Complex anal fistulas remain challenging for the colorectal surgeon. To reduce postoperative incontinence and to offer a more comfortable postoperative course than is possible after traditional seton procedures, many new treatments have been proposed in the past few years.1 In all of these approaches, the main end points were to obtain healing, preserve anal sphincter integrity, and minimize the invasiveness of the procedure. There is general agreement that successful key points should be the correct identification of the internal opening, the course of the primary pathway and the secondary tracts and abscess cavities, as well as the complete destruction of the tracts, and the closure of the internal opening to prevent fecal material from entering the fistula. The aim of this retrospective observational study was to evaluate video-assisted anal fistula treatment (VAAFT), a new method of managing complex fistulas.
MATERIALS AND METHODS
From February 2006 to February 2012, 459 patients with anal fistula were recruited in a tertiary care Italian hospital. Any fistula that could not be adequately treated by simple fistulotomy was considered ‘‘complex.”2 Two hundred thirty-five patients had a simple fistula. We treated 134 of these patients with the lay open technique alone and 101 with lay open technique associated with direct repair of the internal sphincter/subcutaneous external sphincter. Video-assisted anal fistula treatment was performed on 203 patients (124 men and 79 women; median age, 42 years; range, 21–77 years) who had cryptoglandular complex anal fistulas. In 21 other patients with complex anal fistula in active Crohn’s disease, we performed a modified VAAFT procedure with multiple end points besides definitive healing. Patients with Crohn’s disease were therefore excluded from the present study, and we plan to focus on our new approach to this particular patient population in another analysis. The types of fistula were described according to Parks’ classification.3 Data were obtained through a retrospective review of electronic records. A specific informed consent form was drawn up, and the technique was clearly and graphically explained to the patients. Ethics Committee approval was obtained. Main preoperative baseline and clinical features of the selected study population are shown in Table 1.
One hundred forty-nine of the selected patients had undergone previous anal fistula surgery. Most of them were referred to us with a lot of diagnostic investigations, very often with nonconfirmatory findings. Sixty patients underwent MRI or endoanal ultrasonography at our institution, whereas 91 underwent fistula imaging (MRI, ultrasonography (US), or CT) before referral and did not require further testing. In 52 patients, no diagnostic investigations, other than clinical examination, were performed to better assess the diagnostic accuracy of the intraoperative fistuloscopy. Preoperative assessments also included routine blood tests, virtual or traditional colonoscopy, and chest x-ray in patients over 40 years of age who were smokers. Follow-up was at 2, 6, 12, and 24 months. All patients were asked to fill out a dedicated questionnaire about their quality of life preoperatively and postoperatively starting at 3 months from the operation. After 2 years, the patients were asked to contact us once per year. Most of the patients did not live in the area. Therefore, 56 patients were followed up by phone interview after the first year.
The cumulative probability of freedom from fistula has been estimated by a Kaplan-Meier analysis. Comparison between groups for variables (different ways to close the internal opening) was made using the log-rank test. A p value of <0.05 was considered statistically significant.
Video-assisted anal fistula treatment is mainly based on the use of a fistuloscope manufactured by Karl Storz GmbH (Tuttlingen, Germany). It has an 8° angled eyepiece; it is equipped with an optical channel and also a working and irrigation channel. Its sheath is 18 cm long, and its operative length is reduced to 14 cm when a removable handle is attached (Fig. 1). The kit also includes an obturator, a unipolar electrode, an endobrush, a forceps, and 0.5 mL of synthetic cyanoacrylate (Glubran 2-GEM, Viareggio, Italy). The fistuloscope has 2 taps, one of which is connected to a bag of glycine-mannitol 1% solution, acting both as a washing and current conductor solution. The VAAFT procedure is performed as described in our previous article.4 This technique comprises a diagnostic and an operative phase. The aims of the diagnostic phase are to correctly locate the internal fistula opening, the secondary tracts, and any abscess cavities. The 3 essential steps are: first, insertion of the fistuloscope through the external opening; second, location of the internal opening; and finally, isolation of the internal opening. In the case of multiple external orifices or horseshoe fistula, the operation is repeated for each opening. Before the introduction of the fistuloscope, it is useful to dilate the tract by the injection of saline solution with the use of a syringe inserted in the external opening. We remove the fibrous scar tissue from around the external opening to better insert the fistuloscope. We place the fistuloscope’s