, USA) with two-tailed significance levels of less than Chi-squared test was used for categorical variables and Fisher s exact test was used where expected cell sizes were less than five. Numerical data were expressed as number and percentage. Results Our series is retrospective study conducted from 2011 till 2014 including 25 female patients proved to have cancer vulva. All patients in our series have squamous cell carcinoma as it is the commonest neoplasm that affects vulva. There is no operative related mortality. All complications are estimated per patient. Patients and tumor characteristics are reviewed in (Table 1). In Table (2) we compare the incidence of complications between inguinal crease and sub-inguinal incision where there is significant difference in the incidence of wound breakdown (58.3% vs 15.4% respectively) p-value <0.05; but other complications there are no significant differences. In Table (3) we evaluate the effect of sartorious muscle transposition on surgical wound related morbidity where we did not found any significant differences between patients with muscle transposition or those without. When comparing the incidence of complications between patients with saphenous vein preservation

3 Mahmoud H. Eshoieby & Badawy M. Ahmed 345 and those without there are only significant difference in seroma formation (15.4% vs 66.7% respectively) p-value 0.01 and lymphedema (23.1 % vs 75% respectively) p-value 0.01; this in (Table 4). In Table (5) we found that seroma p-value 0.04 and cellulitis p-value 0.02 are significantly higher in group of patients with early removal of suction drain. In our series we document seroma in 10 (40%) cases; they were treated with repeated aspiration, bandage, covering antibiotics, anti inflammatory and edema drugs; in resistant cases we may inject sclerosing agent. Wound breakdown presented in 13 (52%) cases and were treated by repeated dressing with covering antibiotics and anti inflammatory, debridement and secondary surgical closure. Cellulitis was found in 12 (48%) cases and were treated by antibiotics, anti inflammatory and edema drugs, hot fomentations, lower limb elevation and immobilization. Lymphedema found in 15 (60%) cases; it was mild and of short duration; we treat it by antibiotics, anti inflammatory, anticoagulant, diuretics and edema drugs, lower limb elevation and elastic stocking and this usually succeed in resolving it in few weeks. All patients complete their treatment at home and came for follow-up. Table (1): Patients tumor characteristics. Age: Range Mean 55.6 yrs Hospital stay: Mean Range BMI: Range Mean Lymphadenectomy: Unilateral Bilateral Tumor site (N, %): Clitoral Post Right Left Tumor size: Mean Range Surgical margin: Grading: Will diff Mod. Diff Poorly diff FIGO staging: Stage 1 Stage 2 Stage Table (2): Relation between complications and type of incision. Inguinal Incision Subinguinal p-value Seroma: Yes 7 (58.3%) 3 (23.1%) 0.1* No 5 (41.7%) 10 (76.9%) Wound breakdown: No 5 (41.7%) 11 (84.6%) 0.04* Yes 7 (58.3%) 2 (15.4%) Cellulitis: No 5 (41.7%) 8 (61.5%) 0.3** Yes 7 (58.3%) 5 (38.5%) Lymphedema: No 7 (58.3%) 9 (69.2%) 0.6* Yes 5 (41.7%) 4 (30.8%) * : Fisher's exact test used. **: Chi square test was used. p<0.05 is considered significant. Table (3): Relation of complications and Sartorius transpositioning. Yes Sartorioustransposition No p-value Seroma: Yes 3 (30%) 7 (46.7%) 0.6* No 7 (70%) 8 (53.3%) Wound breakdown: No 3 (30%) 9 (60%) 0.6* Yes 7 (70%) 6 (40%) Cellulitis: No 4 (40%) 9 (60%) 0.6* Yes 6 (60%) 6 (40%) Lymphedema: No 2 (20%) 8 (53.3%) 0.2* Yes 8 (80%) 7 (46.7%) *: Fisher's exact test used. p<0.05 is considered significant Table (4): Relation of complications to saphenous vein preservation. 14 (56%) 11 (44%) 3 (12%) 4 (16%) 8 (32%) 10 (40%) All are free 10 (40%) 11 (44%) 4 (16%) 2 (8%) 7 (28%) 16 (64%) Yes Saphenous preservation No p-value Seroma: Yes 2 (15.4%) 8 (66.7%) 0.01 * No 11 (84.6%) 4 (33.3%) Wound breakdown: No 9 (69.2%) 7 (58.3%) 0.6* Yes 4 (30.8%) 5 (41.7%) Cellulitis: No 9 (69.2%) 4 (33.3%) 0.07** Yes 4 (30.8%) 8 (66.7%) Lymphedema: No 10 (76.9%) 3 (25%) 0.01 * Yes 3 (23.1%) 9 (75%) * : Fisher's Exact test used. **: Chi square test was used. p<0.05 is considered significant.

