|Year : 2019 | Volume
| Issue : 2 | Page : 729-733
A comparative study between tubularized incised plate urethroplasty with and without fibrin glue
Tarek F Kishk1, Alaa Abd El-Azeem El-Sisy1, Shreif M El-Kashty1, Ahmed AM Fawzy2
1 Plastic Surgery Department, Faculty of Medicine, Menoufia University, Shebeen El-Kom, Egypt
2 Plastic Surgery Department, El-Sahel Teaching Hospital, Cairo, Egypt
|Date of Submission||15-Mar-2018|
|Date of Acceptance||10-Apr-2018|
|Date of Web Publication||25-Jun-2019|
Ahmed AM Fawzy
New Damietta, Damietta Governorate
Source of Support: None, Conflict of Interest: None
To compare the results of two single-stage hypospadias repairs, namely, tubularized incised plate (TIP) repair with and without fibrin glue as regards fistula formation, penile edema, wound infection, and cosmetic outcome.
One of the most important factors in reducing the incidence of fistula and other complications is incorporation of an intermediate layer between the neourethra and the skin layer. It may be dartos fascia, tunica vaginalis, and others. The key step is using fibrin sealants as a protective covering layer.
Patients and methods
Between December 2014 and December 2016, we enrolled 32 male patients into our study at Menoufia University Hospital. The patients will be divided into two groups. The first group included about 18 patients where fibrin glue was applied after construction of a neourethra before closure of the skin. The second group consisted of about 14 patients who were treated by a construction of a neourethra but without the use of fibrin glue.
The results of group I which underwent TIP urethroplasty with fibrin glue showed an 11% incidence of fistulation. Group II which underwent TIP urethroplasty without fibrin glue showed a 43% incidence of fistulation.
Applying a clot of fibrin glue between the layers of hypospadias repair will decrease the incidence of the complications after the repair. The fibrin glue results are poorer because of the increase in the rate of infection which will be the cause of fistula and wound dehiscence.
Keywords: fibrin glue, fistula formation, hypospadias, wound infection
|How to cite this article:|
Kishk TF, El-Azeem El-Sisy AA, El-Kashty SM, Fawzy AA. A comparative study between tubularized incised plate urethroplasty with and without fibrin glue. Menoufia Med J 2019;32:729-33
|How to cite this URL:|
Kishk TF, El-Azeem El-Sisy AA, El-Kashty SM, Fawzy AA. A comparative study between tubularized incised plate urethroplasty with and without fibrin glue. Menoufia Med J [serial online] 2019 [cited 2019 Sep 21];32:729-33. Available from: http://www.mmj.eg.net/text.asp?2019/32/2/729/260886
| Introduction|| |
Healing is a complex process that passes through multiple stages. All of these are controlled by growth factors; platelets are rich storage of many growth factors and so applying platelets-rich plasma to a wound is supposed to improve and facilitate healing. Fibrin glue, a clot formed by mixing thrombin (derived from plasma) and fibrinogen (prepared by cryoprecipitate), was used successfully to adhere different tissues to each other helping their healing. It was used also to seal minute defects in tissues such as perianal fistula, vesicovaginal fistula, and pilonidal sinuses helping their healing and minimize its recurrence. Human fibrin glue was used in mesh fixation of sutureless tension-free hernia repair. By adding platelets to thrombin and fibrinogen the resultant is a clot of platelets–fibrin glue that has all of the previous properties. Thrombin will act as an activator to platelets to release the growth factors and the formed glue will help to sustain the release of these factors. Hypospadias is a congenital abnormality in which the urethral meatus opens at the ventral side of the penis proximal to the tip of the glans penis. Hypospadias may be associated with a variable degree of ventral curvature of the penis called chordee. Hypospadias treatment is only surgical. The aim of hypospadias surgical treatment is to bring the urethral opening at the tip of the glans, to achieve a regular and straight penis, with a low percentage of postoperative complications. Complications after any surgical procedure are possible and these are higher in hypospadias compared with other reconstructive operations. Correction of hypospadias usually needs a construction of neourethra which carries a high incidence of complications including fistulas, crippled urethra, diverticuli, and wound dehiscences. Overall, problems are reported in 7% of boys undergoing distal hypospadias and in 12% with proximal repairs. One of the most important factors in reducing the incidence of fistula and other complications of hypospadias repair is incorporation of an intermediate layer between the neourethra and the skin layer. It may be dartos fascia, dartos muscle, or tunica vaginalis and others. Fibrin sealants have been used as a protective covering layer. It is proposed that applying a clot of fibrin glue between the layers of hypospadias repair will decrease the incidence of the complications after the repair. The aim of the study was to compare the results of two single-stage hypospadias repairs with and without fibrin glue as a protective layer.
