Comparative Outcomes of Standard Laser Fistula Closure (FiLaC) versus FiLaC Combined with Advancement Flap in the Treatment of Complex Anal Fistulas

doi:10.21203/rs.3.rs-4722390/v1

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Comparative Outcomes of Standard Laser Fistula Closure (FiLaC) versus FiLaC Combined with Advancement Flap in the Treatment of Complex Anal Fistulas

https://doi.org/10.21203/rs.3.rs-4722390/v1

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Aim: This study aims to compare the clinical outcomes of patients treated for complex anal fistulas using standard laser fistula closure (FiLaC) versus FiLaC combined with an advancement flap (+FLAP).

Methods: A retrospective review was conducted on patients treated for complex anal fistulas between January 2022 and December 2023. Treatments included standard FiLaC and FiLaC combined with an advancement flap. Main outcome measures included operation duration, hospital stay, postoperative pain (VAS score), complications, and success rate

Results: A total of 47 patients were included in the study, with 25 in the standard FiLaC group and 22 in the +FLAP group. The +FLAP group had significantly longer operation times (29.7 ± 4.7 minutes vs. 18.7 ± 4.0 minutes, p < 0.001) and hospital stays (16.2 ± 5.04 hours vs. 3.9 ± 2.3 hours p < 0.001). Postoperative pain scores were similar between groups. The mean follow-up periods for the FILAC and +FLAP groups were 10.5±3.5 months and 8.4±4.0 months, respectively. The success rate was significantly higher in the +FLAP group (95.5% vs. 72%, p = 0.03).

Conclusion: Combining FiLaC with an advancement flap significantly improves primary success rates in the treatment of complex anal fistulas, despite longer operation and hospital stay times. This combined approach should be considered to enhance clinical outcomes for patients with complex anal fistulas.

Complex Anal Fistula

Laser Fistula Closure

FiLaC

Advancement Flap

Complex anal fistulas represent a significant clinical challenge due to their intricate anatomy and propensity for recurrence. These fistulas often involve multiple tracts and deep extensions, making treatment difficult and outcomes variable. Traditional surgical methods, such as fistulotomy or seton placement, while effective, are associated with significant morbidity and potential complications, including fecal incontinence and prolonged healing times. As a result, there is a continuous search for effective, minimally invasive techniques that offer high success rates with fewer complications (1).

The Fistula-tract Laser Closure (FiLaC) procedure has gained attention as a minimally invasive treatment for anal fistulas. This technique involves the use of a radial laser probe to ablate the fistula tract from the inside, promoting healing while preserving the sphincter muscles and reducing the risk of incontinence. Despite its advantages, the success rate of FiLaC varies, and recurrence remains an issue for some patients (2–7)

To address this, the combination of FiLaC with other techniques, such as the advancement flap, has been explored. The advancement flap involves covering the internal opening of the fistula with a flap of rectal mucosa or skin, which can enhance healing and reduce recurrence rates. This study aims to compare the clinical outcomes of patients treated with standard FiLaC versus those treated with FiLaC combined with an advancement flap, evaluating parameters such as operation duration, hospital stay, postoperative pain, complications and success rates.

Study Design and Population

This retrospective study included patients treated for complex anal fistula at our clinic between January 2022 and December 2023. Inclusion criteria were patients diagnosed with complex anal fistula and treated with either standard FiLaC or FiLaC combined with an advancement flap (+ FLAP group). Patients previously treated with different methods, those with intersphincteric, or low transsphincteric fistula tracts, those with incomplete data or a follow-up period of less than 3 months were excluded.

Institutional ethics committee approved the study design (108 − 24). Since the study was retrospective, no additional intervention was performed other than routine patient care. Informed consent is not applicable because information is anonymized and the submission does not include images that may identify the person.

Treatment Protocols

All patients received at least three months of seton placement prior to laser ablation treatment. In the standard FiLaC procedure, laser energy was applied to the fistula tract (SWING 15®, diode laser 15 W, 1470 nm), and the internal opening was primarily closed with absorbable sutures. In the + FLAP group, the internal opening was closed using a mucosal advancement flap. In our clinic, we prefer U-shaped partial thickness flaps. Our suture preference is intermittent absorbable sutures for flap re-approximation.

Outcomes and Definitions

Patients were followed postoperatively, primary healing defined as the cessation of discharge by the end of the second month. Continuous discharge indicated treatment failure, and during follow-up, recurrent discharge from the same tract indicated recurrence. If no recurrence developed after at least 3 months of follow-up after primary healing, the treatment of the patients was considered successful.