4 346 Vulvar Cancer Surgical Treatment Complications Management Table (5): Relation of complications to time of suction removal. 42% Suction removal Early Late 29% 12% 17% p-value Seroma: Yes 8 (61.5%) 2 (16.7%) 0.04* No 5 (38.5%) 10 (83.3%) Wound breakdown: No 6 (46.2%) 10 (83.3%) 0.09* Yes 7 (53.8%) 2 (16.7%) Cellulitis: No 4 (30.8%) 9 (75%) 0.02** Yes 9 (69.2%) 3 (25%) Lymphedema: No 6 (46.2%) 10 (83.3%) 0.09* Yes 7 (53.8%) 2 (16.7%) *: Fisher's Exact test used. **: Chi square test was used. p<0.05 is considered significant. N.B: Early removal of suction drain where it drains more than 30cm while late removal means it drains less than 30cm for at least two successful days. 44% 56% Bilateral Unilateral LN laterality: Unilateral: 14 cases. Bilateral: 11 cases. Fig. (1): Shows laterality of the tumor. Clitoral Post Right Left Fig. (2): Shows the locations of the tumor is vulvar. Discussion Epidemiology of vulvar cancer accounts for approximately 3-5% of all gynaecological malignancies and 1% of all cancers in women, with an incidence rate of 1-2/100,000 [1]. Typically these cancers occur in the seventh decade when comorbidity is common [3]. The mainstay of treatment for most vulvar malignancies is surgery to the vulva with lymphadenectomy to the inguinofemoral areas, plus radiotherapy or/and chemotherapy for locally advanced, or recurrent disease [10]. Despite technical advances, complications following surgical treatment for vulva cancer remain high [10]. Although there is a trend towards a more conservative surgical approach in the treatment of vulva cancer, wound breakdown and infection, including sepsis, occurs in approximately 40-60% of patients after radical vulvectomy. In these cases postoperative morbidity is relatively high and hospital stay is increased. Wound breakdown is primarily due to infection of and tension on the wounds [11]. The GOG has reported less wound morbidity when performing a modified radical vulvectomy and ipsilateral, superficial, inguinal lymphadenectomy in highly selected, stage I patients as opposed to the traditional radical surgery [12]. Despite this, wound complications associated with these surgeries remain common [13-16], with some groups reporting breakdown rates in excess of 50% [17]. The Gynecologic Oncology Group (GOG) randomized patients to groin lymph node dissection vs. groin radiation [18]. They reported an 86% grade 3 cutaneous toxicity/wound breakdown among patients undergoing groin dissection. Hacker et al., [19] reported a decrease in wound morbidity when separate groin incisions were utilized; however, these rates continued to be quite high with wound breakdown in 44%, cellulitis in 9%, and seroma formation in 13%. This significant rate of postoperative morbidity demands further evaluation and innovation to identify additional protective measures. Sartorius transposition was first introduced by Way in 1959 [20]. Dr. Way postulated this modification would protect the femoral vessels in the event of wound breakdown and would reduce the risk of secondary hemorrhage. This procedure has been shown to reduce infections of vascular grafts in the groin [21]. Another retrospective analysis of 100 patients demonstrating sartorius transposition to significantly reduce the incidence of wound cellulitis and breakdown [22]. Patricia et al., in a prospective study conclude that transposition of the sartorius muscle does not reduce the overall incidence of wound complication [23]. The classic description of inguinal lymphadenectomy includes resection of the saphenous vein to facilitate the process [24]. In 1988, Catalona et al., proposed preservation of the saphenous vein during inguinal lymphadenectomy to decrease postopera-

5 Mahmoud H. Eshoieby & Badawy M. Ahmed 347 tive morbidity in patients with carcinoma of the penis [25]. In 1993, Plaxe et al., proposed that this technique should be applied to inguinal lymphadenectomy in patients with carcinoma of the vulva [26]. In 2000, Zhang et al., demonstrated that preservation of the saphenous vein in inguinal lymphadenectomy decreased overall complication rate from 56 to 23% (p<0.001) and chronic lymphedema decreased from 70 to 32% ( p<0.001) [27]. However, Lin et al., failed to show any decrease in chronic lymphedema with saphenous vein preservation, 17 vs. 13% [28]. Similarly, Hopkins and colleagues looked at this issue as part of a broader series and observed no difference [29]. Another retrospective study suggest that routine