|Year : 2021 | Volume
| Issue : 3 | Page : 61-67
A prospective, noncomparative, study to evaluate the efficacy and safety of sphincter saving distal laser proximal ligation surgery in complex fistula-in-ano
Ashwin Porwal, Paresh Gandhi, Deepak Kulkarni
Colorectal Surgeon and Founder, Healing Hands Clinic, Pune, Maharashtra, India
|Date of Submission||11-Oct-2020|
|Date of Decision||10-Nov-2020|
|Date of Acceptance||06-Dec-2020|
|Date of Web Publication||24-May-2022|
Healing Hands Clinic, 105, Mangalmurti Complex, Near Hirabaug, Tilak Road, Pune - 411 002, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Distal laser proximal ligation technique (DLPL) is a minimally invasive sphincter-saving surgery which addresses the inter sphincteric space, which is the root cause of complex fistula. Objective: To evaluate efficacy and safety outcomes of new technique. Design: A prospective, noncomparative. Settings: A single-center study. Patients: Complex fistula-in-ano cases were included. Patients with uncomplicated fistula, inflammatory bowel disease, Chronic immunosuppressive treatment, and cancer were excluded. Interventions: Laser debridement of fistula tract by use of Radial Fiber with 1470 nm Diode laser at a power of 10W and proximal Ligation technique. Outcome Measures: Data were collected prospectively on effectiveness (disease severity, ODSscore, hospitalization, time to resume routine), safety (morbidity, adverse outcomes), Wexner incontinence score and quality of life score before surgery and after surgery at week 6, at 6 months and 12 months physically and thereafter telephonically for 2 years. Outcomes other than overall complete healing were considered as failure. Results: 683 patients underwent DLPL, predominantly male with a median age of 41.06 years (range, 11-86y). The overall success rate was 98.98%with a minimum long term follow-up period of 30 months. Complete healing time was average 10 weeks for most of the cases. No case reported permanent(major or minor) anal incontinence.The difference between quality of lifescore wasstatistically highly significant (p<0.001). Limitations: Single-institution and noncomparative data. Conclusion: DLPL is a minimally invasive, sphincter saving surgery for complex fistula.
Keywords: Complex fistula-in-ano, distal laser proximal ligation, intersphincteric space, laser, minimally invasive, quality of life, recurrence rate, sphinctersaving
|How to cite this article:|
Porwal A, Gandhi P, Kulkarni D. A prospective, noncomparative, study to evaluate the efficacy and safety of sphincter saving distal laser proximal ligation surgery in complex fistula-in-ano. Indian J Colo-Rectal Surg 2021;4:61-7
|How to cite this URL:|
Porwal A, Gandhi P, Kulkarni D. A prospective, noncomparative, study to evaluate the efficacy and safety of sphincter saving distal laser proximal ligation surgery in complex fistula-in-ano. Indian J Colo-Rectal Surg [serial online] 2021 [cited 2023 Jan 30];4:61-7. Available from: https://www.ijcrsonweb.org/text.asp?2021/4/3/61/345918
| Introduction|| |
Fistula-in-ano is one of the commonly encountered surgical problems with the prevalence of 1.2–2.8/10,000. Park's classification of the fistula is based on the location of the tract in relation to anal sphincter muscle: Inter-sphincteric, trans-sphincteric, supra-sphincteric, or extrasphincteric. Complex anal fistulae can be defined as those with tracks extending above the level of the dentate line (mid-anal canal), multiple tracks, ano-vaginal fistulae, and fistulae associated with Crohn's disease. With the modifications in Park's classification, the complex fistula is one when with multiple tracks ortrack/s cross/es more than 30%–50% of the external sphincter, recurrent or with incontinence., The surgical management of complex fistula carries a greater risk of incontinence, due to the involvement of the anal sphincters.,
There are many surgeries performed for complex anal fistulas, but their success rates are variable. With the recent advances in the surgical field, many sphincter-saving techniques with minimal sphincter injury like Transanal Advancement Flap Repair (TAFR), Ligation Of The Intersphincteric Fistula Tract (LIFT), Video-Assisted Anal Fistula Treatment (VAAFT), laser-FiLaC and the OTSC proctology procedure have been introduced. With TAFR, the recurrence rates range from 7% to 49%.,, LIFT is another widely recognized sphincter-saving technique with a success rate of approximately 81.4%. With VAAFT success rate reported ranges from 84.6% to 87.1. There is no single technique which can be called as gold standard in managing complex fistula-in-ano. The surgery with good postoperative healing, with minimal or no functional loss, less recurrence is need of the hour. Hence, the present study was conducted to evaluate the efficacy of a novel technique, DLPL surgery, in the treatment of complex fistula-in-ano.
