Management of Complex Fistula-in-ano by Interception of Fistula Track with Application of Ksharasutra (IFTAK): A Novel Technique

Abstract

Objective

Despite all the technological advances, successful management of complex fistula-in-ano is still a challenge due to recurrence and incontinence. The present study evaluates the outcomes of a novel technique, Interception of Fistula Track with Application of Ksharasutra (IFTAK) in terms of success rate and degree of incontinence.

Methods

In the present prospective study, 300 patients with complex fistula-inano were treated by the IFTAK technique, whose surgical steps include: incision at the anterior or posterior midline perianal area, identification and interception of the fistulous track at the level of the external sphincter, rerouting the track (and extensions) at the site of interception, and application of a ksharasutra (medicated seton) in the proximal track (from the site of interception to the internal opening) that is laid open gradually, with the resulting wound healing with minimum scarring. The distal track is allowed to heal spontaneously.

Results

There were 227 transsphincteric and 73 intersphincteric varieties of fistula with supralevator extension in 23 cases, of which 130 were recurrent fistulas, 29 had horseshoe track, while 25 had blind fistula with no cutaneous opening. The mean duration of the ksharasutra application was 8.11 ± 3.86 weeks with an overall success rate of 93.33% at the 1-year follow-up. A total of 3.67% of the cases reported with a mild impairment of continence on the Wexner incontinence scoring system. Pre- and postoperative anal manometry evaluation showed minimal reduction in median basal and squeeze pressures.

Conclusion

The IFTAK technique is a minimally invasive, daycare surgical procedure for the management of complex fistula-in-ano with low recurrence and minimal sphincter damage.

Keywords
complex fistula-in-ano; ksharasutra; IFTAK; recurrence; incontinence

Introduction

Fistula-in-ano may be defined as an abnormal chronic track lined with granulation tissue that leads from the anorectal lumen (from the internal opening) to the perineum or adjacent structures.¹ Most anal fistulas occur as a sequela of infection of the anal glands, resulting in the formation of an abscess in the intersphincteric plane, from where the sepsis may track in all four directions and may either open at the exterior or extend blindly internally.² The extension of sepsis into deeper or multiple planes and a greater involvement of the sphincter musculature (> 30%) make a fistula complex in nature and pose challenges to treatment.³ The ideal treatment for anal fistula should aim at the eradication of the primary source of infection and promoting healing of the track without jeopardizing continence. Conventional surgical options like fistulotomy and fistulectomy have shown good results for simple, low anal fistulas in terms of success rates and functional outcome. However, in complex cases, a great concern remains about recurrence, greater degree of incontinence, and loss of anatomical integrity which, at times, causes more distress than the disease itself.³, ⁴, ⁵ Therefore, various sphincter-sparing procedures like endorectal advancement flaps, fistula plugs, ligation of intersphincteric fistula track (LIFT), and video assisted anal fistula treatment (VAAFT), among others, have been proposed and evaluated from time to time; however, with variable results.⁶, ⁷, ⁸, ⁹

In the traditional Indian Medicine system of Ayurveda, anal fistula is described as bhagandara, a surgical disease to be treated either by excision or laying open. Sushruta (500 BC), the ancient Indian surgeon, in addition, prescribed an alternative, safe, and minimally invasive treatment with the use of a medicated seton known as ksharasutra (kshara -caustic/alkali, sutra - thread; in Sanskrit).¹⁰ A ksharasutra is prepared by smearing oleoresins of Commiphora mukul, powder of Curcuma longa and the alkaline ash (kshara) obtained from Achyranthes aspera on a surgical linen thread no. 20. According to the conventional therapeutic mode, the ksharasutra is applied snugly in the fistulous track from one end (opening) to the other using a probe and is changed weekly by the railroad technique. The drugs coated on the thread gradually dissolve and cause lysis of the unhealthy granulation tissue; the whole track is therefore laid open gradually by chemical fistulectomy as well as by mechanical pressure, with an average cutting and healing rateof1 cm per week.¹¹ Although the success rate of this conventional mode of ksharasutra therapy has been reported to be as high as 96.5% with a low incidence of incontinence,¹² the duration of treatment has been long, with patients requiring multiple hospital visits in long fistulas and other complex cases.¹³ To address these difficulties, a novel technique named Interception of Fistula Track with Application of Ksharasutra (IFTAK) was devised, in which only a small, proximal part of the fistulous track is laid open and the whole complex fistula is treated in less time with minimal sphincter damage and a good success rate. The present paper describes the technique in detail with its results in a single center, prospective study.

