Fibrin Glue Sealing in the Treatment of Perineal Fistulas

PURPOSE: The surgical management of complex perineal fistulas, such as high transsphincteric and suprasphincteric fistulas, or those associated with Crohn's disease, radiotherapy, surgical trauma, or cavity or a secondary tract, is associated with the risk of sphincter injury and significant discomfort. Fibrin glue may close fistula tracts without muscle division. Therefore, the aim of this study was to evaluate the use of fibrin glue sealing in treatment of perineal fistulas. METHODS: A retrospective chart review of all patients in whom fibrin glue was used for the treatment of perineal fistula was performed. Patients were contacted by telephone to establish follow-up. RESULTS: Thirty-seven patients underwent injection of fibrin glue for complex perineal fistulas. Twenty-four patients had fibrin glue injection as the principal treatment for the perineal fistula, and 13 had fibrin glue in conjunction with an endorectal advancement flap. The fistula was of cryptoglandular origin in 16 (42 percent) cases and associated with Crohn's disease and trauma in 7 (19 percent) and 14 (38 percent) patients, respectively. At a mean follow-up of 12.1 months, healing occurred in only 15 (41 percent) patients. The healing rate was 33 percent when fibrin glue was the principal treatment, and 54 percent when used with an endorectal advancement flap. Fistulas of noncryptoglandular origin had a higher success rate, although this difference did not reach statistical significance. There was no morbidity associated with the injection of fibrin glue. CONCLUSION: In this study, fibrin glue had moderate success in the definitive treatment of perineal fistulas. However, 33 percent of the patients in whom fibrin glue was the only treatment used were able to avoid more extensive surgery. Fibrin glue is associated with minimal risk, therefore its application should be considered in patients with complex anal fistulas.     

Efficacy of Anal Fistula Plug vs. Fibrin Glue in Closure of Anorectal Fistulas

Purpose Long-term closure rates of anorectal fistulas using fibrin glue have been disappointing, possibly because of the liquid consistency of the glue. A suturable bioprosthetic plug (Surgisis?, Cook Surgical, Inc.) was fashioned to close the primary opening of fistula tracts. A prospective cohort study was performed to compare fibrin glue vs. the anal fistula plug. Methods Patients with high transsphincteric fistulas, or deeper, were prospectively enrolled. Patients with Crohn's disease or superficial fistulas were excluded. Age, gender, number and type of fistula tracts, and previous fistula surgeries were compared between groups. Under general anesthesia and in prone jackknife position, the tract was irrigated with hydrogen peroxide. Fistula tracts were occluded by fibrin glue vs. closure of the primary opening using a Surgisis^? anal fistula plug. Results Twenty-five patients were prospectively enrolled. Ten patients underwent fibrin glue closure, and 15 used a fistula plug. Patient's age, gender, fistula tract characteristics, and number of previous closure attempts was similar in both groups. In the fibrin glue group, six patients (60 percent) had persistence of one or more fistulas at three months, compared with two patients (13 percent) in the plug group (P < 0.05, Fisher exact test). Conclusions Closure of the primary opening of a fistula tract using a suturable biologic anal fistula plug is an effective method of treating anorectal fistulas. The method seems to be more reliable than fibrin glue closure. The greater efficacy of the fistula plug may be the result of the ability to suture the plug in the primary opening, therefore, closing the primary opening more effectively. Further prospective, long-term studies are warranted. Dr. David Armstrong has a patent-licensing agreement with the manufacturers of Surgisis? (Cook Surgical, Bloomington, IN). Presented at the meeting of The American Society of Colon and Rectal Surgeons, Philadelphia, Pennsylvania, April 30 to May 5, 2005.     