| Methodology|| |
A Prospective, Open-label, noncomparative study, single-center study was planned. A detailed protocol was submitted to the ethical committee, and ethical clearance was obtained. Patients attending/visiting the study center between January 2013 and December 2017 with any types of complex fistula were screened by the Colorectal Surgeon for eligibility in the study using the inclusion and exclusion criteria.
- Patients with all type of complex fistula, including
- Fistula-in-ano with multiple tracts
- Long tracts (any tract length >10 cm) fistulas
- Fistula-in-ano with abscess/pus
- Anterior fistula in females
- Horseshoe type
- Fistula with supra levator blind extension (not with high rectal opening)
- Fistula-in-ano with an internal opening which cannot be localized
- Participants willing to sign informed consent.
- Uncomplicated fistula curable by simple fistulotomy.
- Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months
- Estimated life expectancy inferior to 6 months
- Incompetent subject
- Any clinical condition, according to the investigator which does not allow safe fulfillment of the study protocol.
All study subjects were examined by the colorectal surgeon in the outpatient clinic. After signing the informed consent, detailed history was taken using pretested semi-structured pro forma, digital rectal examination, physical examination, and video proctoscopy. All of the patients underwent preoperative methylene blue dye test just before surgery under anesthesia. Park's classification was used for describing the anal fistulas type according to the methylene blue dye test. All patients were operated by single surgeon, under spinal anesthesia. Histopathology was done in all operated patients.
To assess the Quality of Life, the WHOQOL-BREF questionnaire was used. The assessment of all patients was done twice, i.e., before surgery and at the time of the second follow-up i.e., 8th week postoperatively. Literate subjects completed the pro forma by themselves after receiving the required instructions, while face-to-face interview was conducted to get information from illiterate patients. A five-point Likert scale was used to rate all the four domains of WHOQOL-BREF viz. physical health, psychological, social, and environmental. The raw scores for all the domains of the WHOQOL-BREF questionnaire were calculated as per the WHO manual by adding values of each domain and transformed to the scale from 0 to 100. The mean WHOQOL-BREF score for each domain was calculated and compared.
Primary efficacy outcome
- The time to heal anal fistula
- Comparing visual analog scale (VAS) proctologic pain score (at day 0, 7, 15, 30, 60, 90)
- The anal incontinence score (by using Wexner Faecal Incontinence)
- Baseline score of defecography and at the end of the study
- Length of hospital stay and time to return to the working activities
- Anal fistula recurrence rate.
Secondary efficacy outcome
- Improvement in quality of life assessed on WHO QOL-BREF (Overall perception ofQuality of Life, Physical, Psychological, Social and Environmental DomainOverall perception of health,
- Treatment satisfaction assessed on 5 point Likert scale (at day1,1 week, 8 week, and 12 months)
Safety assessment was based on the number of adverse events and complications (The Adverse events, either spontaneously reported by the patient or noticed by the surgeon recorded during the study period.)
Distal laser proximal ligation
A novel technique innovated by the author for complex/recurrent fistula [Figure 1]:
Step 1: The internal opening was identified by per rectal examination. By palpating the tract, the external opening was identified.
Step 2: The internal opening was approached by making a superficial incision over anal skin. A bare tip laser fiber was inserted in the internal opening (up to 1 cm or less) and around 50–70 Joules of energy was delivered.