Materials and Methods

After due approval from the ethical committee of the institute, patients with complex fistula-in-ano who attended the Anorectal clinic at Sir Sunder Lal Hospital, Banaras Hindu University, Varanasi, India, were recruited for the study. The study period spanned from August 2011 to July 2018. Fistulas that were anatomically higher (such as high intersphincteric, high trans-sphincteric, or suprasphincteric fistula), which involved significant portions of the sphincter musculature (> 50%), which had multiple tracks and/or distant extensions, as well as high horseshoe and recurrent fistulas were included in the category of complex fistula. Extra sphincteric and noncryptoglandular fistula-in-ano as well as simple fistulas like low intersphincteric and low trans-sphincteric tracks were excluded from the study.

The preoperative assessment of the anatomy of the fistula was performed by clinical examination, three-dimensional (3D)-transrectal ultrasonography (TRUS) (BK medical, transducer type 2052) and MR fistulogram. Assessment of continence status was done by the Jorge and Wexner Scoring system¹⁴ as well as by using 16-channel high resolution water perfusion anal manometry system (The Royal Melbourne Hospital, Victoria, Australia, Model-Kangaroojeff, Software - Trace 1.2 V). The procedure was thoroughly explained to all patients and informed consents were obtained. No bowel preparation is needed for this surgical approach and only sodium phosphate enema (100 ml) was given to the patient before the operative procedure. Follow-up was conducted 15 days, 1 month, 3 months, 6 months, and, finally, at 1 year.

Surgical Technique

The extended lithotomy position was adopted for the procedure. Local infiltration anesthesia with an injection of ligno-caine 0.5% with adrenaline (1:200,000) was preferred in most cases. Regional or general anesthesia was also used in some cases whenever considered necessary. The internal opening and the course of the fistulous track was assessed by digital rectal examination as well as with the cautious help of a malleable silver probe. If necessary, the internal opening was also visualized by injecting methylene blue or hydrogen peroxide into the fistulous track, which could be seen with the help of an illuminated anal speculum. Invariably, the internal opening was found either in the posterior or in the anterior midline; accordingly, a 1- to 1.5-cm linear vertical incision was made either in the posterior or in the anterior midline ~ 2cm away from the anal verge (►Fig. 1a). The underlying tissue and muscle fibers were separated by using a pair of mosquito artery forceps at the level of the external sphincter until the fistulous track was identified. Fistulous tracks are usually whitish, shiny, cord-like structures and can be identified after proper dissection near their site of origin or the internal opening. However, at times of difficulties like in cases of blind fistulas or of high trans-sphincteric tracks, digital guidance by the index finger of the opposite hand placed in the anal canal as well as a malleable probe passed into the fistulous track can help in better identifying and intercepting the track.

Fig.1
Diagrammatic demonstration of the IFTAK technique in a case of posterior trans-sphincteric fistula (track shown by white dotted lines) extending from the left perianal region to the posterior midline with internal opening at the 6 o’clock position; (a) A linear vertical incision made in the posterior midline ~2cm away from the anal verge to explore the fistulous track; (b) Tissue over the fistulous track carefully separated to reach up to the track that is identified as a white cord-like structure and is intercepted at the level of the external sphincter; (c) Probe passed in the proximal track through the site of interception (window) and the ksharasutra is mounted at the tip of the probe. (Inset shows the tip of the probe with a notch like a cobbler’s needle); and (d) Ksharsutra applied in the proximal track.