Large Volume Apheresis of Autologous Plasma and Preparation of Autologous Fibrin Glue from the Plasma

Abstract: Autologous blood transfusion (ABT) is useful for prevention of undesirable effects of allogeneic blood transfusion. In our hospital, not only autologous whole blood but also autologous red blood cells, autologous fresh frozen plasma (Auto‐FFP), and autologous fibrin glue (Auto‐FG) are routinely produced for surgical patients. The Auto‐FG is prepared from plasma which is separated from manually collected whole blood. However, when a large volume of Auto‐FG is required, the plasma obtained by an apheresis method may be useful. Therefore, a pilot study was conducted to determine whether a collection of 2 U (160 ml) of red blood cells (RBCs) and 400 ml of plasma at 1 apheresis is acceptable. We first performed the apheresis on healthy donors, and then applied for autologous blood donation. The apheresis is safe. The collected plasma is used for the production of Auto‐FFP and Auto‐FG. The remaining RBCs also are used for ABT. The preparation of Auto‐FG is simple, and it is effective for the reduction of allogeneic fibrin glue.     

Fibrin Glue Treatment of Low Rectal and Pouch-Anal Anastomotic Sinuses

PURPOSE: This report describes a treatment method for patients with persistent anastomostic sinuses in which fibrin glue is used. METHODS: A retrospective review was conducted of the medical records of seven patients with radiologically documented sinus tracts after restorative proctocolectomy or low rectal anastomosis was managed with fibrin glue obliteration of the tract. The sinus was gently debrided with a curette and then filled with fibrin glue. Postoperatively, the patients received metronidazole 1.5 g per day in divided doses for one week. Outpatient examination of the internal opening was performed at 1, 3, and 12 weeks postoperatively. RESULTS: In all patients, healing of the sinus was observed after one week. After an average of 11.2 months (range, 3–15) of follow-up there were no recurrences and no episodes of pelvic sepsis. CONCLUSION: On the basis of this experience, we believe that fibrin glue injection may be an alternative method of managing pelvic anastomotic sinuses. Presented at the American Society of Colon and Rectal Surgeons, Chicago, Illinois, June 3 to 8, 2002     

Fibrin Glue for Anal Fistulas

PURPOSE: The aim of this study was to evaluate the long-term success and complication rate of fibrin-glue treatment of anal fistulas. METHODS: Patients with an anal fistula presenting to a single surgeon over a three-year period were enrolled in this study. At their first operation, all 48 patients (26–72 years old) underwent anoscopy, biopsy, destruction of the internal gland, and placement of a draining seton. Approximately two months later after preoperative bowel preparation, the seton was removed, the internal opening closed with a single suture, and fibrin glue instilled by way of the external opening to seal the fistula tract. Patients were followed closely to document the results of treatment and any complications. Long-term follow-up was done by telephone interview. RESULTS: Cause of the anal fistula was cryptoglandular in 36 (75 percent) patients, Crohns disease in 5 (10 percent), and miscellaneous in 7 (15 percent). Median follow-up was 22 months (range, 6–46 months). After a single treatment with fibrin glue, 29 (60 percent) fistulas closed. Retreatment with fibrin glue brought the successful number of fistula tracts closed to 33 (69 percent). The 15 (29 percent) patients who failed either one or two treatments with fibrin glue were successfully treated with either fistulotomy or advancement flap. Bowel function and fecal incontinence were not altered by the fibrin-glue treatment. In one patient who failed fibrin glue, the fibrin-glue treatment may have created a more complicated fistula tract. Late recurrences (>6 months) occurred in three (6 percent) patients, two of whom were successfully retreated with fibrin glue. CONCLUSIONS: Fibrin-glue treatment of anal fistulas is successful in up to 69 percent of patients if initial failures are retreated. This sphincter-saving technique is associated with minimal complications and no functional detriment. Late recurrences are unusual.     

Fibrin Glue for Bleeding Peptic Ulcers

Fibrin glue is a complex plasma-derived product formed by mixing human fibrinogen and human factor X111 with human thrombin and bovine aprotinin following virus inactivation. It has been used to treat bleeding peptic ulcer by injecting the material through a dual lumen endoscopy injection needle into the floor of the ulcer around the bleeding point. In experimental and uncontrolled studies in patients it appears effective and produces little tissue damage. A large randomized trial in 854 patients admitted because of bleeding peptic ulcer with active bleeding or non bleeding visible vessel at endoscopy suggests that repeated injection of fibrin tissue glue had a significantly lower rebleeding rate than single injection of the sclerosant polidocanol.     