Patient Demographics

A total of 78 patients underwent anal fistula treatment during the study period at our clinic, with 47 meeting the inclusion criteria. Among these, 41 patients (87.2%) were male, and the mean age was 40.4 ± 11.8 years. The standard FiLaC group included 25 patients, while the + FLAP group included 22 patients. There were no statistically significant differences in demographics, fistula types and tract multiplicity between the two groups (Table 1).

Table 1

Comparative Analysis of Clinical Outcomes between Standard FiLaC and FILAC + Advancement Flap
Parameters	FiLaC (n = 25)	+FLAP (n = 22)	P VALUE
Age (years ± SD)	39.4 ± 11.4	41.6 ± 12.4	0.52
Gender (M/F)	21/4	20/2	0.48
Fistula Type (TS/S-ES)	24/8^*	20/7^*	0.9
Tract Number (Single/Multipl)	17/8	13/9	0.55
Operation Duration (minutes)	18.7 ± 4.0	29.7 ± 4.7	< 0.001
Hospital Stay (hours)	16.2 ± 5.04	3.9 ± 2.3 hours	< 0.001
Complications (Clavien-Dindo grade 2 or higher)	0	0	1
VAS Score	2.1 ± 1.2	2.6 ± 1.4	0.23
Success (n,%)	18(72%)	21(95.4%)	0.03
Follow-up (months ± SD)	10.5 ± 3.5	8.4 ± 4.0	0.6
^* Total numbers are higher than the number of patients due to multiple tracts
Abbreviations: TS: Transsphincteric ; S-ES: Supra-Extrasphincteric ; VAS: Visual Analog Scale

Operative and Postoperative Outcomes

The + FLAP group had a significantly longer operation duration (29.7 ± 4.7 minutes vs. 18.7 ± 4.0 minutes, p < 0.001) and hospital stay (16.2 ± 5.04 hours vs. 3.9 ± 2.3 hours p < 0.001). Postoperative pain, measured using the Visual Analog Scale (VAS), was similar between the groups (2.6 ± 1.4 vs 2.1 ± 1.2, p = 0.23). None of the patients experienced complications of Clavien-Dindo Classification grade 2 or higher in both groups. The mean follow-up periods for the FILAC and + FLAP groups were 10.5 ± 3.5 months and 8.4 ± 4.0 months, respectively. The success rate was significantly higher in the + FLAP group (95.5% vs. 72%, p = 0.03).

The treatment of complex anal fistulas remains a formidable challenge in colorectal surgery. In 2011, Wilhelm reported on the use of a novel diode laser source and a radial emitting laser probe to obliterate the fistula tract from within. This method, inspired by varicose vein laser treatment, follows the same principle of limiting penetration and uniformly distributing photothermal energy to ensure uniformity. The objective is to effectively close the fistula tract by delivering controlled thermal energy along its entire length. The goal is to destroy the granulation tissue and epithelial cells by combining coagulation with shrinkage of the tract. The thermal energy disrupts proteins within the tissue, aiding in the sealing process. Moreover, the laser's higher precision, compared to electrocautery, is thought to lower the risk of damaging nearby structures, such as the anal sphincters (2).

FiLaC has now been reported in over 600 patients and its feasibility and safety have been demonstrated in these studies. Some of the success rates reported in FiLaC studies are comparable to those of other sphincter-sparing techniques. The efficacy from the literature is somewhat variable, ranging from 20–89% rates of fistula healing. Recent systematic reviews indicate pooled healing rates of around 70% for the LIFT procedure in nearly 500 patients with perianal fistula (8, 9). For advancement flaps, a pooled success rate of about 75% has been reported in analyses of close to 800 patients (10).

There were notable differences among the reported FiLaC studies, particularly with the inclusion of internal opening closure (by simple suturing or advancement flap) in some cohorts (11–14). This combination has been questioned in previous literature, suggesting that using two treatment strategies limits the ability to evaluate the impact of FiLaC alone on treatment outcomes. Additionally, some studies reporting on FiLaC without the internal opening have shown better outcomes (15–16).

This study sought to evaluate whether the addition of an advancement flap to the FiLaC procedure could improve clinical outcomes for patients with complex anal fistulas. The results indicate that while the combination approach leads to longer operation and hospital stay durations, it significantly enhances the primary success rate compared to the standard FiLaC procedure.

The longer operative time observed in the + FLAP group is expected due to the additional steps required for flap creation and placement. While this increases the complexity of the procedure, the significant improvement in primary success rates suggests that the benefits outweigh the additional time. Specifically, the + FLAP group had a primary success rate of 95.5%, compared to 72% in the standard FiLaC group. This finding underscores the effectiveness of the advancement flap in reducing recurrence rates and promoting complete healing.

