Efficacy of a Fibrin Sealant (Tissucol Duo) for the Preventionof Lymphocele after Laparoscopic Pelvic Lymphadenectomy:A Randomized Controlled Trial. 2019

Ibon Jaunarena, and Ruben Ruiz, and Mikel Gorostidi, and Paloma Cobas, and Marisa Avila, and David Del Valle, and Juan Cespedes, and Arantza Lekuona
Gynecologic Oncology Unit, Department of Gynaecology and Obstetrics, Hospital Universitario Donostia, San Sebastián, Spain (all authors).. Electronic address: ibon.jaunarenamarin@osakidetza.eus.

OBJECTIVE To assess the efficacy of Tissucol Duo (Baxter AG, Vienna, Austria) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears. METHODS Randomized controlled trial (Canadian Task Force classification level I). METHODS Tertiary referral and educational center. METHODS Seventy-four patients randomized to the use of sealant per hemipelvis. METHODS Fibrin sealant. RESULTS After bilateral pelvic lymphadenectomy a fibrin sealant was used in 1 hemipelvis but not the other, applied in 41 patients (55.4%) to the left and 33 patients (44.6%) to the right hemipelvis. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography, and magnetic resonance) was performed to detect LC at 3, 6, and 12 months after surgery. Overall, 26 patients (35.1%) developed LC, and 4 were symptomatic (5.4%). Allowing patients to serve as their own treatment group and control, the hemipelvis treated with Tissucol Duo corresponding to the treatment group and that not treated to the control group, LCs were found in 17 (23%) and 14 (19%) cases, respectively, but the difference was not significant. The mean initial LC maximum diameter was 27.1 mm (standard deviaiotn, 35.2), and LCs tended to decrease in size during the first year to a mean of 8.7 mm. CONCLUSIONS Application of Tissucol Duo fibrin sealant after laparoscopic pelvic lymphadenectomy using ultrasonic shears does not decrease the occurrence of symptomatic or asymptomatic LC.

UI MeSH Term Description Entries
D008197 Lymph Node Excision Surgical excision of one or more lymph nodes. Its most common use is in cancer surgery. (From Dorland, 28th ed, p966) Lymph Node Dissection,Lymphadenectomy,Dissection, Lymph Node,Dissections, Lymph Node,Excision, Lymph Node,Excisions, Lymph Node,Lymph Node Dissections,Lymph Node Excisions,Lymphadenectomies,Node Dissection, Lymph,Node Dissections, Lymph
D008210 Lymphocele Cystic mass containing lymph from diseased lymphatic channels or following surgical trauma or other injury. Cyst, Lymphatic,Lymphatic Cyst,Lymphocoele,Cysts, Lymphatic,Lymphatic Cysts,Lymphoceles,Lymphocoeles
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009367 Neoplasm Staging Methods which attempt to express in replicable terms the extent of the neoplasm in the patient. Cancer Staging,Staging, Neoplasm,Tumor Staging,TNM Classification,TNM Staging,TNM Staging System,Classification, TNM,Classifications, TNM,Staging System, TNM,Staging Systems, TNM,Staging, Cancer,Staging, TNM,Staging, Tumor,System, TNM Staging,Systems, TNM Staging,TNM Classifications,TNM Staging Systems
D010388 Pelvis The space or compartment surrounded by the pelvic girdle (bony pelvis). It is subdivided into the greater pelvis and LESSER PELVIS. The pelvic girdle is formed by the PELVIC BONES and SACRUM. Pelvic Region,Region, Pelvic
D010535 Laparoscopy A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY. If appropriate, biopsy or surgery can be performed during laparoscopy. Celioscopy,Laparoscopic Surgical Procedures,Peritoneoscopy,Surgical Procedures, Laparoscopic,Laparoscopic Assisted Surgery,Laparoscopic Surgery,Laparoscopic Surgical Procedure,Procedure, Laparoscopic Surgical,Procedures, Laparoscopic Surgical,Surgery, Laparoscopic,Surgical Procedure, Laparoscopic,Celioscopies,Laparoscopic Assisted Surgeries,Laparoscopic Surgeries,Laparoscopies,Peritoneoscopies,Surgeries, Laparoscopic,Surgeries, Laparoscopic Assisted,Surgery, Laparoscopic Assisted
D011183 Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery. Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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