Once the track was identified, it was intercepted by a pair of fine scissors (►Fig. 1b and ►Fig. 2c). Thus, the fistulous track was divided into a proximal and a distal part with a gap (window) in between, which was widened by using a pair of artery forceps to provide adequate drainage to the primary track as well as to the secondary extensions or abscesses located in adjacent anatomical spaces. A soft, malleable, blunt tip silver probe with a notch at the tip (like a cobbler’s needle) was then passed through the window up to the internal opening at the pectinate line (►Fig. 1c and ►Fig. 2e) and ksharasutra was applied in the proximal track (►Fig. 1d and ►Fig. 2f). The distal part of the fistulous track was left as such for healing. The wound was dressed with a sterile pad.

Fig.2
Demonstrating the IFTAK technique and its outcome; (a) Left trans-sphincteric fistula (curved track shown by white dotted lines) extending from the 1 o’clock position of the external opening (white arrow) to the posterior midline at the 6 o’clock position of the internal opening; (b) 3D-TRUS image showing the course of the track (yellow arrows) from the 1 o’clock position, traversing along the external sphincter on the left lateral side and piercing through the sphincters at the posterior midline to open into the anal canal at the 6 o’clock position; (c) Linear vertical incision taken in the posterior midline with interception of fistulous track (white arrow); (d) Jet of fluid coming out from the external opening on injecting the fluid through the site of interception (window) showing the free communication of the track with the window; (e) Probe passed in the proximal track through the site of interception (window) with ksharasutra mounted at the tip of the probe; (f) Ksharsutra applied in the proximal track; (g) Healed external opening (yellow dotted circle) with healthy granulating wound after 1 week with ksharasutra in situ; and (h) Completely healed fistula (yellow dotted circle) after 3 weeks of IFTAK treatment with minimal scarring in the posterior midline.

Postoperative pain could be managed effectively by oral nonsteroid anti-inflammatory drugs (NSAIDs). After 2hours of observation for immediate postoperative complications like bleeding etc., the patients were sent home with an advice to take sitz bath with lukewarm water (40 to 45°C) twice daily to keep the wound clean and to continue their daily routine as usual. A bowel softener like psyllium husk was prescribed for smooth bowel movements.

The patients were advised to visit the outdoor clinic at 7-to 10-day intervals for change of ksharasutra as well as to assess the patency of the window (site of interception) and the condition of the external opening for any discharge or state of healing. During each visit, the ksharasutra in the proximal track was replaced by a new one by the railroad technique and the window was kept wide open to ensure adequate drainage. Once the external opening(s) ceased to discharge and showed signs of healing, which invariably occurs within 1 to 2 weeks (►Fig. 2g), the ksharasutra was tied snugly so that it resulted into progressive laying open and healing of the proximal fistulous track with minimum scarring (►Fig. 2h).

Results

Our series consisted of 300 cases, 294 (98%) males and 6 (2%) females; with a mean age of 39.27 years old (range: 15 to 72 years old). There were 227 (75.67%) trans-sphincteric and 73 (24.33%) intersphincteric types of complex fistula-in-ano. Of the trans-sphincteric cases, 135 had extensions into the intersphincteric or ischiorectal spaces either on one or both sides, while 18 of them were also associated with a supra-levator extension. Among the intersphincteric fistulae, 10 patients had a contralateral intersphincteric extension, while in 5 cases the sepsis also extended into the supra-levator space. In most (88%) fistulas, the internal opening was present in the posterior midline with 130 (43.33%) of the total 300 cases being recurrent fistulas; 29 (9.67%) cases presented with a horseshoe nature of the track with ≥ 2 external openings on either side of the anal canal; 25 (8.33%) cases were blind in nature, with no cutaneous opening around the anal orifice.