The longer hospital stay associated with the + FLAP group compared to the standard group is another important consideration. While the increase in hospital stay is statistically significant, it remains relatively short and may be considered acceptable given the improved clinical outcomes. The extended stay allows for closer postoperative monitoring and management of any immediate complications, potentially contributing to the higher success rates observed.

Postoperative pain, as measured by the Visual Analog Scale (VAS), was similar between the two groups. This suggests that the addition of the advancement flap does not significantly increase postoperative discomfort, despite the more complex procedure. Effective pain management protocols and the minimally invasive nature of FiLaC likely contribute to this outcome. These findings are important for patient satisfaction and recovery, indicating that the combined approach does not adversely affect the patient's postoperative experience.

Comparison with Existing Literature

The success rates observed in this study align with existing literature on FiLaC and advancement flap techniques. Previous studies have demonstrated that FiLaC is a viable option for treating complex anal fistulas, with success rates varying based on the complexity of the fistula and the surgeon's experience. The addition of the advancement flap has been shown in other studies to improve outcomes, particularly in cases of high or complex fistulas where traditional methods may fail or result in high recurrence rates.

Clinical Implications

The findings of this study have several important clinical implications. First, they suggest that combining FiLaC with an advancement flap should be considered for patients with complex anal fistulas to achieve higher primary success rates. Second, the longer operation and hospital stay times associated with the combined approach are justified by the significantly improved outcomes. Lastly, the similar postoperative pain levels between the two groups highlight the feasibility of the combined approach without increasing patient discomfort.

Limitations

Despite the positive findings, this study has several limitations. The retrospective design and relatively small sample size may limit the generalizability of the results. Additionally, long-term follow-up data are needed to assess the durability of the treatment outcomes and the potential for late recurrences. Future research should include larger, multicenter prospective studies with extended follow-up periods to confirm these findings and provide a more comprehensive evaluation of the combined FiLaC and advancement flap approach.

In conclusion, FiLaC is an effective minimally invasive treatment for complex anal fistulas, offering good outcomes in selected patients. This study demonstrates that combining FiLaC with an advancement flap significantly improves primary success rates, making it a valuable option for enhancing treatment outcomes in complex cases. The increased operation and hospital stay durations are balanced by the higher success rates, suggesting that the combined approach is a viable and advantageous treatment strategy for complex anal fistulas.

Author Contributions:

a. Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data: M.K, H.U, Y.B.K

b. Drafting the article or revising it critically for important intellectual content: M.K, Y.B.K

c. Final approval of the version to be published: M.E, L.K

Competing interests

The authors declare no competing interests.

Conflict of interest

The authors declare that they did not receive any financial and non-financial interest.

Ethical approval

Institutional ethics committee approved the study design (108-24). Since the study was retrospective, no additional intervention was performed other than routine patient care.

Human ethics and consent to participate declaration

Not applicable.

Data Availability

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. Due to privacy and ethical concerns, the data cannot be made publicly available. However, anonymized data that support the findings of this study can be provided by the authors upon reasonable request .

Adegbola, S. O., Sahnan, K., Pellino, G., et al. (2017). Short-term efficacy and safety of three novel sphincter-sparing techniques for anal fistulae: a systematic review. Techniques in Coloproctology, 21(10), 775–782. https://doi.org/10.1007/s10151-017-1699-4
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De Hous, N., de Gheldere, C., Van den Broeck, S., & Komen, N. (2019). FiLaCTM as a last, sphincter-preserving resort for complex perianal fistula. Techniques in Coloproctology, 23(9), 937–938. https://doi.org/10.1007/s10151-019-02070-2
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Adegbola, S. O., Sahnan, K., Tozer, P., & Warusavitarne, J. (2021). Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clinical and Experimental Gastroenterology, 14, 467-475. https://doi.org/10.2147/CEG.S269464
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No competing interests reported.

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You are reading this latest preprint version

Comparative Outcomes of Standard Laser Fistula Closure (FiLaC) versus FiLaC Combined with Advancement Flap in the Treatment of Complex Anal Fistulas

Status:

Version 1

Abstract

Introduction

Methods

Study Design and Population

Treatment Protocols

Outcomes and Definitions

Results

Patient Demographics

Operative and Postoperative Outcomes

Discussion

Comparison with Existing Literature

Clinical Implications

Limitations

Conclusion

Declarations

Data Availability

References

Additional Declarations

Status:

Version 1