For the Intersphincteric fistula without external opening, the Intersphincteric abscess was identified, and debridement of the Intersphincteric abscess wall was done by use of 1470 nm Bare tip fiber, around 100–150 Jules energy was delivered.
Step 3: The fistula tract was flushed with normal saline to identify the exact location of fistula opening within the sphincter muscle.
Step 4: Thorough scooping of the fistula tract was done to achieve good debridement and flushed it with saline.
Step 5: Laser debridement of fistula tract by use of Radial Fiber with 1470 nm Diode laser at power of 10W. Deliver 100 Joules of energy in continuous mode starting from the internal opening or the sphincter muscles and moving out toward external opening.
Step 6: The external opening was widened for good drainage.
Step 7: Single stitch TransAnal Closure of internal opening within the sphincter muscles was done with Uroneedle in cases where the internal opening was wide. Suturing was not done where the Internal Opening was narrow like a hairpin or in cases of Intersphincteric fistulas without external opening.
Step 8: Hemostasis achieved, and both the wounds were kept open for drainage.
Postoperative and follow-up
First follow-up was done on the 5th day. The tract was palpated to drain the serous collection within the tract through the external opening. The exposed Internal opening was flushed with betadine. Bimanual palpation over the anus was done to identify the collection, especially in Intersphincteric fistula cases.
During the second follow-up after 2 weeks, the same steps were followed. Intersphincteric space and fistula tract was examined for any collection. If any was drained at OPD under local anesthesia
At 4 weeks follow-up: The external opening wound was observed and kept open to prevent collection. At 8 weeks follow up, healing of the wound was observed. At 3 months, follow-up was done to ensure the healing was smooth and fistula had healed. Further follow-up was planned at 6 months, and thereafter every 6 months, patients were contacted and telephonic follow-up was taken for minimum 2 years. Patients were instructed to report immediately any recurrence of symptoms.
Data collected on background characteristics, preoperative baseline conditions, procedure, and postoperative period was compiled and analyzed using statistical software SPSS version 8.Wilcoxon sign rank test and paired t-test were used to compare the difference between the proportions. Value of P < 0.05 was considered a statistically significant difference.
| Results|| |
Total number of cases fulfilling inclusion criteria was 683.Out of which 87 were females (12.74%) [Table 1]. The Male to female ratio was 6.8:1. The maximum age reported was 86 yrs. in males and 62yrs. in females while youngest patient was 11yrs. [Table 1] shows number of cases in the age group 31-40 were maximum 36.31% followed by 41- 50(21.08%). Most of the patients were working in IT industry (39.82%) [Table 2]. The distribution of patients as per Park's Classification is given in [Table 3]. 37.48%cases were Suprasphincteric followed by 36.46% Inter sphincteric cases. 25.92%Transsphincteric & 18.74%were combined Transsphincteric and Intersphincteric. There was one (0.15%) case of Extra sphincteric fistula. Among the types of fistula reported there were 111 (16.25%) Horseshoe and 98 (14.35% ) with multiple external openings. 10 (1.46%) had extension up to abdominal wall. In histopathology report none was with tuberculosis or crohn's disease.82 patients had history of injection sclerotherapy for haemorrhoids in past. Mean time required for surgery was 90.1min (SD 16 min) with Range 40 – 180 min. Mean duration of hospitalization was24Hr (SD= 3.2) Range= 12-48 Hr. Mean Time to return normal activities was5.4 Day; (SD=0.8Day; Range =4- 8 Day) [Table 4].
During the follow-up period, 560 (81.99%) cases showed complete healing at 10 weeks post-operatively. 84 (12.30%) cases took 13 weeks & 39 (5.71%) cases took 17 weeks for complete healing. There was statistically significant(p<0.001) improvement seen in VAS pain score [Table 5]. Between 3-5 weeks follow up about 22 (3.22%) cases were examined under anesthesia for widening the internal opening and supralevator collection was drained. Recurrence was observed in 7 (1.02%) cases, 3 at 4months , 2 at 6months and 1at 1-year post operatively and 1 was lost to follow up [Table 6]. Complete healing without recurrence at one year follow up was reported in 676 (98.98%) of cases.