Fibrin Glue in the Treatment of Pilonidal Sinus: Results of a Pilot Study

INTRODUCTION Pilonidal sinus is a common condition of uncertain etiology. There is no agreed best surgical treatment. Treatment of fistula-in-ano has been described with some success with fibrin tissue glue. The use of fibrin glue is investigated in this pilot study.METHODS Six patients with chronic pilonidal sinus were treated with injection of fibrin tissue glue after curettage of the pits.RESULTS There were no complications. Postoperative discomfort was minimal and early return to normal activities was possible. There was no recurrence of disease in five of six patients at one year.CONCLUSIONS Fibrin tissue glue may be a possible novel treatment for pilonidal disease.Reprints are not available.     

Biochemical and Physical Properties of a Solvent-Detergent-Treated Fibrin Glue

A fibrin glue preparation has been obtained from pooled human plasma using a procedure which includes a solvent-detergent (SD) treatment to inactivate lipid-enveloped viruses. The SD treatment inactivated greater than or equal to 5.5 log10 of HIV in less than 45 min, and greater than or equal to 5 log10 and greater than or equal to 6.5 log10 of VSV and Sindbis virus, respectively, in less than 2 h. The product was found to contain high quantities of fibrinogen (116 +/- 2.49 g/l; n = 12), factor XIII (35 +/- 2.88 U/ml) and von Willebrand factor (23 +/- 1.9 U/ml ristocetin cofactor activity), and relatively low levels of fibronectin (5.9 +/- 0.51 g/l). Plasminogen, the precursor of plasmin, which may play a negative role by decreasing the resistance of the fibrin clot, was at only 0.03 g/l. Cellulose acetate electrophoresis showed 95% gamma-proteins and 5% alpha-2-beta proteins. Sodium dodecyl sulfate polyacrylamide gel electrophoresis under reducing conditions detected three main protein bands with apparent molecular weights of 65, 56 and 47 kilodaltons, probably corresponding to the alpha, beta, and gamma fibrinogen subunits. Other characteristics of the product included (1) high clottability of fibrinogen (over 85%); (2) absence of low molecular weight fibrin degradation products; (3) rapid solubilization at room temperature (less than 10 min); (4) high tensile strength (202 +/- 27 g/cm2 after 2 h of application), and (5) high elasticity of the fibrin clot. In addition, scanning electron microscopy revealed a highly organized structure showing tridimensional arrangement of the fibrin fibers. SD treated fibrin glue should efficiently replace autologous fibrinogen or cryoprecipitate preparations for surgical application.     

Prospective, Multicenter Evaluation of Highly Concentrated Fibrin Glue in the Treatment of Complex Cryptogenic Perianal Fistulas

PURPOSE The surgical management of complex perianal fistulas is challenging and may be associated with the risk of sphincter injury. Instillation of fibrin glue to the fistula tract is a simple procedure that does not involve any muscle division, and potentially results in healing of the fistula. This study was designed to assess the use of highly concentrated fibrin glue with intra-adhesive antibiotics in the treatment of complex cryptogenic perianal fistulas. METHODS Patients with complex perianal fistulas of cryptogenic origin were prospectively included in this multicenter study. Injection of the fibrin glue mixed with antibiotics was performed in a uniform fashion. After the procedure, patients were actively examined at fixed time intervals; in cases of recurrent fistula, reinjection of fibrin glue was offered. RESULTS Sixty patients were enrolled; complete healing of the fistula was achieved in 32 patients (53 percent). Eight of 28 patients (29 percent) who were not completely healed had significant symptomatic improvement. All patients resumed normal daily activity the day after surgery and none had any deterioration in continence related to the procedure. The majority of the 26 (43 percent) adverse events were considered mild and spontaneously resolved; 2 patients (3 percent) with perianal septic complications were successfully treated by drainage. CONCLUSIONS Injection of fibrin glue for the treatment of perianal fistulas is safe, simple, and associated with early return to normal activity. Although moderately successful, it may preclude extensive surgery in more than one-half of these patients. The fibrin glue for this study was supplied by Omrix, Israel. The podium presentation was supported by Omrix, Israel. Reprints are not available. Podium presentation at the meeting of the International Society of University Colon and Rectal Surgeons, Budapest, Hungary, June 6 to 10, 2004.     