Four patients each were operated under regional and general anesthesia while the rest was operated under local anesthesia. The operative time varied between 10 and 20 minutes depending on the nature of the track and on the extension to the deeper structures. No intraoperative or immediate postoperative complication was observed in any patient. The patients operated under local anesthesia were discharged on the same day after 2 hours of observation while the patients operated under regional or general anesthesia were discharged on the next morning. All patients resumed their daily routine after discharge. Use of oral NSAIDs for the management of postoperative pain was limited only to 1 or 2 days after the procedure.

Successful healing was achieved in 280 (93.33%) cases. The overall mean duration of ksharasutra application (from the day of the operation until the laying open of proximal track) was 8.11 ± 3.86 weeks (95% confidence interval [CI]: 7.67–8.55 weeks), ranging a mean of 6.63 to 9.3 weeks for intersphincteric fistulas and of 7.55 to 9.87 weeks for transsphincteric fistulas (►Table 1). The duration of therapy showed a statistically significant relationship with types of fistula (p < 0.001; Kruskal-Wallis test) as well as with the presence of supralevator extension (p < 0.01; Pearson chi-squared test). After complete laying open of the proximal track by ksharasutra application, the resulting wound healed completely within 6 to 8 weeks.

Table 1
Success rate after the interception of fistula track with application of ksharasutra technique and mean duration of therapy (ksharasutra application) with reference to the type of fistula

Type of fistula		No. of cases			Duration of therapy (weeks) (mean ± SD)
		Total	Cured	Failed to heal
Intersphincteric	With unilateral high blind track	63	61	2	6.63 ± 3.48
	With contralateral intersphincteric extension	10	10	0	9.3 ± 3.06
Trans-sphincteric	High trans-sphincteric with no secondary extension	92	90	2	7.55 ± 3.88
	With unilateral intersphincteric extension	60	54	6	8.77 ± 3.51
	With bilateral intersphincteric extension	24	19	5	9.87 ± 5.16
	With unilateral ischiorectal extension	32	30	2	8.78 ± 3.26
	With bilateral ischiorectal extension	19	16	3	9.63 ± 3.74
Total		300	280	20	8.11 ± 3.86
p-value		<0.05*			<0.001#

• Abbreviation: SD, standard deviation.
• ^*
  Pearson chi-squared test.
• ^#
  Kruskal-Wallis Ttest.

All patients were followed-up for 1 year after healing of the wound, 79 of which underwent post-therapy anal manometry, and the results showed a reduction of 11.81 mmHg in median resting pressure (pretherapy: 79.35 ± 15.97; post-therapy: 67.54 ± 14.50) and 23.54 mmHg in squeeze pressure (pretherapy: 158.42 ± 36.83; post-therapy: 134.87 ± 37.28). Although the difference was statistically significant (p < 0.001), the subjective assessment done with the Wexner Incontinence Scoring system¹⁴ showed only a mild impairment of flatus continence in 11 (3.67%) cases, with a score increment from 0 to 1 in 7 of the primary fistula cases and of 1 to 2 in 4 of the recurrent fistula cases. Two of these recurrent cases also developed rare incontinence to liquid stool (score 1) after IFTAK therapy.

The remaining 20 cases did not respond to this method of treatment and continued to discharge pus through the external opening. They were subsequently treated by conventional ksharasutra therapy. Two of these were inter-sphincteric fistulas with high blind track reaching up to the supralevator area. The rest consisted of trans-sphincteric cases, of which 2 were high trans-sphincteric cases with no secondary extension, 11 had intersphincteric extensions (6 unilateral and 5 bilateral), while 5 had ischiorectal extensions (2 unilateral and 3 bilateral) (►Table 1). Two of the trans-sphincteric fistulas with bilateral intersphincteric extensions also had supralevator involvement. The chi-squared analysis revealed that treatment failure was independent of factors such as gender of the patient (p = 0.5), history of previous surgery (p = 0.12), and blind (p = 0.16) or horseshoe nature of the track (p = 0.4), but showed statistically significant relationships with the age of the patient (p < 0.05), the type of fistula (p < 0.05), and the presence of supralevator extension (p < 0.05).