Total 662 participant completed the QOL-BREF Questionnaire, 79 females and 583 males. All the domains of Quality of life were seen to be improved significantly after surgery [Figure 2]. As shown in figure, compared with preoperative baseline data (mean, 45.16 -49.26), statistically significant (p<0.001) improvement in QOL- score was found after surgery (mean 69.54 - 74.33) [Table 7].
| Discussion|| |
The condition, complex fistula in ano, has been known since ages and different management techniques have been suggested in literature. Although many attempts have been made over the decades to treat complex anal fistula, it continues to be one of the most challenging clinical problems in anorectal surgery.
Surgical management of complex fistula is usually aimed at the permanent elimination of suppurative process by drainage of sepsis and removal of fistula tracts while maintaining sphincter integrity. The recent surgical techniques have shown promising results as compared to traditional methods in management of the complex fistula in ano. Success rate of these techniques is more than 95% but recurrence and incontinence still remain difficult areas.
Most of the current treatments for complex anal fistula are based on three main principles; correct identification of the fistula tracts and internal opening, complete destruction of the tracts, and preservation of anal sphincter function., However, some studies have shown that the real key to fistula healing lies in the sealed closure of the internal opening coupled with adequate drainage of the fistula tract., Procedures involving trans anal closure of the Internal Opening like VAAFT &FILac ,LIFT have shown varied success rates .Recurrence rate with these procedures was higher with complex fistulas . Study conducted by Malakorn et al stated that Lift has higher a failure rate (19%) with more complex fistula. A considerable difference in the efficacy of the VAAFT in managing simple fistula (73.3% ) and complex fistulas ( 39.47%) has been reported in the study conducted by Michal Romaniszyn and Piotr Walega.
Dönmez and Hatipoğlu study17 stated that Anal Fistula Treatment with FiLaCTMshowed high success rate in low transsphincteric and semi horseshoe fistulas, but a low success rate in high transsphincteric and horseshoe fistulas.
As per the crypto-glandular hypothesis, the infection of inter-sphinteric gland usually initiate the formation of fistulas., The sepsis arising within these glands can spread into the inter-sphincteric space and also towards the different anorectal planes causing abscesses and fistulae., Basically this inter-sphincteric space is the focus of infection .It needs to be addressed for complete healing of fistula without recurrence. DLPL is based on the principle of exploration of Intersphincteric space.
DLPL is a minimally invasive sphincter saving surgery based on two principals i) deep and effective debridement by laser and ii) efficient drainage from fistula . It addresses the intersphincteric space and supralevator space which is the root cause of complex fistula. The space is thoroughly debrided with laser. At times, the internal opening is kept open for drainage after debridement if the complex fistula is associated with abscess. Since the Intersphincteric space is explored, fistula branches can be dealt with radial laser fiber without damaging sphincter muscles. Inefficient debridement is the major cause of recurrence in fistula, use of flexible laser fiber makes it more effective. A wavelength of 1470 nm considered to be effective at creating shrinkage and denaturation and to have the optimal absorption curve in water. Eventually the surgical trauma caused is low and the hyper thermic effect is considered minimal and reversible., Efficient drainage is achieved by widening the external opening. First follow up is advised on 5th day and 2nd follow up on the 10th day. The wound is cleaned with eusol solution. Bimanual palpation is done to squeeze the fluid it and to rule out collection within the fistula wound. In our study 81.99% (560) cases showed complete healing at 10 weeks. In22 (3.22%) cases, Evaluation Under Anaesthesia(EUA) was planned between 3-5 weeks. During EUA, the internal opening was widened and the supralevator collection was drained.