Pilot Study: Fibrin Sealant in Anal Fistula Model

PURPOSE The aim of this study was to investigate the failure of fibrin sealant treatment for fistula-in-ano in an experimental porcine model and to determine histologic changes associated with the sealant and setons.METHODS Three surgically created fistulas were treated by seton drainage in each of eight male pigs. After 26 days, magnetic resonance imaging was performed and setons were removed. Two pigs were killed as controls for stereologic histologic fistula track assessment. In six, fistulas were curetted, and in four the fistulas were treated with fibrin sealant. In these four sealant and two seton pigs, magnetic resonance imaging was repeated a median of 47.5 days after fistula formation. The pigs were killed and stereologic histologic fistula track examination was performed to determine granulation tissue and fistula lumen volumes. These values were compared among control, seton, and sealant groups over time, and related to fistula volumes derived from magnetic resonance imaging.RESULTS Sealant was not visible microscopically within tracks, although some sections revealed a foreign body–type reaction. On stereologic assessment, granulation tissue volumes were smaller in sealant and seton groups than in controls (median, 88 vs. 187 vs. 453 mm³, respectively; P = 0.002) and decreased over time (median, 408 and 152 mm³ (Day 42) vs. 88 and 75 (Day 53), respectively; P = 0.002). Fistula lumen (P < 0.001), and granulation tissue combined with fistula lumen volumes (P = 0.002) were similarly smaller. Magnetic resonance imaging of fistula intensity was less in the sealant group than in the seton group and controls (mean, 777 vs. 978 vs. 1214 units/mm², P = 0.003). Magnetic resonance imaging fistula volumes were least in sealant and seton groups vs. controls (P = 0.024), decreasing significantly in the sealant group over time (P = 0.018). No direct relationship was found between imaging and histologic volumes.CONCLUSIONS In an experimental porcine model of anal fistula, granulation tissue was still present, albeit diminished, following track curettage combined with seton or sealant therapy, and was minimal in the sealant group, confirming some benefit from this procedure. Eradication of all longstanding granulation tissue may ensure complete success of fibrin sealant therapy.G.N.B. was supported by The St. Marks Hospital Foundation. Baxter Healthcare provided fibrin sealant in this study.Published online: 31 January 2005     

Long-Term Outlook after Successful Fibrin Glue Ablation of Cryptoglandular Transsphincteric Fistula-in-Ano

Purpose

Initial success rates for fibrin glue ablation of cryptoglandular transsphincteric fistulas have been disappointing. We examined long-term outcomes after initially successful fibrin glue ablation of cryptoglandular transsphincteric fistulas.

Methods

Retrospective review identified 36 adult patients with cryptoglandular transsphincteric fistula Tisseel VH® fibrin glue ablation that was performed from May 2000 to March 2005. Fibrin glue ablations were performed under supervision of fellowship-trained colorectal surgeons. Follow-up interval was based on time until recurrence of fistula or time of last fistula-free evaluation.

Results

Twenty-four men and 12 women patients had a mean age of 50 (range, 27–85) years. Twenty patients responded to initial fibrin glue ablation treatment. Two additional patients healed with secondary fibrin glue ablation. Sixty-six percent (22/33 patients) of cryptoglandular transsphincteric fistulas were closed at three months. Eleven patients failed fibrin glue ablation at a mean of 33 (range, 6–41) days. Seventeen of 22 short-term success patients (3 months) were available for long-term follow-up. Ninety-four percent (16/17 patients) remained healed at final long-term follow-up. The remaining patient recurred just before the six-month follow-up.