Discussion

Fistula-in-ano is considered a troublesome and difficult-to-treat disease since ancient times.¹⁵ Recurrence and incontinence have been a common phenomenon associated specially with complex fistulas since the cure and the continence come at the cost of each other, similar to what happens with fistulotomy; although the recurrence rate has been reported as being low (4 to 7%) in some studies, high rates of postoperative incontinence (27 to 82%) suggest its limitation in complex cases.¹⁶, ¹⁷, ¹⁸ Outcomes of fistulectomy and even of cutting seton have also not been satisfactory in terms of incontinence rates, reaching upt o 25% for the former¹⁹ and 67% for the latter.²⁰ Therefore, the sphincter-sparing techniques emerged but had one or more significant limitations. For example, the advancement flap repair of fistulas has an average success rate of 80.8%, with a 13.3% incontinence rate, but graft failure, wound dehiscence, ectropion etc. are some of the important complications associated with this technique in addition to the high technical expertise it demands.⁶ On the other hand, use of fibrin sealants or fistula plugs are simple and easy to perform options but reports of very low success rates (9 and 14% for fibrin glue,²¹,²² and 13.9 and 24% for fistula plugs)²³,²⁴ make these an ineffective choice, only to be recommended for cases in which other options are not feasible.⁴ High extrusion rates and cost have been additional issues related with the use of fistula plugs.²⁵ The LIFT technique is another popular example in this list that has shown a quite good success rate (between 94.1 and 94.4%) in some studies²⁶,²⁷ but has been deemed successful mostly in uncomplicated intersphincteric and trans-sphincteric cases as the chances of failure increase in the presence of associated abscesses or multiple tracks.⁴ In case of VAAFT and laser closure of fistulas, the overall estimated success rates have been moderate so far (76.0 and 67.3%, respectively) and their efficacy in cases of complex fistula-in-ano is yet to be established.⁹,²⁸

Conventional ksharasutra therapy has shown high success rates ranging from 94.1 to 100% in single-center prospective studies to 96% in multicenter randomized controlled trials involving both low and high types of fistulas with no or minor incontinence.²⁹, ³⁰, ³¹ The therapy is a daycare procedure and the patients remain ambulatory during treatment.¹²,³⁰

Dutta et al. found ksharasutra therapy to be more cost-effective than fistulotomy as the hospital stay was shorter in the ksharasutra group and around three-fourths of the subjects remained ambulatory and resumed their work the day after the procedure.³² However, the conventional method hassome disadvantagesin complex cases, like big scars, as it involves laying open the whole track,¹³ prolonged treatment duration,¹³,²⁹ and multiple hospital visits for change of ksharasutra, which may be painful at times.³⁰,³³ The long duration of the treatment and multiple visits also increase the overall financial burden on the patient.

Interception of fistula track with application of ksharasutra is a minimally-invasive technique, the rationale of which is based on the concept of eradicating the primary source of cryptoglandular infection (the infected anal crypt) by the application of ksharasutra and rerouting the fistula track and its extensions at the site of interception. A persistent drainage of the extensions or cavities located in various anatomical spaces such as intersphincteric, ischiorectal, or supralevator isprovided through the newly-createdwindow, which is further facilitated by the application of ksharasutra. Ksharasutra,in addition toeradicating the infected crypt and facilitating drainage, gradually lays open the proximal track while the distal track heals spontaneously, being cut off from the primary source of infection, which may be demonstrated by transrectal ultrasonography (►Fig. 3) as well as by histopathological examination (►Fig. 4). In a study comparing LIFT with LIFT plus partial coring-out fistulectomy of the distal track, the authors found no significant difference between healing rates in both groups and, therefore, concluded that the excision of the distal fistulous track provided no additional increase in the success rate.³⁴

Fig.3
Changes in the fistulous track after IFTAK therapy by 3D-TRUS; (a) Preoperative image showing a hypoechoic area around the posterior 2/3^rd of the anal canal suggestive of a horseshoe-type trans-sphincteric fistula with bilateral intersphincteric involvement, postanal, and the left ischiorectal spaces; and (b) Postoperative image of the same patient 7 months after the completion of IFTAK therapy showing the mixed echogenicity suggestive of healed fistulous track with obliteration of the cavities.