| Patients and Methods|| |
A clinical trial of 32 patients with hypospadias was introduced in the research. The patient and his parent had been informed about the thesis with a written consent about the thesis technique and the possible complications. The patients were divided into two groups. The first group consisted of about 18 patients where fibrin glue was applied after construction of a neourethra before closure of the skin. Fibrin glue was prepared by adding equal amounts of thrombin and fibrinogen supplied from blood bank laboratory. The second group of about 14 patients was treated by a construction of a neourethra, but without the use of fibrin glue. Inclusion criteria: Patients with hypospadias treated by the technique where there was a construction of a neourethra. Exclusion criteria: Patients treated by urethral advancement techniques. All cases were subjected to detailed history, clinical examination of phallus and scrotum for meatal site, depth of the glandular groove, and width of the urethral plate. This was a prospective study comparing two different modalities for repair of such cases of hypospadias. All cases were divided into two groups. The cases were distributed randomly into two groups. Group I: including 18 patients, all patients in this group underwent the tubularized incised plate (TIP) technique for the repair of hypospadias using fibrin glue for covering the suture line of neourethra. Group II: including 14 patients, all patients in this group underwent the TIP technique for repair of hypospadias as in group I, but we used a vascularized dartos flap to cover the suture line of the neourethra instead of the fibrin glue. Preoperative preparations: the preoperative workup included a complete blood count, urine analysis, and a bleeding profile. Any Urinary Tract Infection was managed by using appropriate antibiotics. The area in the span between the umbilicus and the mid-thigh was thoroughly sterilized with povidone iodine, and extended to involve the inner thigh and the perineum. Operative considerations: group I: 'TIP with fibrin glue' [Figure 1],[Figure 2],[Figure 3].
|Figure 3: Application of fibrin glue over the suture line of the neourethra.|
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The idea of this technique was the use of fibrin glue to cover the neourethra instead of the dartos flap in an attempt to decrease postoperative complications especially urethrocutaneous fistulation. Preparation of the biological glue (fibrin glue): fibrin sealant, also called fibrin glue, is a blood-derived biomaterial. It was produced by the fractionation of human plasma to obtain fibrinogen in a high concentration, and thrombin which was reconstituted with calcium chloride. Fibrogloo is a lyophilized fibrin glue that was produced through a formula developed by the Cairo Medical Center Blood Bank. The lyophilized fibrin glue kit consists of two vials: fibrin and thrombin, each one was dissolved in 1 ml of sterile water, gently swirled for 1 min. The vials were allowed to stand in the ambient temperature for 5 min to insure complete protein rehydration. The thrombin and fibrinogen remain viable for use for 60 min after reconstitution. By adding thrombin to fibrinogen through the double-barrel syringe, it was converted to fibrin, and fibrinogen coagulum takes place. After the glue was prepared, we put it over the suture line of the neourethra and then the skin was sutured. The 18 candidates selected for this group were picked randomly from a pool of 32 cases. Of the 18 candidates, four (22%) had subcoronal, five (28%) distal penile, nine (50%) had midpenile hypospadias. Their ages ranged from 2 to 21 years (mean age = 6.4 years). Six (30%) cases exhibited mild degrees of chordee (<30°), and all were corrected by penile degloving alone. To ease mobility and handling of the penis throughout the operation, a 5–0 prolene stay suture was applied in a deep bite in the dorsum of the glans. The U-shaped incision was done with the two vertical limbs parallel to and including the native urethral plate, and proximally curved medially to intersect at a point 2 mm proximal to the hypospadiac meatus. The incision was attempted by an 11-blade and extended from the sides in a circumferential pattern 3 mm proximal to the