Conclusions

Despite the suboptimal early success rate of fibrin glue ablation for cryptoglandular transsphincteric fistulas, when a fistula does close for at least six months this appears to be a durable closure. A single patient recurred after appearing healed at the three-month check.

     

Efficacy of Fibrin Sealant in the Management of Complex Anal Fistula

PURPOSE: A prospective trial was conducted to establish long-term healing of complex idiopathic anorectal fistula, without extension, after fibrin glue treatment, with clinical assessment and magnetic resonance imaging to determine tract healing. METHODS: Twenty-two patients undergoing glue instillation after fistula curettage and irrigation were followed up for a median of 14 months. Clinical assessment, short tau inversion recovery sequence magnetic resonance imaging, and combined short tau inversion recovery and dynamic contrast-enhanced magnetic resonance imaging were performed at a median of three months postoperatively, and their ability to predict outcome in the presence of early skin healing was determined. RESULTS: Of 22 patients, 19 (86.5 percent) had transsphincteric fistulas, 1 (4.5 percent) had a suprasphincteric fistula, 1 (4.5 percent) had an extrasphincteric fistula, and 1 (4.5 percent) had a rectovaginal fistula. None had clinical or radiologic evidence of secondary extension. Despite skin healing in 17 (77 percent) of 22 patients at a median of 14 days after treatment, only 3 (14 percent) remained healed at 16 months. Magnetic resonance imaging with short tau inversion recovery sequences in combination with dynamic contrast-enhanced magnetic resonance imaging predicted outcome in all 10 assessments (100 percent), compared with short tau inversion recovery sequence alone in 16 (94 percent) of 17 assessments or clinical examination in 12 (71 percent) of 17 (P = 0.02). CONCLUSIONS: The success rate of fibrin glue application for complex anorectal fistulas without extension is 14 percent. Magnetic resonance imaging predicts outcome at an earlier stage than clinical examination.     

纤维蛋白胶外周支持对大鼠颈静脉移植物内膜增生的影响

目的:探讨可降解纤维蛋白胶血管外周支持对静脉移植物内膜增生的影响.方法:建立大鼠颈总动脉自体颈静脉移植模型,按照有无纤维蛋白胶血管外周支持,分为纤维蛋白胶血管外周支持组、无血管外周支持组,每组24只大鼠.术后1周、2周、4周分别切除移植静脉,计算机图像分析系统测量和计算内膜、中膜厚度,进行透射电镜检查,用免疫组织化学方法检测静脉移植物平滑肌细胞增殖细胞核抗原(PCNA)的表达.结果:纤维蛋白胶血管外周支持组静脉移植物术后1～4周内膜、中膜的厚度,明显低于无血管外周支持组(P<0.001).纤维蛋白胶血管外周支持组静脉移植物的PCNA指数也明显低于无血管外周支持组(P<0.01～0.001).透射电镜检查显示纤维蛋白胶血管外周支持组静脉移植物破坏程度轻于无血管外周支持组.结论:纤维蛋白胶血管外周支持可抑制血管内膜、中膜在移植术后的增生.     

Therapeutic Effects of Gelatin-Resorcin-Formal Glue in the Treatment of Postoperative Fistula Following a Low Anterior Resection: Report of a Case

Abstract Postoperative fistulas are among the most difficult and distressing of surgical problems. We describe a case of a discharging fistula that developed after low anterior resection and was successfully treated with a new biologic adhesive agent, gelatin-resorcin-formal glue. To our knowledge, this is the first reported case of a postoperative fistula after colorectal surgery successfully treated with gelatin-resorcin-formal glue. In conclusion, gelatin-resorcin-formal glue is useful for uncontrollable postoperative fistula.