The application of fibrin sealant for the prevention of lymphocele after lymphadenectomy in patients with gynecological malignancies: A systematic review and meta-analysis of randomized controlled trials
Gynecologic oncology. 2019
PURPOSE The aim of the present study was to evaluate the correlation between the use of fibrin-collagen sealants on lymph node dissection areas and formation of lymphocele after lymphadenectomy in patients with gynecological malignancies. MATERIALS AND METHODS A systematic search of 5 electronic databases for articles published up to November 2018 was performed. All randomized controlled clinical trials (RCTs) which reported outcomes after application of fibrin collagen agents in patients who underwent lymphadenectomy for gynecological malignancies, were finally included in the present meta-analysis. Statistical meta-analysis was performed using the RevMan 5.3 software. RESULTS A total of 6 RCTs which recruited 481 patients were included in the present study. Meta-analysis revealed significantly decreased total amount of drained fluid and of mean duration of drainage in fibrin sealant group when compared to control, (187 patients MD -86.40ml 95% CI -100.2 to -72.60 p<0.00001 and 113 patients MD -1.00days 95% CI -1.13 to -0,87 p<0.00001, respectively). No difference in overall incidence of lymphocele and in the incidence of symptomatic ones among the two groups was observed (592 cases OR 0.61 95% CI 0.36 to 1.05 p=0.08, and 444 cases OR 0.59 95% CI 0.26 to 1.35 p=0.22, respectively). CONCLUSIONS The present meta-analysis supports the safety of the use of fibrin sealants in women undergoing pelvic and/or para-aortic lymphadenectomy due to gynecologic cancer but its benefit remains uncertain. It was found effective in reducing the duration and volume of drainage, but it was not associated with difference in the incidence of lymphocele. Further studies are required to confirm our conclusion and broaden our knowledge about its impact on other parameters.
A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery
Journal of Investigative Surgery : the Official Journal of the Academy of Surgical Research. 2018;:1-13.
BACKGROUND/PURPOSE Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery. METHODS Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied. The trial consisted of a preliminary phase (to familiarize investigators with the technique for FS Grifols application and the intraoperative procedures required by the clinical protocol) and a primary phase: in both phases, patients were randomized 1:1 to FS Grifols or Surgicel((R)). The primary efficacy endpoint, based on analysis of subjects in the primary phase of the study, was to evaluate whether FS Grifols was non-inferior to Surgicel((R)) in achieving hemostasis, based on the proportion of subjects in both treatment groups who achieved hemostasis at the target bleeding site (TBS) by 4 min (T4) following the start of treatment application. Safety assessments included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests, viral markers, and immunogenicity. RESULTS A total of 224 subjects were randomized (primary phase): FS Grifols (N = 116), Surgicel((R)) (N = 108). The 95% CI at T4 for the ratio of the proportion of patients achieving hemostasis in the two treatment groups was 1.064 (0.934, 1.213), indicating non-inferiority for FS Grifols vs. Surgicel((R)). The rate of hemostasis at the TBS by T4 in both phases of the study was higher in the FS Grifols treatment group (preliminary phase: 90.2%; primary phase: 82.8%) than in the Surgicel((R)) treatment group (preliminary phase: 78.8%; primary phase: 77.8%). Overall, reported AEs were as expected in surgical patients and were similar between the two treatment groups. CONCLUSIONS This study shows the non-inferiority in time to hemostasis of FS Grifols vs. Surgicel as an adjunct to hemostasis in patients undergoing soft tissue open surgery, and a similar rate of AEs.
Usefulness of hemostatic sealants for minimizing ovarian damage during laparoscopic cystectomy for endometriosis
The Journal of Obstetrics and Gynaecology Research. 2017;44((3):):532-539
AIM: We aimed to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian endometriotic cyst resection on ovarian reserve by comparing the rates of decrease in anti-Mullerian hormone (AMH). METHODS A randomized prospective data collection was made on women aged 19-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions (n = 80), Kangbuk Samsung Hospital, Seoul, Korea or National Health Insurance Service Ilsan Hospital, Goyang, Korea, from January 2014 to April 2016. Patients were randomly divided into two groups treated with either a topical hemostatic sealant or bipolar coagulation for hemostasis. The hemostatic group was randomized to the FloSeal or TachoSil subgroups. Preoperative and 3-month postoperative AMH levels were checked and the rates of decrease of AMH were compared. All patients enrolled were treated with dienogest (Visanne) for 6-12 months. None were lost to follow-up at postoperative 3 months, but about one-third of the patients had been lost to follow-up by 6-12 months. RESULTS AMH was significantly decreased in both groups 3 months postoperatively; however, the rate of decrease in the bipolar coagulation group was greater than that in the hemostatic sealant group, 41.9% (interquartile range [IQR], 22.29-65.24) versus 18.1% (IQR, 10.94-29.90), P = 0.007. Between the two hemostatic subgroups, there was no significant difference in AMH decrease rate, 14.95% (IQR, 11.34-21.21) versus 18.1% (IQR 9.76-40.70), P = 0.204. CONCLUSION Hemostatic sealants may be an alternative to bipolar coagulation for preservation of ovarian reserve after laparoscopic ovarian cystectomy for endometriosis.
Prevention of lymphocele in female pelvic lymphadenectomy by a collagen patch coated with the human coagulation factors: a pilot study
Journal of Surgical Oncology. 2012;105((8):):835-40.
