Ligasure versus conventional surgery for inguinofemoral lymphadenectomy in vulvar cancer patients; MAMBO-IC

Vulvar cancer is the fourth most common gynecologic cancer after endometrial,
ovarian and cervical cancer, with an incidence of 2.4 per 100,000 women. The
histological type squamous cell carcinoma (SCC) accounts for over 80% of the
cases. Nowadays, the standard treatment of early stage SCC of the vulva
consists of radical local excision of the tumor and inguinofemoral lymph node
staging. The sentinel node procedure (SN) has been introduced as alternative
for IFL in patients with an unifocal tumor measuring less than four centimeters
without suspicious groin lymph nodes. Although the introduction of the sentinel
node has significantly reduced the surgical related morbidity, IFL is still
indicated in around 50% of the patients with vulvar SCC. Unfortunately, IFL is
associated with significant postoperative morbidity reported in up to 85% of
the patients. Wound breakdown, wound infection, formation of lymphoceles,
development of lymphedema and cellulitis or erysipelas are the most documented
complications. A recent prospective study of our study group showed that 47-66%
of the patients needed treatment for a short-term complication after IFL.
Furthermore, 27-32% of the patients needed to be readmitted because of a
complication. These complications are both a high burden for the patient and
the treating clinician and a significant increase in the costs for healthcare.
For these reasons, there is a high need for other surgical techniques in order
to reduce the morbidity after IFL.

During IFL, lymph vessels are damaged in order to remove the lymph nodes. By
sealing the lymph vessels, there may be less lymph fluid leakage after surgery
and may result in a reduction in the postoperative morbidity. The use of
LigaSure for (lymph)vessel sealing is widely accepted and used during surgery
for different surgical procedures. The use of Ligasure for IFL in vulvar SCC
may reduce: the overall short-term complication rate, the number of
lymphoceles, the volume lymph fluid drained, the duration of drainage and the
duration of hospital stay in patients treated by LigaSure for IFL.

Our primary objective is to assess the differences in the incidence of short
term complications (wound infection, wound breakdown and lymphocele) after IFL
using LigaSure versus the conventional method. Furthermore, we will assess the
differences in operating time, duration of hospital stay, frequency of
re-admission, the need for a intervention following any short term complication
and the number of days of external wound care between of the groin after using
LigaSure versus the conventional method for performing IFL.

Prospective observational pilot study at the Radboud university medical center
and the University Medical Centre Groningen.

The LigaSure sealing device has been incorporated in clinical practice for
several years already, and is used in many different surgical procedures
including lymph node dissection, both in open and laparoscopic surgery. The
U.S. Food and Drug Administration (FDA) has given clearance for LigaSure Small
Jaw, for the following indication; open general surgical procedures where
ligation of vessels and lymphatics is performed. The advantages (reducing;
short-term complications, lymphoceles, volume drained, duration of drainage,
duration of hospital stay) and safety of the LigaSure sealing device has been
reported in many published studies, but not for the IFLs in patients with
vulvar SCC. Participation in this study therefore does not pose any risk. The
patient will receive standard follow-up care by the gyneacologic oncologist.
Patients will only be asked to give permission to the researcher to collect
data from the patient records. The results from this study may benefit the
women with vulvar cancer with an indication for IFL in the future.