Objective
This prospective randomized pilot study compared the use of the Ligaclip (Ethicon Endo-Surgery, Cincinnati, OH) with bipolar coagulation in preventing lymphoceles after laparoscopic pelvic lymphadenectomy for gynecologic cancer.
Study Design
Thirty patients with gynecologic malignancy, who had laparoscopic pelvic lymphadenectomy were randomly assigned for lymphadenectomy in 1 side of the pelvis using the Ligaclip, whereas, in the other side, the bipolar coagulation to seal lymphatic vessels was used.
Results
At ultrasound examination, we detected lymphocele in 10 patients (33%). Lymphocele developed in 9 (30%) patients on the side where laparoscopic pelvic lymphadenectomy was perfomed using bipolar coagulation, and in 1 (3.3%) patient on the side where laparoscopic pelvic lymphadenectomy was performed using the Ligaclip. Univariate analysis revealed that the Ligaclip’s use compared with electrocoagulation in the laparoscopic pelvic lymphadenectomy is an independent predictive factor for development of lymphocele ( P = .006).
Conclusion
This study demonstrates that the use of the Ligaclip to close lymphatic vessels may reduce the incidence of lymphoceles in patients undergoing laparoscopic pelvic lymphadenectomy.
Pelvic lymphadenectomy (PL) is a crucial step in the surgical staging and treatment of several gynecologic malignancies. To date, no imaging studies equal PL in the detection of lymph node metastases.
However, this potential benefit must be weighed against the additional morbidity and costs associated with PL. The most frequently recorded postoperative complication of lymph node dissection are lymphoceles, also known as lymphocysts, which consists of a collection of lymphatic fluid, especially along the iliac vessels, as a consequence of surgical dissection and the inadequate closure of afferent lymphatic vessels (LV). In literature, the reported incidences of clinically detected lymphoceles after PL ranges from 1% to 49%. Most lymphoceles are incidental findings and have no clinical significance. However, sometimes lymphocele of significant size may lead to symptoms resulting from compression on the surrounding structures and causing pelvic pain, unilateral leg edema and pain, hydronephrosis, deep vein thrombosis, infection, or sepsis. In some cases, adjuvant radiotherapy is delayed or absolutely contraindicated in the presence of lymphoceles. For these reasons, a number of techniques to reduce the incidence of postoperative lymphoceles after open lymphadenectomy have been described. These include the nonclosure of pelvic peritoneum, the absence of retroperitoneal drainage, omentoplasty, or fibrin application. None of these procedures, however, absolutely reduce the rate of postoperative lymphocysts after PL.
It is now widely accepted by the community of gynecologists-oncologists that laparoscopic pelvic lymphadenectomy (LPL) can be performed in the majority of patients and has a low complication rate. Recently, Benedetti- Panici et al found no statistically significant difference between laparotomy and a laparoscopic approach with regard to postoperative complications. However, to our knowledge, despite the increasing diffusion of LPL in gynecologic oncology, no prospective studies have been conducted to minimize the incidence of lymphoceles after LPL.
Conventional bipolar electrosurgery is the most popular energy-based modality for tissue management in laparoscopic procedures and is the most described (used) technique to perform LPL. Considering that Ligaclip (Ethicon Endo-Surgery, Cincinnati, OH) use, with a similar action to surgical ligation, is an ideal alternative to decrease vessels weeping by clamping main LV and create a seal of LV by mechanical compression.
This prospective randomized pilot study was aimed to compare the systematic use of the Ligaclip with bipolar electrosurgery in the prevention of lymphocele during LPL.
Materials and Methods
This was an open, randomized, prospective pilot study conducted between November 2008 and July 2009 at the Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome. Consecutive patients who have gynecological malignancy (endometrial or cervical cancer) submitted to systematic laparoscopic PL were enrolled.
Approval from the institutional review board of the Catholic University was obtained and patients involved in the study signed a written informed consent to participate before recruitment. Inclusion criteria were as follows: cervical or endometrial cancer patients undergoing to systematic LPL, expected survival longer than 12 weeks, performance status ≤2, adequate liver, kidney, and bone marrow function. Exclusion criteria from the study were as follows: previous radio- or chemotherapy, hematologic or coagulation disorders, previous thromboembolic disease, and previous lymphatic system disease (lymphedema or lymphocele).
Surgical procedure
The same surgical team, using a transperitoneal approach, performed all surgical procedures. At the beginning of the operation, patients received a single-shot antibiotic treatment (Ceftizoxima; Pfizer, New York, NY). Systematic PL was defined as removal of all lymphatic tissue in the following regions: common iliac, external iliac, internal iliac, obturator, and sacral (or presacral). The limits of the lymph node dissection were considered: the psoas muscle laterally, the internal iliac artery posteromedially, the bifurcation of the common iliac artery cranially, where the ureter crosses the vessels, and the origin of the epigastric vessels caudally, at the level of the deep circumflex iliac vein.
After the identification of the ureter and the umbilical artery, the paravesical and pararectal spaces are developed. The dissection begins at the origin of the deep inferior epigastric vessels from the external iliac vessels immediately under the round ligament. It continues cranially, preserving the aponeurotic fascia of the psoas muscle and the 2 braches of the genitofemoralis nerve, separating the external iliac vessels from the lateral pelvic wall, and then each other. The clearing of the obturator fossa begins with the mobilization of the superficial obturator nodes, which are completely dissected after the identification of the obturator nerve.
Parametrial lymphadenectomy was additionally performed in patients with cervical cancer, which includes the removal of all lymphatic tissue of the vascular part of the cardinal ligament, including all branches of the internal iliac vessels and the lymph nodes of the lumbosacral fossa.
We decided to perform randomization of the technique in the same patient, to have identical clinical and body characteristics and consequently to reduce the influence of nontreatment factors.
A 10 mm titanium Ligaclip was applied at 1 side (right/left), according to the randomization assignment. The patients were randomly assigned to 1 of the 2 trial arms. Randomization was centralized and computer based before surgery. In particular, 3 specific levels were discussed and agreed by the surgeons (G.S., A.F., F.F.) before starting the study, which were as follows: (1) at the level of obturator fossa, where numerous channels are connected with the lateral parametria; (2) at the level of the femoral canal, on the ventral walls of external iliac vessels; and (3) at the bifurcation of common iliac vessels, cranially to the internal iliac vessels, and medially to the external iliac vessels ( Figure 1 ). The anatomic rationale for positioning the clips will be discussed in the Comment section. For each identified LV, we applied 1 clip laterally to the point where LV was transected. Conversely, on the other side, only the bipolar dissector (Olympus Winter & Ibe GmbH, Hamburg, Germany) was used for coagulation and dissection of LV during PL.
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