tip against the external orifice with the washing solution already running. We wait a few seconds to allow an adequate distension of the lumen and, consequently, to have a better view. The use of a Kocher forceps pulling back the external opening allows the fistula tract to be straightened. A finger inserted into the anus helps this maneuver (Fig. 2). The orientation of the fistuloscope is correct when the obturator appears in the lower part of the screen. During the progression of the fistuloscope, secondary tracts and abscess cavities can be identified and, finally, the internal opening can be reached. At this point, in most cases, the tip can enter the anorectal lumen, but, sometimes, if the internal opening is partially or completely closed, the bright light of the fistuloscope behind the mucosa identifies the site of the internal opening. Here, 2 or 3 stitches must be used to isolate the opening. After this step, the operative phase begins. Its aims are fistula destruction from the inside, cleaning of the fistula, and finally closure of the internal opening. We remove the obturator, insert a unipolar electrode into the fistuloscope, and start to gradually retract the fistuloscope, cauterizing the fistula walls under direct vision, from the internal opening to the external opening. When the tract appears completely destroyed, we insert the endobrush to obtain adequate cleaning under direct vision. The closure of the internal opening can be performed with a semicircular stapler, a linear stapler, or a flap. The choice depends on the position of the internal opening and the characteristics of the internal opening tissue. If the patient has been operated on several times, we prefer to use a flap because of the scar tissue that does makes it difficult to lift the internal opening properly for correct stapler placement. To reinforce the suture, especially if we have used a flap, we put 0.5 mL of synthetic cyanoacrylate (Glubran 2) immediately behind the suture. The final aesthetic result is excellent (Fig. 3).
Two hundred three patients were followed up with a median duration of follow-up of 15 months (range, 6–69 months). In 121 cases (59.6%), secondary tracts and abscesses were found. Intraoperative data are shown in Table 2. In 171 patients (84.2%), the internal opening was located in less than 5 minutes. In the other 32 (15.8%), it was found by viewing the fistuloscope light in the rectum. The operative time was progressively reduced (from 2 hours to 30 minutes) following improvement of a short learning curve. No major complications occurred, and no infection or bleeding was observed. However, there were 2 cases of postoperative urinary retention. In 1 case, scrotal edema was observed that was caused by the infiltration of the irrigation solution after rupture of the fistula wall. Two cases of allergy to the synthetic cyanoacrylate were reported. One patient was discharged after 6 days because of a headache related to the spinal anesthesia, but all the other patients were discharged within 24 hours. Most patients reported that the pain was acceptable both in the early and in the later postoperative period. Pain control was based on the visual analogue scale with a mean value of 4.0 (on a scale of 1–10) during the first 48 hours. None of the patients reported pain after the first postoperative week. Thirty-six patients (17.8%) did not require any analgesics, whereas 141 patients (69.4%) needed Ketorolac trimetamine for 3 to 4 days, and only 26 (12.8%) needed Ketorolac trimetamine for a week. The main results are shown in Table 3. The 6-month cumulative probability of freedom from fistula estimated according to a Kaplan-Meier analysis is 70% (95%CI, 64%–76%). (Fig 4). In the group of 118 patients who underwent stapling closure, the 12-month probability of freedom from fistula was 74% (95%CI, 66%–82%), and, in the group of 85 patients who underwent sutured closure, the probability of freedom from fistula was 58% (95%CI, 48%–68%). There was a statistically significant difference between the 2 methods in favor of staple closure (log-rank test, 6.5; p = 0.011) (Fig 5).
Thirty-one of the 65 patients (47 unhealed + 18 with recurrences) underwent reoperation with VAAFT (6 patients were lost to follow-up and 28 are waiting to be treated), and 17 of them healed, whereas 14 had a recurrence. The 12-month cumulative probability of ultimate freedom from fistula (including the option of VAAFT re-treatment), is 74% (95% CI, 68%–80%) (Fig. 6). We did not formally evaluate anal continence with a validated score before and after surgery. Our aim was only to determine whether the operation might have worsened patients’ continence, and this was evaluated by simply asking the patients about continence problems. All patients denied worsening of fecal continence postoperatively. Among those who had an active job, the longest time off work was 3 days. In the quality-of-life questionnaire completed by the patients, all responded that fecal continence had improved dramatically, in particular, the 89% who had undergone previous traditional surgery. After discharge, the patients were asked to keep the external orifice open for at least 2 weeks and to wash the wound through this opening twice a day by using a syringe with saline solution.
