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Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

ABSTRACT: This prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy.Each patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product application being the control side. The amount of lymph drainage at each side of the pelvis was measured for 3 days, and computed tomography scans were obtained 7 days and 6 months after surgery for detection of pelvic lymphocele.Among 37 cases, the median amount of lymph drainage was significantly decreased in the hemi-pelvis treated with FloSeal compared to the control hemi-pelvis (p=0.025). The occurrence of lymphocele was considerably reduced in treated hemi-pelvis (8/37, 21.6%) compared with control hemi-pelvis (12/37, 32.4%) after 7 post-operative days (p=0.219), and more decreased in the treated hemi-pelvis (5/37, 13.5%) compared with control hemi-pelvis (9/37, 24.3%) after postoperative 6 months (p=0.344).The application of FloSeal as a tissue sealant in lymph nodes resected tissues can reduce the incidence of pelvic lymphocele in gynecologic cancer patients. A large randomized controlled study could confirm these preliminary results.

SUBMITTER: Kim YH

PROVIDER: S-EPMC5391396 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

Kim Yun Hwan YH Shin Hyun Joo HJ Ju Woong W Kim Seung Cheol SC

Journal of gynecologic oncology 20170228 3

<h4>Objective</h4>This prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy.<h4>Methods</h4>Each patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product appli ...[more]

PMID: 28382800

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Project description:Despite that pelvic and para-aortic lymphadenectomy (PPaLND) is recommended as part of accurate surgical staging by International Federation of Gynecology and Obstetrics (FIGO) in endometrial cancer, the impact of para-aortic lymphadenectomy on survival remains controversial. The aim of this work is to evaluate the survival benefits or risks in endometrial cancer patients who underwent surgical staging with or without para-aortic lymphadenectomy using meta-analysis.Literature search was undertaken using PubMed, Embase, and Cochrane Library databases for relevant articles published between January 1, 1990, and January 1, 2017, without language restriction. The primary outcome was overall survival (OS); progression-free survival (PFS)/recurrence-free survival (RFS)/disease-free survival (DFS)/disease-related survival (DRS) was also analyzed. Subgroup analysis and sensitivity analysis were conducted to investigate the source of heterogeneity. Quality assessments were performed by Newcastle-Ottawa Quality Assessment Scale (NOS). Publication bias was evaluated by using Begg and Egger tests. The hazard ratio (HR) was pooled with random-effects or fixed-effects model as appropriate.Eight studies with a total of 2793 patients were included. OS was significantly longer in PPaLND group than in pelvic lymphadenectomy (PLND) group for patients with endometrial cancer [HR 0.68; 95% confidence interval (CI) 0.55-0.84, P?<?.001, I?=?12.2%]. Subgroup analysis by recurrence risk explored the same association in patients at intermediate- or high-risk (HR 0.52; 95% CI 0.39-0.69, P?<?.001, I?=?41.4%), but not for low-risk patients (HR 0.48; 95% CI 0.21-1.08, P?=?.077, I?=?0). PPaLND with systematic resection of all para-aortic nodes up to renal vein also improved PFS/RFS/DFS/DRS, compared with PLND (HR 0.52, 95% CI 0.37-0.72, P?<?.001, I?=?0). No publication bias was observed among included studies.PPaLND is associated with favorable survival outcomes in endometrial cancer patients with intermediate- or high-risk of recurrence compared with PLND, particularly with regards to OS. PPaLND with systematic resection of all para-aortic nodes up to renal vein also improve PFS compared with PLND. Further large-scale randomized clinical trials are required to validate our findings.

Dataset Information

Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

Publications

Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

Similar Datasets

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