preservation of the saphenous vein during inguinal lymphadenectomy for vulvar carcinoma may reduce the incidence of wound cellulitis, wound breakdown, and chronic lymphedema [30]. Improved patient recovery, reduced postoperative complications, and improved life quality without compromising the outcomes after sartorius tendon transposition during inguinal lymphadenectomy [31]. A randomized prospective study performed by Judson and his group failed to show any decrease in the incidences of wound cellulitis, wound breakdown, lymphedema, or rehospitalization in the sartorius transposition group [32]. A. A. Soliman et al., found that local complications after inguino-femoral lymphadenectomy were very high, with no single pre-, intra-, or postoperative factor that could be incriminated. Saphenous vein sparing provided no significant difference in decreasing the rate of local complications [33]. Manci et al., in his randomized prospective study which comparing the effect of the wound incision above and below inguinal crease on operative complications of inguinofemoral lymphadenectomy found that upper incision allows more precise identification of the camper fascia, is less painful, and gives better cosmetic results. However there was no statistical significance; regarding flap length, wound dehiscence rate, and speed of wound healing. There was no difference in chronic leg edema, number of nodes removed, or hospital stay [34]. Our series is retrospective study conducted from 2011 till 2014 including 25 female patients proved to have cancer vulva. All patients in our series have squamous cell carcinoma as it is the commonest neoplasm that affects vulva. There is no operative related mortality. In our series the overall incidence of complications were seroma 10 (40%), wound breakdown 13 (52%), cellulitis 12 (48%) and lymphedema 15 (60%); all were successfully treated with conservative therapy and all patients complete their treatment at home as follows; seroma were treated by repeated aspiration, bandage, covering antibiotics, anti inflammatory and edema drugs; in resistant cases we may inject sclerosing agent. Wound breakdown was treated by repeated dressing with covering antibiotics and anti inflammatory, debridement and secondary surgical closure. Cellulitis was treated by antibiotics, anti inflammatory and edema drugs, hot fomentations, lower limb elevation and immobilization. Lymphedema was mild and of short duration and treated by antibiotics, anti inflammatory, anticoagulant, diuretics and edema drugs, lower limb elevation and elastic stocking and this usually succeed in resolving it in few weeks. In our study there is significant difference in the incidence of wound breakdown between inguinal crease and sub-inguinal incision p-value <0.05; but when evaluating the effect of sartorious muscle transposition on surgical wound related morbidity we did not found any significant differences between patients with muscle transposition or those without. When comparing the incidence of complications between patients with saphenous vein preservation and those without there are only significant difference in seroma formation p-value 0.01 and lymphedema p-value0.01. Also we found that seroma p- value <0.05 and cellulitis p-value 0.02 are significantly higher in group of patients with early removal of suction drain. Conclusion: Inguino-femoral dissection is an important step in surgical treatment of vulvar cancer but has many post-operative complications as wound dehiscence, seroma, cellulitis and lympedma which affect patient socio-psychological state and increase hospital stay. From our study we recommend: 1- Subinguinal incision as it has lower incidence of wound infection and breakdown. 2- Suction drain should not removed before drainage less than 30cm for at least 2 successful days with bandage of the wound for at least one week to avoid seroma.