Our data indicate that the VAAFT procedure is effective and safe for the treatment of complex fistula-in-ano. The acceptable healing rates, the very high level of patient satisfaction and of postoperative quality of life, and the absence of functional sphincter impairment encouraged us to adopt this approach in all cases of anal fistula not suitable for lay open/direct sphincter repair. The main goals of VAAFT are the video assistance in finding the internal opening and the fistula course, and the use of different stapled or handmade closures modulated on each case. Fistuloscopy is extremely effective in defining the anatomy of the fistula tracts and localizing the internal opening; thus, probing can be avoided. We are firmly convinced that correct localization of the internal opening is a key part of fistula treatment. Moreover, treatment of the fistula walls by using electrocautery and curettage can stimulate fibrosis and replacement of the infected tract by new granulation tissue. Because of the study design, it was impossible to estimate the relative contributions of the various maneuvers performed as part of VAAFT to the healing process. The only way to define the role of the videoscopy and the ablation of the tract by electrocautery would be to randomly assign patients into different groups: probing or fistuloscopy + ablation and closure by flap; probing or fistuloscopy + ablation and staple closure. This is an area for further study. However, a comparison of the results of staple closure and suture closure in our series showed that the former provides a higher and statistically significant percentage of primary definitive healing. Our data suggest that, despite the elevation of the final costs, staple closure is the criterion standard and offers the best opportunity to adequately cure complex anal fistulas.
Our study has other limitations, as follows: potential selection bias, because we excluded from the study all patients with intrasphincteric or low transsphincteric tracts treated by lay open and/or internal sphincter/subcutaneous external sphincter direct repair; potential single-institution bias; and the lack of an evaluation of the role of anal manometry, because anal manometry was not performed. To improve functional results, many alternative attempts have been made to treat high anal fistulas. Closure of the internal fistula opening by means of variously shaped and constructed flaps with or without partial removal of the fistula tract has been widely adopted for many years.5 Applying the same rationale of keeping feces from reinfecting the fistula, the ligation of intersphincteric fistula tract procedure creates an interruption of the tract by ligation and division in the intersphincteric plane.6 Other recent procedures are aimed at eliminating the tract by an obliteration with biologically derived products such as fibrin glue, the Surgisis Anal Fistula Plug, and the Gore Bio-A Fistula Plug.7–10 The comparison of traditional techniques with these new approaches shows a trend toward a lower healing rate with the new techniques instead of a lower incidence of postoperative fecal incontinence, but the results reported in the literature are very heterogeneous, and there is a need for well-conducted randomized trials.11 The only common denominator in all these old and new treatments is the blind probing of the tract to define the fistula course and to locate the internal opening. Colorectal surgeons know that this step offers the best opportunity to successfully cure anal fistulas; however, the accidental creation of false passages contributes to a high probability of failure. The main innovation in VAAFT is the ability to explore the fistula by means of an endoluminal evaluation under direct vision that includes, in addition to the main tract, secondary tracts and abscess cavities. The true revolutionary concept of VAAFT is that the entire procedure is performed under direct vision and it could be considered compatible with, instead of an alternative to, other different recent sphincter-sparing techniques such as ligation of intersphincteric fistula tract or anal plug. In fact, fistuloscopy could be helpful at the beginning of any operation. Thanks to the fistuloscopy, we can also distinguish the true fistulas from the false. In the true fistula, the tissue is characteristically red and floating, whereas, in the false tract, the tissue is whitish and not floating. This difference is very important in the case of recurrence, because we can see and treat secondary tracts or abscess cavities never identified before. Certainly, the preoperative diagnostic investigations such as MRI or US are important to define what type of fistula we have to treat, but no articles in the literature have demonstrated a direct correlation between good preoperative images and improvement of the healing percentage after surgery. We are currently collecting some data which suggest that fistuloscopy is more reliable and accurate than US and MRI.
An important area of future study is the use of VAAFT in patients with Crohn’s disease. Schwandner12 has adopted VAAFT to treat 11 patients with perianal Crohn’s disease and reports an 82% success rate after a mean follow-up of 9 months. These results are confirmed in our preliminary experience in 21 cases. Cauterization and cleaning of the fistula tracts with VAAFT makes possible closure and temporary healing and the avoidance of seton insertion. We did not include patients with Crohn’s disease in the present study, but we intend to perform a separate analysis of VAAFT in these patients.
And last, but by no means least, our results indicate that there is great improvement in the quality of life after VAAFT. In the future, we plan to study quality of life in depth, including a formal evaluation of continence.
Our preliminary results are very encouraging, because acceptable healing rates for complex anal fistula were obtained without worsening continence and with a high level of patient acceptance and improved quality of life. Although more studies on VAAFT are needed, we believe that this new endoluminal approach has the potential to become the acknowledged criterion standard for the treatment of anal fistula.
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Keywords:© 2014 The American Society of Colon and Rectal Surgeons
Complex anal fistula; Video-assisted; Fistuloscope; Sphincter-saving