BACKGROUND AND OBJECTIVES The prevention of lymphoceles was tested using collagen patch coated with the human coagulation factors (TachoSil) on 58 consecutive patients with endometrial cancer who had undergone hysterectomy and pelvic lymphadenectomy (PL). METHODS Patients were randomized in two groups: standard technique plus TachoSil (30 patients, group 1) and standard technique only (28, group 2). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 7, 14, and 28. The main outcome measures were: the development of symptomatic or asymptomatic lymphoceles, the need for further surgical intervention, as adverse effect of surgery and the drainage volume and duration. RESULTS Same number of lymph nodes in both groups was removed; group 1 showed a lower drainage volume. Lymphoceles developed in 7 patients in group 1 and 16 in group 2, but only 3 were symptomatic in group 1 and 9 symptomatic in group 2, with statistical difference. Percutaneous drainage proved necessary in five cases: only one was in group 1 and four in group 2. CONCLUSIONS Intraoperative application of TachoSil reduced rate of postoperative lymphocysts after PL, and it seems to provide a useful additional treatment option for reducing drainage volume and preventing lymphocele development after PL. Copyright 2011 Wiley Periodicals, Inc.
Adhesion-prevention effects of fibrin sealants after laparoscopic myomectomy as determined by second-look laparoscopy: a prospective, randomized, controlled study
The Journal of Reproductive Medicine. 2005;50((8):):571-7.
OBJECTIVE To examine the adhesion prevention effects of 2 types of fibrin sealant after laparoscopic myomectomy (LM). STUDY DESIGN A prospective, randomized study (Canadian Task Force I) was conducted at a University-affiliated hospital. A total of 91 patients showing a minimal myoma > 5 cm, excluding pedunculated myomas, underwent LM alone: 32 patients in the control group, 29 in the fibrin gel group and 30 patients in the fibrin sheet group. After LM, postoperative adhesions were evaluated by second-look laparoscopy. The frequency of postoperative adhesions was the main outcome. RESULTS The frequency of postoperative adhesions of the uterus was significantly lower (p < 0. 05) in the fibrin gel group, with 20/32 (62. 5%) in the control group, 10/29 (34. 5%) in the fibrin gel group and 20/30 (67. 7%) in the fibrin sheet group. Although no significant differences were found in the incidence of de novo adnexal adhesions, the lowest rate was found in the fibrin gel group, with 4/32 patients (12. 5%) in the control group, 2/29 patients (6. 8%) in the fibrin gel group and 5/30 patients (16. 7%) in the fibrin sheet group. No bilateral adnexal adhesions were observed in the 3 groups. CONCLUSION After LM for myomas as large as > or = 5 cm, postoperative adhesions were observed in > or = 50% of patients. The use of fibrin gel after LM is recommended.
Fibrin application for preventing lymphocysts after retroperitoneal lymphadenectomy in patients with gynecologic malignancies
Gynecologic Oncology. 2002;84((1):):43-6.
OBJECTIVE We performed a randomized, prospective trial to assess the impact of fibrin glue on the incidence of lymphocysts after systematic pelvic or pelvic and paraaortic lymphadenectomy in patients with gynecologic malignancies. METHODS Ninety-three consecutive patients with gynecologic pelvic malignancies who underwent surgery including pelvic or pelvic and paraaortic lymphadenectomy were randomized during surgery to be treated with fibrin glue or not. Serial computed tomography (CT) scans were performed during follow-up. CT findings of a smooth and thin-walled cavity filled with a water-equivalent fluid, sharply demarcated from its surroundings and without signs of infiltration were interpreted as lymphocysts. RESULTS Forty-seven patients (51%) were treated with fibrin glue and 46 (49%) were not. All 93 patients underwent pelvic lymphadenectomy; 15 patients (32%) of the fibrin group and 12 (26%) of the controls also underwent paraaortic lymphadenectomy. We found no significant differences between patients who received fibrin glue and those who did not. CONCLUSION Intraoperative application of fibrin glue did not reduce the rate of postoperative lymphocysts after lymphadenectomy and had no impact on any follow-up parameter. Its use seems not to be indicated in systematic gynecologic pelvic or pelvic and paraaortic lymphadenectomy.
Isovolemic hemodilution alters the ratio of whole-body to large-vessel hematocrit (F-cell ratio). A prospective, randomized study comparing the volume effects of hydroxyethyl starch 200,000/0.62 and albumin
Infusionstherapie und Transfusionsmedizin. 1995;22((2):):74-80.
OBJECTIVE To evaluate potential changes in the ratio of whole-body/large-vessel hematocrit (f-cell ratio) during isovolemic hemodilution and to compare the volume effects of 2 different plasma exchange solutions (hydroxyethyl starch 200,000/0.62 6% and human albumin 5%). DESIGN Prospective, randomized, controlled trial. SETTING Operating theater in a university hospital. PATIENTS 24 gynecological patients scheduled for elective surgery. INTERVENTIONS Isovolemic hemodilution was performed using 2 different plasma exchange solutions. Plasma volume was determined using dye dilution technique before and after hemodilution. The volume of withdrawn blood was measured from the change in weight of the blood bags taking into account the specific gravity of blood. RESULTS The volume of administered plasma exchange solutions exceeded the amount of withdrawn blood by 80 +/- 47 ml (p < 0.001). Plasma volume was 3,067 +/- 327 ml before and 3,517 +/- 458 ml after hemodilution. Using red cell volumes calculated from measured plasma volumes and peripheral hematocrit, a deficit of 249 +/- 133 ml (p < 0.0001) in red cells after hemodilution appeared with the measured withdrawn red cell volumes taken into account. This finding can be explained by a change in the f-cell ratio during isovolemic hemodilution. The volume effect of the exchange solutions was 1.05 for hydroxyethyl starch and 0.95 for albumin. CONCLUSIONS The results demonstrate that a change in the f-cell ratio occurs during isovolemic hemodilution. The estimation of red cell volume or plasma volume changes by using either the hematocrit or plasma or red cell volume determinations together with the hematocrit may lead to erroneous results.