coronal sulcus. An artificial erection was performed preoperatively before penile degloving. If chordee was present we performed penile degloving. The degloving was performed by a circumcoronal incision, and then by dissection between the dartos fascia and the deep layer of Buck's fascia. Erection was performed by applying a tourniquet around the base of the penis, then applying a butterfly needle through the glans and into the corporal bodies. Saline solution was then injected until engorgement of the cavernous tissue. The degree of chordee would then determine the management. Nine (50%) cases exhibited mild degrees of chordee (<30°), which were corrected by penile degloving alone, but if no chordee could be detected preoperatively, no penile degloving was required in group I which needed more time, and more tissue trauma for dissection so this would decrease postoperative complications. Any case that may have required division of the urethral plate in order to straighten the chordee was immediately omitted. A longitudinal incision was then performed in the midline of the urethral plate, aiming to add extra width to the urethra without compromising more penile skin. The incision was performed by a new sharp blade and included not only skin, but deeper, up to the Buck's fascia that enveloped the corporal bodies. Glanular wings were then developed by sharp and blunt dissection astride the neourethra. Dissection was ceased when sufficient span was created and could be approximated over the urethral catheter with no tension assumed. An adequate indwelling silicon urethral catheter was applied and the urethra was closed by subcuticular continuous running 6–0 vicryl sutures. After preparation of the glue, we put it over the suture line of the neourethra then skin closure was performed. Group II underwent 'TIP with dartos flap' [Figure 4]: of the 14 candidates, two (14%) had subcoronal, five (36%) distal penile, and seven (50%) had midpenile hypospadias. Their ages ranged from 2 to 18 years (mean was 5.9 years), five (50%) cases exhibited mild degrees of chordee (<30°), all of which were corrected by penile degloving alone. The same steps were done as in group one but a vascularized dartos flap was created from the dorsal penile skin and then rotated to cover the suture line of the neourethra instead of fibrin glue. Penile skin was closed by interrupted 6–0 vicryl suture. And lastly it was wrapped by dressing [Figure 5] which was meticulously applied, starting with a vaseline-impregnated gauze, and then mild compression to ensure hemostasis. It was undressed on the fourth day postoperatively, and kept in a light dressing for another 2 days; and the urethral catheter retained for a further 1–4 day period (total of 7–10 days). Postoperative medications included an injectable third-generation cephalosporin for 24 h. The patient was discharged from the hospital the morning after the operation on a broad-spectrum antibiotic (for 5 days), an analgesic, and oral oxybutynin were added. Follow-up: our follow-up protocol extended 6 months postoperatively. The patient was examined for: (a) urethrocutaneous fistulation, (b) penile edema, hematoma, or infection (c) skin discoloration, sloughing, or encrustation (d) meatus shape and caliber, (e) penile torsion or curvature, (f) urethral caliber as determined by the early streams of urine after removing the catheter and (g) initial cosmetic outcome.
All data were collected and tabulated. The comparison was done to compare the results of groups I and II, to identify any statistical significance between the use of fibrin glue instead of dartos flap in TIP repair. Results were presented as percentages and the corresponding P value. P values were used to analyze the difference in proportions of the different complications in the two groups. The statistical analysis (P value) was done using SPSS statistics software in version 24.0, SPSS Inc. (Chicago, Illinois, USA) is a leading global manufacturer of software used in data analysis, reporting and modeling (https://spss.en.softonic.com/?ex=REG-60.1). Z test was done using EpiCalc 2000 in version 1.02 (a statistical calculator that works with pretabulated data) (http://www.brixtonhealth.com/epicalc.html); Brixton Health, Llanidloes, London, United Kingdom).