Fig.4
Changes in the fistulous track after IFTAK therapy by histopathological examination; (a) Intraoperative biopsy of the fistulous track showing the diffuse infiltration of chronic inflammatory cells with fibroblastic proliferation suggestive of active fistulous track; (b) Subsequent biopsy of the remaining (distal) track taken after 3 weeks showing the hyalinized scar tissue suggestive of healing of fistulous track (Hematoxylin and Eosin staining; magnification: 40x).

Ksharasutra applied in the proximal track also has other merits. In an earlier study, Srivastava et al. showed that drugs coated with ksharasutra help healing the fistulous track by debriding the unhealthy granulation tissue, and reducing the inflammatory components, early fibroblastic proliferation, proper collagen laying, and vascular proliferation in the wound.¹¹ Moreover, the alkaline nature of the drugs coated with ksharasutra that are released in the fistulous track change the local environment toward alkaline and render it unfavorable to microbial growth. Thus, in addition to gradual cutting of the track, a simultaneous healing of the wound also takes place. Therefore, the damage to the sphincter is minimal and the chances of incontinence become practically lower.

The techniqueisalso equally effective in cases of recurrent fistula-in-ano that, otherwise, pose a problem while being treated with other techniques due to more fibrosis and difficulty in the identification of the track.³⁵ It is an ambulatory daycare procedure unlike operative techniques such as endorectal flaps, core out fistulectomy etc., which may require hospital stay extending up to a week or more.³⁶,³⁷

The patients can continue their daily routine during the treatment period. Due to minimal intervention, there is less postoperative pain, which is manageable with NSAIDs only. The requirement of postoperative antibiotics is limited only in few cases to manage secondary infection. Being a daycare procedure performed under local anesthesia, the cost of treatment is also lower.

A total of 6.67% of the cases in our study did not respond to the treatment; the possible cause for this was observed to be inadequate drainage of the blind pockets or ramifications of the track in higher or deeper planes. This inadequate drainage may occur due to the inverted bottleneck phenomenon that is further augmented by the muscle tone of the sphincter, which tend to narrow the site of interception. The other possible reason was inaccurate identification of the involved infected crypt or inappropriate interception of the track.

Conclusion

The primary cause of fistula-in-ano is the infection of anal glands or crypts from where the sepsis extends around the anal canal into the perianal area that, at times, may extend into the deeper planes and distant regions (scrotal, gluteal, thigh etc.) by traversing through the previously healthy structures and making the disease complex. The aim of fistula treatment should primarily focus on the eradication of this root-cause, that is, the cryptoglandular infection rather than laying open or excising the entire fistulous track. The IFTAK technique addresses this issue by eradicating the cryptoglandular infection with the application of ksharasutra while the distal part of the fistulous track is left to heal as such without cutting or laying open the innocent tissues through which it travels. Even multiple tracks or branches of a fistula can be dealt effectively through a single, small incision. Hence, there is a need to reconsider the laying open or coring out of the entire fistulous track in the management of fistula-in-ano, which seems to be unnecessary.

Acknowledgments

The authors would like to thank Prof. Mohan Kumar, Former Head, Department of Pathology, Institute of Medical Sciences, Banaras Hindu University, Varanasi -221005 (U.P.), India, for his help in the histopathological examination of the biopsy tissue from fistulous tracks and Dr. KKVS Peshala, Research Scholar, Department of Shalya Tantra, Faculty of Ayurveda, IMS, BHU, Varanasi, India, for the help in Anal Manometry analysis.

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Publication Dates

• Publication in this collection
  07 Apr 2023
• Date of issue
  Oct-Dec 2022

History

• Received
  18 Apr 2022
• Accepted
  01 Aug 2022