In present study, 37.48% (256) cases were with Supralevator fistula and 16.25%(111) cases were with horseshoe shaped fistula. In our experience, Supralevator fistula cases were difficult to treat. The challenge was pre mature closure of Internal Opening. It has been observed that, it is not the internal opening which needs attention during the complex fistula surgery. It is the Intersphincteric space which is the focus of infection. VAAFT &FILac involves trans anal closure of the Internal Opening. But the Intersphincteric space is inadequately debrided or dealt with, making the recurrence rate with VAAFT and Filac higher for complex fistula. LIFT is seen effective in complex fistula with single tract or linear tract. But it could be less effective when associated with abscess or multiple branches. In our study all the cases reported with recurrence were having suprasphincteric fistula. All the recurrent cases were male.A study conducted by P. Garg24 on highly complex fistula treated with Transanal Opening ofIntersphincteric Space (TROPIS) Procedure also based on addressing the Intersphinctericspace. The study showed promising results with overall healing rate 90.4%.
In present study, mean age was 41.06 years, similar finding was reported before ,, but male to female ratio was seen to be higher than previous studies.The minimal time required for complete healing was 8 to 10 weeks as compared to 10 to 12weeks with other procedures. The mean duration of surgery was 90.1-minute, mean time required for hospitalization was 24 hours. Most of the patients were discharged next day of surgery and were highly satisfied with surgery. Average time required to resume normal activities was less than a week. Improvement in quality of life is quite significant. In our experience, the novel procedure of Distal Laser and proximal Ligation is minimally invasive, sphinctersaving and has negligible recurrence rate
| Conclusion|| |
We conclude that minimally invasive, sphincter-saving DLPL surgery is safe and effective treatment for complex fistula-in-ano. Being sphincter sparing it preserves anal continence. Effective and adequate laser debridement facilitates healing and efficient drainage of Intersphincteric space reduces chances of recurrence. We recommend that this surgery should be promoted as an option for the management of complex fistula due to its feasibility and negligible recurrence rate.
Innovations and breakthrough
DLPL is a minimally invasive, sphincter-saving surgery for complex fistula.
It addresses the Intersphincteric space, which is the root cause of complex fistula.
It is based on two principals
- Debridement: This is achieved in a minimally invasive way by the use of laser. The use of laser makes the debridement thorough and deep. It is more effective and takes care of the fibrosis associated complex fistulas. Laser fiber can be easily negotiated within the Intersphincteric space and supralevator space. Inefficient debridement is one of the causes of recurrence in the fistula
- Drainage: Efficient drainage from the fistula in the first two to 3 weeks is key to success in curing fistula after surgery. Widening of the external opening serves that purpose. Similarly, superficial incision over the internal opening helps in proper drainage in the initial 3 weeks after surgery. This is achieved by timely follow-up planned at 5 days, 2 weeks, 4 weeks, and 6 weeks.
That's the reason why DLPL is associated with a negligible recurrence rate. There is no need of daily dressing with DLPL and patients can resume work in 3–5 days.
There is no risk of incontinence as sphincter muscles are not incised.
Thus, DLPL serves the purpose in bridging the gap in the surgical management of complex fistula.
The authors would like to thank Dr. Snehal Porwal, Founder and Director, Healing Hands and Herbs, Pune and Dr. Swapna Kadam, Consultant, Healing Hands Clinical Research Services, Pune, India, for valuable guidance and encouragement. We would also like to thank all the team of healing hands research and development.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Zanotti C, Martinez-Puente C, Pascual I, Pascual M, Herreros D, García-Olmo D. An assessment of the incidence of fistula-in-ano in four countries of the European Union. Int J Colorect Dis 2007;22:1459-62.
Parks AG, Gordon PH, Hardcastle JD. A classification of fistula in ano. Br J Surg 1976;63:1-12.
Kodner IJ, Mazor A, Shemesh EI, Fry RD, Fleshman JW, Birnbaum EH: Endorectal advancement flap repair of rectovaginal and other complicated anorectal fistulas. Surgery 1993;114:682-690.
Mizrahi N, Wexner SD, Zmora O, Da Silva G, Efron J, Weiss EG, Vernava AM 3rd, Nogueras JJ. Endorectal advancement flap: Are there predictors of failure? Dis Colon Rectum 2002;45:1616-21.
Schouten WR, Zimmerman DD, Briel JW. Transanal advancement flap repair of transsphincteric fistulas. Dis Colon Rectum 1999;42:1419-22.