6 348 Vulvar Cancer Surgical Treatment Complications Management 3- Saphenous vein preservation has significant impact in reducing seroma and lymhedema otherwise not affecting the oncological outcome. 4- We also recommend direct post operative wearing of elastic stocking, optimal antibiotic covering, anti-inflammatory and edema drugs. 5- Sentinel lymph node technique is successful to avoid unnecessary lymphatic dissection and its complications specially in early tumors and clinically an evident lymphatic metastasis so we recommend more trials in this aspect. References 1- HACKER N.F.: Vulvar cancer. In: Berek J.S., Hacker N.F., editors. Practical gynecologic oncology. 4 th ed. Philadelphia: Williams & Wilkins, p , VISSER O., COEBERGH J.W.W. and SCHOUTEN L.J.: Incidence of cancer in the Netherlands Utrecht: Hoonte-Holland BV, COULTER J. and GLEESON N.: Local and regional recurrences of vulval cancer: Management dilemmas. Best Pract. Res. Clin. Obstet. Gynaecol., 17: , PODRATZ K.C., SYMMONDS R.E., TAYLOR W.F., and WILLIAMS T.J.: Carcinoma of the vulva: Analysis of treatment and survival. Obstet. Gynecol., 61: 63-74, ROSEN C. and MALMSTROM H.: Invasive cancer of the vulva. Gynecol. Oncol., 65: 213-7, RUTLEDGE F., SMITH J.P. and FRANKLIN E.W.: Carcinoma of the vulva. Am. J. Obstet. Gynecol., 106: , FINAN M.A. and BARRE G.: Bartholin s gland carcinoma, malignant melanoma and other rare tumours of the vulva. Best Pract. Res. Clin. Obstet. Gynaecol., 17: , SHEPHERD J.H.: Staging announcement. FIGO staging of gynecologic cancers; cervical and vulva. Int. J. Gynecol. Cancer, 5: 319, HOMESLEY H.D., BUNDY B.N., SEDLIS A., et al.: Assessment of current International Federation of Gynecology and Obstetrics staging of vulvar carcinoma relative to prognostic factors for survival (A Gynecologic Oncology Group Study). Am. J. Obstet., 164: , WILLS A. and OBERMAIR A.: A review of complications associated with the surgical treatment of vulvar cancer. Gynecologic Oncology, 131 (2): , MORROW C.P. and TOWNSEND D.E.: Synopsis of Gynaecologic Oncology, New York: John Wiley and Sons, STEHMAN F.B., BUNDY B.N., DVORETSKY P.M. and CREASMAN W.T.: Early stage carcinoma of the vulva treated with ipsilateral superficial inguinal lymphadenectomy and modified radical hemivulvectomy: A prospective study of the Gynecologic Oncology Group. Obstet. Gynecol., 79: 490-7, GAARENSTROOM K.N., KENTER G.G., TRIMBOS J.B., et al.: Postoperative complications after vulvectomy and inguinofemoral lymphadenectomy using separate groin incisions. Int. J. Gynecol., 13 (4): 522-7, GOULD N., KAMELLE S., TILLMANNS T., et al.: Predictors of complications after inguinal lymphadenectomy. Gynecol. Oncol., 82 (2): , ROUZIER R., HADDAD B., DUBERNARD G., DUBOIS P. and PANIEL B.J.: Inguinofemoral dissection for carcinoma of the vulva: Effect of modifications of extent and technique on morbidity and survival. J. Am. Coll. Surg., 196 (3): , CAVANAGH D., FIORICA J.V., HOFFMAN M.S., et al.: Invasive carcinoma of the vulva: Changing trends in surgical management. Am. J. Obstet. Gynecol., 163: , STEHMAN F.B., BUNDY B.N., THOMAS G., et al.: Groin dissection versus groin radiation in carcinoma of the vulva: A Gynecologic Oncology Group study. Int. J. Radiat. Oncol. Biol. Phys., 24: , HACKER N.F., LEUCHTER R.S., BEREK J.S., CASTAL- DO T.W. and LAGASSE L.D.: Radical vulvectomy and bilateral inguinal lymphadenectomy through separate groin incisions. Obstet. Gynecol. 58: 574-9, WAY S.: Carcinoma of the vulva. Am. J. Obstet. Gynecol., 79: 692-7, SCHER K.S.: Sartorius transposition to protect vascular grafts in the groin. Am. Surg., 55: , PALEY P.J., JOHNSON P.R., ADCOCK L.L., et al.: The effects of Sartorius transposition on wound morbidity following inguinal-femoral lymphadenectomy. Gynecol. Oncol., 64: , LEVENBACK C., BURKE T.W., GERSHENSON D.M., MORRIS M., MALPICA A. and ROSS M.I.: Intraoperative lymphatic mapping for vulvar cancer. Obstet. Gynecol., Aug., 84 (2): 163-7, PATRICIA L. JUDSON A., AMY L. JONSON A., PAM- ELA J. PALEY B., ROBIN L. BLISS C., KARUNA P. MURRAY D., LEVI S. DOWNS Jr. A., MATTHEW P. BOENTE A., PETER A. ARGENTA A. and LINDA F. CARSON: A prospective, randomized study analyzing sartorius transposition following inguinal-femoral lymphadenectomy. Gynecologic Oncology, 95: , WHEELESS C.H.: Atlas of Pelvic Surgery. Philadelphia Lea and Febiger, p , CATALONA W.J.: Modified inguinal lymphadenectomy for carcinoma of the penis with preservation of saphenous veins: Technique and preliminary results. J. Urol., 51: , PLAXE S.C., BRALEY P.S. and DOTTINO P.R.: A simplified approach to superficial inguinal node dissection with sparing of the saphenous vein in patients with carcinoma of the vulva. Surg. Gynecol. Obstet., 176: , ZHANG S.H., SOOD A.K., SOROSKY J.I., ANDERSON B. and BULLER R.E.: Preservation of the saphenous vein during inguinal lymphadenectomy decreases morbidity in patients with carcinoma of the vulva. Cancer, 89: , 2000.

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8 350 Vulvar Cancer Surgical Treatment Complications Management