| Results|| |
In comparing the two groups together, we have some comments on postoperative findings. In group I, the age ranges between 2 and 21 years with a mean age of 6.4 years. In group II, the age ranged between 2 and 18 years with a mean age of 5.9 years. First there was a higher incidence of postoperative penile edema after the TIP technique using dartos flap, six (43%) cases, as compared with the fibrin glue group which occurred in two (11%) cases with P = 0.049 and Z test = 1.56; second postoperative fistula was seen more frequently with the TIP procedure where six (43%) cases showed fistula, in comparison to two (11%) cases with the fibrin glue group with P = 0.049 and Z test = 1.56). Postoperative infection was seen less frequently with the TIP procedure which occurred in three (21%) cases in comparison to 11 (61%) cases with the fibrin glue group with P = 0.045 and Z test = 1.89. Also, skin discoloration was experienced more with the TIP procedure for nine (64%) cases, but in the fibrin glue group it occurred in four (22%) cases with P = 0.045 and Z test = 1.89 [Table 1]. Results are poor with high incidence of fistula in both groups because of the increase in the rate of infection which will be the cause of fistula and wounded dehiscence. Although statistical significance between the two groups regarding the postoperative complication was detected, we have to comment on a few points. Development of the dartos flap needs more dissection with more tissue trauma, more time for the procedure, and more incidences of postoperative penile edema and skin discoloration. Reviewing the literature showed few studies using fibrin glue as an interpositioning material in hypospadias repair, compared between the repair of urethrocutaneous fistula with and without fibrin sealant application. Their study showed superior effect of fibrin sealant over anatomical repair where the success rate with the fibrin glue was 90%, but with the anatomical repair it was (60%). These results support our conclusion that fibrin glue acts as a good sealant and healing promoter to lower fistula rate. Our study showed a lower incidence of fistula with fibrin glue, only two (11%) cases showed urethrocutaneous fistula. We refer our less good result, as we treat hypospadias from the start, their study treated fistula following hypospadias repair but their successful results support the beneficial effect of fibrin glue as a good sealant and its healing power in decreasing the incidence of urethrocutaneous fistula. In our study, the results showed that the incidence of postoperative penile edema was 11% in group I and the incidence increases to 43% in group II (P = 0.049), showing a statistical difference. The same study showed an increased incidence of infection, four (7%) cases in the first group and less incidence of infection in the second group, just two (3.5%) cases. We showed more higher incidence of infection in our study where 11 cases show postoperative mild infection in group I (61%) which was treated well medically by intravenous third-generation cephalosporin and anti-inflammatory drugs, group II showed more less incidence of infection, three (21%) cases showed mild purulent discharge which was treated conservatively (P = 0.045), which is highly significant. We can explain their less incidence of infection as they use premade fibrin manufactured by Baxter India Company in Raheja Twp, Malad East, Mumbai, Maharashtra 400097, India. Our study showed the superior outcome of fibrin glue over TIP technique, as it does not act only as a sealant separating the suture line but also as a good hemostatic and healing promoter. Hemostatic and healing power of this product has been demonstrated repeatedly in the literature. Dartos flap sometimes is difficult to develop and add more difficulty to the technique; also the creation of dartos flap needs more dissection, more tissue trauma, and more time. Our study shows that the fibrin sealant can replace this layer decreasing the postoperative complications. We can say that the fibrin glue add another step in the surgical success of hypospadias repair.
| Discussion|| |
History has recorded a number of attempts to repair the hypospadias anomaly. A lot of these attempts were unfruitful and disappointing, yet some were promising, and were established as the foundation of the art of hypospadias repair still standing today. Many modifications are added daily, all aiming to achieve the so-called gold standard. Recurrent fistula is a frustrating complication of urethral reconstructive surgery. Extensive scar formation and compromised blood supply of adjacent tissues limit the use of transpositioning flaps and highlight the need for advanced techniques such as fibrin sealant with better wound-healing properties that might lessen the chance of recurrence. Fibrin sealant is used in different reconstructive surgeries, such as urethroplasty, radical prostatectomy, partial nephrectomy, urethral anastomosis, and hypospadias repair with proved efficacy as a healing and growth promoter. The benefit of fibrin glue is mainly in hemostasis and it also facilitates cellular migration, increases angiogenesis, and can act as a sustained release reservoir for several growth factors. These characteristics make this product a great help in hypospadias repair and other complex urinary tract reconstruction. Fibrin glue is semipermeable and allows cellular migration and passage of nutrients to the healing site. Thrombin stimulates fibroblast proliferation and growth during the healing process. The fibrin polymer promotes the growth of fibroblasts during wound healing. The complex interaction of neutrophils, macrophages, and fibroblasts provides the basis of wound contraction and remodeling necessary for healthy wound healing. Currently, the commercially available fibrin glue prepared from pooled cryoprecipitated fibrinogen from multiple plasma donors has been utilized. Donor screening, heat treating, and the use of detergent suspension for the inactivation of lipid-enveloped blood-borne viruses in plasma derivatives have made these products safer. Fibrin sealant has important characteristics in reconstructive surgery that may contribute to its role as a bioadhesive and tissue matrix allowing cellular influent tissue regeneration. In urethral surgery, it reduces fistula formation, recurrence, and urethroplasty failure. It prevents urinary extravagation between suture lines, facilitates hemostasis, and promotes tissue healing.
| Conclusion|| |
Fibrin glue facilitates cellular migration, increases angiogenesis, and can act as a sustained release reservoir for several growth factors. These characteristics make this product a great help in hypospadias repair and other complex urinary tract reconstructions.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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