Rojanasakul A. LIFT procedure: A simplified technique for fistula-in-ano. Tech Coloproctol 2009;13:237-40.
Meinero P, Mori L. Video-assisted anal fistula treatment (VAAFT): A novel sphincter-saving procedure for treating complex anal fistulas. Tech Coloproctol 2011;15:417-22.
Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser-FiLaC™: An effective novel sphincter-saving procedure for complex disease. Colorectal Dis 2014;16:110-5.
Prosst RL, Joos AK, Ehni W, Bussen D, Herold A. Prospective pilot study of anorectal fistula closure with the OTSC proctology. Colorectal Dis 2015;17:81-6.
Ortíz H, Marzo J. Endorectal flap advancement repair and fistulectomy for high trans-sphincteric and suprasphincteric fistulas. Br J Surg 2000;87:1680-3.
van Onkelen RS, Gosselink MP, Schouten WR. Is it possible to improve the outcome of transanal advancement flap repair for high transsphincteric fistulas by additional ligation of the intersphincteric fistula tract? Dis Colon Rectum 2012;55:163-6.
Jiang HH, Liu HL, Li Z, Xiao YH, Li AJ, Chang Y, Zhang Y, Lv L, Lin MB. Video-assisted anal fistula treatment (VAAFT) for complex anal fistula: A preliminary evaluation in China. Med Sci Monitor 2017;23:2065-71. doi: 10.12659/msm.904055. PMID: 28456815; PMCID: PMC5421740.
Alasari S, Kim NK. Overview of anal fistula and systematic review of ligation of the intersphincteric fistula tract (LIFT). Tech Coloproctol 2014;18:13-22.
Development of the world health organization WHOQOL-BREF quality of life assessment. The WHOQOL group. Psychol Med 1998;28:551-8.
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993;36:77-97.
Bubbers EJ, Cologne KG. Management of complex anal fistulas. Clin Colon Rectal Surg 2016;29:43-9.
Dönmez T, Turgut & Hatipoğlu, Engin. Closure of fistula tract with filac™ laser as a sphincter preserving method in anal fistula treatment. Turkish J Colorect Dis 2017;27:72-7. doi-10.4274/tjcd.06025.
Wang JY, Garcia-Aguilar J, Sternberg JA, Abel ME, Varma MG. Treatment of transsphincteric anal fistulas: Are fistula plugs an acceptable alternative? Dis Colon Rectum 2009;52:692-7.
Seow-En I, Seow-Choen F, Koh PK. An experience with video-assisted anal fistula treatment (VAAFT) with new insights into the treatment of anal fistulae. Tech Coloproctol 2016;20:389-93.
Malakorn S, Sahakitrungruang C, Khomvilai S, Pattana-arun J, Rojanasakul A. The authors reply. Dis Colon Rectum 2018;61:e26-7.
Romaniszyn M, Walega P. Video-assisted anal fistula treatment: Pros and cons of this minimally invasive method for treatment of perianal fistulas. Gastroenterol Res Practice 2017;2017:9518310. doi.org/10.1155/2017/9518310.
Johnson EK, Gaw JU, Amstrong DN. Efficacy of anal fistula plug vs. fibrin glue in clousure of anorectal fistulas. Dis Col Rectum 2006;49:371-6.
Sileri P, Cadeddu F, D'Ugo S, Franceschilli L, Del Vecchio Blanco G, De Luca E, Calabrese E, Capperucci SM, Fiaschetti V, Milito G, Gaspari AL. Surgery for fistula-in-ano in a specialist colorectal unit: A critical appraisal. BMC Gastroenterol 2011;11:120. doi: 10.1186/1471-230X-11-120. PMID: 22070555; PMCID: PMC3235969.
Garg P. Transanal opening of intersphincteric space (TROPIS) -A new procedure to treat high complex anal fistula. Int J Surg 2017;40:130-4.
Al-Jasmawi HO, Al-Mhanaa AB, Al-Janabi MS. Video-assisted anal fistula treatment in the management of fistula-in-ano: A 3-year experience. Med J Babylon 2019;16:267-70. [Full text]
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]